MIDDLE EAST CUSTOMS GUIDE V3 July 2012
The Information provided is based on customs regulations and requirements as of 29th July 2012. Please note customs regulations and sanctions are fluid and may change, we will provide updated information in a timely fashion however the information communicated in this document from June 2012 onwards is to be used as a guide.
SAUDI ARABIA
SAUDI ARABIADocumentation Requirements
Saudi Arabia Gateway Details
Import Requirements
Product Labeling & Country of Origin Markings
Commercial invoice
Certificate of Origin
SASO
Authorization Letter
Customer Reference Documents
Kingdom of Saudi Arabia Websites
KUWAITDocumentation Requirements
Commercial invoice
Certificate of Origin
Certificate Of Conformity
Shipment Labeling
BAHRAINDocumentation Requirements
Commercial invoice
OMANDocumentation Requirements
Commercial invoice
QATARDocumentation Requirements
Commercial invoice
Certificate of Origin
Authorization letter
Legalization Charges – Road Shipment
Legalization Charges – Air Shipment
Additional Import Requirements
Product Labeling & Country of Origin Markings
UNITED ARAB EMIRATESDocumentation Requirements
Commercial invoice
YEMENDocumentation Requirements
Commercial invoice
Certificate of Origin
Broker Arrangements
LEBANONDocumentation Requirements
Commercial invoice
Broker Arrangements
JORDANDocumentation Requirements
Commercial invoice
Broker Arrangements
IRAQDocumentation Requirements
Oil & Gas Imports For Southern Iraq
Commercial invoice
Certificate of Origin
AFGHANISTANDocumentation Requirements
Commercial invoice
SYRIADocumentation Requirements
Commercial invoice
EGYPTDocumentation Requirements
Customs Clearance Paperwork
Special approvals for inbound shipments
Commercial invoice
Certificate of Origin
KUWAIT BAHRAIN OMAN QATAR UAE YEMEN LEBANON JORDAN EGYPT IRAQ AFGHANISTAN
WELCOME TO DHL EXPRESS MIDDLE EAST CUSTOMS GUIDE
SYRIA
KINGDOM OF SAUDI ARABIA CUSTOMS GUIDE
DOCUMENTATION REQUIREMENTS
CERTIFICATE OF ORIGIN
SAUDI ARABIA GATEWAY DETAILS
SASO
IMPORT REQUIREMENTS
AUTHORIZATION LETTER
PRODUCT LABELING & COUNTRY OF ORIGIN MARKINGS
CUSTOMER REFERENCE DOCUMENTS
COMMERCIAL INVOICE
KSA WEBSITES
KINGDOM OF SAUDI ARABIA
Gateways Dhahran Causeway Riyadh Airport
Line Haul DHL B727 DHL road movements
DHL Clearance Yes
Broker Handover Not possible
DDP Yes
Deminimus US$150.00
KINGDOM OF SAUDI ARABIA
DOCUMENTATION REQUIREMENTS
CERTIFICATE OF ORIGIN
SAUDI ARABIA GATEWAY DETAILS
SASO
IMPORT REQUIREMENTS
AUTHORIZATION LETTER
PRODUCT LABELING & COUNTRY OF ORIGIN MARKINGS
CUSTOMER REFERENCE DOCUMENTS
COMMERCIAL INVOICE
KSA WEBSITES
KINGDOM OF SAUDI ARABIA
DOCUMENTATION REQUIREMENTS
The following documents are required to complete the clearance of a shipment into Saudi Arabia
1. Airwaybill
2. Detailed Commercial Invoice
3. Packing List
4. Certificate of Origin The requirement for a COO is value dependent and varies by gateway
5. Saudi Arabian Standards Organization (SASO) Required for certain products
6. Company Registration Importer to provide a copy of a valid Company Registration
7. Authorization Letter Importer to provide Authorization letter to DHL to act as their broker
The importer may be required to provide Ministerial approvals for restricted products such as telecommunications equipment, drugs, food items, CD’s, publications, and chemicals to facilitate customs clearance.
DOCUMENTATION REQUIREMENTS
CERTIFICATE OF ORIGIN
SAUDI ARABIA GATEWAY DETAILS
SASO
IMPORT REQUIREMENTS
AUTHORIZATION LETTER
PRODUCT LABELING & COUNTRY OF ORIGIN MARKINGS
CUSTOMER REFERENCE DOCUMENTS
COMMERCIAL INVOICE
KSA WEBSITES
KINGDOM OF SAUDI ARABIA
KINGDOM OF SAUDI ARABIA GATEWAY DETAILS
Dhahran Causeway1. Shipments consigned to locations in the Eastern Province of Kingdom of Saudi Arabia are cleared at the DHL facility on the Bahrain –
Kingdom Of Saudi Arabia Causeway.
2. The Causeway is also the primary clearance point for road shipments entering Kingdom of Saudi Arabia.
3. Shipments for the Central & Western Provinces with values exceeding US$5,300 are also cleared on the Causeway.
4. “Shipments valued in excess of US$13,149 require a Certificate of Origin if clearing at the Causeway”.
Riyadh1. Shipments consigned to locations in the Central Province of Kingdom of Saudi Arabia are cleared at the DHL facility at the Riyadh Airport.
2. Only shipments with values less than US$5,300 can be cleared.
3. Shipments for the Central Province with values exceeding US$5,300 are cleared on the Causeway.
4. Shipments valued in excess of US$2,500 require a Certificate of Origin “If clearing at Riyadh Airport”.
DOCUMENTATION REQUIREMENTS
CERTIFICATE OF ORIGIN
SAUDI ARABIA GATEWAY DETAILS
SASO
IMPORT REQUIREMENTS
AUTHORIZATION LETTER
PRODUCT LABELING & COUNTRY OF ORIGIN MARKINGS
CUSTOMER REFERENCE DOCUMENTS
COMMERCIAL INVOICE
KSA WEBSITES
KINGDOM OF SAUDI ARABIA
IMPORT REQUIREMENTS
Importer of Record• All shipments with a value above US$100 require that the Company or individual be identified as
the Importer of record (IOR).
• DHL cannot act as the importer of Record into Kingdom of Saudi Arabia
Company Registration• The customs declaration form prepared by DHL at time of customs clearance must be accompanied
by a copy of the consignee’s commercial registration or personal ID.
• Copies of CR’s & ID’s provided by importers will be kept on file by DHL for use as and when required.
Authorization Letter (AL)• For shipments valued at > US$13,249 for DHA or US$2,499 for JED & RUH an original letter
authorizing DHL to act as the clearance broker on behalf of the customer is required.
• The AL should be in the approved format and on the company letter head.
• The AL can be issued for a period of 12 months and will be kept on file by DHL for use as and when required.
DOCUMENTATION REQUIREMENTS
CERTIFICATE OF ORIGIN
SAUDI ARABIA GATEWAY DETAILS
SASO
IMPORT REQUIREMENTS
AUTHORIZATION LETTER
PRODUCT LABELING & COUNTRY OF ORIGIN MARKINGS
CUSTOMER REFERENCE DOCUMENTS
COMMERCIAL INVOICE
KSA WEBSITES
KINGDOM OF SAUDI ARABIA
IMPORT REQUIREMENTS
Saudi Arabian Standards Organization (SASO)• SASO approval is required for some items valued at over US$ 100 . The exporter should check the
SASO website to confirm if the products they are shipping require SASO approval.
• SASO is similar to a Clean Report Finding (CRF) and can be obtained from a reputable inspection company such as Intertek. SGS or Bureau Veritas.
Certificate of Origin (COO)• All shipments for DHA above US$ 13,249 require a COO.
• All shipments for JED & RUH above US$ 2,500.00 require COO.
Communications and Information Technology Commmission (CITC)• All telecommunications related equipment and spare parts are subject to CITC approval.
• The consignee is responsible for obtaining CITC approval and this must be in place before the shipment is collected. A copy of the CITC approval should be attached to the shipping documents
DOCUMENTATION REQUIREMENTS
CERTIFICATE OF ORIGIN
SAUDI ARABIA GATEWAY DETAILS
SASO
IMPORT REQUIREMENTS
AUTHORIZATION LETTER
PRODUCT LABELING & COUNTRY OF ORIGIN MARKINGS
CUSTOMER REFERENCE DOCUMENTS
COMMERCIAL INVOICE
KSA WEBSITES
KINGDOM OF SAUDI ARABIA
PRODUCT LABELING & COUNTRY OF ORIGIN MARKINGS
1. Product labeling indicating the Made In and brand name are compulsory for any products to be exported to Saudi Arabia.
2. Labeling is required for all products and is particularly important for spare parts, finished goods, food products, personal care products, health care products, and pharmaceuticals.
3. Where physically possible the actual product should be embossed / engraved or have an irremovable label stating the made in country as well as the product brand name.
4. Where product labeling is not possible due to size or product sensitivity the external packing should carry the required markings.
5. SASO has specific requirements for identifying marks and labels for various imported items. Companies can request a copy of the labeling requirements on the SASO website : www.saso.org.sa/English/Pages/Default.aspx
6. Shipments / parts which do not have a country of origin stamp or sticker may be rejected for clearance by Saudi Customs and returned to origin.
DOCUMENTATION REQUIREMENTS
CERTIFICATE OF ORIGIN
SAUDI ARABIA GATEWAY DETAILS
SASO
IMPORT REQUIREMENTS
AUTHORIZATION LETTER
PRODUCT LABELING & COUNTRY OF ORIGIN MARKINGS
CUSTOMER REFERENCE DOCUMENTS
COMMERCIAL INVOICE
KSA WEBSITES
KINGDOM OF SAUDI ARABIA
COMMERCIAL INVOICEInvoice on company letter headFOR DELIVERY OF COMMERCIAL GOODS (FOR SALE)
PRINTED ON CONSIGNOR’S LETTERHEAD SHOWING LEGAL ADDRESS
COMMERCIAL INVOICE
Invoice no 25Date 01/04/2010
Invoice Address (no private individuals):Dubai, UAETerminal 2,Al TwarINN 123546683
DescriptionCountry of
originNet
weight/kg HS Code Qty (pieces) Unit price, USD Total price, USD
Total price, USD:
Insurance cost, USD:
Freight cost, USD:
Total for payment, USD:
Gross Weight (total):
Signed by:
Suit, mod, Business, art, 23840-27, trade mark Loops; wool(65%), silk(35%), lining
viscose(100%)
Italy,Lignano spa 5 kg 61042900 10
7,6 kg 6104290000 15
4 kg 6110111000 34
3,1 kg 3924909000 100
6,3 kg 4911101000 5
500
500
45
5
10
5000
7500
1530
500
50
14580
200
9500
24280
30 Kg
Signature, Stamp of CNOR
Italy,Lignano spa
China, BailihuaTrade ltd
Malaysia, Intertrade ltd
Italy, Masterprint
srl
Suit, mod, Business, art, 23840-29, trade mark Loops; wool(65%), silk(35%), lining
viscose(100%)
Sweater, mod, Holiday, trade mark Mosiac; wool(98%),
polyester(2%)
Brush for cleaning of clothes, plastic 100%
Catalogues Loops
Ship to (no private individual): Delivered under:Dubai, UAE Contact 110 dd 25.03.2010Elektra Street, Building 3, Gate 2, Of�ce 1001P.O.Box 7833 Payment terms 90 days from Invoice dateContact person: Vikram Mahef
Phone: + 971 56 1547700
Delivery terms (Incoterms): CIF
An invoice number is mandatory for the invoice.
Your Incoterms will also influence whether you include insurance and transport costs separately in the invoice.
HS Code essential as well as country of origin
Signature and company stamp
Realistic valuation required. Provide unit price as well as total price
Same currency throughout the invoice.
Description needs to be as detailed as possible - commodity name, intended use, part/serial numbers, materials, components, sizes etc,
The name and addresses should match the consignee’s registration documents.
DOCUMENTATION REQUIREMENTS
CERTIFICATE OF ORIGIN
SAUDI ARABIA GATEWAY DETAILS
SASO
IMPORT REQUIREMENTS
AUTHORIZATION LETTER
PRODUCT LABELING & COUNTRY OF ORIGIN MARKINGS
CUSTOMER REFERENCE DOCUMENTS
COMMERCIAL INVOICE
KSA WEBSITES
KINGDOM OF SAUDI ARABIA
CERTIFICATE OF ORIGIN
Certificate of origin is issued by the local chamber of commerce in IN THE ORIGIN COUNTRY and an invoice and the certificate of origin is legalized by the neareast Saudi Embassy or Consulate in THE ORIGIN COUNTRY – “local”, “in the origin country” , Saudi, in the Origin Country do not have to be in Uppers case, was meant to show you the placement and replacement of words – please change to lower care.
When countries unite in trading agreements, they may allow Certificate of Origin to state the trading bloc as the origin, rather than the specific country i.e. EU.
For shipments that require a Certificate of Origin endorsement by the Chamber of Commerce of the Invoice is sufficient.
DOCUMENTATION REQUIREMENTS
CERTIFICATE OF ORIGIN
SAUDI ARABIA GATEWAY DETAILS
SASO
IMPORT REQUIREMENTS
AUTHORIZATION LETTER
PRODUCT LABELING & COUNTRY OF ORIGIN MARKINGS
CUSTOMER REFERENCE DOCUMENTS
COMMERCIAL INVOICE
KSA WEBSITES
KINGDOM OF SAUDI ARABIA
SASO
The role of SASO in Kingdom of Saudi Arabia is primarily consumer protection and the maintenance of public health and safety as well as environmental protection and the guarantee of the well being of the general public through the issuing and implementing of standards, quality and metrology systems.
Web Site www.saso.org.sa/English/Pages/Default.aspx
All shipments are subject to mandatory verification prior import clearance into Saudi Arabia and related certificate is required for clearance.
Exceptions are limited to specific products.
Products for which conformity to SASO standards is mandatory shall have been subject to satisfactory laboratory testing.
Conformity to international and equivalent standards is recognized.
Products shall also comply with national deviations such as :
Language (Instructions in Arabic)
Local climate
Electric supply (domestic 127/220V, 60Hz) and electric plug Religious requirements
SASO certification can be obtained through 3rd party entities such as Bureau Veritas and SGS – (www.bivac.com & www.sgs.com)
Exporters should present documents showing the conformity of their products in accordance with the specified Standards to BVQI / SGS who will assess the documents and the product prior to issuing the SASO certificate.
DOCUMENTATION REQUIREMENTS
CERTIFICATE OF ORIGIN
SAUDI ARABIA GATEWAY DETAILS
SASO
IMPORT REQUIREMENTS
AUTHORIZATION LETTER
PRODUCT LABELING & COUNTRY OF ORIGIN MARKINGS
CUSTOMER REFERENCE DOCUMENTS
COMMERCIAL INVOICE
KSA WEBSITES
KINGDOM OF SAUDI ARABIA
AUTHORIZATION LETTER
For shipments clearing through the Causeway were the value exceeds US$13,249.00 the importer is required to issue an Authorization Letter (AL).
For shipments clearing through Riyadh Airport were the value exceeds US$ 2,500.00 the importer is required to issue an Authorization Letter (AL).
This letter authorizes DHL to act as their clearing agent.
The AL can be valid for a specific shipment or for a defined period of time up to a maximum of 12 months.
DHL will retain the original AL on file at the clearance gateway and submit a copy with each shipment cleared for the corresponding importer.
DATE:
Authorization
Civil record #................................... Importer Computer # …………….. Authorization #............................. Import -- Export
Director General of customs King Fahad Causeway Custom Manager Dear Sir, I, Residing in P.O. Box: ------ Zip Code: --------- Tel: … -------. Fax: ---------------- Telex: C.R. #: ------------- Date: ----------- Issued by: ---------On: -------------Expire ---------- Member of Chamber of Commerce and industry In AL-KHOBAR. Holding membership Do hereby state that I have authorize customs broker Name Sameer Hameed Al Judaibi License #.1601 Date 20/01/1411 H To finalize all customs procedures, expedite transactions, submit all require documents, attend inspection and examination, pay customs duties, sign Release card and receive the goods. I also state the following: My commercial activity and goods I deal with and Import and export is The imported goods is: Quantity: Origin: This consignment(s) belong to me personally. I shall Be fully responsible for validity of the information. It is confirming with my statement on the Declaration and documents attached to it. I am also responsible for violation committed in connection with this authorization. This authorization is valid for one year from to
Corporation Name: Signature: ……………………………………………. Seal Chamber of commerce stamp
:
:010263697831 ......................: ..................................:
: :
- .
:
: ----5641--: . --- ---11432
:4919624 : .4919736 : ..............:1010011557
: 10/9/1428 -: .
:30/5/1433 .:
.:160120/01/1411
. :
:
/
.................... .
. -
- 131431131433
: . :
..................................................: .....................................................:
DOCUMENTATION REQUIREMENTS
CERTIFICATE OF ORIGIN
SAUDI ARABIA GATEWAY DETAILS
SASO
IMPORT REQUIREMENTS
AUTHORIZATION LETTER
PRODUCT LABELING & COUNTRY OF ORIGIN MARKINGS
CUSTOMER REFERENCE DOCUMENTS
COMMERCIAL INVOICE
KSA WEBSITES
KINGDOM OF SAUDI ARABIA
CUSTOMER REFERENCE DOCUMENTS
Saudi Food & Drug Authority
Communication & Information Technology Commission
Saudi Arabian Standards Organization
DOCUMENTATION REQUIREMENTS
CERTIFICATE OF ORIGIN
SAUDI ARABIA GATEWAY DETAILS
SASO
IMPORT REQUIREMENTS
AUTHORIZATION LETTER
PRODUCT LABELING & COUNTRY OF ORIGIN MARKINGS
CUSTOMER REFERENCE DOCUMENTS
COMMERCIAL INVOICE
KSA WEBSITES
KINGDOM OF SAUDI ARABIA
KINGDOM OF SAUDI ARABIA WEBSITES
SASO – Saudi Arabian Standards Organization
http://www.saso.org.sa/English/Pages/Default.aspx
SFDA - Saudi Food & Drug Authority
http://www.sfda.gov.sa/En/Home
MOCI - Ministry of Commerce & Industry
http://mci.gov.sa/english/default.aspx
CITC - Communications & Information Technology Commission
http://www.citc.gov.sa/English/Pages/default.aspx
For SASO – Certification Bodies
If you need to have goods certified prior to export then please check which of these service providers have an agreement with SASO for your country of origin.
Intertek
http://www.intertek.com/government/product-conformity/exports/saudi-arabia/
SGS Group
http://www.sgs.com/import_certification_me.htm?serviceId=10096307&lobId=5550
Bureau Veritas
http://www.bureauveritas.com/wps/wcm/connect/bv_com/group
KUWAIT CUSTOMS GUIDE
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE CERTIFICATE OF ORIGIN CERTIFICATE OF CONFORMITY SHIPMENT LABELING
KUWAIT
KUWAIT
Gateways Kuwait Airport (Road & Air) Sulabiya (Road only)
Line Haul DHL 727 DHL road movements
DHL Clearance Yes
Broker Handover Yes
DDP Yes
Deminimus US$0.00
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE CERTIFICATE OF ORIGIN CERTIFICATE OF CONFORMITY SHIPMENT LABELING
KUWAIT
DOCUMENTATION REQUIREMENTS
The following documents are required to complete the clearance of a shipment into Kuwait
1. Airwaybill
2. Detailed Commercial Invoice
3. Packing List
4. Certificate of Origin Required for shipments >100 kilos or where the value is in excess of US$2,999.00.
5. Certificate of Conformity Required for certain products (ICCP - International Conformity Certification Program is required for
certain commodities including all electronics items. The Public Authority for Industry (PAI) is the regulatory authority responsible for ICCP)
6. Legalized Invoices Legalization is required when the shipments value is >100 kilos in weight or where the value exceeds
US$1499.00 Legalization can be done on arrival in Kuwait with cnee paying charges Legalization Costs KD 10.00 per invoice , KD 15.00 for a Cert of Origin, KD 4.00 admin charge
The importer may be required to provide Ministerial approvals for restricted products such as telecommunications equipment, drugs, food items, CD’s, publications, and chemicals to facilitate customs clearance.
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE CERTIFICATE OF ORIGIN CERTIFICATE OF CONFORMITY SHIPMENT LABELING
KUWAIT
COMMERCIAL INVOICEInvoice on company letter headFOR DELIVERY OF COMMERCIAL GOODS (FOR SALE)
PRINTED ON CONSIGNOR’S LETTERHEAD SHOWING LEGAL ADDRESS
COMMERCIAL INVOICE
Invoice no 25Date 01/04/2010
Invoice Address (no private individuals):Dubai, UAETerminal 2,Al TwarINN 123546683
DescriptionCountry of
originNet
weight/kg HS Code Qty (pieces) Unit price, USD Total price, USD
Total price, USD:
Insurance cost, USD:
Freight cost, USD:
Total for payment, USD:
Gross Weight (total):
Signed by:
Suit, mod, Business, art, 23840-27, trade mark Loops; wool(65%), silk(35%), lining
viscose(100%)
Italy,Lignano spa 5 kg 61042900 10
7,6 kg 6104290000 15
4 kg 6110111000 34
3,1 kg 3924909000 100
6,3 kg 4911101000 5
500
500
45
5
10
5000
7500
1530
500
50
14580
200
9500
24280
30 Kg
Signature, Stamp of CNOR
Italy,Lignano spa
China, BailihuaTrade ltd
Malaysia, Intertrade ltd
Italy, Masterprint
srl
Suit, mod, Business, art, 23840-29, trade mark Loops; wool(65%), silk(35%), lining
viscose(100%)
Sweater, mod, Holiday, trade mark Mosiac; wool(98%),
polyester(2%)
Brush for cleaning of clothes, plastic 100%
Catalogues Loops
Ship to (no private individual): Delivered under:Dubai, UAE Contact 110 dd 25.03.2010Elektra Street, Building 3, Gate 2, Of�ce 1001P.O.Box 7833 Payment terms 90 days from Invoice dateContact person: Vikram Mahef
Phone: + 971 56 1547700
Delivery terms (Incoterms): CIF
An invoice number is mandatory for the invoice.
Your Incoterms will also influence whether you include insurance and transport costs separately in the invoice.
HS Code essential as well as country of origin
Signature and company stamp
Realistic valuation required. Provide unit price as well as total price
Same currency throughout the invoice.
Description needs to be as detailed as possible - commodity name, intended use, part/serial numbers, materials, components, sizes etc,
The name and addresses should match the consignee’s registration documents.
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE CERTIFICATE OF ORIGIN CERTIFICATE OF CONFORMITY SHIPMENT LABELING
KUWAIT
CERTIFICATE OF ORIGIN
Certificate of origin is issued by the local chamber of commerce in IN THE ORIGIN COUNTRY and an invoice and the certificate of origin is legalized by the neareast Kuwait Embassy or Consulate in the origin country.
When countries unite in trading agreements, they may allow Certificate of Origin to state the trading bloc as the origin, rather than the specific country i.e. EU.
For shipments that require a Certificate of Origin endorsement by the Chamber of Commerce of the Invoice is sufficient.
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE CERTIFICATE OF ORIGIN CERTIFICATE OF CONFORMITY SHIPMENT LABELING
KUWAIT
CERTIFICATE OF CONFORMITY
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE CERTIFICATE OF ORIGIN CERTIFICATE OF CONFORMITY SHIPMENT LABELING
KUWAIT
SHIPMENT LABELING
1. Labeling and marking requirements are compulsory for any products to be exported to Kuwait.
2. Labeling is required for all products and is particularly important for companies marketing food products, personal care products, health care products, and pharmaceuticals.
3. Kuwait Conformity Assurance Scheme (KCAS) has specific requirements for identifying marks and labels for various imported items.
4. All products should carry a stamp or permanent irremovable sticker which states the country or manufacture.
5. Shipments / parts which do not have a country of origin stamp or sticker will be rejected by Kuwait customs for further actions by importer.
6. For further details customers can visit the following link:
https://www.pai.gov.kw/portal/page/portal/pai/KUCAS
BAHRAIN CUSTOMS GUIDE
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE
BAHRAIN
BAHRAIN
Gateways Bahrain Airport (Road and Air)
Line Haul DHL 727 DHL road movements
DHL Clearance Yes
Broker Handover Yes
DDP Yes
Deminimus US$0.00
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE
BAHRAIN
DOCUMENTATION REQUIREMENTS
The following documents are required to complete the clearance of a shipment into Bahrain
1. Airwaybill
2. Detailed Commercial Invoice
3. Packing List
4. Certificate of Origin Required for shipments valued in excess of US$1,300 A penalty of BD10.00 (US$30.00) may be paid in the absence of a Certificate of Origin
The importer may be required to provide Ministerial approvals for restricted products such as telecommunications equipment, drugs, food items, CD’s, publications, and chemicals to facilitate customs clearance.
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE
BAHRAIN
COMMERCIAL INVOICEInvoice on company letter headFOR DELIVERY OF COMMERCIAL GOODS (FOR SALE)
PRINTED ON CONSIGNOR’S LETTERHEAD SHOWING LEGAL ADDRESS
COMMERCIAL INVOICE
Invoice no 25Date 01/04/2010
Invoice Address (no private individuals):Dubai, UAETerminal 2,Al TwarINN 123546683
DescriptionCountry of
originNet
weight/kg HS Code Qty (pieces) Unit price, USD Total price, USD
Total price, USD:
Insurance cost, USD:
Freight cost, USD:
Total for payment, USD:
Gross Weight (total):
Signed by:
Suit, mod, Business, art, 23840-27, trade mark Loops; wool(65%), silk(35%), lining
viscose(100%)
Italy,Lignano spa 5 kg 61042900 10
7,6 kg 6104290000 15
4 kg 6110111000 34
3,1 kg 3924909000 100
6,3 kg 4911101000 5
500
500
45
5
10
5000
7500
1530
500
50
14580
200
9500
24280
30 Kg
Signature, Stamp of CNOR
Italy,Lignano spa
China, BailihuaTrade ltd
Malaysia, Intertrade ltd
Italy, Masterprint
srl
Suit, mod, Business, art, 23840-29, trade mark Loops; wool(65%), silk(35%), lining
viscose(100%)
Sweater, mod, Holiday, trade mark Mosiac; wool(98%),
polyester(2%)
Brush for cleaning of clothes, plastic 100%
Catalogues Loops
Ship to (no private individual): Delivered under:Dubai, UAE Contact 110 dd 25.03.2010Elektra Street, Building 3, Gate 2, Of�ce 1001P.O.Box 7833 Payment terms 90 days from Invoice dateContact person: Vikram Mahef
Phone: + 971 56 1547700
Delivery terms (Incoterms): CIF
An invoice number is mandatory for the invoice.
Your Incoterms will also influence whether you include insurance and transport costs separately in the invoice.
HS Code essential as well as country of origin
Signature and company stamp
Realistic valuation required. Provide unit price as well as total price
Same currency throughout the invoice.
Description needs to be as detailed as possible - commodity name, intended use, part/serial numbers, materials, components, sizes etc,
The name and addresses should match the consignee’s registration documents.
OMAN CUSTOMS GUIDE
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE
OMAN
OMAN
Gateways Seeb Airport (Road and Air)
DHL Clearance Yes
Broker Handover Yes
DDP Yes
Deminimus US$0.00
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE
OMAN
DOCUMENTATION REQUIREMENTS
The following documents are required to complete the clearance of a shipment into Oman
1.Airwaybill
2.Detailed Commercial Invoice
3.Packing List
The importer may be required to provide Ministerial approvals for restricted products such as telecommunications equipment, drugs, food items, CD’s, publications, and chemicals to facilitate customs clearance.
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE
OMAN
COMMERCIAL INVOICEInvoice on company letter headFOR DELIVERY OF COMMERCIAL GOODS (FOR SALE)
PRINTED ON CONSIGNOR’S LETTERHEAD SHOWING LEGAL ADDRESS
COMMERCIAL INVOICE
Invoice no 25Date 01/04/2010
Invoice Address (no private individuals):Dubai, UAETerminal 2,Al TwarINN 123546683
DescriptionCountry of
originNet
weight/kg HS Code Qty (pieces) Unit price, USD Total price, USD
Total price, USD:
Insurance cost, USD:
Freight cost, USD:
Total for payment, USD:
Gross Weight (total):
Signed by:
Suit, mod, Business, art, 23840-27, trade mark Loops; wool(65%), silk(35%), lining
viscose(100%)
Italy,Lignano spa 5 kg 61042900 10
7,6 kg 6104290000 15
4 kg 6110111000 34
3,1 kg 3924909000 100
6,3 kg 4911101000 5
500
500
45
5
10
5000
7500
1530
500
50
14580
200
9500
24280
30 Kg
Signature, Stamp of CNOR
Italy,Lignano spa
China, BailihuaTrade ltd
Malaysia, Intertrade ltd
Italy, Masterprint
srl
Suit, mod, Business, art, 23840-29, trade mark Loops; wool(65%), silk(35%), lining
viscose(100%)
Sweater, mod, Holiday, trade mark Mosiac; wool(98%),
polyester(2%)
Brush for cleaning of clothes, plastic 100%
Catalogues Loops
Ship to (no private individual): Delivered under:Dubai, UAE Contact 110 dd 25.03.2010Elektra Street, Building 3, Gate 2, Of�ce 1001P.O.Box 7833 Payment terms 90 days from Invoice dateContact person: Vikram Mahef
Phone: + 971 56 1547700
Delivery terms (Incoterms): CIF
An invoice number is mandatory for the invoice.
Your Incoterms will also influence whether you include insurance and transport costs separately in the invoice.
HS Code essential as well as country of origin
Signature and company stamp
Realistic valuation required. Provide unit price as well as total price
Same currency throughout the invoice.
Description needs to be as detailed as possible - commodity name, intended use, part/serial numbers, materials, components, sizes etc,
The name and addresses should match the consignee’s registration documents.
QATAR CUSTOMS GUIDE
DOCUMENTATION REQUIREMENTS
LEGALIZATION CHARGES – AIR SHIPMENT
COMMERCIAL INVOICE
ADDITIONAL IMPORT REQUIREMENTS
CERTIFICATE OF ORIGIN
PRODUCT LABELING & COUNTRY OF ORIGIN MARKINGS
AUTHORIZATION LETTER LEGALIZATION CHARGES – ROAD SHIPMENT
QATAR
QATAR
Gateways Doha Airport (Air only)
DHL Clearance Yes
Broker Handover No
DDP Yes
Deminimus US$0.00
QCCSW (Qatar Customs Clearance Single Window) has been effectively implemented in Qatar. Currently, this
applies only for sea freight shipments and implementation for air freight and couriers is yet to be announced.
Qatar customs has now migrated into QCCSW. All importers in Qatar must register their business activity online
with Qatar customs by visiting the Qatar customs website www.ecustoms.gov.qa. It is mandatory for all importers
to have the DHL Qatar license details - DHL QATAR LTD” Under the CR no 4642 - entered as a one time process,
which authorizes DHL Qatar to act on behalf of the importer as a customs clearance broker.
Please advise all importers in Qatar to complete the registration as early as possible to ensure shipments are
cleared from customs without delay
KINGDOM OF SAUDI ARABIA / Qatar Land Border (Road)
DOCUMENTATION REQUIREMENTS
LEGALIZATION CHARGES – AIR SHIPMENT
COMMERCIAL INVOICE
ADDITIONAL IMPORT REQUIREMENTS
CERTIFICATE OF ORIGIN
PRODUCT LABELING & COUNTRY OF ORIGIN MARKINGS
AUTHORIZATION LETTER LEGALIZATION CHARGES – ROAD SHIPMENT
QATAR
DOCUMENTATION REQUIREMENTS
The following documents are required to complete the clearance of a shipment into Qatar
1. Airwaybill
2. Detailed Commercial Invoice
3. Legalized Invoices Legalization can be done on arrival in Qatar with charges paid by the cnee
4. Packing List
5. Certificate of Origin Required for shipments moving by air with a weight exceeding 100 kilos (actual or volumetric) COO required for all shipments moving by road.
6. Authorization Letter
The importer may be required to provide Ministerial approvals for restricted products such as telecommunications equipment, drugs, food items, CD’s, publications, and chemicals to facilitate customs clearance.
DOCUMENTATION REQUIREMENTS
LEGALIZATION CHARGES – AIR SHIPMENT
COMMERCIAL INVOICE
ADDITIONAL IMPORT REQUIREMENTS
CERTIFICATE OF ORIGIN
PRODUCT LABELING & COUNTRY OF ORIGIN MARKINGS
AUTHORIZATION LETTER LEGALIZATION CHARGES – ROAD SHIPMENT
QATAR
COMMERCIAL INVOICEInvoice on company letter headFOR DELIVERY OF COMMERCIAL GOODS (FOR SALE)
PRINTED ON CONSIGNOR’S LETTERHEAD SHOWING LEGAL ADDRESS
COMMERCIAL INVOICE
Invoice no 25Date 01/04/2010
Invoice Address (no private individuals):Dubai, UAETerminal 2,Al TwarINN 123546683
DescriptionCountry of
originNet
weight/kg HS Code Qty (pieces) Unit price, USD Total price, USD
Total price, USD:
Insurance cost, USD:
Freight cost, USD:
Total for payment, USD:
Gross Weight (total):
Signed by:
Suit, mod, Business, art, 23840-27, trade mark Loops; wool(65%), silk(35%), lining
viscose(100%)
Italy,Lignano spa 5 kg 61042900 10
7,6 kg 6104290000 15
4 kg 6110111000 34
3,1 kg 3924909000 100
6,3 kg 4911101000 5
500
500
45
5
10
5000
7500
1530
500
50
14580
200
9500
24280
30 Kg
Signature, Stamp of CNOR
Italy,Lignano spa
China, BailihuaTrade ltd
Malaysia, Intertrade ltd
Italy, Masterprint
srl
Suit, mod, Business, art, 23840-29, trade mark Loops; wool(65%), silk(35%), lining
viscose(100%)
Sweater, mod, Holiday, trade mark Mosiac; wool(98%),
polyester(2%)
Brush for cleaning of clothes, plastic 100%
Catalogues Loops
Ship to (no private individual): Delivered under:Dubai, UAE Contact 110 dd 25.03.2010Elektra Street, Building 3, Gate 2, Of�ce 1001P.O.Box 7833 Payment terms 90 days from Invoice dateContact person: Vikram Mahef
Phone: + 971 56 1547700
Delivery terms (Incoterms): CIF
An invoice number is mandatory for the invoice.
Your Incoterms will also influence whether you include insurance and transport costs separately in the invoice.
HS Code essential as well as country of origin
Signature and company stamp
Realistic valuation required. Provide unit price as well as total price
Same currency throughout the invoice.
Description needs to be as detailed as possible - commodity name, intended use, part/serial numbers, materials, components, sizes etc,
The name and addresses should match the consignee’s registration documents.
DOCUMENTATION REQUIREMENTS
LEGALIZATION CHARGES – AIR SHIPMENT
COMMERCIAL INVOICE
ADDITIONAL IMPORT REQUIREMENTS
CERTIFICATE OF ORIGIN
PRODUCT LABELING & COUNTRY OF ORIGIN MARKINGS
AUTHORIZATION LETTER LEGALIZATION CHARGES – ROAD SHIPMENT
QATAR
CERTIFICATE OF ORIGIN
Certificate of origin is issued by the local chamber of commerce in IN THE ORIGIN COUNTRY and an invoice and the certificate of origin is legalized by the neareast Qatar Embassy or Consulate in the origin country.
When countries unite in trading agreements, they may allow Certificate of Origin to state the trading bloc as the origin, rather than the specific country i.e. EU.
For shipments that require a Certificate of Origin endorsement by the Chamber of Commerce of the Invoice is sufficient.
DOCUMENTATION REQUIREMENTS
LEGALIZATION CHARGES – AIR SHIPMENT
COMMERCIAL INVOICE
ADDITIONAL IMPORT REQUIREMENTS
CERTIFICATE OF ORIGIN
PRODUCT LABELING & COUNTRY OF ORIGIN MARKINGS
AUTHORIZATION LETTER LEGALIZATION CHARGES – ROAD SHIPMENT
QATAR
AUTHORIZATION LETTER
Required for all shipments and provided by the consignee.
Can be valid for a period of time and for a max period of 12 months after which it needs to be renewed.
DOCUMENTATION REQUIREMENTS
LEGALIZATION CHARGES – AIR SHIPMENT
COMMERCIAL INVOICE
ADDITIONAL IMPORT REQUIREMENTS
CERTIFICATE OF ORIGIN
PRODUCT LABELING & COUNTRY OF ORIGIN MARKINGS
AUTHORIZATION LETTER LEGALIZATION CHARGES – ROAD SHIPMENT
QATAR
LEGALIZATION CHARGES – ROAD SHIPMENT
Road shipments cannot be moved by paying penalty original certificate of origin has to be present
* All prices in QAR
Shipment Value
From To
Certificate of Origin
Attestation of Commercial
InvoiceTotal Payable
0.4% of declared invoice value
0.01
5,000
15,000
50,000
100,000
150,000
250,000
500,000
1,000,000
4,999
14,999
49,999
99,999
149,999
249,999
499,999
999,999
above
150
150
150
150
150
150
150
150
100
200
500
900
1300
1800
2200
3000
250
350
650
1050
1450
1950
2350
3150
DOCUMENTATION REQUIREMENTS
LEGALIZATION CHARGES – AIR SHIPMENT
COMMERCIAL INVOICE
ADDITIONAL IMPORT REQUIREMENTS
CERTIFICATE OF ORIGIN
PRODUCT LABELING & COUNTRY OF ORIGIN MARKINGS
AUTHORIZATION LETTER LEGALIZATION CHARGES – ROAD SHIPMENT
QATAR
LEGALIZATION CHARGES – AIR SHIPMENT
If the value of the shipment more 50,000QAR 1% will be the fine from invoice value
* All prices in QAR
Shipment Value
From To
Certificate of Origin
Attestation of Commercial
InvoiceTotal Payable
0.4% of declared invoice value
0.01
5,000
15,000
50,000
100,000
150,000
250,000
500,000
1,000,000
4,999
14,999
49,999
99,999
149,999
249,999
499,999
999,999
above
150
150
150
150
150
150
150
150
100
200
500
900
1300
1800
2200
3000
250
350
650
1050
1450
1950
2350
3150
DOCUMENTATION REQUIREMENTS
LEGALIZATION CHARGES – AIR SHIPMENT
COMMERCIAL INVOICE
ADDITIONAL IMPORT REQUIREMENTS
CERTIFICATE OF ORIGIN
PRODUCT LABELING & COUNTRY OF ORIGIN MARKINGS
AUTHORIZATION LETTER LEGALIZATION CHARGES – ROAD SHIPMENT
QATAR
ADDITIONAL IMPORT REQUIREMENTS
AGENCY PRODUCTS COMMENTS WEBSITE
Ministry of Health Medicine, Cosmetics, Nutrition foods Will be rwquested on arrival www.sch.gov.qa
Ministry of Interior Security devices, Specialist cameras Will be requested on arrival www.moi.gov.qa
Ministry of Interior Fire related items like Alarm and Equipments Will be rwquested on arrival www.moi.gov.qa
Supreme Educational Council Educational books Will be rwquested on arrival www.education.gov.qa
Qatar General Organization for Standards and Metrology Automotive spare parts Will be requested on arrival for air but must
be obtained in advance for road www.moi.gov.qa
ICT (information & CommunicationTechnology)
Computer items, Network equipments,Wireless devices
Will be requested on arrival for air but must be obtained in advance for road shipments www.ictqatar.qa
EPC (Environmental Protection Council) Chemical, Liquids, Lubricants, Radioactive material
Will be requested on arrival for air but must be obtained in advance for road www.moi.gov.qa
DOCUMENTATION REQUIREMENTS
LEGALIZATION CHARGES – AIR SHIPMENT
COMMERCIAL INVOICE
ADDITIONAL IMPORT REQUIREMENTS
CERTIFICATE OF ORIGIN
PRODUCT LABELING & COUNTRY OF ORIGIN MARKINGS
AUTHORIZATION LETTER LEGALIZATION CHARGES – ROAD SHIPMENT
QATAR
PRODUCT LABELING & COUNTRY OF ORIGIN MARKINGS
1. Product labeling indicating the Made In and brand name are compulsory for any products to be exported to Qatar
2. Labeling is required for all products and is particularly important for spare parts, finished goods, food products, personal care products, health care products, and pharmaceuticals.
3. Where physically possible the actual product should be embossed / engraved or have an irremovable label stating the made in country as well as the product brand name.
4. Where product labeling is not possible due to size or product sensitivity the external packing should carry the required markings.
5. Shipments / parts which do not have a country of origin stamp or sticker may be rejected for clearance by Qatar customs and be destroyed or returned to origin.
UNITED ARAB EMIRATES CUSTOMS GUIDE
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE
UNITED ARAB EMIRATES
UNITED ARAB EMIRATES
Gateways Dubai Airport (Air only)
Abu Dhabi Airport ( Air & Road)
DHL Clearance Yes
Broker Handover Yes
DDP Yes
Deminimus US$270.00
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE
UNITED ARAB EMIRATES
DOCUMENTATION REQUIREMENTS
The following documents are required to complete the clearance of a shipment into United Arab Emirates
1. Airwaybill
2. Detailed Commercial Invoice
3. Packing List
4. Importer must have a valid import code
There are a number of Free Trade Zones in the UAE including Jebel Ali Free Zone and Dubai Airport Free Zone) where duty is not applicable. Imports to a UAE Free Trade Zone must be consigned to a registered company operating within the Free Trade Zone the shipment is to be delivered to. Import documentation requirements are the same for regular import shipments to the UAE.
The importer may be required to provide Ministerial approvals for restricted products such as telecommunications equipment, drugs, food items, CD’s, publications, and chemicals to facilitate customs clearance.
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE
UNITED ARAB EMIRATES
COMMERCIAL INVOICEInvoice on company letter headFOR DELIVERY OF COMMERCIAL GOODS (FOR SALE)
PRINTED ON CONSIGNOR’S LETTERHEAD SHOWING LEGAL ADDRESS
COMMERCIAL INVOICE
Invoice no 25Date 01/04/2010
Invoice Address (no private individuals):Dubai, UAETerminal 2,Al TwarINN 123546683
DescriptionCountry of
originNet
weight/kg HS Code Qty (pieces) Unit price, USD Total price, USD
Total price, USD:
Insurance cost, USD:
Freight cost, USD:
Total for payment, USD:
Gross Weight (total):
Signed by:
Suit, mod, Business, art, 23840-27, trade mark Loops; wool(65%), silk(35%), lining
viscose(100%)
Italy,Lignano spa 5 kg 61042900 10
7,6 kg 6104290000 15
4 kg 6110111000 34
3,1 kg 3924909000 100
6,3 kg 4911101000 5
500
500
45
5
10
5000
7500
1530
500
50
14580
200
9500
24280
30 Kg
Signature, Stamp of CNOR
Italy,Lignano spa
China, BailihuaTrade ltd
Malaysia, Intertrade ltd
Italy, Masterprint
srl
Suit, mod, Business, art, 23840-29, trade mark Loops; wool(65%), silk(35%), lining
viscose(100%)
Sweater, mod, Holiday, trade mark Mosiac; wool(98%),
polyester(2%)
Brush for cleaning of clothes, plastic 100%
Catalogues Loops
Ship to (no private individual): Delivered under:Dubai, UAE Contact 110 dd 25.03.2010Elektra Street, Building 3, Gate 2, Of�ce 1001P.O.Box 7833 Payment terms 90 days from Invoice dateContact person: Vikram Mahef
Phone: + 971 56 1547700
Delivery terms (Incoterms): CIF
An invoice number is mandatory for the invoice.
Your Incoterms will also influence whether you include insurance and transport costs separately in the invoice.
HS Code essential as well as country of origin
Signature and company stamp
Realistic valuation required. Provide unit price as well as total price
Same currency throughout the invoice.
Description needs to be as detailed as possible - commodity name, intended use, part/serial numbers, materials, components, sizes etc,
The name and addresses should match the consignee’s registration documents.
YEMEN CUSTOMS GUIDE
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE CERTIFICATE OF ORIGIN BROKER ARRANGEMENTS
YEMEN
YEMEN
Gateways S’anna Airport (Air) Border (Road)
Line Haul Commercial Air DHL road movement
DHL Clearance No – Broker
Broker Handover Yes
DDP NO
Deminimus US$
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE CERTIFICATE OF ORIGIN BROKER ARRANGEMENTS
YEMEN
DOCUMENTATION REQUIREMENTS
The following documents are required to complete the clearance of a shipment into Yemen
1. Airwaybill
2. Detailed Commercial Invoice
3. Packing List
4. Certificate of Origin
Required for all shipments valued >US$250.00
The COO must be attested by the Yemeni Embassy
The importer may be required to provide Ministerial approvals for restricted products such as telecommunications equipment, drugs, food items, CD’s, publications, and chemicals to facilitate customs clearance.
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE CERTIFICATE OF ORIGIN BROKER ARRANGEMENTS
YEMEN
COMMERCIAL INVOICEInvoice on company letter headFOR DELIVERY OF COMMERCIAL GOODS (FOR SALE)
PRINTED ON CONSIGNOR’S LETTERHEAD SHOWING LEGAL ADDRESS
COMMERCIAL INVOICE
Invoice no 25Date 01/04/2010
Invoice Address (no private individuals):Dubai, UAETerminal 2,Al TwarINN 123546683
DescriptionCountry of
originNet
weight/kg HS Code Qty (pieces) Unit price, USD Total price, USD
Total price, USD:
Insurance cost, USD:
Freight cost, USD:
Total for payment, USD:
Gross Weight (total):
Signed by:
Suit, mod, Business, art, 23840-27, trade mark Loops; wool(65%), silk(35%), lining
viscose(100%)
Italy,Lignano spa 5 kg 61042900 10
7,6 kg 6104290000 15
4 kg 6110111000 34
3,1 kg 3924909000 100
6,3 kg 4911101000 5
500
500
45
5
10
5000
7500
1530
500
50
14580
200
9500
24280
30 Kg
Signature, Stamp of CNOR
Italy,Lignano spa
China, BailihuaTrade ltd
Malaysia, Intertrade ltd
Italy, Masterprint
srl
Suit, mod, Business, art, 23840-29, trade mark Loops; wool(65%), silk(35%), lining
viscose(100%)
Sweater, mod, Holiday, trade mark Mosiac; wool(98%),
polyester(2%)
Brush for cleaning of clothes, plastic 100%
Catalogues Loops
Ship to (no private individual): Delivered under:Dubai, UAE Contact 110 dd 25.03.2010Elektra Street, Building 3, Gate 2, Of�ce 1001P.O.Box 7833 Payment terms 90 days from Invoice dateContact person: Vikram Mahef
Phone: + 971 56 1547700
Delivery terms (Incoterms): CIF
An invoice number is mandatory for the invoice.
Your Incoterms will also influence whether you include insurance and transport costs separately in the invoice.
HS Code essential as well as country of origin
Signature and company stamp
Realistic valuation required. Provide unit price as well as total price
Same currency throughout the invoice.
Description needs to be as detailed as possible - commodity name, intended use, part/serial numbers, materials, components, sizes etc,
The name and addresses should match the consignee’s registration documents.
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE CERTIFICATE OF ORIGIN BROKER ARRANGEMENTS
YEMEN
CERTIFICATE OF ORIGIN
Certificate of origin is issued by the local chamber of commerce in IN THE ORIGIN COUNTRY and an invoice and the certificate of origin is legalized by the neareast Yemen Embassy or Consulate in the origin country.
When countries unite in trading agreements, they may allow Certificate of Origin to state the trading bloc as the origin, rather than the specific country i.e. EU.
For shipments that require a Certificate of Origin endorsement by the Chamber of Commerce of the Invoice is sufficient.
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE CERTIFICATE OF ORIGIN BROKER ARRANGEMENTS
YEMEN
BROKER ARRANGEMENTS
1. DHL does not have a broker license in Yemen and must use the services of a 3rd party broker to clear shipments on behalf of the importer.
2. This is standard practice with the courier industry in Yemen where shipment clearance is outsourced
3. The importer has the option to use their own broker or to engage the services of the DHL broker.
4. If the cnee uses their own broker DHL will hand over the clearance documents to the nominated broker and they will be responsible for clearance and delivery of the shipment.
5. If the cnee uses the DHL broker we will be responsible for the clearance and delivery of the shipment.
6. Brokerage charges are as follows:
from 0-100Kg US$60.00
from 101-300Kg US$75.00
from 301-600Kg US$100.00
from 601-1000Kg US$120.00
More than 1000Kg 12 cent per kilo
LEBANON CUSTOMS GUIDE
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE BROKER ARRANGEMENTS
LEBANON
LEBANON
Gateways Beirut Airport
Line Haul Commercial Air DHL road movement
DHL Clearance No – Broker clearance
Broker Handover Yes
DDP Yes
Deminimus US$0.00
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE BROKER ARRANGEMENTS
LEBANON
DOCUMENTATION REQUIREMENTS
The following documents are required to complete the clearance of a shipment into Lebanon
1.Airwaybill
2.Detailed Commercial Invoice
3.Packing List
DHL does not have a brokerage license to clear shipments and instead use a 3rd party broker to clear shipments into Lebanon
The importer has the option to use the DHL broker or their own broker.
Note – the use of 3rd party brokers is industry practice in Lebanon and all courier companies are operate in the same way
The importer may be required to provide Ministerial approvals for restricted products such as telecommunications equipment, drugs, food items, CD’s, publications, and chemicals to facilitate customs clearance.
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE BROKER ARRANGEMENTS
LEBANON
COMMERCIAL INVOICEInvoice on company letter headFOR DELIVERY OF COMMERCIAL GOODS (FOR SALE)
PRINTED ON CONSIGNOR’S LETTERHEAD SHOWING LEGAL ADDRESS
COMMERCIAL INVOICE
Invoice no 25Date 01/04/2010
Invoice Address (no private individuals):Dubai, UAETerminal 2,Al TwarINN 123546683
DescriptionCountry of
originNet
weight/kg HS Code Qty (pieces) Unit price, USD Total price, USD
Total price, USD:
Insurance cost, USD:
Freight cost, USD:
Total for payment, USD:
Gross Weight (total):
Signed by:
Suit, mod, Business, art, 23840-27, trade mark Loops; wool(65%), silk(35%), lining
viscose(100%)
Italy,Lignano spa 5 kg 61042900 10
7,6 kg 6104290000 15
4 kg 6110111000 34
3,1 kg 3924909000 100
6,3 kg 4911101000 5
500
500
45
5
10
5000
7500
1530
500
50
14580
200
9500
24280
30 Kg
Signature, Stamp of CNOR
Italy,Lignano spa
China, BailihuaTrade ltd
Malaysia, Intertrade ltd
Italy, Masterprint
srl
Suit, mod, Business, art, 23840-29, trade mark Loops; wool(65%), silk(35%), lining
viscose(100%)
Sweater, mod, Holiday, trade mark Mosiac; wool(98%),
polyester(2%)
Brush for cleaning of clothes, plastic 100%
Catalogues Loops
Ship to (no private individual): Delivered under:Dubai, UAE Contact 110 dd 25.03.2010Elektra Street, Building 3, Gate 2, Of�ce 1001P.O.Box 7833 Payment terms 90 days from Invoice dateContact person: Vikram Mahef
Phone: + 971 56 1547700
Delivery terms (Incoterms): CIF
An invoice number is mandatory for the invoice.
Your Incoterms will also influence whether you include insurance and transport costs separately in the invoice.
HS Code essential as well as country of origin
Signature and company stamp
Realistic valuation required. Provide unit price as well as total price
Same currency throughout the invoice.
Description needs to be as detailed as possible - commodity name, intended use, part/serial numbers, materials, components, sizes etc,
The name and addresses should match the consignee’s registration documents.
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE BROKER ARRANGEMENTS
LEBANON
BROKER ARRANGEMENTS
1 .DHL does not have a broker license in Lebanon and must use the services of a 3rd party broker to clear shipments on behalf of the importer.
2. This is standard practice with the courier industry in Lebanon where shipment clearance is only possible through licensed brokers.
3. The importer has the option to use their own broker or to engage the services of the DHL broker.
4. If the cnee uses their own broker DHL will hand over the clearance documents to the nominated broker and they will be responsible for clearance and delivery of the shipment.
5. If the cnee uses the DHL broker we will be responsible for the clearance and delivery of the shipment.
6. Brokerage charges are based on shipments value and as follows:
JORDAN CUSTOMS GUIDE
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE BROKER ARRANGEMENTS
JORDAN
JORDAN
Gateways Amman Airport (Air & road)
Line Haul Commercial Air DHL road movement
DHL Clearance No – Broker clearance
Broker Handover Yes
DDP Yes
Deminimus US$0.00
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE BROKER ARRANGEMENTS
JORDAN
DOCUMENTATION REQUIREMENTS
The following documents are required to complete the clearance of a shipment into Jordan
1.Airwaybill
2.Detailed Commercial Invoice
3.Packing List
DHL can clear shipments up to US$100.00
DHL does not have a brokerage license to clear shipments >US$100.00 and instead use a 3rd party broker to clear shipments into Jordan.
The importer has the option to use the DHL broker or their own broker.
Note – the use of 3rd party brokers is industry practice in Jordan and all courier companies are operate in the same way
The importer may be required to provide Ministerial approvals for restricted products such as telecommunications equipment, drugs, food items, CD’s, publications, and chemicals to facilitate customs clearance.
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE BROKER ARRANGEMENTS
JORDAN
COMMERCIAL INVOICEInvoice on company letter headFOR DELIVERY OF COMMERCIAL GOODS (FOR SALE)
PRINTED ON CONSIGNOR’S LETTERHEAD SHOWING LEGAL ADDRESS
COMMERCIAL INVOICE
Invoice no 25Date 01/04/2010
Invoice Address (no private individuals):Dubai, UAETerminal 2,Al TwarINN 123546683
DescriptionCountry of
originNet
weight/kg HS Code Qty (pieces) Unit price, USD Total price, USD
Total price, USD:
Insurance cost, USD:
Freight cost, USD:
Total for payment, USD:
Gross Weight (total):
Signed by:
Suit, mod, Business, art, 23840-27, trade mark Loops; wool(65%), silk(35%), lining
viscose(100%)
Italy,Lignano spa 5 kg 61042900 10
7,6 kg 6104290000 15
4 kg 6110111000 34
3,1 kg 3924909000 100
6,3 kg 4911101000 5
500
500
45
5
10
5000
7500
1530
500
50
14580
200
9500
24280
30 Kg
Signature, Stamp of CNOR
Italy,Lignano spa
China, BailihuaTrade ltd
Malaysia, Intertrade ltd
Italy, Masterprint
srl
Suit, mod, Business, art, 23840-29, trade mark Loops; wool(65%), silk(35%), lining
viscose(100%)
Sweater, mod, Holiday, trade mark Mosiac; wool(98%),
polyester(2%)
Brush for cleaning of clothes, plastic 100%
Catalogues Loops
Ship to (no private individual): Delivered under:Dubai, UAE Contact 110 dd 25.03.2010Elektra Street, Building 3, Gate 2, Of�ce 1001P.O.Box 7833 Payment terms 90 days from Invoice dateContact person: Vikram Mahef
Phone: + 971 56 1547700
Delivery terms (Incoterms): CIF
An invoice number is mandatory for the invoice.
Your Incoterms will also influence whether you include insurance and transport costs separately in the invoice.
HS Code essential as well as country of origin
Signature and company stamp
Realistic valuation required. Provide unit price as well as total price
Same currency throughout the invoice.
Description needs to be as detailed as possible - commodity name, intended use, part/serial numbers, materials, components, sizes etc,
The name and addresses should match the consignee’s registration documents.
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE BROKER ARRANGEMENTS
JORDAN
BROKER ARRANGEMENTS
1. DHL does not have a broker license in Jordan and must use the services of a 3rd party broker to clear shipments on behalf of the importer.
2. This is standard practice with the courier industry in Jordan where shipment clearance is only possible through licensed brokers.
3. The importer has the option to use their own broker or to engage the services of the DHL broker.
4. If the cnee uses their own broker DHL will hand over the clearance documents to the nominated broker and they will be responsible for clearance and delivery of the shipment.
5. If the cnee uses the DHL broker we will be responsible for the clearance and delivery of the shipment.
6. Brokerage charges are based on shipments value and range from JD 40.00 to JD 60.00.
SYRIA CUSTOMS GUIDE
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE
SYRIA
SYRIA
Gateways Damascus Airport (Air)
Line Haul Commercial Air
DHL Clearance Yes
Broker Handover Yes
DDP No
Deminimus US$0.00
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE
SYRIA
DOCUMENTATION REQUIREMENTS
The following documents are required to complete the clearance of a shipment into Syria
1. Airwaybill
2. Detailed Commercial Invoice
3. Packing List
4. Certificate of Origin
Shipments > 50 kg ex China or manufactured in China should have a COO certified by Syrian Embassy in China
The importer may be required to provide Ministerial approvals for restricted products such as telecommunications equipment, drugs, food items, CD’s, publications, and chemicals to facilitate customs clearance.
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE
SYRIA
COMMERCIAL INVOICEInvoice on company letter headFOR DELIVERY OF COMMERCIAL GOODS (FOR SALE)
PRINTED ON CONSIGNOR’S LETTERHEAD SHOWING LEGAL ADDRESS
COMMERCIAL INVOICE
Invoice no 25Date 01/04/2010
Invoice Address (no private individuals):Dubai, UAETerminal 2,Al TwarINN 123546683
DescriptionCountry of
originNet
weight/kg HS Code Qty (pieces) Unit price, USD Total price, USD
Total price, USD:
Insurance cost, USD:
Freight cost, USD:
Total for payment, USD:
Gross Weight (total):
Signed by:
Suit, mod, Business, art, 23840-27, trade mark Loops; wool(65%), silk(35%), lining
viscose(100%)
Italy,Lignano spa 5 kg 61042900 10
7,6 kg 6104290000 15
4 kg 6110111000 34
3,1 kg 3924909000 100
6,3 kg 4911101000 5
500
500
45
5
10
5000
7500
1530
500
50
14580
200
9500
24280
30 Kg
Signature, Stamp of CNOR
Italy,Lignano spa
China, BailihuaTrade ltd
Malaysia, Intertrade ltd
Italy, Masterprint
srl
Suit, mod, Business, art, 23840-29, trade mark Loops; wool(65%), silk(35%), lining
viscose(100%)
Sweater, mod, Holiday, trade mark Mosiac; wool(98%),
polyester(2%)
Brush for cleaning of clothes, plastic 100%
Catalogues Loops
Ship to (no private individual): Delivered under:Dubai, UAE Contact 110 dd 25.03.2010Elektra Street, Building 3, Gate 2, Of�ce 1001P.O.Box 7833 Payment terms 90 days from Invoice dateContact person: Vikram Mahef
Phone: + 971 56 1547700
Delivery terms (Incoterms): CIF
An invoice number is mandatory for the invoice.
Your Incoterms will also influence whether you include insurance and transport costs separately in the invoice.
HS Code essential as well as country of origin
Signature and company stamp
Realistic valuation required. Provide unit price as well as total price
Same currency throughout the invoice.
Description needs to be as detailed as possible - commodity name, intended use, part/serial numbers, materials, components, sizes etc,
The name and addresses should match the consignee’s registration documents.
EGYPT CUSTOMS GUIDE
DOCUMENTATION REQUIREMENTS CUSTOMS CLEARANCE PAPERWORK SPECIAL APPROVALS FOR INBOUND SHIPMENTS COMMERCIAL INVOICE CERTIFICATE OF ORIGIN
EGYPT
EGYPT
Gateways Cairo Airport
Line Haul Commercial Air
DHL Clearance Yes
Broker Handover Yes
DDP No
Deminimus US$0.00
DOCUMENTATION REQUIREMENTS CUSTOMS CLEARANCE PAPERWORK SPECIAL APPROVALS FOR INBOUND SHIPMENTS COMMERCIAL INVOICE CERTIFICATE OF ORIGIN
EGYPT
DOCUMENTATION REQUIREMENTS
The following documents are required to complete the clearance of a shipment into Egypt
1. Airwaybill
2. Detailed Commercial Invoice
3. Packing List
4. Certificate of Origin
Required for shipments valued at >US$1,999.00
COO must be endorsed by the Egyptian Embassy
5. China (Origin only) shipper must issue Certificate of Inspections & Quarantine “CIQ”
6. Importation registration
7. Bank Transfer form ( proof of payment for commercial shipments).
8. Company or Private use forms
Under Egyptian Postal Authority regulations the maximum weight permissible under a single Airwaybill as a courier shipment into Egypt is 100 kilos. Shipments above 100 kilos will be transferred to main cargo for customs clearance incurring clearance delays of up to 5 days
The importer may be required to provide Ministerial approvals for restricted products such as telecommunications equipment, drugs, food items, CD’s, publications, and chemicals to facilitate customs clearance.
DOCUMENTATION REQUIREMENTS CUSTOMS CLEARANCE PAPERWORK SPECIAL APPROVALS FOR INBOUND SHIPMENTS COMMERCIAL INVOICE CERTIFICATE OF ORIGIN
EGYPT
CUSTOMS CLEARANCE PAPERWORK
Paperwork Required for investment Companies
Ministry Of Investment›s approval
Customs dealing Card Copy
Taxes Card Copy
Commercial Registration Card Copy
Authorization Letter Original
Paperwork Required for Petroleum Companies
EGPC declaration for exemption purposes
Customs dealing Card Copy
Non Exemption clearance process will require
Co’s registration Copy
Taxes Card Copy
Paperwork Required for Diplomatic Entities
Ministry Of Foreign Affairs approval required to release shipments without inspection & for duty exemption purposes.
Customs dealing Card Copy
Authorization Letter Original
Paperwork Required for Industrial Companies
Industrial License Copy
Customs dealing Card Copy
Taxes Card Copy
Commercial Registration Card Copy
Form 6 (For Company use)
Form 5 (For industrial use)
Bank form 4 for industrial use -declare value is + US$ 5,000.00
Paperwork Required for Commercial Companies
Import License Copy
Customs dealing Card Copy
Taxes Card Copy
Commercial Registration Card Copy
Internal use form stamped and signed
Bank Form 4 for industrial use where value >US$ 5,000.00
Authorization Letter Original
Paperwork Required for Free Zone Companies
Customs dealing Card Copy
Free Zone declaration original form
Paperwork Required for Repair & Return “R&R”
Customs dealing Card Copy
Taxes Card Copy
Commercial Registration Card Copy
126 KM original Form
R&R Invoice shows repair cost
Serial number must be engraved on all parts
If shipment arrives with a different serial number, customs will treat shipment as a new unit (subject to duty and taxes)
DOCUMENTATION REQUIREMENTS CUSTOMS CLEARANCE PAPERWORK SPECIAL APPROVALS FOR INBOUND SHIPMENTS COMMERCIAL INVOICE CERTIFICATE OF ORIGIN
EGYPT
SPECIAL APPROVALS FOR INBOUND SHIPMENTS
DESCRIPTION OF GOODS REGULATORY AUTHORITIES NAME
Food or food samples Ministry of Health
Seeds / Plants Ministry of Agriculture & Land Reclamation
Video cassettes, CDs, DVDs The Public Authority For Audio & Visual Works Censorship
Color printer, Scanners The Ministry of Interior Public Security Department
Telephones (regular/cellular) and telecom equipment, GPS Ministry Of TelecommunicationNational Telecommunication Regulatory Authority - “NTRA”
Satellite receiver Ministry Of Telecommunication
Books , Brochure, Magazine Ministry Of Culture
Drugs,medical product, Cosmetics: Dental instruments: Ministry of Health Population. Central Administration of Pharmaceutical Affairs
Films Films Import & Export Licenses Committee
Wooden products Ministry of Agriculture & Land Reclamation
DOCUMENTATION REQUIREMENTS CUSTOMS CLEARANCE PAPERWORK SPECIAL APPROVALS FOR INBOUND SHIPMENTS COMMERCIAL INVOICE CERTIFICATE OF ORIGIN
EGYPT
COMMERCIAL INVOICEInvoice on company letter headFOR DELIVERY OF COMMERCIAL GOODS (FOR SALE)
PRINTED ON CONSIGNOR’S LETTERHEAD SHOWING LEGAL ADDRESS
COMMERCIAL INVOICE
Invoice no 25Date 01/04/2010
Invoice Address (no private individuals):Dubai, UAETerminal 2,Al TwarINN 123546683
DescriptionCountry of
originNet
weight/kg HS Code Qty (pieces) Unit price, USD Total price, USD
Total price, USD:
Insurance cost, USD:
Freight cost, USD:
Total for payment, USD:
Gross Weight (total):
Signed by:
Suit, mod, Business, art, 23840-27, trade mark Loops; wool(65%), silk(35%), lining
viscose(100%)
Italy,Lignano spa 5 kg 61042900 10
7,6 kg 6104290000 15
4 kg 6110111000 34
3,1 kg 3924909000 100
6,3 kg 4911101000 5
500
500
45
5
10
5000
7500
1530
500
50
14580
200
9500
24280
30 Kg
Signature, Stamp of CNOR
Italy,Lignano spa
China, BailihuaTrade ltd
Malaysia, Intertrade ltd
Italy, Masterprint
srl
Suit, mod, Business, art, 23840-29, trade mark Loops; wool(65%), silk(35%), lining
viscose(100%)
Sweater, mod, Holiday, trade mark Mosiac; wool(98%),
polyester(2%)
Brush for cleaning of clothes, plastic 100%
Catalogues Loops
Ship to (no private individual): Delivered under:Dubai, UAE Contact 110 dd 25.03.2010Elektra Street, Building 3, Gate 2, Of�ce 1001P.O.Box 7833 Payment terms 90 days from Invoice dateContact person: Vikram Mahef
Phone: + 971 56 1547700
Delivery terms (Incoterms): CIF
An invoice number is mandatory for the invoice.
Your Incoterms will also influence whether you include insurance and transport costs separately in the invoice.
HS Code essential as well as country of origin
Signature and company stamp
Realistic valuation required. Provide unit price as well as total price
Same currency throughout the invoice.
Description needs to be as detailed as possible - commodity name, intended use, part/serial numbers, materials, components, sizes etc,
The name and addresses should match the consignee’s registration documents.
DOCUMENTATION REQUIREMENTS CUSTOMS CLEARANCE PAPERWORK SPECIAL APPROVALS FOR INBOUND SHIPMENTS COMMERCIAL INVOICE CERTIFICATE OF ORIGIN
EGYPT
CERTIFICATE OF ORIGIN
Certificate of origin is issued by the local chamber of commerce in IN THE ORIGIN COUNTRY and an invoice and the certificate of origin is legalized by the neareast Egypt Embassy or Consulate in the origin country.
When countries unite in trading agreements, they may allow Certificate of Origin to state the trading bloc as the origin, rather than the specific country i.e. EU.
For shipments that require a Certificate of Origin endorsement by the Chamber of Commerce of the Invoice is sufficient.
IRAQ CUSTOMS GUIDE
DOCUMENTATION REQUIREMENTS OIL & GAS IMPORTS FOR SOUTHERN IRAQ COMMERCIAL INVOICE CERTIFICATE OF ORIGIN
IRAQ
IRAQ
Gateways Basra, Baghdad and Erbil Airports
Line Haul DHL & Commercial Air
DHL Clearance Yes
Broker Handover Yes
DDP No
Deminimus US$
DOCUMENTATION REQUIREMENTS OIL & GAS IMPORTS FOR SOUTHERN IRAQ COMMERCIAL INVOICE CERTIFICATE OF ORIGIN
IRAQ
DOCUMENTATION REQUIREMENTS
The following documents are required to complete the clearance of a shipment into Iraq
1.Airwaybill
2.Detailed Commercial Invoice
3.Packing List
See separate slide on import requirements for the Oil and Gas industry in Southern Iraq.
The importer may be required to provide Ministerial approvals for restricted products such as telecommunications equipment, drugs, food items, CD’s, publications, and chemicals to facilitate customs clearance.
DOCUMENTATION REQUIREMENTS OIL & GAS IMPORTS FOR SOUTHERN IRAQ COMMERCIAL INVOICE CERTIFICATE OF ORIGIN
IRAQ
OIL & GAS IMPORTS FOR SOUTHERN IRAQ
Dutiable Shipments1. Commercial Invoice (English & translated into Arabic)2. Packing list (English & translated into Arabic)3. Certificate of Origin (endorsed by Iraqi Embassy)4. Certificate of Conformity (only were required by the Iraqi authorities)5. Import license from relevant ministry – based on the imported product (example: medicine – need approval from Ministry of Health)
Non Dutiable / South Oil Company (SOC) Contract1. Commercial Invoice (English & translated into Arabic)2. Packing list (English & translated into Arabic)3. Certificate of Origin (endorsed by Iraqi Embassy)4. Copy of the Contract with SOC (translated into Arabic)5. Letter from the consignee declaring whether shipment is temporary or permanent import (also needs to be translated into Arabic)6. Original HAirwaybill copy (provided by DHL)
Important Notes:Exemptions for O&G shipments are only applicable to importers/Consignees that have contracts with the SOC and the imported items are part of the agreed contracted list of items. SOC manage and regulate all O&G imports into the Southern Governate of Iraq and work hand in hand with the customs. SOC determine what paperwork and documentation are required in clearance and they are the only ones authorized to issue permits for exemption material in South Iraq. SOC Brokers are employees of SOC working for the SOC – they are not 3rd party independent brokers thus DHL cannot replace them or performtheir activities.
Any shipment arriving without a COO will be detained in customs and there will be a deposit fee of (Iraqi Dinar) ID 250,000 to ID 750,000 depending on the declared value. Be advised that values are reassessed by customs if deemed to low based on internal Iraqi Custom Guidelines.
If COO is not produced within 30 days – the deposit will be CONFISCATED and official receipt will be provided.
DOCUMENTATION REQUIREMENTS OIL & GAS IMPORTS FOR SOUTHERN IRAQ COMMERCIAL INVOICE CERTIFICATE OF ORIGIN
IRAQ
COMMERCIAL INVOICEInvoice on company letter headFOR DELIVERY OF COMMERCIAL GOODS (FOR SALE)
PRINTED ON CONSIGNOR’S LETTERHEAD SHOWING LEGAL ADDRESS
COMMERCIAL INVOICE
Invoice no 25Date 01/04/2010
Invoice Address (no private individuals):Dubai, UAETerminal 2,Al TwarINN 123546683
DescriptionCountry of
originNet
weight/kg HS Code Qty (pieces) Unit price, USD Total price, USD
Total price, USD:
Insurance cost, USD:
Freight cost, USD:
Total for payment, USD:
Gross Weight (total):
Signed by:
Suit, mod, Business, art, 23840-27, trade mark Loops; wool(65%), silk(35%), lining
viscose(100%)
Italy,Lignano spa 5 kg 61042900 10
7,6 kg 6104290000 15
4 kg 6110111000 34
3,1 kg 3924909000 100
6,3 kg 4911101000 5
500
500
45
5
10
5000
7500
1530
500
50
14580
200
9500
24280
30 Kg
Signature, Stamp of CNOR
Italy,Lignano spa
China, BailihuaTrade ltd
Malaysia, Intertrade ltd
Italy, Masterprint
srl
Suit, mod, Business, art, 23840-29, trade mark Loops; wool(65%), silk(35%), lining
viscose(100%)
Sweater, mod, Holiday, trade mark Mosiac; wool(98%),
polyester(2%)
Brush for cleaning of clothes, plastic 100%
Catalogues Loops
Ship to (no private individual): Delivered under:Dubai, UAE Contact 110 dd 25.03.2010Elektra Street, Building 3, Gate 2, Of�ce 1001P.O.Box 7833 Payment terms 90 days from Invoice dateContact person: Vikram Mahef
Phone: + 971 56 1547700
Delivery terms (Incoterms): CIF
An invoice number is mandatory for the invoice.
Your Incoterms will also influence whether you include insurance and transport costs separately in the invoice.
HS Code essential as well as country of origin
Signature and company stamp
Realistic valuation required. Provide unit price as well as total price
Same currency throughout the invoice.
Description needs to be as detailed as possible - commodity name, intended use, part/serial numbers, materials, components, sizes etc,
The name and addresses should match the consignee’s registration documents.
DOCUMENTATION REQUIREMENTS OIL & GAS IMPORTS FOR SOUTHERN IRAQ COMMERCIAL INVOICE CERTIFICATE OF ORIGIN
IRAQ
CERTIFICATE OF ORIGIN
Certificate of origin is issued by the local chamber of commerce in IN THE ORIGIN COUNTRY and an invoice and the certificate of origin is legalized by the neareast Iraq Embassy or Consulate in the origin country.
When countries unite in trading agreements, they may allow Certificate of Origin to state the trading bloc as the origin, rather than the specific country i.e. EU.
For shipments that require a Certificate of Origin endorsement by the Chamber of Commerce of the Invoice is sufficient.
AFGHANISTAN CUSTOMS GUIDE
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE INCOTERMS 2012
AFGHANISTAN
AFGHANISTAN
Gateways Kabul Airport
Line Haul DHL
DHL Clearance Yes
Broker Handover Yes
DDP No
Deminimus US$0.00
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE INCOTERMS 2012
AFGHANISTAN
DOCUMENTATION REQUIREMENTS
The following documents are required to complete the clearance of a shipment into Afghanistan
1. Airwaybill
2. Detailed Commercial Invoice
3. Packing List
4. Authorization letter for DHL to act as importers broker.
Approval from Kabul US Embassy is required to proceed with any import exemptions. Approval will be granted after letter of exemption is received from the Military/ISAF.
Exemption process takes an average of 2-3 weeks for standard cargo & 4-5 weeks for any medical shipments, military supplies
The importer may be required to provide Ministerial approvals for restricted products such as telecommunications equipment, drugs, food items, CD’s, publications, and chemicals to facilitate customs clearance.
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE INCOTERMS 2012
AFGHANISTAN
COMMERCIAL INVOICEInvoice on company letter headFOR DELIVERY OF COMMERCIAL GOODS (FOR SALE)
PRINTED ON CONSIGNOR’S LETTERHEAD SHOWING LEGAL ADDRESS
COMMERCIAL INVOICE
Invoice no 25Date 01/04/2010
Invoice Address (no private individuals):Dubai, UAETerminal 2,Al TwarINN 123546683
DescriptionCountry of
originNet
weight/kg HS Code Qty (pieces) Unit price, USD Total price, USD
Total price, USD:
Insurance cost, USD:
Freight cost, USD:
Total for payment, USD:
Gross Weight (total):
Signed by:
Suit, mod, Business, art, 23840-27, trade mark Loops; wool(65%), silk(35%), lining
viscose(100%)
Italy,Lignano spa 5 kg 61042900 10
7,6 kg 6104290000 15
4 kg 6110111000 34
3,1 kg 3924909000 100
6,3 kg 4911101000 5
500
500
45
5
10
5000
7500
1530
500
50
14580
200
9500
24280
30 Kg
Signature, Stamp of CNOR
Italy,Lignano spa
China, BailihuaTrade ltd
Malaysia, Intertrade ltd
Italy, Masterprint
srl
Suit, mod, Business, art, 23840-29, trade mark Loops; wool(65%), silk(35%), lining
viscose(100%)
Sweater, mod, Holiday, trade mark Mosiac; wool(98%),
polyester(2%)
Brush for cleaning of clothes, plastic 100%
Catalogues Loops
Ship to (no private individual): Delivered under:Dubai, UAE Contact 110 dd 25.03.2010Elektra Street, Building 3, Gate 2, Of�ce 1001P.O.Box 7833 Payment terms 90 days from Invoice dateContact person: Vikram Mahef
Phone: + 971 56 1547700
Delivery terms (Incoterms): CIF
An invoice number is mandatory for the invoice.
Your Incoterms will also influence whether you include insurance and transport costs separately in the invoice.
HS Code essential as well as country of origin
Signature and company stamp
Realistic valuation required. Provide unit price as well as total price
Same currency throughout the invoice.
Description needs to be as detailed as possible - commodity name, intended use, part/serial numbers, materials, components, sizes etc,
The name and addresses should match the consignee’s registration documents.
DOCUMENTATION REQUIREMENTS COMMERCIAL INVOICE INCOTERMS 2012
AFGHANISTAN
INCOTERMS 2012
MIDDLE EAST REGION CUSTOMS GUIDE
ADDITIONAL SERVICES GLOSSARY OF TERMS DISCLAIMER
ADDITIONAL SERVICES
Importer of Record DHL cannot act as an importer of recorder but can assist in identifying an entity that can act as an IOR in the destination country.
Repair & Return DHL can support repair and return services in most countries.
Temporary Import Services DHL can support temporary import services in most countries.
Documentation Services DHL can provide documentation services such as Certificate of Origin, SASO, Certificate of Conformity and invoice legalization either directly or through 3rd party service providers.
Break Bulk Services DHL can support Break Bulk services in a number of countries
Duty Exemptions DHL can support the importation of goods that are exempted from duty once the importer has the required exemption approvals.
Ministerial Approvals DHL can assist the importer in obtaining ministerial approvals but is unable to act on behalf of the importer where they are required to make the application directly with the relevant ministry / agency.
ADDITIONAL SERVICES GLOSSARY OF TERMS DISCLAIMER
GLOSSARY OF TERMS
Deliver Duty Paid (DDP) Duty is paid at destination and billed back to the shipper
Certificate of Origin (COO) Required in certain countries to demonstrate true origin of the shipment.
Authorization Letter (AL) Approval from the importer to permit DHL to act as their broker.
Importer of Record (IOR) Registered importer of goods into country of final destination.
ADDITIONAL SERVICES GLOSSARY OF TERMS DISCLAIMER
DISCLAIMER
The information included in this guide is designed to provide general guidance on the basic import requirements for countries in the Middle East region. It is not a definitive document and should be used primarily as a basic introduction to customs requirements across the region. Should a customer have more specific questions regarding import regulations and requirements the DHL customs and operational teams will be happy to respond in detail.
Procedures for Obtaining ICT Equipment Approval
The Communications and Information Technology Commission (CITC) is mandated by its Statutes to
license ICT equipment to be used in the Kingdom of Saudi Arabia. Any party desiring to get equipment
approval of any wireline or wireless ICT equipment is required to follow the following procedures.
First Step: Equipment Approval Application Form
1. Complete the Equipment Approval Application Form on the CITC website www.citc.gov.sa for
each piece of equipment of one model.
2. Print out the application form on the official letterhead of the organization or company.
3. Attach the following documents to the application form:
1. Detailed technical information and catalogues of the equipment, including description of
the mechanism by which the equipment and its accessories will be operated, the planned
applications, and data related to the public network interface characteristics and
compatibility.
2. Declaration of Conformity from a test lab accredited by the International Laboratory
Accreditation Cooperation (ILAC) that the equipment conforms to the international
standards approved by CITC.
3. Certification from the manufacturer including an undertaking that the equipment
conforms to the CITC technical specifications. The certification must be signed by an
authorized officer of the manufacturer.
4. A report certified by the test labs providing details of the approved tests that were
performed for the equipment and the results of those tests.
5. A statement identifying the names and addresses of the test labs and the dates the tests
were conducted. If the tests were conducted by independent test labs, names of the
countries that have accredited the test labs for the equipment should also be indicated.
6. If the equipment supports encryption systems, provide the details of the equipment types
from the manufacturer.
7. CITC may require the equipment supplier to provide a sample for testing.
Second Step: Application Submission
After completing the application with all required documents, it should be hand delivered or
mailed to the following address:
Technical Standards and Type Approval Department, Technical Affairs Sector,
Communications and Information Technology Commission, King Fahad Road, Rahmaniya
District, PO Box 75606, Riyadh 11588, Kingdom of Saudi Arabia; Tel +966‐14618000. It may
also be hand delivered to one of the CITC branches. Acknowledgement of receipt of the
documents should be obtained from the receiver at CITC if hand delivered.
Third Step: Application Follow‐up
CITC will send the result of the tests to the applicant either by regular mail, fax or email.
Equipment Approval Request Form جهازنموذج طلب اعتماد :Date: Request No :التاريخ :رقم الطلب
Information on the enterprise submitting the قدمة الطلب مالجهةمعلومات application
:Name of the enterprise :الجهةاسم
الرمز /ب .ص( :)البريدي
Postal Code:
:Tel :الهاتف
:Fax :الفاآس
:E-mail :البريد اإللكتروني
:Contact Person :المسئول اإلداري
:Mobile Phone :الهاتف المتنقل
لها شهادة المطابقةالصادرة معلومات الجهةInformation on the enterprise to which conformity Certificate will be issued:
:Name of the enterprise :اسم الجهة
Device Details بيانات الجهاز
:Product Name :اسم المنتج
:Product model :موديل المنتج
:Manufacturer :الشرآة المصنعة
:Product Description :وصف عمل المنتج
رقم مواصفة الهيئة :المطابقة للجهاز
CITC Technical Specification Number:
Additional Details بيانات إضافية
:Operating Frequency :الترددات المستخدمة
قدرة الخرج القصوى )ERIP:(
Maximum Transmit Power (ERIP):
Antenna Gain :آسب الهوائي
اقر أنا الموقع أدناه بأن آافة البيانات المذآورة أعاله :صحيحة
I, the undersigned that all the above statements are true:
Applicant's Name اسم مقدم الطلب
Applicant's Signature توقيع مقدم الطلب
ختمال لالستعمال الرسمي
For official use
Stamp
Sort by: None
Number Type Category Approval Name
AI001 Analog Interface PSTN Equipment connecting to the Analogue PSTN
AI003 Analog Interface DSL Equipment connecting to ADSL, ADSL2 and ADSL2+ Services
DI001 Digital Interface Digital Interface Equipment connecting to 2.048 Mb/s Digital Leased Line Services
DI002 Digital Interface Digital Interface Equipment connecting to 34 Mb/s Digital Leased Line Services
DI003 Digital Interface Digital Interface Equipment connecting to Co-directional G.703 Digital Leased Line Services
DI004 Digital Interface Digital Interface Equipment connecting to X.25 Packet Switched Networks
DI005 Digital Interface Digital Interface Equipment connecting to High Speed Serial Interfaces (HSSI)
DI006 Digital Interface Digital Interface Equipment connecting to 64Kbit/s Services
DI007 Digital Interface Digital Interface Equipment connecting to X.21 Services
DSL001 Digital Subscriber Line
Digital Interface Equipment connecting to SHDSL Services
GEN001 General General
Glossary General
IT001 Information Technology
General IT Equipment
IT002 Information Technology
Voice over IP Voice over IP Equipment ( Private usage only )
IT003 Information Technology
Radio Links Laser P-P-Links Equipment
IT004 Information Technology
Fibre Optics Fibre Optics Equipment
IT005 Information Technology
Receivers Receivers with Internet Support
RI001 Radio Interface GSM GSM Handsets, Terminals and Ancillary Equipment
RI002 Radio Interface GSM GSM Base Station and Ancillary Equipment
RI003 Radio Interface Paging Paging terminals and Ancillary Equipment
RI004 Radio Interface Paging Paging Base Stations and Ancillary Equipment
RI009 Radio Interface PMR Analogue PMR handsets and Ancillary Equipment
RI010 Radio Interface PMR Analogue PMR base stations Ancillary Equipment
RI011 Radio Interface TETRA TETRA handsets and Ancillary Equipment
RI012 Radio Interface TETRA TETRA base stations and Ancillary Equipment
RI013 Radio Interface TETRAPOL TETRAPOL handsets and Ancillary Equipment
RI014 Radio Interface TETRAPOL TETRAPOL base stations and Ancillary Equipment
RI015 Radio Interface APCO APCO 25 handsets and Ancillary Equipment
RI016 Radio Interface APCO APCO 25 base stations and Ancillary Equipment
RI017 Radio Interface iDEN iDEN handsets and Ancillary Equipment
RI018 Radio Interface iDEN iDEN base stations and Ancillary Equipment
RI019 Radio Interface Citizens’ Band Citizens’ Band radio and Ancillary Equipment
RI021 Radio Interface Amateur Radio Amateur Radio and Ancillary Equipment
RI022 Radio Interface Mobile satellite Mobile satellite service (MSS) <1GHz Terminals and Ancillary Equipment
RI023 Radio Interface Mobile satellite Mobile satellite service (MSS) > 1GHz Terminals and Ancillary Equipment
RI025 Radio Interface Mobile satellite SPCN Mobile Satellite Service (MSS) Terminals and Ancillary Equipment
RI026 Radio Interface V-SAT V-SAT Terminals and Ancillary Equipment
RI027 Radio Interface other Satellite News Gathering (SNG) Transportable Earth Stations and Ancillary Equipment
RI028 Radio Interface other SIT and SUT Terminals and Ancillary Equipment
RI029 Radio Interface Radio MF Radio MF (AM) Broadcast Services Equipment and Ancillary Equipment
RI030 Radio Interface Radio MF Radio MF (FM) Broadcast Services Equipment and Ancillary Equipment
RI031 Radio Interface Radio Links Point to Point (PP) Radio Fixed Links
RI032 Radio Interface Radio Links Multipoint (PMP) Radio Fixed Links
RI033 Radio Interface other Wireless Local Loop Subscriber Equipment
RI034 Radio Interface other Wireless Local Loop Base Stations and Ancillary Equipment
RI035 Radio Interface other Broadband Wireless Access Subscriber equipment, Base Stations and Ancillary Equipment
RI037 Radio Interface other Wireless Telemetry Equipment
RI038 Radio Interface other Analogue Cordless Telephones, Base Stations and Ancillary Equipment
RI040 Radio Interface DECT DECT Cordless Telephones Handsets and Ancillary Equipment
RI041 Radio Interface DECT DECT Base Stations and Ancillary Equipment
RI044 Radio Interface SRD Radio Microphones/In-Ear Monitoring and Ancillary Equipment
RI045 Radio Interface other Wideband Data Transmission systems and Ancillary Equipment
RI048 Radio Interface Detection of Movement
Detection of Movement Equipment, Tanks Level Probing Radar Applications and Ancillary Equipment (Radio determination Applications)
RI049 Radio Interface other Road Transport, Traffic Telematics and Ancillary Equipment
RI050 Radio Interface SRD Inductive Applications and Ancillary Equipment
RI051 Radio Interface other Ground and Airborne Model Control Equipment
RI052 Radio Interface SRD Radio Hearing Aids
RI053 Radio Interface other Wireless Audio Applications Equipment
RI054 Radio Interface SRD Non-Specific Short Range Devices and Ancillary Equipment
RI055 Radio Interface SRD Radio Frequency Identification (RFID) Equipment
RI056 Radio Interface UMTS UMTS (3G) handsets and related Equipment
RI057 Radio Interface UMTS UMTS (3G) Handsets Base Stations and Related Equipment
RI058 Radio Interface WiMAX WiMAX Subscriber equipment, Base Stations and Ancillary Equipment
RI080 Radio Interface other Tracking, Tracing and Data Acquisition Equipment
RI081 Radio Interface other Avalanche Beacons
RI082 Radio Interface SRD Alarms
RI083 Radio Interface SRD Medical devices
RI084 Radio Interface other Animal implantable devices
RI085 Radio Interface SRD Ultra Wideband Equipment
RI086 Radio Interface Broadcasting Broadcasting DAB Transmitting Equipment
RI087 Radio Interface Broadcasting Broadcasting DVB Transmitting Equipment
RI088 Radio Interface other Digital Radio Mondiale (DRM) Equipment
RI089 Radio Interface Powerline Powerline Equipment
RI090 Radio Interface Navigation Navigation (Air) Equipment
RI091 Radio Interface Navigation Navigation (Ground) Equipment
RI092 Radio Interface Navigation Navigation (Water) Equipment
RI093 Radio Interface GSM Alarm Systems with GSM
RI094 Radio Interface other Wireless beamer
RI095 Radio Interface SRD Cameras with radio Interfaces
RI096 Radio Interface other Emergency Beacons
RI101 Radio Interface SRD Wireless HD Equipment
RI102 Radio Interface other GPS Receiver
RI103 Radio Interface SRD Bluetooth Equipment
RI104 Radio Interface SRD Zigbee Equipment
RI105 Radio Interface WiFi WiFi Router with WiMAX
RI106 Radio Interface WiFi WiFi Router with UMTS (3G)
RI108 Radio Interface other Software Defined Radio Equipment (SDR)
RI109 Radio Interface Receivers DAB, DVB and DRM Broadcasting Receivers
RI110 Radio Interface GSM Encryption GSM Equipment
R I111 Radio Interface other Automatic Identification System (AIS) Equipment
بموجب الصالحيات الممنوحة لها وفقا ألنظمتها ) الهيئة(تعتبر هيئة االتصاالت وتقنية المعلومات
هي الجهة المسئولة عن إصدار التراخيص الالزمة الستخدام أجهزة االتصاالت وتقنية المعلومات ية ألجهزة االتصاالت وتقنفسح جمرآي أية جهة ترغب في الحصول على ويتعين علىبالمملكة،
:إتباع اإلجراءات التاليةالمعلومات
لغير مشغلي - أجهزة محجوزة بالجمرك وترخيص فسحنموذج نموذج طلب : أوال شبكات االتصاالت العامة
لغير مشغلي شبكات االتصاالت - أجهزة محجوزة بالجمرك وترخيصفسحطلب " تعبئة نموذج .1
:آالتالي sa.gov.citc.www موقع الهيئة االلكترونيالمنشور على "العامة :الشحنةبيانات - أ
البيانات الخاصة بالجهة الموردة للشحنة باإلضافة إلى البيانات المعرفة للشحنة مع إيضاح هي . إليه الشحنة من حيث االستخداملمن تعود
:الشحنةمحتويات - بدها، وعند امتالء الخانات بجدول بمحتويات الشحنة فإنه يانات األجهزة المراد استيراتفاصيل ب
.يتطلب إضافة صفوف جديدة للجدول :الغرض من استيراد األجهزة المضمنة بالشحنة - ت
.إيضاح سبب استيراد هذه الشحنة .اإلقرار - ث
. صحة المعلومات المدونة بالنموذجتحمل مسئولية . الشرآةطباعة الطلب على الورق الرسمي الخاص بالمؤسسة أو .2 :إرفاق الوثائق التالية .3
.)Airway bill (صورة من بوليصة الشحن - أ .)Packing list(صورة من بيان التعبئة - ب .)Invoices (الفواتيرمن صورة - تاألجهزة والكتالوجات الخاصة بتلك)Technical Specification(البيانات الفنية التفصيلية - ث
المتعلقة اتالتطبيقات المزمعة لها والبيانوصف آللية عمل األجهزة وملحقاتها و شاملة .لالتصاالت العامة مع الشبكاتةموالموائ بخصائص الربط
تتضمن التعهد بأن األجهزة (Declaration of Conformity)شهادة من الجهة المصنعة - جالمعنية تطابق المواصفات الصادرة عن هيئة االتصاالت و تقنية المعلومات، على أن يتم توقيع
.وآذلك المورد لشهادة من قبل صاحب الصالحية لدى الجهة المصنعةامن الشرآة المصنعة ما يوضح األجهزة تدعم أنظمة تشفير فإنه يلزم موافاتنا آانتفي حال - ح
.نوع هذه األنظمة :آما يجب توفير الوثائق التالية في حال تم طلبها من قبل الهيئة - خ
ص التي تم فيها إجراء الفحوصات على األجهزة بيان يوضح أسماء وعناوين مختبرات الفح .1المعنية مع إيضاح تاريخ إجراء الفحوصات، وذلك في الحاالت التي تكون األجهزة قد تم
فحصها في مختبرات مستقلة مع إيضاح أسماء الدول التي اعتمدت المختبرات التي قامت .بإجراء الفحوصات
تقرير معتمد يوضح تفاصيل الفحوصات التي تم إجراؤها على األجهزة ونتائج تلك .2وعلى المورد االحتفاظ لديه بنتائج الفحوصات وإبرازها لدى طلبها من قبل . الفحوصات
.الهيئة
تعهدات:ثانيا
طلب وفي حال .sa.gov.citc.www موقع الهيئة االلكترونيالمنشورة على قائمة التعهداتيرجع إلى ) الشرآة/المؤسسة(توقيع أي تعهد من التعهدات فإنه يلزم طباعتها على األوراق الرسمية الخاصة بـ .مع إرفاق صورة من السجل التجاري و صورة من بطاقة أحوال الموقع على التعهد
استيراد أجهزة لطرف آخر :ثالثا
عائد إلحدى الجهات الحكومية او غير الحكومية مشروعسيجري توريدها ضمن إذا آانت األجهزة
وطبيعة يوضح ملكيتها لهذه األجهزةفيجب على المورد إرفاق خطاب من الجهة المستفيدة . األجهزةاتاستخدامها ويدون بالخطاب رقم بوليصة الشحنة وموديالت وآمي
أخرىرخص: رابعا
مثل ( من الهيئة مسبقةاستيرادها يتطلب استخدامها الحصول على رخصةإذا آانت األجهزة المراد
، فيجب )رخصة تقديم خدمة أو رخصة استخدام طيف ترددي أو رخصة جهاز اتصاالت السلكي .ترخيص ساري المفعولذلك الإرفاق صورة من
الكشف الفني: خامسا
راء الفحوصات عليهاقد تطلب الهيئة من مورد األجهزة تزويدها بعينه منها ألج. ينبغي على الجهة الموردة األمر الكشف على الشحنة المحجوزة بالجمرك فإنه تطلبفي حال
.القيام بحجز األجهزة في قسم المحجوزات بالجمرك، تمهيدا للكشف الفني تتطلب في حال أن الشحنة المحجوزة المراد الكشف عليها تحتوي على أجهزة اتصاالت السلكية
. العائد لها الشحنة الترددات المخصصة للجهةفإنه يلزم ضبط تردداتها على ترددات، تخصيص يجوز للهيئة أخذ عينات من الشحنة المراد الكشف عليها.
تقديم الطلب: سادسا
:يرسل هذا الطلب إلى العنوان التالي/ بعد إآمال الطلب مع جميع الوثائق المطلوبة يسلم – هيئة االتصاالت وتقنية المعلومات - قطاع الشئون الفنية -ية واعتماد النوعية إدارة المعايير الفن , المملكة العربية السعودية11588 الرياض 75606ب . ص- حي الرحمانية -طريق الملك فهد
.أو احد فروعها واستالم رقم للمعاملة , )+966-1-4618000هاتف (
متابعة الطلب :سابعا ب عن طريق الحضور للمرآز الرئيسي للهيئة أو أحد فروعها أو االتصال على يمكن متابعة الطل
+).966-1-4618000(الهاتف رقم يتم إرسال إذن الفسح إلى المنفذ الجمرآي مباشرة، وتزود الجهة الموردة بصورة من إذن الفسح
.للمتابعة، وذلك عن طريق البريد السريع دة بذلكفي حال التعذر يتم إبالغ الجهة المور .
لغير مشغلي شبكات االتصاالت العامة- أجهزة محجوزة بالجمرك وترخيص فسحنموذج طلب
:التاريخ :الرقم سعادة نائب المحافظ للشؤون الفنية
السالم عليكم ورحمة اهللا وبرآاته .طلب وفقا لألنظمة المعمول بها في الهيئةهذا الاسة لذا آمل من سعادتكم در, أفيدآم بأننا استوردنا األجهزة حسب البيانات المدونة باألسفل
,,,نا تحياتتقبلواو
الشحنةبيانات اسم الجهة مقدمة الطلب
الهاتف العنوان عنوان الجهة مقدمة الطلب
الرمز البريدي المدينة ب.ص الفاآس
إيصال الحجز/ رقم البوليصة
رقم الفاتورة
الشحنة به ة المحجوزالمنفذ الجمرآي
الجهة العائدة إليها الشحنة
الشحنةمحتويات ذه األعمدة في حال آون األجهزة السلكيةتعبأ ه
اسم المنتج Product Name
نوع الجهازDevice Type
الموديلModel
الشرآة المصنعةManufacturer
الكميةQuantity
الترددات التي يعمل عليها الجهاز
Operating Frequencies
قدرة الخرجOutput Power
آسب الهوائيAntenna Gain
1
2
3
4
5
6
: ةالغرض من استيراد األجهزة المضمنة بالشحن
الختم
:اقر أنا الموقع أدناه بأن آافة البيانات المذآورة أعاله صحيحة
اسم المسئول اإلداري
)جوال(رقم االتصال
التوقيع
لالستعمال الرسمي
)رق الرسمي لهافي حال آون مقدم الطلب شرآة أو مؤسسة يتم طباعة النموذج على الو: (يرسل هذا الطلب إلى العنوان التالي/ يسلم -1 (4618000هاتف , المملكة العربية السعودية11588 الرياض 75606ب . ص- حي الرحمانية- طريق الملك فهد- هيئة االتصاالت وتقنية المعلومات - قطاع الشئون الفنية -إدارة المعايير الفنية واعتماد النوعية
966(
Item that require SASO (Pre export CRF)
GROUP I - Toys
No. Item HS Code
I-01
Toys and Playground Equipment 9501/9502/9503/9505/From 9506.99/9508/From 3407/8712.00
GROUP II - Electronics and Electrical Products
No. Item HS Code
II-01 Air conditioning systems up to 60,000 BTU (5 tons)
8415.10.20 / 8415.81.20 / 8415.82.20/ 8415.83.20
II-02 Combined function audio and/or video systems(non-professional)
8518.30 / 8518.50 / 8520.30/ Combinations of II-03, II-04, II-41, II-43
II-03 Non-professional stand-alone audio products(except radio receivers)
8518.21 / 8518.22 / 8518.29 / 8518.40 / 8519.21 / 8519.29 / 8519.31 / 8519.39 / 8519.92 / 8519.93 / 8519.99 / 8520.20 / 8520.90
II-04 Video playing and recording systems(non-professional)
8521.10 / 8521.90 / 8525.40
II-05 Generator sets up to12 KW 8502.11 / 8502.20
II-06 Motors up to12 KW 8501.10 / 8501.31 / 8501.32
/ 8501.40 / 8501.51 / 8501.52
II-07 Fax and telex machines 8517.21 / 8517.22
II-08 Household cooking appliances 8516.60 / 8516.72
II-09 Clothes washing machines up to 10 KG
8450.11 / 8450.12 / 8450.19
II-10 Clothes drying machines up to 10 KG
8451.21
II-11 Electric irons, ironers and clothes steamers and hand-held hair dryers
8516.31 / 8516.32 / 8516.40
II-12 Food processors (non-industrial) 8509.40 / 8509.80
II-13 Meat choppers and grinders (non-industrial) 8509.40
II-14 Lift and elevator systems 8428.10 / 8431.31
Page 1 of 5
Item that require SASO (Pre export CRF)
II-15 Household microwave ovens 8516.50
II-16 Electric ovens up to 10 KW 8516.60
II-17 Copy machines 9009.11 / 9009.12 / 9009.30 / 9009.21 / 9009.22
II-18 Computers (desktops and portables) and monitors
8471.41 / 8471.49 / 8471.50 / 8471.60 / 8471.70 / 8471.80 / 8473.30
II-19 Power transformers and distribution transformers up to 1,000 KVA
8504.21 / 8504.22 / 8504.31 / 8504.32 / 8504.33 / 8504.34
II-20 Household refrigerators and freezers up to 40 cubic feet
8418.10 / 8418.21 / 8418.22 /8418.29 / 8418.30 / 8418.40
II-21 Telephone sets and modems 8517.19 / 8517.50
II-22 Electric wires and cables up to 1,000V
8544.51 / 8544.59
II-23 Non-industrial vacuum cleaners, water suction appliances and shampooers
8509.10 / 8509.80
II-24 Household electric fires and heaters
8516.21/8516.29
II-25 Drinking water coolers and fountains
8418.69.10
II-26 Evaporative air coolers (desert coolers) up to 1.5 KW
8415.10.10 / 8415.82.10 / 8415.82.90 / 8415.83.10 / 8415.83.90
II-27 Domestic electric fans 8414.51 / 8414.60
II-28 Compressors for cooling units up to 60,000 BTU
8414.30
II-29 Tea and coffee brewing appliances and appliancesfor heating liquids
8516.10 / 8516.71
II-30 Incandescent, fluorescent and discharge luminaires, fixtures, and lampholders
8536.61/ 9405.10 / 9405.20
II-31 Manually operated switches, circuit breakers and fuses up to 30A
8536.10 / 8536.20 / 8536.50
II-32 Incandescent, tubular fluorescent and discharge lamps
8539.21 / 8539.22 / 8539.29 / 8539.31 / 8539.32
II-33 Ballasts for discharge type lamps 8504.10
Page 2 of 5
Item that require SASO (Pre export CRF)
(including tubular fluorescent lamps)
II-34 Starters for discharge type lamps (including tubular fluorescent lamps)
8532.29 / 8536.50
II-35 General use mains plugs, socket outlets and mains configuration adapters
8536.69
II-36 Luminaires for road and street lighting
9405.40
II-37 Batteries 8506.10 / 8506.30 / 8506.40 / 8506.50/ 8506.60 / 8506.80 / 8507.10 / 8507.30 / 8507.40
II-38 Immersed swimming pool luminaires
9405.40
II-39 Battery terminals and jump cables 8536.90 / 8544.41
II-40 Water pumps up to 12 KW 8413.70
II-41 T.V. sets (color and black/white) 8528.12 / 8528.13
II-42 General use mains voltage converters and power supplies
8504.40
II-43 Stand alone radio receivers 8527.12 / 8527.13 / 8527.19 / 8527.21 / 8527.29
II-44 Storage type water heaters up to 200 liters
8516.10
II-45 Watt hour meters 9028.30
II-46 Cordless telephone sets 8517.11 / 8525.20
II-47 Domestic pressure cookers, including non-electric
7323.93 / 7323.99 / 7615.10
Page 3 of 5
Item that require SASO (Pre export CRF)
GROUP III - Automotive Products
No. Item H.S. Code
III-01a Passenger automobiles, trucks buses and multi-purpose vehicles (new)
8701 / 8702 / 8703 / 8704 / 8705
III-01b Passenger automobiles, trucks, buses and multi-purpose vehicles (used)
8701 / 8702 / 8703 / 8704 / 8705
III-02 Automotive glass (windshield, side, and rear glass)
7007.21
III-03 Automotive brake fluid 2710.00.94 / 3819
III-04 New tires for passenger automobiles, trucks, buses and multi-purpose vehicles
4011.10 / 4011.20 / 4012.10
GROUP IV - Chemical Products
No. Item H.S. Code
IV-01 Engine, transmission, hydraulic, turbine, and transformer oils
2710.00.52 / 2710.00.53 / 2710.00.54 / 2710.00.55 / 2710.00.95 / 2710.00.96
IV-02 Paints All 3208 / All 3209
IV-03 Perfumes and cosmetics 3302.90 / All 3303 / All 3304 / All 3305 / All 3306 / 3307.10 / 3307.20 / 3307.30 / 3307.49.10 / 3307.90.10 / 3401.11
IV-04 Domestic use pesticides and insecticides
3808
Page 4 of 5
Item that require SASO (Pre export CRF)
Page 5 of 5
GROUP V - Others
No. Item H.S. Code
V-01 Aluminum and aluminum alloy products for architectural application
7604 / 7606 / 7608 / 7609 / 7610 / 7616
V-02 Steel and iron alloy pipes 7304 / 7305 / 7306 / 7307
V-03 Gold and silver jewelry (including gemstones)
7113.11 / 7113.19 7113.20 / 7114.11 / 7114.19 / 7114.20
V-04 Head dress for men -- cotton shimaghs 6505.91.0
V-05 Fire extinguishers up to 24 KG 8424.10
V-06 Cement 2523.21 / 2523.29.10 / 2523.29.20
V-07 Safety matches 3605.00
V-08 Low pressure regulators for domestic gas cylinders
8481.80.30
V-09 Facial tissue paper 4803 / 4818.20
V-10 Cigarettes only 2402.20
Version 2
GGGuuuiiidddaaannnccceee fffooorrr SSSuuubbbmmmiiissssssiiiooonnn
July 2009
July 2009
Saudi Food & Drug Authority 2009 2
GGGuuuiiidddaaannnccceee fffooorrr SSSuuubbbmmmiiissssssiiiooonnn Version 2
Drug Sector
Saudi Food & Drug Authority
Kingdome of Saudi Arabia
Please visit SFDA’s website at http://www.sfda.gov.sa/En/Drug for the latest update
July 2009
Saudi Food & Drug Authority 2009 3
Drug Sector
Vision & Mission
Vision
To be the leading regional Drug Regulatory Authority for pharmaceuticals and safety of cosmetic products, with professional excellence and services that contribute to the protection and advancement of public health in the Kingdom of Saudi Arabia.
א
،א א א א אא אא אאאאK
Mission
Protecting public health by ensuring safety, quality, efficacy and accessibility of human, veterinary drugs and biological products, and safety of cosmetics, through administration of a national regulatory system which is consistent with international best practice. Through our mission, we also provide accurate and scientific‐based information to the public and healthcare professionals.
א
אאאאאאאא א א א א א
אאאאא.
July 2009
Saudi Food & Drug Authority 2009 4
Document Control
Version Date Author(s) Comments 1.0 11/05/2009 Licensing department Initial draft for internal consultation
1.1 20/05/2009 Licensing department Draft revision 1.2 06/06/2009 Licensing department Draft revision 1.3 28/06/2009 Licensing department Revisions after management
discussion 2.0 08/07/2009 Licensing department Published for comments
July 2009
Saudi Food & Drug Authority 2009 5
Table of Contents
Document Control ............................................................................................................ 4
Table of Contents ............................................................................................................... 5
1 Introduction ................................................................................................................ 7
2 Scope ............................................................................................................................ 8
3 Registration Process ................................................................................................ 9
4 Structure and Content of Submission .....................................................................13
5 Presentation of the Product File ..............................................................................16
5.1 Hardcopy and Softcopy Requirements: ................................................................... 16
5.3 MEDIA ....................................................................................................................... 18
5.3.1 System compatibility: ........................................................................................ 18
5.4 Security ..................................................................................................................... 19
5.4.1 Password protection: ......................................................................................... 19
5.4.2 Virus protection: ................................................................................................ 19
6 Document Requirements .......................................................................................20
6.1 Legibility and Size ..................................................................................................... 20
6.2 Pagination................................................................................................................. 20
6.3 Language .................................................................................................................. 20
6.4 Authentication .......................................................................................................... 20
Appendices .......................................................................................................................21
Appendix A: Data Requirements ................................................................................. 21
Appendix B: Electronic Version of the Paper‐Based Submission ............................. 29
Appendix C: File Formats ............................................................................................. 30
Appendix D: ICH Common Technical Document ........................................................ 34
Appendix E: Target Performance Timelines .............................................................. 37
Appendix F: Required Quantities of Samples ................................................................. 38
Appendix G: References ............................................................................................... 39
Appendix H: Contact Address ...................................................................................... 40
Appendix I: Price List ................................................................................................... 41
Appendix J: Cover Letter .............................................................................................. 42
Appendix K: Laboratory Samples Form ...................................................................... 43
Appendix L: Abbreviation and Acronyms ................................................................... 44
July 2009
Saudi Food & Drug Authority 2009 6
July 2009
Saudi Food & Drug Authority 2009 7
1 Introduction
The Drug Sector in the Saudi Food & Drug Authority (SFDA) has developed
this document, "Guidance for Submission" to assist applicants and industry in the
preparation and submission of drug applications for new Marketing Authorization
(MA) as well as renewals and variations to existing products to the SFDA. The
guidance provides an outline of the way the Framework will be managed with
respect to drug applications by the SFDA.
It is intended to provide clarification to applicants of the way in which the Drug
Sector in the SFDA manage information and material submitted in accordance with
the Regulatory framework for Drug Approvals (version 4). Also, it provides
assistance to comply with the requirements of filing and maintenance of their
application.
Industry representatives, as well as the staff of the SFDA responsible for the
drug application management, will follow this guidance and operational directions
in various areas, including the handling of application information, procedure
related to drug assessment, clarification and performance target of drug
assessments.
To maintain its consistency and enhanced transparency, this guidance will be
updated regularly to reflect the current practices in regulatory sciences. It is
expected that this guidance and any amendments to it will create efficiency in the
drug application management and reduce the number of clarification requests.
It should be noted that the SFDA has the right to request any information and
data within the context of this guidance in order to assess adequately the safety,
efficacy and quality of any medicinal products available in the Kingdom of Saudi
Arabia. The SFDA is committed to ensuring that such requests are justifiable and
decisions are clearly documented.
July 2009
Saudi Food & Drug Authority 2009 8
2 Scope
This guidance document applies to all drug submission types:
• Generics
• New drugs (NCE and Known Active Substances)
• Biologics
• Radiopharmaceuticals
• Herbal & Health products
• Veterinary products
• Renewal of MA
• Variations type I & II
All submitted information and material will be screened to ensure that it is
complete and of suitable quality to be reviewed. The same management principles
will be applied consistently to all submission types.
This guidance document covers the preparation and filling requirements for
submissions in paper-based CTD and electronic format. It is based on the ICH
CTD and the eCTD Specifications, and the SFDA Regulatory Framework for Drug
Approval.
This guidance document DOES NOT currently apply to Clinical Trials
Application.
July 2009
Saudi Food & Drug Authority 2009 9
3 Registration Process
All Applications will be subjected to the following procedures:
1. Online Filing of Application
The applicant shall fill up the appropriate application form in the SFDA
website. Once completed, application form cannot be submitted unless the
payment details are entered into the system. A reference number will be
assigned to the application once submitted to facilitate the communication with
the SFDA. Then, the applicant will be given an opportunity to book an
appointment to hand over the drug application (figure 1). The earliest
appointment is 1 week, up to 12 weeks in advance. An automatic reminder will
be sent 3 days before the appointment. The applicant can reschedule a week
before the chosen appointment. If it is missed, the earliest appointment that can
be booked is one month after the missed one.
Figure 1: A “Drug Application” includes the application form, the product file and the drug
samples.
2. Acceptance of Drug Application
Upon receipt of the drug application in the appointment day, a checklist for
‘Phase I Validation’ will be used to verify that the information and materials
provided are complete.
July 2009
Saudi Food & Drug Authority 2009 10
a. Drug application Without Deficiencies:
The applicant will be notified of the acceptability by printing an
Acknowledgement Letter. Then, the drug application will be forwarded
to the product manager (Licensing Department) for further processing
and assessment. Once these applications are accepted, they will be
assessed in the order in which they are received.
b. Drug application With Deficiencies:
If deficiencies are identified, an Acknowledgment Letter stating the
deficiencies will be issued. The applicant will be required to submit the
requested information within 60 days from the date of the letter. The
applicant will be given only ONE opportunity to complete the file.
• If the applicant has provided the requested information within
60 days, the application will be accepted and the applicant will
be notified of the acceptability by e-mail. The drug application
will be forwarded to the product manager for further processing
and assessment.
• If the applicant has provided the requested information within
60 days but it was found to be still incomplete, the application
will be rejected and the applicant will be required to file a new
application. An acknowledgment letter will be provided to the
applicant.
• If the applicant fails to provide the requested information within
60 days, the drug application will be rejected and securely
disposed of.
3. Phase II Validation
After accepting the drug application from the applicant, the submitted
information and material will be validated to ensure that it has suitable quality
to be assessed. However, if deficiencies are identified, the applicant will be
asked to submit the required information, and it will follow one of the
following cases:
July 2009
Saudi Food & Drug Authority 2009 11
• If the applicant has provided the requested information within
60 days, the product file will be forwarded for further
processing and assessment. The applicant will be notified by e-
mail.
• If the applicant has provided the requested information within
60 days but it was found to be still incomplete, SFDA will study
the case and may extend the period for another maximum 30
days. The applicant will be notified by e-mail.
• If the applicant fails to provide the requested information within
60 days, the drug application will be rejected and securely
disposed of.
4. Assessment of Application
All applications will be assessed in terms of quality, safety and efficacy –
as needed – depending on the type of the product.
If issues are identified during the assessment, these issues will be resolved
through electronic Inquiry Forms. Although there is no limitation of inquiries,
it is expected that these issues be resolved by two to three inquiries. Responses
to inquiries are required within 30 days.
5. Pricing
The pricing will be calculated according to the pricing rules outlined in the
pricing guideline.
6. Testing
All drug products will be subjected to appropriate testing according to the
type of the application and dosage form, to ensure the quality of the products as
required by Drug Law. Moreover, the applicant is requested to deliver the
samples to SFDA headquarters as part of the drug application. There will be no
direct contact between the applicant and SFDAs laboratory.
July 2009
Saudi Food & Drug Authority 2009 12
7. Inspection
The head of the inspection unit will communicate with the applicant to
decide the appropriate time for inspection – if needed, depending on the
schedules of the inspectors. After the inspection is done, an inspection report
will be written and a copy of this report will be sent to the applicant. In case of
deficiencies, further details will follow.
8. Stop-clock
The stop-clock starts whenever SFDA issues an Inquiry Form. Inquiries
may be raised at any time from the Phase II Validation to SFDA decision. The
stop-clock ends whenever SFDA receives complete and acceptable responses
from the applicant.
If the applicant faces difficulties in responding to inquiries within the
specified time, applicant should contact SFDA as soon as possible. A drug
application will be considered rejected if the stop-clock time exceeds the SFDA
deadline.
9. SFDA Decision
The final decision is made based on the outcome of SFDA's assessment,
pricing, testing and inspection. The decision can be one of the following:
• Approval: when the drug application has satisfied the registration requirements for quality, safety and efficacy.
• More information is needed: when the drug application has minor deficiencies.
• Rejection: when the drug application has not satisfied the registration requirements.
10. Appeal Process
The applicant will have the right to appeal within 30 days against the SFDA
decision. The relevant guidance will be published soon.
July 2009
Saudi Food & Drug Authority 2009 13
4 Structure and Content of Submission
4.1 Structure of Submission:
The SFDA will require all applicants to submit their applications in
accordance to the ICH Common Technical Document (CTD) format. For more
information on the CTD, please refer to appendix D.
The dossier requirements for each application will differ, depending on the
type of application. The table below outlines the CTD Modules required for all
types of applications:
CTD Modules
Type of drug submission
1 2 3 4 5
Generics R1 P2 R P P
New drugs R R R R R
Biologics R R R R R
Radiopharmaceutical R R R R R
Herbal & Health product R P R P P
4.2 Content of Submission
The content will differ from a drug type to another. For more details, see
appendix A.
It is important to remember that the CTD provides a format for an MAA and
does not indicate the content of a dossier and which studies should be performed.
Regional and national requirements may affect the content of the dossier; therefore
the dossier will not necessarily be identical for all regions.
1 R: Required 2 P: Partially required
July 2009
Saudi Food & Drug Authority 2009 14
Relevant guidelines, such as Stability guideline, should be followed in
providing the information or studies. For updated guidelines, visit the SFDA
website.
4.3 Module 1: Regional Administrative Information
This module includes the regional required information specific to SFDA, such
as administrative information and certificates. The information to be provided are
identified below and includes:
• 1.0 Cover letter:
The applicant shall include a cover letter for each drug type submission. A
template is provided in appendix J.
• 1.1 Comprehensive table of contents (ToC):
The ToC for the entire submission should list all documents included in
Module 1 and the contents of Modules 2 to 5 to the level of detail or
‘granularity’ defined in the Organization of the Common Technical
Document guidance.
• 1.2 Application Form:
The completed and signed Application Form should be presented in this
section.
• 1.3 Product Information:
This section contains the Summary of Product Characteristics (SPC),
Labeling, Patient information leaflet (PIL) in Arabic and English, Artwork
and the samples. SPC, Labeling and PIL information shall follow the WHO
templates.
• 1.4 Information on the Experts:
The relevant quality, non-clinical and clinical expert declaration(s),
signature(s) and CV(s) must be provided – if applicable, corresponding to
the Overview/Summary submitted in Module 2.3, 2.4 and 2.5 respectively.
July 2009
Saudi Food & Drug Authority 2009 15
• 1.5 Environmental Risk Assessment:
The application for MA shall be accompanied by an environmental risk
assessment, evaluating any potential risks of the medicinal product to the
environment. Such risk may include those arising from use, storage
disposal and synthesis or manufacture of medicinal products.
• 1.6 Pharmacovigilance:
It shall contain a detailed description of the pharmacovigilance system
including the proof that the applicant has the services of a qualified person
responsible for pharmacovigilance and the necessary means for the
notification of any adverse reaction.
• 1.7 Certificates:
This section contains different type of required certificates such as
Certificate of Pharmaceutical Product (CPP), certificate of analysis and
others.
• 1.8 Pricing:
It should contain the price of the product in countries listed in appendix I.
• 1.9 Responses to questions:
The applicant answers on the SFDA questions shall be placed here. This
part is only applicable to eCTD submissions.
July 2009
Saudi Food & Drug Authority 2009 16
5 Presentation of the Product File
BOTH the hard-copy (paper-based) and soft-copy (electronic-based) of the
product file shall be submitted by applicants. The hard-copy shall be in the CTD
structure. Whereas, the soft-copy shall be either as:
a. eCTD (appendix D), or
b. An electronic version of the paper-based submission in a specific
structure (appendix B).
5.1 Hardcopy and Softcopy Requirements:
For the hardcopy (paper-submission), the full dossier should be bound into
one volume (ring binder) or more according to the number of pages. For every
300 pages, one volume is needed.
The ring binder specifications:
A4 D-ring 2-ring binder (box file)
Binder Dimensions: width 26.5cm, height 34cm and thickness
7.5cm (26.5 X 34 cm X 7.5 cm)
Label: should contain the following information (figure 2):
1. Reference number (generated from the system)
2. Company name
3. Product trade name
4. Product Generic name
5. Date of submission (DD/MM/YYYY)
6. Number of volumes
7. Type of submission (e.g. new, renew or variation)
If more than one volume is needed, avoid spanning the content of a
Part or a Module of the dossier over two volumes - if applicable.
Tabs should be used to separate the modules
July 2009
Saudi Food & Drug Authority 2009 17
For the softcopy (electronic-submission), each CD or DVD submitted should
include the following label information, clearly presented and printed on the
media:
• The label should be printed on the CD with the font of 12 Times New
Roman
• The reference number
• The company name
• The product trade name
• The Generic name
• Date of submission (DD/MM/YYYY)
• Number of media units per full set and an indication of the place of the
individual CD/DVD within this set (e.g. 1(4), 2(4)...)
• The submission type of each submission(s) contained on the CD/DVD
(e.g. Initial Application, Variation Type II)
• The sequence number(s) of the eCTD submissions contained on the
CD/DVD (when applicable)
5.2 Number of copies:
Applicants should submit TWO softcopies (identical) and ONE hardcopy of
the product file for all drug submission types. However, in case of NCE,
HG00015-00-00-00 Company ABCDE
Trade Name® Generic Name
01/06/2009 1 of 2
New application
Figure 2: the binder label information
July 2009
Saudi Food & Drug Authority 2009 18
biologicals and biosimilars only module 1, 2 & 3 are required as a hardcopy
(i.e. the softcopy will contain all the CTD structure).
5.3 MEDIA
The electronic submission may only be submitted in CD or DVD (single or
dual layer). The disc must not be bootable or have auto-start programs. Two
electronic copies are required to be submitted.
Applicant must provide the electronic information on the smallest number
of media units possible, taking into consideration the size of the submission.
Currently both CD-ROM and DVD ISO 9660 are considered an acceptable
media standard.
If more than one CD-ROM or DVD is needed, avoid spanning the content
of a Part or a Module of the dossier over two CD-ROMs or DVDs.
Hard media (e.g. CD, DVD) must be used for the submission of all CTD
documents and eCTDs. It is appreciated that it may be necessary at certain
times in the evaluation process, to submit certain documents via email in the
first instance in order to ensure that the documents are received by SFDA in a
timely manner. However, it is expected to receive an exact copy of the same
submission on hard media as soon as possible, and this electronic submission
will become the formal SFDA record. The electronic submission will be
appropriately processed once received on hard media. The SFDA strongly
advises that eCTD sequences should ONLY be submitted via CD or DVD as
far as possible to ensure that only one communication channel is used.
However, the SFDA will not accept any hardware (laptops, desktops,
thumb drives, hard drive, floppy discs etc.) from applicants in connection with
the electronic submission.
5.3.1 System compatibility:
The electronic submission (as provided) must be directly readable and
usable on SFDA hardware and software.
Although it is the policy of the SFDA to maintain desktop
configurations and IT infrastructure in line with common office standards,
July 2009
Saudi Food & Drug Authority 2009 19
the electronic information provided in the submission must not only be
readable on the latest operating system, but support a reasonable number of
backward versions of windows operating systems.
5.4 Security
There are various aspects related to security. The physical security of the
submission during transportation/transmission is the responsibility of the applicant.
Once received within the SFDA, security and submission integrity is the sole
responsibility of the SFDA. In this respect, it should be noted that the SFDA will
take appropriate measures to prevent loss, unauthorized duplication and/or access
or theft of regulatory information presented both on paper and electronic media
that are distributed throughout the SFDA.
5.4.1 Password protection:
One-time security settings or password protection of electronic submissions
for security purposes is not acceptable during transportation/transmission
from the applicant to the SFDA.
Applicants should also not include any file level security settings or
password protection for individual files in the electronic submission.
Applicants should allow printing, annotations to the documents, and
selection of text and graphics. The Internal security and access control
processes in the SFDA maintain the integrity of the submitted files.
5.4.2 Virus protection:
The applicant is responsible for checking the submission for viruses.
Checking must be performed with an up-to-date and well-recognized virus-
checker.
After receipt of the submission at the SFDA, a similar internal virus check
will be performed. If a virus is detected it can constitute grounds for refusal
of the electronic submission.
July 2009
Saudi Food & Drug Authority 2009 20
6 Document Requirements
6.1 Legibility and Size
All documents should be legible. The page size, including tables, shall be
uniform.
6.2 Pagination
The pagination may be sequential for the entire submission or by volume.
Cross-references should include both volume and page number.
6.3 Language
Information and documents supporting a drug application – such as
certificates and approval letters– must be either in Arabic or English. If
documents are neither in Arabic nor English, a translation to English from an
authorized translation office and authentication from the Saudi Embassy in the
COO are required.
6.4 Authentication
Authentication – also known as legalization – refers to the process whereby
the origins of a document are attested. Authentication of documents are made
to SFDA by the Health authority and/or the Ministry of Foreign affairs in the
country of origin, in addition to the Saudi Arabia Embassy or Consulate where
the document was issued.
Certificates that must be authenticated are:
1. CPP or Free Sale Certificate
2. Certificate of analysis
3. Pork-free declaration
4. Price List
July 2009
Saudi Food & Drug Authority 2009 21
Appendices
Appendix A: Data Requirements
The data requirements for each application will differ, depending on the drug submission type. However, all the required data should be in accordance with the CTD structure.
• In case of New Chemical Entity (NCE), Biologicals and Biosimilars ALL the CTD Modules are required.
• On the other hand the table below outlines the CTD Modules required for Generics (Human and Veterinary) Herbal & Health products3:
G: Generics R: Required H: Herbal & Health products O: Optional4
Section Requirements G H
Module 1 Regional Administrative Information
1.0 Cover letter R R 1.1 Comprehensive Table of content R R 1.2 Application Form R R 1.3 Product Information 1.3.1 Summary of Product Characteristics (SPC) R R 1.3.2 Labeling R R 1.3.3 Patient information leaflet (PIL)
1.3.3.1 Arabic leaflet R R 1.3.3.2 English leaflet R R
1.3.4 Artwork (Mock-ups) R R 1.3.5 Samples R R
1.4 Information on the experts 1.4.1 Quality O O 1.4.2 Non-Clinical O O 1.4.3 Clinical O O
1.5 Environmental Risk Assessment 1.5.1 Non-Genetically Modified Organism (Non-GMO) O O 1.5.2 GMO O O
1.6 Pharmacovigilance 1.6.1 Pharmacovigilance System R R 1.6.2 Risk Management Plan O
1.7 Certificates 1.7.1 CPP or Free-sales R R 1.7.2 Certificate of analysis – Drug Substance R R 1.7.3 Certificate of analysis – Excipients O O 1.7.4 Alcohol-free declaration R R 1.7.5 Pork-free declaration R R
3 Blank fields are not required at this stage or not applicable for that specific drug submission type. 4 Optional means that it might not be needed at this stage
July 2009
Saudi Food & Drug Authority 2009 22
Section Requirements G H 1.7.6 The diluents and coloring agents in the product formula R R 1.7.7 Patent Information R R
1.8 Pricing 1.8.1 Price list R R 1.8.2 Other documents related O O
1.9 Responses to questions R R
Module 25 Common Technical Document Summaries
2.1 Table of Contents of Module 2-5 2.2 Introduction 2.3 Quality Overall Summary Introduction
2.3.S Drug substance 2.3.S.1 General Information 2.3.S.2 Manufacture 2.3.S.3 Characterization 2.3.S.4 Control of Drug Substance 2.3.S.5 Reference Standards or Materials 2.3.S.6 Container/Closure System 2.3.S.7 Stability
2.3.P Drug Product 2.3.P.1 Description and Composition of the Drug Product 2.3.P.2 Pharmaceutical Development 2.3.P.3 Manufacture 2.3.P.4 Control of Excipients 2.3.P.5 Control of Drug Product 2.3.P.6 Reference Standards or Materials 2.3.P.7 Container/Closure System 2.3.P.8 Stability
2.3.A Appendices 2.3.A.1 Facilities and Equipment 2.3.A.2 Adventitious Agents Safety Evaluation 2.3.A.3 Novel Excipients
2.3.R Regional Information 2.4 Nonclinical Overview 2.5 Overview of the Nonclinical Testing Strategy 2.5.1 Product Development Rationale 2.5.2 Overview of Biopharmaceutics 2.5.3 Overview of Clinical Pharmacology 2.5.4 Overview of Efficacy 2.5.5 Overview of Safety 2.5.6 Benefits and Risks Conclusions
5 Module 2 Should reflect the information provided in modules 3, 4 and 5.
July 2009
Saudi Food & Drug Authority 2009 23
Section Requirements G H 2.5.7 References
2.6 Non clinical written and tabulated summaries: Pharmacology, pharmacokinetics Toxicology
2.6.1 Introduction 2.6.2 Pharmacology Written Summary
2.6.2.1 Brief Summary 2.6.2.2 Primary Pharmacodynamics 2.6.2.3 Secondary Pharmacodynamics 2.6.2.4 Safety Pharmacology 2.6.2.5 Pharmacodynamic Drug Interactions 2.6.2.6 Discussion and Conclusions 2.6.2.7 Tables and Figures
2.6.3 Pharmacology Tabulated Summary 2.6.4 Pharmacokinetics Written Summary
2.6.4.1 Brief Summary 2.6.4.2 Methods of Analysis 2.6.4.3 Absorption 2.6.4.4 Distribution 2.6.4.5 Metabolism (interspecies comparison) 2.6.4.6 Excretion 2.6.4.7 Pharmacokinetic Drug Interactions 2.6.4.8 Other Pharmacokinetic Studies 2.6.4.9 Discussion and Conclusions 2.6.4.10 Tables and Figures
2.6.5 Pharmacokinetics Tabulated Summary 2.6.6 Toxicology Written Summary
2.6.6.1 Brief Summary 2.6.6.2 Single-Dose Toxicity 2.6.6.3 Repeat-Dose Toxicity 2.6.6.4 Genotoxicity 2.6.6.5 Carcinogenicity 2.6.6.6 Reproductive and Developmental Toxicity 2.6.6.7 Local Tolerance 2.6.6.8 Other Toxicity Studies (if available) 2.6.6.9 Discussion and Conclusions 2.6.6.10 References
2.6.7 Toxicology Tabulated Summary 2.7 Clinical Summary
2.7.1 Summary of Biopharmaceutic and Associated Analytical Methods 2.7.1.1 Background and Overview 2.7.1.2 Summary of Results of Individual Studies 2.7.1.3 Comparison and Analyses of Results Across Studies 2.7.1.4 Appendix
July 2009
Saudi Food & Drug Authority 2009 24
Section Requirements G H 2.7.2 Summary of Clinical Pharmacology Studies
2.7.2.1 Background and Overview 2.7.2.2 Summary of Results of Individual Studies 2.7.2.3 Comparison and Analyses of Results Across Studies 2.7.2.4 Special Studies 2.7.2.5 Appendix
2.7.3 Summary of Clinical Efficacy 2.7.3.1 Background and Overview of Clinical Efficacy 2.7.3.2 Summary of Results of Individual Studies 2.7.3.3 Comparison and Analyses of Results Across Studies
2.7.3.3.1 Study Populations 2.7.3.3.2 Comparison of Efficacy Results Across All Studies 2.7.3.3.3 Comparison of Results in Sub-Populations
2.7.3.4 Analysis of Clinical Information Relevant to Dosing Recommendations
2.7.3.5 Persistence of Efficacy and/or Tolerance Effects 2.7.3.6 Appendix
2.7.4 Summary of Clinical Safety 2.7.4.1 Exposure to the Drug
2.7.4.1.1 Overall Safety Evaluation Plan and Narratives of Safety Studies 2.7.4.1.2 Overall Extent of Exposure 2.7.4.1.3 Demographic and Other Characteristics of Study Population
2.7.4.2 Adverse Events 2.7.4.2.1 Analysis of Adverse Events by Organ System or Syndrome 2.7.4.2.2 Narratives
2.7.4.3 Clinical Laboratory Evaluations 2.7.4.4 Vital Signs, Physical Findings, Observations Related to Safety 2.7.4.5 Safety in Special Groups and Situations
2.7.4.5.1 Intrinsic Factors 2.7.4.5.2 Extrinsic Factors 2.7.4.5.3 Drug Interactions 2.7.4.5.4 Use in Pregnancy and Lactation 2.7.4.5.5 Overdose 2.7.4.5.6 Drug Abuse 2.7.4.5.7 Withdrawal and Rebound 2.7.4.5.8 Effects on Ability to Drive or Operate Machinery or Impairment
of Mental Ability
2.7.4.6 Post-Marketing Data 2.7.4.7 Appendix
2.7.5 References 2.7.6 Synopses of Individual Studies
Module 3 Quality
July 2009
Saudi Food & Drug Authority 2009 25
Section Requirements G H 3.1 Table of Contents of Module 3 R R 3.2 Body of data
3.2.S Drug Substance 3.2.S.1 General Information
3.2.S.1.1 Nomenclature R R 3.2.S.1.2 Structure R R 3.2.S.1.3 General Properties R R
3.2.S.2 Manufacture 3.2.S.2.1 Manufacturer(s) R R 3.2.S.2.2 Description of Process and Process Controls R O
3.2.S.2.3 Control of Materials R O
3.2.S.2.4 Control of Critical Steps and Intermediates R O 3.2.S.2.5 Process Validation and/or Evaluation R O 3.2.S.2.6 Manufacturing Process Development R O
3.2.S.3 Characterization 3.2.S.3.1 Elucidation of Structure and Other Characteristics R O 3.2.S.3.2 Impurities R R
3.2.S.4 Control of Drug Substance 3.2.S.4.1 Specifications R O 3.2.S.4.2 Analytical Procedures R O 3.2.S.4.3 Validation of Analytical Procedures R O 3.2.S.4.4 Batch Analyses R R 3.2.S.4.5 Justification of Specification R O
3.2.S.5 Reference Standards or Materials R O 3.2.S.6 Container/Closure Systems R O 3.2.S.7 Stability
3.2.S.7.1 Stability Summary and Conclusions R O 3.2.S.7.2 Post-approval Stability Protocol and Commitment R O 3.2.S.7.3 Stability Data R O
3.2.P Drug Product 3.2.P.1 Description and Composition of the Drug Product R R 3.2.P.2 Pharmaceutical Development
3.2.P.2.1 Components of the Drug Product 3.2.P.2.1.1 Drug substance R R 3.2.P.2.1.2 Excipients R R
3.2.P.2.2 Drug Product 3.2.P.2.2.1 Formulation Development O O 3.2.P.2.2.2 Overages R R 3.2.P.2.2.3 Physiochemical and Biological Properties R R
3.2.P.2.3 Manufacturing Process Development R R 3.2.P.2.4 Container Closure System R R 3.2.P.2.5 Microbiological Attributes R R 3.2.P.2.6 Compatibility O O
July 2009
Saudi Food & Drug Authority 2009 26
Section Requirements G H 3.2.P.3 Manufacture
3.2.P.3.1 Manufacturer(s) R R 3.2.P.3.2 Batch Formula R R 3.2.P.3.3 Description of Manufacturing Process and Process Controls R R 3.2.P.3.4 Controls of Critical Steps and Intermediates R O 3.2.P.3.5 Process Validation and/or Evaluation R O
3.2.P.4 Control of Excipients 3.2.P.4.1 Specifications R R 3.2.P.4.2 Analytical Procedures R R 3.2.P.4.3 Validation of Analytical Procedures R R 3.2.P.4.4 Justification of Specifications R R 3.2.P.4.5 Excipients of Human or Animal Origin R R 3.2.P.4.6 Novel Excipients R R
3.2.P.5 Control of Drug Product
3.2.P.5.1 Specifications R R 3.2.P.5.2 Analytical Procedures R R 3.2.P.5.3 Validation of Analytical Procedures R R 3.2.P.5.4 Batch Analyses R R 3.2.P.5.5 Characterization of Impurities R R 3.2.P.5.6 Justification of Specifications R R
3.2.P.6 Reference Standards or Materials R R 3.2.P.7 Container/Closure System R R
3.2.P.8 Stability
3.2.P.8.1 Stability Summary and Conclusions R R 3.2.P.8.2 Post-Approval Stability Protocol and Stability Commitments R R 3.2.P.8.3 Stability Data R R
3.2.A Appendices
3.2.A.1 Facilities and Equipment O O 3.2.A.2 Adventitious Agents Safety Evaluation O O 3.2.A.3 Excipients R R
3.2.R Regional Information 3.2.R.1 Alcohol Content Declaration R R 3.2.R.2 Porcine/Pork – content/origin R R 3.2.R.3 The diluents and coloring agents in the product formula
3.3 Literature References R R
Module 4 Non-Clinical Study Reports
4.1 Table of Contents of Module 4 R 4.2 Study Reports
4.2.1 Pharmacology 4.2.1.1 Primary Pharmacodynamics R 4.2.1.2 Secondary Pharmacodynamics R
July 2009
Saudi Food & Drug Authority 2009 27
Section Requirements G H 4.2.1.3 Safety Pharmacology R 4.2.1.4 Pharmacodynamic Drug Interactions R
4.2.2 Pharmacokinetics 4.2.2.1 Analytical Methods and Validation Reports R 4.2.2.2 Absorption R 4.2.2.3 Distribution R 4.2.2.4 Metabolism R 4.2.2.5 Excretion R 4.2.2.6 Pharmacokinetic Drug Interactions R 4.2.2.7 Other Pharmacokinetic Studies R
4.2.3 Toxicology R 4.2.3.1 Single-Dose Toxicity R 4.2.3.2 Repeat-Dose Toxicity R 4.2.3.3 Genotoxicity
4.2.3.3.1 In vitro Studies 4.2.3.3.2 In vivo Studies
4.2.3.4 Carcinogenicity 4.2.3.4.1 Long Term Studies 4.2.3.4.2 Short or medium term studies 4.2.3.4.3 Other studies
4.2.3.5 Reproductive and Development Toxicity 4.2.3.5.1 Fertility and Embryonic Development 4.2.3.5.2 Embryo-Fetal Development 4.2.3.5.3 Pre- and Post-natal Development & Maternal Function 4.2.3.5.4 Offspring, Juvenile, Second & Third-Generation Studies
4.2.3.6 Local Tolerance 4.2.3.7 Other Toxicity Studies
4.2.3.7.1 Antigenicity 4.2.3.7.2 Immunogenicity 4.2.3.7.3 Mechanistic Studies (not included elsewhere) 4.2.3.7.4 Dependence 4.2.3.7.5 Metabolites 4.2.3.7.6 Impurities 4.2.3.7.7 Other
4.3 Literature References O O
Module 5 Clinical Study Reports
5.1 Table of Contents of Module 5 R R 5.2 Tabular Listing of All Clinical Studies R R 5.3 Clinical Study Reports
5.3.1 Reports of Biopharmaceutic Studies 5.3.1.1 Bioavailability (BA) Study Reports R O 5.3.1.2 Comparative BA & BE Study Reports R O
July 2009
Saudi Food & Drug Authority 2009 28
Section Requirements G H 5.3.1.3 In vitro/In vivo Correlation (IV/IVC) study reports R O 5.3.1.4 Reports of Bioanalytical and Analytical Methods for Human studies R R
5.3.2 Reports of Studies Pertinent to Pharmacokinetics using Human Biomaterials
5.3.2.1 Plasma Protein Binding Study Reports O 5.3.2.2 Reports of Hepatic Metabolism and Drug Interactions studies O 5.3.2.3 Reports of Studies Using other Human Biomaterials O
5.3.3 Reports of Human Pharmacokinetic Studies
5.3.3.1 Healthy Subject PK and Tolerability
5.3.3.2 Patient PK and Initial Tolerability
5.3.3.3 Intrinsic Factor PK Study Reports
5.3.3.4 Extrinsic Factor PK Study Reports 5.3.3.5 Population PK Study Reports
5.3.4 Reports of Human Pharmacodynamic (PD) Studies 5.3.4.1 Healthy Subject PD and PK/PD Study Reports 5.3.4.2 Patient PD and PK/PD Study Reports
5.3.5 Reports of Efficacy and Safety Studies 5.3.5.1 Study reports of Controlled Clinical Studies pertinent to the claimed
Indication
5.3.5.2 Study reports of Uncontrolled Clinical Studies 5.3.5.3 Reports of Analyses of Data from More than One Study 5.3.5.4 Other Study Reports
5.3.6 Reports of Post-Marketing Experience R R 5.3.7 Case Report Forms and Individual Patient Listings R R
5.4 Literature References R R
July 2009
Saudi Food & Drug Authority 2009 29
Appendix B: Electronic Version of the PaperBased Submission
The electronic version of the paper-based submission is the submission of electronic information by applicants to support a marketing authorization application.
It is formatted as a simple set of electronic files and folders organized into module folders as per the CTD structure.
How to create an electronic version?
1. Create a folder and name it as:
“Product name – Reference No.”.
For example, “Drug AAA – HG-00253-00-00-00”
2. Inside that folder, create 5 new folders and name it from m1 to m5 (figure 3).
3. Copy the related documents of module 1 and paste it in the folder m1 (figure 4).
4. Repeat step 3 for all modules.
5. After finishing, burn the product file to a CD or a DVD and name it as in step 1.
Figure 3: View of the product file after creation of m1 to m5
Figure 4: View of the product file after creation of m1
July 2009
Saudi Food & Drug Authority 2009 30
Appendix C: File Formats
General requirements:
Generally, the relevant information must be structured according to the requirements of the Common Technical Document (CTD). The following files formats are accepted:
• XML
• Word and RTF6 file formats, but only in addition to a PDF-file of the same document.
• For graphics: Joint Photographic Experts Group (JPEG), Portable Network Graphics (PNG), Scalable Vector Graphics (SVG) or Graphic Interchange Format (GIF).
Please refer to the Status of the Common Technical Document Guidelines:
http://www.ich.org/cache/compo/276-254-1.html
Portable Document Format:
PDF is an open, de facto, published format created by Adobe Systems Incorporated (http://www.adobe.com). It is not necessary to use a product from Adobe or from any specific company to produce PDF documents. PDF is accepted as a standard for documents defined in this specification. The following recommendations support the creation of PDF files that agencies can review effectively. To ensure that PDF files can be accessed efficiently, PDF files should be no larger than 100 megabytes. Optimize PDF files for fast web view.
The following points can be made in relation to PDF files:
• Files must be legible with PDF version 1.4
• PDF files produced from an electronic source document are highly preferred over PDF files produced from scanned paper, since those 'electronic' PDF files provide the maximum functionality to the reviewers in terms of search and print capabilities, and copy and paste functionality. The overviews/summaries in the CTD Module 2 should always be generated from an electronic source document.
• If scanning is unavoidable, readability and file size must be balanced; the following is recommended: resolution 300 dpi (photographs up to 600 dpi), avoid grayscale or color where possible, use only lossless compression techniques.
6 Rich Text Format (often abbreviated RTF) is a document file format
July 2009
Saudi Food & Drug Authority 2009 31
• If colors other than black are used, the colored pages must be tested on a black and white printer for acceptable reproduction and legibility prior to submission.
• Print area for pages must fit on an A4 sheet of paper; margins must allow binding in multi-ring binders without affecting readability.
• Landscape-oriented tables must automatically appear in landscape on screen.
Indexing PDF Documents:
The software installed in the SFDA for reviewing use full text indexes to help find specific documents and/or search for text within documents. When a document or group of documents is indexed, all words and numbers in the file and all information stored in the Document
Information fields are stored in special index files that are functionally accessible using the search tools available in Acrobat. Portions of a document that are imaged are not indexed.
These full text indexes should not be confused with a table of contents.
Extensible Markup Language (XML):
XML is developed by a working group of the World Wide Web Consortium (W3C). It is an open-source language developed to improve on previous mark-up languages including Standard Generalized Markup Language (SGML) and Hypertext Markup Language (HTML).
Additional details on XML can be found in the ICH eCTD Specification Document.
Text Searchable Files:
Applicants are requested to ensure that all submissions contain the maximum amount of text searchable content. Documents with searchable text will aid the assessor, or any other user, in searching for specific terms and also in copying and pasting information into another document, such as an assessment report. The SFDA recognizes that not all documents need to be text searchable. This appendix provides some guidance about what must be text searchable and the ways to ensure that files are created appropriately.
July 2009
Saudi Food & Drug Authority 2009 32
Documents that must always be text searchable:
The PDF should be produced wherever possible from a text source, such as MS Word, but if sourced from a scanned original then they must be OCR’d.
• Key administrative documents in Module 1 including, the cover letter, application form, SPC, labeling documents
• Any document in Module 2 of the submission (QOS, Preclinical Overview and Summaries, Clinical Overview and Summaries).
• The main body of text of Periodic Safety Update Reports (PSURs)
• The main body of text of Risk Management Plans
• The main body of text and main tables in any preclinical or clinical report required to support the main claim of the application.
• The main body of text in any reports, methods, analytical procedures, etc. supplied in Module 3 of the submission
Documents that do not need to be text searchable:
The PDF should be produced wherever possible from a text source, such as MS Word, but if sourced from a scanned original then there is no need for OCR.
• Any original Certificate of Pharmaceutical Product
• Any original Certificate that confirm that the product is free from BSE/TSE
• Any original GMP certificate
• Any original certificate of analysis
• Any manufacturer’s licenses
• Any certificates of suitability
• Any Manufacturing Authorization
• Any literature references sourced from journals, periodicals and books (except when these are used in a bibliographic application so support the main claims of the application).
• Any page with a signature that does not contain other information key to the understanding of the submission
• Applicants should consider providing signatures on separate pages from key text in reports, overviews, etc.
July 2009
Saudi Food & Drug Authority 2009 33
Use of Electronic Signatures:
The use of advanced electronic signatures (digital signatures) will be crucial in achieving pure electronic communication between the pharmaceutical industry and regulatory agencies, particularly for authentication of electronic submissions and documents contained therein. Saudi Arabia is therefore developing a long-term strategy to implement digital signatures. Currently however, the use of digital signatures for electronic submissions within the kingdom of Saudi Arabia is not fully supported and digital signatures should therefore not be used.
Handling Empty or Missing eCTD sections:
For new applications (including generic applications), detailed statements justifying the absence of data or specific CTD sections should be provided in the relevant Quality Overall Summary and/or Non-Clinical/Clinical Overviews (Module 2.3, 2.4, 2.5). Note that placeholder documents highlighting 'no relevant content' should not be placed in the eCTD structure, as these would create a document lifecycle for non-existent documents, and unnecessary complication and maintenance of the eCTD.
NB: for a generic application, note that there is no need to provide a justification for content that is typically absent.
July 2009
Saudi Food & Drug Authority 2009 34
Appendix D: ICH Common Technical Document
Common Technical Document (CTD)
The Common Technical Document is an internationally agreed format for the preparation of a marketing authorization (MA) that is to be submitted to the regulatory authorities in the three ICH regions (USA, EU and Japan) and in some other countries and regions. The CTD provides a common format for the preparation of a well structured dossier. It uses a modular framework described in ICH Topic M47. This guidance document should be read in conjunction with the most recent version of the ICH CTD guidance documents.
It is important to remember that the CTD provides a format for an MAA and does not indicate the content of a dossier and which studies should be performed. Regional and national requirements may affect the content of the dossier; therefore the dossier will not necessarily be identical for all regions.
The CTD is applicable for all types of products (new chemical entities, biologicals, herbals etc.)
The CTD is organized into five modules (figure 4). Module 1 is region specific. Modules 2, 3, 4, and 5 are intended to be common for all regions.
• Module 1: Administrative Information and prescribing Information
• Module 2: Common Technical Document Summaries
• Module 3: Quality
• Module 4: Non-Clinical Study Reports
• Module 5: Clinical Study Reports
7 http://www.ich.org/
July 2009
Saudi Food & Drug Authority 2009 35
Figure 5: Diagrammatic representation of the organization of the ICH CTD8
eCTD
The eCTD is defined as an interface for industry to agency transfer of regulatory information while at the same time taking into consideration the facilitation of the creation, review, lifecycle management and archival of the electronic submission.
The eCTD is an electronic version of the CTD. The structure, folder and file names correspond to those of the CTD. As a submission format, however, it contains additional technical components which enable the lifecycle of individual files in the application, and the lifecycle of the product itself, to be managed.
An eCTD has the following components: Folder structure, Contents (files) and XML backbone.
The folder structure has a hierarchical organization reflecting that of the CTD, and it holds the scientific and technical contents of the eCTD (divided into many files which are the same as those in the non-eCTDs, usually in PDF format).
8 Source: adapted from the ICH guideline……
July 2009
Saudi Food & Drug Authority 2009 36
The XML backbone is recognisable as ‘index.xml’ at the root level of the submission folder of an eCTD and provides two useful functions:
• It provides a hyperlinked table of contents of the entire submission when viewed in a web browser with a suitable style sheet
• It provides descriptive information (‘metadata’) on the files that make up the actual contents of the eCTD.
July 2009
Saudi Food & Drug Authority 2009 37
Appendix E: Target Performance Timelines
Target performance timelines from the date of acceptance to SFDA decision, excluding the stop-clock for various submission types are as follows:
The timelines stated (in working days) are subject to change.
Process Total Performance Target
Marketing Authorization Application for Generics 165 days
Marketing Authorization Application for NCEs 290 days
Marketing Authorization Application for Biologicals 290 days
Marketing Authorization Application for Radiopharmaceuticals
290 days
Marketing Authorization Application for Veterinary drugs
195 days
Marketing Authorization Application for Herbal products
155 days
Renewal of Marketing Authorization 30 days
Variation to a Marketing Authorization Type I: Notifiable Change
30 days
Variation to a Marketing Authorization Type II: Supplemental to MA
165 days
July 2009
Saudi Food & Drug Authority 2009 38
Appendix F: Required Quantities of Samples
The following table shows the required quantities of the samples for different sample types.
No. Sample Type Volume Quantity
1 Tablets - 100 tablets
2 Capsule - 100 capsules
3 Syrup > 250 mL 6-8 packs
4 Solution 250-500 mL 6 packs
5 Solution 5-10 L 2 packs
6 Antiseptic 1 L 6 packs
7 Antiseptic 5 L 2 packs
8 Drops 15 mL 15 packs
9 Ointment & Creams - 15 packs
10 Raw materials - 2 packs
12 Ampoules, Vials & PFS 0.5 mL 25 packs
13 Ampoules, Vials & PFS 1 mL 20 packs
14 Ampoules, Vials & PFS 2-5 mL 15 packs
15 Bottles ≥ 5 mL 6 bottles
16 BCG vaccine - 50 packs
17 Blood bags - 8 bags
18 Infusion sets - 6 packs Notes:
• The SFDA has the right to ask for additional quantities as needed.
• The SFDA has the right to ask for analysis tools and standard materials as needed.
July 2009
Saudi Food & Drug Authority 2009 39
Appendix G: References
SFDA Reference Documents:
• Regulatory Framework for Drug Approvals (version 4)
• Bioequivalence Guidelines
• Stability Guidelines
• SPC, Labeling and PIL guidelines (published soon)
• SA Module 1 Specification (published soon)
The latest versions of SFDA's guidance documents are available on the website at the following address:
http://www.sfda.gov.sa/En/Drug/Topics/Regulations+-+Guidelines.htm
ICH Reference Documents:
M4 : The Common Technical Document
• Organization of The Common Technical Document for the Registration of Pharmaceuticals for Human Use
• Implementation Working Group – Questions & Answers (R3)
• Electronic Common Technical Document Specification (version 3.2)
• The Common Technical Document for The Registration of Pharmaceuticals for Human Use: Quality – M4Q(R1)
• The Common Technical Document for The Registration of Pharmaceuticals for Human Use: Safety – M4S(R2)
• The Common Technical Document for The Registration of Pharmaceuticals for Human Use: Efficacy – M4E(R1)
These documents and more are found at the ICH website at the following address:
http://www.ich.org/
July 2009
Saudi Food & Drug Authority 2009 40
Appendix H: Contact Address
Saudi Food and Drug Authority – Drug Sector
3292 Northern Ring Road – An nafal District
Riyadh 13312 – 6288
Kingdom of Saudi Arabia
Tel: +966-1-275- 9222 extensions: 1302 or 5302
Fax: +966-1-275-7195
e-mail: [email protected]
July 2009
Saudi Food & Drug Authority 2009 41
Appendix I: Price List
Product trade name
Package size
Strength/unit Ex-Factory price
Dosage form COO Wholesale
price
Company name COO public
price
Nationality CIF to SA
The other prices in the countries where the product is marketed
No. Country COO Currency Package
size Ex-factory
price CIF price
Public price
1 Algeria 2 Australia 3 Argentina 4 Bahrain 5 Belgium 6 Canada 7 Cyprus 8 Denmark 9 Egypt
10 Finland 11 France 12 Germany 13 Greece 14 Netherlands 15 Hungary 16 Ireland 17 Italy 18 Japan 19 Jordan 20 Kuwait 21 New Zealand 22 Norway 23 Oman 24 Portugal 25 Lebanon 26 Spain 27 Sweden 28 Switzerland 29 U.A.E. 30 U.K.
July 2009
Saudi Food & Drug Authority 2009 42
Appendix J: Cover Letter
אאאאאאאא א
،،،אא
،אאאאאאאאW
אא Trade Name
אא Generic Name
א Strength
אא Dosage Form
אא manufacturer
אא Marketing Company
،،،אאא
KKKKKKKKKKKKKKKKKKKKKKKK
July 2009
Saudi Food & Drug Authority 2009 43
Appendix K: Laboratory Samples Form
אא Trade Name
אא Generic Name
א Strength
אא Dosage Form
א Storage condition
א Sample Quantity
אא Marketing Company
אא Manufacturer
אא Expiry Date
א Batch No.
July 2009
Saudi Food & Drug Authority 2009 44
Appendix L: Abbreviation and Acronyms
COO Country of Origin
CPP Certificate of Pharmaceutical Product
CTD Common Technical Document
MA Marketing Authorization
MAA Marketing Authorization Application
NCE New Chemical Entity
PFS Prefilled syringe
PIL Patient Information Leaflet
SA Saudi Arabia
SFDA Saudi Food and Drug Authority
SPC Summary of Product Characteristics