Administrative Order No. 2014-0034

Republic of the PhilippinesDepartment of Health

Food and Drug Administration

Administrative Order No. 2014-0034

CENTER FOR DRUG REGULATION AND RESEARCH24 JUNE 2015

[email protected]

Sheralyn A. Opeña, RPhFDRO-II

CDRR-LRD

http://www.fda.gov.ph/

mailto:[email protected]

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MARIA LOURDES C. SANTIAGO, MSc, MMDeputy Director-General For Field

Regulatory Operations

SEC. JANETTE LORETO-GARINActing Director-General

Regulatory Enforcement Unit (REU)

Regional Field Offices - North Luzon (HAYDEE B. GUANIO)

- South Luzon (NEMIA T. GETES)

- Visayas (GOMEL GABUNA)

- West Mindanao (FLORITA MORALEJA)

- East Mindanao (JESUSA JOYCE CIRUNAY)

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SEC. JANETTE LORETO-GARINActing Director-General For Field Regulatory Operations

CENTER FOR COSMETIC

REGULATION AND RESEARCH

CENTER FOR DEVICE REGULATION, RADIATION HEALTH AND RESEARCH

CENTER FOR DRUG REGULATION AND

RESEARCH

CENTER FOR FOOD REGULATION AND

RESEARCH

MELODY M. ZAMUDIOOfficer-in-Charge, Center for Drug Regulation and Research (CDRR)

GRACE L. MEDINAOfficer-in-Charge, Licensing and

Registration Division (LRD)

SHERALYN A. OPEÑA

[email protected]/RONPD

LABORATORY SUPPORT DIVISION

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Pharma/Human

Drug Registration

Veterinary Drug

Registration

Vaccines and

Biologicals Registration

Clinical Trial

Evaluation

PMS Section

STANDARDSDEVELOPMENT

Section

CLINICAL RESEARCH

Section

PRODUCT RESEARCH AND STANDARDS DEVELOPMENT

DIVISION - 4R

EVANGELINE S. MANALO

([email protected], DD, Sponsor and

CRO



1. Licensing of establishments

• GMP, GDP, GSP, GCP, GLP and GPP

2. Pre-marketing assessment

• Quality, safety, and efficacy (for innovative medicines)

• Quality+interchangeability (for generics)

3. Post-marketing surveillance

• Safety (benefit/risk balance)

• Quality (quality testing and compliance monitoring)

4. CommunicationRegulatory Framework

Elements

Good Distribution Practice???










Elements

• MANILA, Philippines–The Food and Drug Administration (FDA) has reminded all food and dietary supplement manufacturers, distributors and advertisers to stop using the phrase “No Approved Therapeutic Claims” in product labels and switch to the standard message in Filipino as ordered by the Department of Health (DOH).

• In an advisory, the FDA said all food and dietary supplement products sold in the market should strictly carry on their labels the phrase “Mahalagang paalala: Ang (name of product) ay hindi gamotat hindi dapat gamiting panggamot sa anumang uri ng sakit(Important reminder: This is not a medicinal drug and should not be used to treat the symptoms of any disease).”

• FDA officer in charge Nicolas Lutero III said the change in the message on the labels of food supplements was in view of a decision by the Court Appeals (CA) issued in November last year that upheld the DOH-FDA Administrative Order (AO) No. 2011-0008 under then Health Secretary

Drop ‘no therapeutic claim’ from labels–DOH

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• But in its decision, the appellate court said the DOH’s issuance of the order was merely an exercise of the state’s police power “which cannot be hindered by property rights.”

• “As such right is innately ingrained in every state, there is no violation committed by the DOH when it issued the AO, which has for its end the health and welfare of the consuming public,” read the CA ruling.

• It added that the public has the right to be informed of the nature and the established curative effects of the food supplements they bought from the market.

• He also noted that under the DOH order, audio advertisements or promotions should carry the standard message in Filipino and that it shall be “clearly and audibly voiced over, without being cut off in the last line of the advertisement or promotions regardless of its duration.”

http://newsinfo.inquirer.net/676191/drop-no-therapeutic-claim-from-labels-doh#ixzz3TIoL93A5@inquirerdotnet on Twitter | inquirerdotnet on Facebook

http://newsinfo.inquirer.net/676191/drop-no-therapeutic-claim-from-labels-doh














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Elements

1. Pharmacovigilance

- Consumer reporting of Adverse Drug Reaction (ADR)/ Adverse Events Following Immunization (AEFI)

2. Monitoring, collecting, sampling and testing of drugs

3. Audits and inspection of manufacturers/ distributors/ retail outlets

4. Advertisements and claims monitoring

5. Product recall - Administrative sanctions

Post-marketing Surveillance



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ADMINISTRATIVE ORDER NO. 2014-0034

Rationale and Legal Bases

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• 1987 Constitution• RA No. 3720 (FDC Act)• RA No. 9711 (FDA Act of 2009)• RA No. 7394 (Consumer Act of the Phils.)• RA No. 9502 (Universally Accessible Cheaper

and Quality Medicines Act)• RA No. 8792 (E-Commerce Act)• AO 56 (Licensing Regulation for Drug

Establishments and Outlets)

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Objectives

• To establish rules and regulations in the licensing of drugestablishments to align with the recently promulgated laws and regulations;

• To ensure compliance of establishments to FDA and internationalregulatory standards and requirements of the following, but not limited to,Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), GoodStorage Practice (GSP), and Good Clinical Practice (GCP); and

• To prescribe the use and implementation of innovations, such as but notlimited to, electronic data messages, electronic submission of documentsand electronic signatures in the Food of Drug Administration pursuant toRepublic Act No. 8792 or the “Electronic Commerce Act of 2000.”

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• Adoption and Implementation of the World Health Organization Annex 5 Guide to Good Distribution Practices (GDP) for Pharmaceutical Products, and Annex 9 Guide to Good Storage Practices for Pharmaceuticals

• Adoption and Implementation of the Pharmaceutical Inspection Cooperation Scheme (PIC/S) Guides for the Good Manufacturing Practice (GMP) for Medical Products


2224 June 2015


Administrative Order No. 2012- ICH



24 June 2015 24

Scope/Coverage

• Shall apply to establishments in the country, including localgovernment units, government owned and controlledcorporations, non-government organizations, other governmentoffices and instrumentalities engaged in the manufacture,distribution, importation, exportation, sale, offer for sale andtransfer of drug product. This shall also apply to Contract ResearchOrganizations (CROs) and/or Sponsors engaged in the conduct ofclinical trials.

• Entities engaged in the activities such as donation, promotion,advertising, or sponsorship of drug product shall secure appropriateauthorizations in accordance with existing rules and regulations.

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GENERAL PROVISIONS

• No drug establishment shall manufacture, import, export, sell, offer for sale, distribute, transfer, promote, advertise and/or sponsor any activity that involves drug product without first securing a License to Operate or an appropriate authorization from FDA pursuant to this Administrative Order.

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• The responsibility of ensuring the safety, efficacy, quality and/or purity of any drug product sold in its original packaging (container) of which the seal has not been broken or tampered with shall rest upon the drug establishments involved in the supply chain of sale, handling, transport, distribution, trading and storage, among others.

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FLOW OF QUALITY IN TRADE Manufacturer (DM/DT)

(GMP)Operates in high level of

quality assurance to produce quality products

Distributor (DI/DW)(GDSP)

Maintains the quality of the products

Retailer – DS/ HP/RONPD/(GDSP)

Ensures that only qualityproducts are made

available to the public

• All establishments are required to implement a risk management plan which is a requirement for the issuance of an LTO or other authorization

• All drug distributors shall not sell directly to the general public or consumer, unless they have a License to Operate as a retailer.

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• All institutional pharmacies procuring drugs to be dispensed whether at a cost or as part of employee’s benefits and/or its dependents must secure a LTO

• All establishments engaged in retail, whether privately owned or government-owned, shall be under the supervision of a registered pharmacist when operating or open for business, except otherwise allowed by other pertinent laws

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• All licensed establishments engaged in the manufacture, distribution, exportation, importation, selling, transportation/ shipment of vaccines, biologics and other temperature-sensitive drug products are hereby directed to comply with the Cold Chain Management requirement

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• Any information, education and communication campaign material promoting the safe and rational use of drugs shall be displayed in a conspicuous area of the drugstore

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• The FDA shall have the authority to enter any establishment for (1) inspection of compliance and/or (2) verification of submitted documentsin relation to any application for issuance of appropriate authorization

• All establishments shall abide with the guidelines of the FDA on electronic submissions and processes of LTO applications into electronic format pursuant to Republic Act No. 8792 or the “Electronic Commerce Act of 2000”

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CLASSIFICATION OF DRUG ESTABLISHMENTS

Classification of Drug Establishments

• Drug Manufacturer

• Drug Distributor

• Drugstore

• Retail Outlet For Non-prescription Drug (RONPD)

• Sponsor

• Contract Research Organization (CRO)48

Repacker, Packer and Trader

Importer, Exporter and Wholesaler

DRUGSTORE/PHARMACY/BOTICA AND SIMILAR OUTLETS

• Drugstore/Pharmacy/Botika, including hospitalpharmacy and institutional pharmacy shall referto drug establishment where registered drugs,chemical products, dental, medicinal andhousehold remedies are dispensed directly tothe general public on a retail basis

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• Botika ng Barangay and its variants that sellthe same shall be reclassified and requiredto secure LTO as a drugstore.

• All institutional pharmacies procuringdrugs to be dispensed whether at a cost oras part of employee’s benefits and/or itsdependents must secure a LTO.


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Violative productsPhotos taken by Dr. Sonia Cabahit (Inside the House)

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• Activities Requiring Prior Approval

– Online ordering and delivery

– Sterile compounding as well as non-sterilecomplex compounding, as defined under UnitedStates Pharmacopeia, latest edition

– Mobile Pharmacy


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• Drug establishment such as a supermarket, convenientstore and other similar retail establishment authorizedto sell only identified Over-The-Counter (OTC) andhousehold remedy products directly to the generalpublic on a retail basis.

• Botika ng Barangay and its variants that opt to sell thesame shall be reclassified and required to secure LTOas RONPD.

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RETAIL OUTLET FOR NON-PRESCRIPTION DRUGS (RONPD)



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VARIATIONS IN THE LTO

MAJOR VARIATIONS

• Refers to changes in the drug establishmentoperations that may affect significantly and/ordirectly the aspects of safety, efficacy andquality of drug products they are engaged in,and those changes affecting significantparticulars of the issued LTO

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Major Variation

• Change of Ownership

• Transfer of Location

• Additional Activity

VARIATIONS: Drugstores/Hospital Pharmacies/Institutional

Pharmacies

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• Variations are subject to the existingvariation/amendment fee except fortransfer of location which is subject toinitial payment for two (2) years validity ofLTO

• Establishments applying for minor variationmay continue business operations providedthat an application for such variation hasalready been filed.

VARIATIONS

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PAYMENT OF REQUIRED FEE FOR AN LTO

• Initial payment is good for two (2) years

• Renewal payment is good for three (3) years

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VALIDITY OF LTO

• For Initial issuance, the LTO is valid for two (2) years from the date of issuance

• Renewal is valid for three (3) years

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MINORVARIATIONS

• Refers to changes in administrative documentsand/or changes in the drug establishmentoperations with minimal impact on the aspectsof safety, efficacy and quality of drug productsthey are engaged in

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Minor Variation – Prior Approval

• Expansion of Establishment

• Change of Business Name

• Zonal Change in Address

Minor Variation – Notification

• Change of the Responsible Pharmacist or Pharmacy Assistant

• Deletion of Activity

VARIATIONS: Drugstores/Hospital Pharmacies/Institutional

Pharmacies

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Major Variation

• Change of Ownership

• Transfer of Location

Minor Variation – Prior Approval

• Expansion of Establishment

• Change of Business Name

• Zonal Change in Address

Minor Variation – Notification

• Change of Supervising Pharmacist or Pharmacy Assistant

VARIATIONS:RONPD

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RENEWAL OF LTO

WHEN SHOULD AN LTO BE RENEWED?

• Application for regular renewal shall be filedwithin six (6) months from the date ofexpiration of LTO

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RENEWAL OF LTO

• Renewal of LTO received after its expiration date shall pay asurcharge equivalent to twice the renewal fee and additional10% per month or a fraction thereof of continuing non-submission of renewal application up to a maximum of 120days.

• Renewal filed thereafter shall be considered expired and theapplication shall be subject to a fee equivalent to the totalsurcharge plus the initial filing fee; the application shall undergothe initial filing and evaluation procedure (FDA Circular # 2011-004 dated 02 Nov 2011 for computation of surcharge or penalty)

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RENEWAL OF LTO

• For applications that undergo the initial filing andevaluation:

– Submission of documentary requirement is herebywaived except when there is a change or variationeffected on the drug establishment.

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• A Drugstore (DS) with LTO Validity of 21 July 2013 was renewed on 22 Aug 2013; DS Renewal Fee (RF) is P3000

• To Compute Total Surcharge/Penalty (TS/P):

RF x 2 + 20% of RF

= 3000 x 2 + (20% x 3000)

= 6000 + 600

= 6600 (TS/P)

• Total amount to be paid will be:

TS/P + RF + LRF (1% of RF)

= 6600 + 3000 + 30

= 9630 (Total payment)

Sample of Computation with Surcharge/Penalty

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AUTOMATIC RENEWAL(in IRR of RA 9711)

• May be granted under the followingconditions:

–Application is filed before the expiration date

–Prescribed renewal fee is paid upon filing

–A sworn statement indicating no change orvariation whatsoever in the establishment isattached to the application

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EXEMPTION IN PROVIDING ANOTHER PHARMACIST FOR

ADDITIONAL LICENSED ACTIVITY

• MULTIPLE RONPD SUPERVISION

– A single pharmacist is allowed to supervise multiple RONPDs provided the following rules are met:

• The pharmacist is required to dedicate a minimum of two (2) hours a week of physical presence in the RONPD;

• The location of each RONPD must be within the same provincial local government unit (LGU) within each region, with the National Capital Region considered as a single area due to its comparatively smaller land mass;

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• The distance between the two farthest RONPDs mustnot exceed 25 km in distance;

• All other RONPDs supervised by a single pharmacistmust be within a circumferential area when plottedbetween the two farthest RONPDs; and

• A maximum of fifteen (15) RONPDs is allowed to besupervised by a single pharmacist

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• Considerations may be given to geographicallydisadvantaged areas.

• This exemption shall be duly noted in theapplication indicating the pharmacist’s dutiesand responsibilities, schedule & hours ofsupervision to each establishment signed both bythe pharmacist and owner/authorizedrepresentative, LTO number, validity and nameof establishment.

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INSPECTION

INSPECTION

• Sec. VI. B. 3)

– (a) Pre-opening Inspection

– Applications for LTO of drugstores, RONPDS, Sponsorsand CROS - pre-opening inspection may be waivedprovided all necessary requirements are complied with.Nevertheless, on-site verification may be done ifdeemed necessary.

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INSPECTION

• Sec. VI. B. 3)

– (b) All establishments, after approval and issuance oftheir LTO are subjected to post-approvalinspection as part of post-marketing surveillanceactivities to monitor continuous compliance withexisting requirements and standards.

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Disapproval of Application

• Sec. VI. B. 4) (b)

- If found that there was no satisfactoryevidence to prove compliance with therequirements, a notice of disapproval shall beissued

(Book II Article I, Section 4 (A) provides the Groundsfor Disapproval of Application and Suspension orCancellation of License)

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Cancellation of LTO

(Sec. VI. B. 9 of AO 2014-0034)

• (a) Automatic – existing establishments thatfailed to file an application for renewal after one-hundred twenty days from the date of expirationshall be automatically cancelled and deletedfrom the list of registered establishmentswithout prejudice to re-application.

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Cancellation of LTO

(Sec. VI. B. 9 of AO 2014-0034)

• (b) voluntary – the owner or authorized personof a licensed establishment may apply forvoluntary cancellation of its existing licensed byfiling a formal notification.

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FDA CIRCULAR NO. 2014-025

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DOCUMENTARY REQUIREMENTS

A. Initial LTO Application

1. Application Form

2. Proof of Business Name Registration

3. Credentials of Pharmacist

- Credentials of Responsible Pharmacy Assistant

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Application Form (all regions)

24 June 2015 82

24 June 2015 83



1. Application Form

2. Proof of Business Name Registration



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4. Risk Management PlanHow to identify, characterize, prevent or minimize risk relating to product and patient safety

5. Location Plan (GPS coordinates)

6. Picture of establishment with display of signage

7. Proof of payment e.g official receipt or authorized bank payment slip

8. Self-Assessment Toolkit (SATK)

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• Shall be provided to serve as a guide toclients in assuring the completeness andcorrectness of the documentaryrequirements to be submitted

SELF-ASSESSMENT TOOL KIT(SATK)

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ADDITIONAL REQUIREMENTS(for on-site inspection only)

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UIREMENTS

B. Renewal LTO Application

1. Application Form

2. Copy of Certifications issued as a result of LTO Variation

3. Proof of Payment e.g official receipt or authorized bank payment slip

4. Self-Assessment Toolkit (SATK)

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UIREMENTS

C. Reissuance of Lost or Destroyed LTO

1. Letter of Request

2. Affidavit of Loss or Destruction

3. Proof of Payment (e.g official receipt or authorized bank payment slip)

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UIREMENTS

D. Voluntary Cancellation of LTO

1. Letter of Request

2. Original LTO

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There is a story about four people named EVERYBODY, SOMEBODY, ANYBODY and NOBODY.

There was an important job to be done and EVERYBODY was asked to do it. EVERYBODY was sure that SOMEBODY will do it. ANYBODY could

have done it but NOBODY did it.

SOMEBODY got angry about that because it was EVEYBODY’s job. EVERYBODY thought ANYBODY

could do it, but NOBODY realized that EVERYBODY wouldn’t do it.

It ended up that EVERYBODY blamed SOMEBODY when NOBODY did what ANYBODY could have

done.

THANK YOU!

References:

• Republic Act No. 9711 s. 2009• Administrative Order No. 2014-0034• FDA Circular No. 2014-025• WHO Guide Annex 5 (Good Distribution Practice) & Annex 9 (Good Storage Practice)• Powerpoint presentation of Lanette Querubin, Ofelyn

Cabrido, Dr. Sonia Cabahit of FDA and Peter Vanquile (WHO consultant)

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[email protected]

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Administrative Order No. 2014-0034

Health & Medicine