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1. Which products must have sanitary (health) registration?Pharmaceutical Products: Simple or compound substance, natural, synthetic, or a mixturethereof, in a defined pharmaceutical farm, used to diagnose, treat, prevent diseases or modify thephysiological function of huma ns.
Cosmetics: Any substance or preparation intended to be placed in contact with the externa! parts of the human body (epidermis, hair system, nails, lips and externa! genital organs) or with the teeth and oral mucosa, with the purpose of cleaning, perfuming, modifying their appearance and / or correcting body odors and / or protecting them or keeping them in good condition.
Cleaning and Hygienic products: Products applied to dwellings, buildings and other places used far cleaning, disinfecting, deodorizing and aromatizing.
Food and Beverages: Processed, semi-processed or unprocessed substances which are intended far human consumption.
Pesticides for household use: Any substance or mixture of chemical substances intended to prevent, destroy or control any plague, including human diseases or undesirable plant and animal species.
Veterinary Products: Any substance or mixture which can be given or applied to animals.
2. Is obtaining a registered mark necessary for securing a sanitary (health) registration?Pharmaceutical Products No Food and Beverages No Cosmetics No Pesticides far household use No Cleaning and Hygienic Products No Veterinary Products No
3. How long does it take to get a sanitary (health) registration?Pharmaceutical Products 4 to 5 months Food and Beverages Cosmetics 1 to 2 months Pesticides far household use Cleaning and Hygienic Products 2 to 3 months Veterinary Products
1 to 2 months 1 to 2 months 2 to 3 months
4. Are sanitary (health) registrations required for the sale of products within the country?Pharmaceutical Products Yes Food and Beverages Yes Cosmetics Yes Pesticides far household use Yes Cleaning and Hygienic Products Yes Veterinary Products Yes
S. Is a local distributor mandatory for filing and obtaining a sanitary (health) registration?Pharmaceutical Products Yest Food and Beverages Yes Cosmetics Yes Pesticides far household use Yes Cleaning and Hygienic Products Yes Veterinary Products Yes
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6. How long does a sanitary (health) registration remain in effect?Pharmaceutical Products 5 years Food and Beverages
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Cosmetics 5 years Pesticides far household use Cleaning and Hygienic Products 5 years Veterinary Products
7. Are samples of the product required for analysis?Pharmaceutical Products Yes Food and Beverages Cosmetics No Pesticides far household use Cleaning and Hygienic Products No Veterinary Products
8. What is the minimum shelf life of the product samples for analysis and requiredquantity?Pharmaceutical Products: The sample must have at least 1 year of shelf life.
5 years 5 years 5 years
No No No
Quantity: five samples of the product are required and a minimum of 1 g far the standardof the active ingredient.
Cosmetics: No standard or sample is required.
Cleaning and Hygienic Products: No standard or sample is required.
Food and Beverages:No samples are required.
Pesticides for household use: No samples are required.
Veterinary Products: No standard or sample is required.
9. What happens if the product or registration undergoes a change?The Health Authorities must be duly notified when a product undergoes a change in itsfarmulation, presentation, name, social address of the manufacturer, monograph, shelf life, storageconditions, type of packing material and ownership. A resolution from said authorities acceptingthe change will be issued.
10. Is registration homologation possible and for which products?Yes, homologation is possible far faod, cleaning products, cosmetics, household pesticides andveterinary products that are manufactured in the fallowing countries: Guatemala, El Salvador,Nicaragua, and Honduras.
COSTA RICA (Conr.)
11. What are the requisites for the labels of products?Please visit our website www.bufetemejia.com and download the
6abelling Reguisites for Regulatory Affairs" files for detailed information.
12. Which documents submitted with the application require legalization?Pharmaceutical Products: Certificate of Good Manufacturing Practice (GMP)
+ Free Sale Certificate
Cosmetics: Certificate of Good Manufacturing Practice (GMP)
Cleaning and Hygienic Products: None
Food and Beverages:
Pesticides for household use:
Veterinary Products:
Free Sale Certificate
Free Sale Certificate
Certificate of Good Manufacturing Practice (GMP) + Free Sale Certificate
Note: Al/ documents receíved from abroad must be legalízed by the Apostille or nearest Costa Rícan Consu/ate.
13. In what language should the documentation be submitted?AII documents filed must be submitted in Spanish*.
* We offer translation services at very competitive prices. Please contact us for a quotation
14. How long in advance can a renewal application be filed?Pharmaceutical Products Up to three months in advance within the precedent year. Cosmetics Up to three months in advance within the precedent year. Cleaning and Hygienic Products Up to three months in advance within the precedent year. Food and Beverages Up to three months in advance within the precedent year. Pesticides for household use Up to three months in advance within the precedent year. Veterinary Products Up to three months in advance within the precedent year.
15. Are grace periods allowed for renewing a sanitary (health) registration?Pharmaceutical Products Yes Food and Beverages No Cosmetics Yes Pesticides for household use Yes Cleaning and Hygienic Products Yes Veterinary Products No
1. Which products must have sanitary (health) registration?Pharmaceutical Products: Simple or compound substance, natural, synthetic, or a mixturethereof, in a defined pharmaceutical farm, used to diagnose, treat, prevent diseases or modify thephysiological function of huma ns.
Cosmetics: Any substance or preparation intended to be placed in contact with the externa! parts of the human body (epidermis, hair system, nails, lips and externa! genital organs) or with the teeth and oral mucosa, with the purpose of cleaning, perfuming, modifying their appearance and / or correcting body odors and / or protecting them or keeping them in good condition.
Cleaning and Hygienic products: Products applied to dwellings, buildings and other places used far cleaning, disinfecting, deodorizing and aromatizing.
Food and Beverages: Processed, semi-processed or unprocessed substances which are intended far human consumption.
Pesticides for household use: Any substance or mixture of chemical substances intended to prevent, destroy or control any plague, including human diseases or undesirable plant and animal species.
Veterinary Products: Any substance or mixture which can be given or applied to animals.
2. Is obtaining a registered mark necessary for securing a sanitary (health) registration?Pharmaceutical Products No Food and Beverages No Cosmetics No Pesticides far household use No Cleaning and Hygienic Products No Veterinary Products No
3. How long does it take to get a sanitary (health) registration?Pharmaceutical Products 1 O to 12 months Food and Beverages Cosmetics 8 to 9 months Pesticides far household use Cleaning and Hygienic Products 1 O to 12 months Veterinary Products
* There is a simplified process in which the registrations take less time and demand lessrequirements (for more information, please contact us)
4 to 5 months 1 O to 12 months 5 to 6 months
4. Are sanitary (health) registrations required for the sale of products within the country?Pharmaceutical Products Yes Food and Beverages Yes Cosmetics Yes Pesticides far household use Yes Cleaning and Hygienic Products Yes Veterinary Products Yes
5. Is a local distributor mandatory for filing and obtaining a sanitary (health) registration?Pharmaceutical Products Yes Food and Beverages Yes Cosmetics Yes Pesticides far household use Yes Cleaning and Hygienic Products Yes Veterinary Products Yes
DOMINICAN REPUBLIC (Conr.)
6. How long does a sanitary (health) registration remain in effect?Pharmaceutical Products 5 years Food and Beverages Cosmetics 5 years Pesticides far household use Cleaning and Hygienic Products 5 years Veterinary Products
7. Are samples of the product required for analysis?Pharmaceutical Products Yes Food and Beverages Cosmetics Yes Pesticides far household use Cleaning and Hygienic Products No Veterinary Products
8. What is the minimum shelf life of the product samples for analysis and requiredquantity?
5 years 5 years 5 years
Yes Yes Yes
Pharmaceutical Products: The products must have a minimum of one year shelf life.Additionally, standards of the active ingredient are required with a minimum of 14 MONTHS andits content must be of a minimum of O.Sg. The quantity required depends on the type ofpharmaceutical farm of the product.*
Cosmetics: The products must have a minimum of one year of shelf life. Three samples are required. lf there are different fragrances and colors, then three quantities of each fragrance or color will be required.
Cleaning and Hygienic Products: No standard or sample is required.
Food and Beverages:Samples must have a current shelf life and of the same lot. Quantity: Three samples will be required if sol id 200 g or if liquid 250 mi.
Pesticides for household use: Samples are required. Quantity: six.
Veterinary Products: The products must have a minimum of ONE YEAR shelf life. The quantity required depends on the type of the product.*
* Please contact us far more information.
9. What happens if the product or registration undergoes a change?The Health Authorities must be duly notified when a product undergoes a change in its farmulation,presentation, name, social address of the manufacturer, monograph, shelf life, storage conditions,type of packing material and ownership. A resolution from said authorities accepting the changewill be issued.
10. Is registration homologation possible and for which products?Homologation is not applicable in this country.
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11. What are the requisites for the la beis of products?Please visit our website www.bufetemejia.com and download the
6abelling Reguisites for Regulatory Affairs" files for detailed information.
12. Which documents submitted with the application require legalization?Pharmaceutical Products: Certificate of Good Manufacturing Practice (GMP)
Cosmetics: Certificate of Good Manufacturing Practice (GMP) + Free Sale Certificate
Cleaning and Hygienic Products: Certificate of Good Manufacturing Practice (GMP) + Free Sale Certificate
Food and Beverages:
Pesticides for household use:
Veterinary Products:
Free Sale Certificate
Free Sale Certificate
Certificate of Registration and Free Sale (CAMEVET model) + Certificate of Qualification of the Establishment.
Note: Ali documents received from abroad must be /egalized by the Apostille or
nearest Dominican Consulate.
13. In what language should the documentation be submitted?AII documents filed must be submitted in Spanish*.
* We offer translation services at very competitive prices. Please contact us for a quotation
14. How long in advance can a renewal application be filed?Pharmaceutical Products Up to three months in advance within the precedent year. Cosmetics Up to three months in advance within the precedent year. Cleaning and Hygienic Products Up to three months in advance within the precedent year. Food and Beverages Up to three months in advance within the precedent year. Pesticides for household use Up to three months in advance within the precedent year. Veterinary Products Up to three months in advance within the precedent year.
15. Are grace periods allowed for renewing a sanitary (health) registration?Pharmaceutical Products No Food and Beverages No Cosmetics No Pesticides for household use No Cleaning and Hygienic Products No Veterinary Products No
1. Which products must have sanitary (health) registration?Pharmaceutical Products: Simple or compound substance, natural, synthetic, or a mixturethereof, in a defined pharmaceutical farm, used to diagnose, treat, prevent diseases or modify thephysiological function of huma ns.
Cosmetics: Any substance or preparation intended to be placed in contact with the externa! parts of the human body (epidermis, hair system, nails, lips and externa! genital organs) or with the teeth and oral mucosa, with the purpose of cleaning, perfuming, modifying their appearance and / or correcting body odors and / or protecting them or keeping them in good condition.
Cleaning and Hygienic products: Products applied to dwellings, buildings and other places used far cleaning, disinfecting, deodorizing and aromatizing.
Food and Beverages: Processed, semi-processed or unprocessed substances which are intended far human consumption.
Pesticides for household use: Any substance or mixture of chemical substances intended to prevent, destroy or control any plague, including human diseases or undesirable plant and animal species.
Veterinary Products: Any substance or mixture which can be given or applied to animals.
2. Is obtaining a registered mark necessary for securing a sanitary (health) registration?Pharmaceutical Products No Food and Beverages No Cosmetics No Pesticides far household use No Cleaning and Hygienic Products No Veterinary Products No
3. How long does it take to get a sanitary (health) registration?Pharmaceutical Products 4 to 7 months Food and Beverages Cosmetics 4 to 7 months Pesticides far household use Cleaning and Hygienic Products 4 to 7 months Veterinary Products
2 to 4 months 4 to 7 months 4 to 7 months
4. Are sanitary (health) registrations required for the sale of products within the country?Pharmaceutical Products Yes Food and Beverages Yes Cosmetics Yes Pesticides far household use Yes Cleaning and Hygienic Products Yes Veterinary Products Yes
S. Is a local distributor mandatory for filing and obtaining a sanitary (health) registration?Pharmaceutical Products Yes Food and Beverages Yes Cosmetics Yes Pesticides far household use Yes Cleaning and Hygienic Products Yes Veterinary Products Yes
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6. How long does a sanitary (health) registration remain in effect?Pharmaceutical Products 5 years Food and Beverages
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Cosmetics 5 years Pesticides far household use Cleaning and Hygienic Products 5 years Veterinary Products
7. Are samples of the product required for analysis?Pharmaceutical Products No Food and Beverages Cosmetics No Pesticides far household use Cleaning and Hygienic Products No Veterinary Products
8. What is the minimum shelf life of the product samples for analysis and requiredquantity?
5 years 5 years 5 years
Yes No No
Pharmaceutical Products: Samples are not required; however, the standard of the activeingredient must have at least 1 year of shelf life.
Cosmetics: No standard or sample is required.
Cleaning and Hygienic Products: No standard or sample is required.
Food and Beverages: Samples are required with a minimum shelf life of 1 year. Quantity: three samples of 200g far sol id or 300 ml far liquid.
Pesticides for household use: Samples are not required; however, the standard of the active ingredient must have at least 1 year of shelf life.
Veterinary Products: No standard or sample is required.
9. What happens if the product or registration undergoes a change?The Health Authorities must be duly notified when a product undergoes a change in itsfarmulation, presentation, name, social address of the manufacturer, monograph, shelf life, storageconditions, type of packing material and ownership. A resolution from said authorities acceptingthe change will be issued.
10. Is registration homologation possible and for which products?Yes, homologation is possible far faod, cleaning products, cosmetics, household pesticides, andveterinary products that are manufactured in the fallowing countries: Guatemala, Costa Rica,Nicaragua, and Honduras.
EL SALVADOR (Conr.)
11. What are the requisites for the labels of products?Please visit our website www.bufetemejia.com and download the
6abelling Reguisites for Regulatory Affairs" files for detailed information.
12. Which documents submitted with the application require legalization?Pharmaceutical Products: Certificate of Good Manufacturing Practice (GMP)
+ Free Sale Certificate
Cosmetics: Certificate of Good Manufacturing Practice (GMP)
Cleaning and Hygienic Products: None
Food and Beverages:
Pesticides for household use:
Veterinary Products:
Free Sale Certificate
Free Sale Certificate
Certificate of Good Manufacturing Practice (GMP) + Free Sale Certificate
Note: Ali documents received from abroad must be legalized by the Apostille or nearest Sa/vadoran Consu/ate.
13. In what language should the documentation be submitted?AII documents filed must be submitted in Spanish*.
* We offer translation services at very competitive prices. Please contact us for a quotation
14. How long in advance can a renewal application be filed?Pharmaceutical Products Up to three months in advance within the precedent year. Cosmetics Up to three months in advance within the precedent year. Cleaning and Hygienic Products Up to three months in advance within the precedent year. Food and Beverages Up to three months in advance within the precedent year. Pesticides for household use Up to three months in advance within the precedent year. Veterinary Products Up to three months in advance within the precedent year.
15. Are grace periods allowed for renewing a sanitary (health) registration?Pharmaceutical Products No Food and Beverages No Cosmetics No Pesticides for household use No Cleaning and Hygienic Products No Veterinary Products No
1. Which products must have sanitary (health) registration?Pharmaceutical Products: Simple or compound substance, natural, synthetic, or a mixturethereof, in a defined pharmaceutical farm, used to diagnose, treat, prevent diseases or modify thephysiological function of huma ns.
Cosmetics: Any substance or preparation intended to be placed in contact with the externa! parts of the human body (epidermis, hair system, nails, lips and externa! genital organs) or with the teeth and oral mucosa, with the purpose of cleaning, perfuming, modifying their appearance and / or correcting body odors and / or protecting them or keeping them in good condition.
Cleaning and Hygienic products: Products applied to dwellings, buildings and other places used far cleaning, disinfecting, deodorizing and aromatizing.
Food and Beverages: Processed, semi-processed or unprocessed substances which are intended far human consumption.
Pesticides for household use: Any substance or mixture of chemical substances intended to prevent, destroy or control any plague, including human diseases or undesirable plant and animal species.
Veterinary Products: Any substance or mixture which can be given or applied to animals.
2. Is obtaining a registered mark necessary for securing a sanitary (health) registration?Pharmaceutical Products No Food and Beverages No Cosmetics No Pesticides far household use No Cleaning and Hygienic Products No Veterinary Products No
3. How long does it take to get a sanitary (health) registration?Pharmaceutical Products 6 to 8 months Food and Beverages Cosmetics 5 to 6 months Pesticides far household use Cleaning and Hygienic Products 5 to 6 months Veterinary Products
1 to 3 months 5 to 6 months 5 to 6 months
4. Are sanitary (health) registrations required for the sale of products within the country?Pharmaceutical Products Yes Food and Beverages Yes Cosmetics Yes Pesticides far household use Yes Cleaning and Hygienic Products Yes Veterinary Products Yes
S. Is a local distributor mandatory for filing and obtaining a sanitary (health) registration?Pharmaceutical Products Yes Food and Beverages Yes Cosmetics Yes Pesticides far household use Yes Cleaning and Hygienic Products Yes Veterinary Products Yes
GUATEMALA (Conr.)
6. How long does a sanitary (health) registration remain in effect?Pharmaceutical Products 5 years Food and Beverages Cosmetics 5 years Pesticides far household use Cleaning and Hygienic Products 5 years Veterinary Products
7. Are samples of the product required for analysis?Pharmaceutical Products Yes Food and Beverages Cosmetics Yes Pesticides far household use Cleaning and Hygienic Products No Veterinary Products
* Depending on the type of pesticide, please contact us far more infarmation.
8. What is the minimum shelf life of the product samples for analysis and requiredquantity?
5 years 5 years 5 years
Yes Yes* Yes
Pharmaceutical Products: The product sample and standard of the active ingredient musthave a minimum of 1 year and minimum of 1 g. The quantity required depends on the type ofpharmaceutical farm of the product.*
Cosmetics: Standard and samples are required far sunscreens products. The quantity required depends on the type of sunscreen.*
Cleaning and Hygienic Products: No standard or sample is required.
Food and Beverages:Sample are required far high risk faod and beverages. Quantity: Four samples are required and they must have at least 1 year of shelf life.
Pesticides for household use: The product and standard must have a minimum of 1 year and minimum of 1 g. The quantity required depends on the type of pesticide.*
Veterinary Products: The samples must have a minimum of 6 months of shelf life. The quantity required depends on the type of veterinary product.*
* Please contact us far more infarmation.
9. What happens if the product or registration undergoes a change?The Health Authorities must be duly notified when a product undergoes a change in itsfarmulation, presentation, name, social address of the manufacturer, monograph, shelf life, storageconditions, type of packing material and ownership. A resolution from said authorities acceptingthe change will be issued.
10. Is registration homologation possible and for which products?Yes, homologation is possible far faod, cleaning products, cosmetics, pharmaceutical productsthat are manufactured in the fallowing countries: El Salvador, Nicaragua, Honduras,and Costa Rica.
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11. What are the requisites for the la beis of products?Please visit our website www.bufetemejia.com and download the
6abelling Reguisites for Regulatory Affairs" files for detailed information.
12. Which documents submitted with the application require legalization?Pharmaceutical Products: Certificate of Good Manufacturing Practice (GMP)
+ Free Sale Certificate
Cosmetics: Certificate of Good Manufacturing Practice (GMP)
Cleaning and Hygienic Products: None
Food and Beverages:
Pesticides for household use:
Veterinary Products:
Free Sale Certificate
Free Sale Certificate
Certificate of Good Manufacturing Practice (GMP) + Free Sale Certificate
Note: Al/ documents received from abroad must be legalized by the Apostille or nearest Guatemalan Consu/ate.
13. In what language should the documentation be submitted?AII documents filed must be submitted in Spanish*.
* We offer translation services at very competitive prices. Please contact us for a quotation.
14. How long in advance can a renewal application be filed?Pharmaceutical Products Up to eight months in advance within the precedent year. Cosmetics Up to eight months in advance within the precedent year. Cleaning and Hygienic Products Up to eight months in advance within the precedent year. Food and Beverages Up to two months in advance within the precedent year. Pesticides for household use Up to six months in advance within the precedent year. Veterinary Products Up to six months in advance within the precedent year.
15. Are grace periods allowed for renewing a sanitary (health) registration?Pharmaceutical Products Yes* Food and Beverages Yes* Cosmetics Yes* Pesticides for household use No Cleaning and Hygienic Products Yes* Veterinary Products No
*Within the fol/owing six months once expired.
1. Which products must have sanitary (health) registrattion?Pharmaceutical Products: Simple or compound substance, natural, synthetic, or a mixturethereof, in a defined pharmaceutical farm, used to diagnose, treat, prevent diseases or modify thephysiological function of huma ns.
Cosmetics: Any substance or preparation intended to be placed in contact with the externa! parts of the human body (epidermis, hair system, nails, lips and externa! genital organs) or with the teeth and oral mucosa, with the purpose of cleaning, perfuming, modifying their appearance and / or correcting body odors and / or protecting them or keeping them in good condition.
Cleaning and Hygienic products: Products applied to dwellings, buildings and other places used far cleaning, disinfecting, deodorizing and aromatizing.
Food and Beverages: Processed, semi-processed or unprocessed substances which are intended far human consumption.
Pesticides for household use: Any substance or mixture of chemical substances intended to prevent, destroy or control any plague, including human diseases or undesirable plant and animal species.
Veterinary Products: Any substance or mixture which can be given or applied to animals.
2. Is obtaining a registered mark necessary for securing a sanitary (health) registration?Pharmaceutical Products No Food and Beverages No Cosmetics No Pesticides far household use No Cleaning and Hygienic Products No Veterinary Products No
3. How long does it take to get a sanitary (health) registration?Pharmaceutical Products 1 O to 12 months Food and Beverages Cosmetics 8 to 9 months Pesticides far household use Cleaning and Hygienic Products 1 O to 12 months Veterinary Products
4 to 5 months 1 O to 12 months 5 to 6 months
4. Are sanitary (health) registrations required for the sale of products within the country?Pharmaceutical Products Yes Food and Beverages Yes Cosmetics Yes Pesticides far household use Yes Cleaning and Hygienic Products Yes Veterinary Products Yes
S. Is a local distributor mandatory for filing and obtaining a sanitary (health) registration?Pharmaceutical Products Yes Food and Beverages Yes Cosmetics Yes Pesticides far household use Yes Cleaning and Hygienic Products Yes Veterinary Products Yes
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6. How long does a sanitary (health) registration remain in effect?Pharmaceutical Products 5 years Food and Beverages
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Cosmetics 5 years Pesticides far household use Cleaning and Hygienic Products 5 years Veterinary Products
7. Are samples of the product required for analysis?Pharmaceutical Products No Food and Beverages Cosmetics No Pesticides far household use Cleaning and Hygienic Products No Veterinary Products
* Only with respect to fish and milk based products.
** Depending on the classification.
8. What is the minimum shelf life of the product samples for analysis and requiredquantity?Pharmaceutical Products: Currently, samples are not required.*
Cosmetics: No standard or sample is required.
Cleaning and Hygienic Products: No standard or sample is required.
5 years 5 years 5 years
Yes* Yes** Yes
Food and Beverages:The samples must have a minimum of 1 year of shelf life. The quantity depends on the type of product.*
Pesticides for household use: The shelf life of the product sample and of the standard of the active ingredient must be of 1 year minimum and the content of the standard must be of a minimum of 1 g. The quantity depends on the type of product.*
Veterinary Products: The samples must have a minimum of 6 months of shelf life. The quantity depends on the type of product.*
* Please contact us far more information.
9. What happens if the product or registration undergoes a change?The Health Authorities must be duly notified when a product undergoes a change in itsfarmulation, presentation, name, social address of the manufacturer, monograph, shelf life, storageconditions, type of packing material and ownership. A resolution from said authorities acceptingthe change will be issued.
HONDURAS (Conr.)
10. Is registration homologation possible and for which products?Yes, homologation is possible for food, pharmaceutical, cosmetics and veterinary products thatare manufactured in the following countries: Guatemala, El Salvador, Nicaragua, andCosta Rica.
11. What are the requisites for the labels of products?Please visit our website www.bufetemejia.com and download the
6abelling Requisites for Regulatory Affairs" files for detailed information.
12. Which documents submitted with the application require legalization?Pharmaceutical Products: Certificate of Pharmaceutical Product or Certificate of Good
Manufacturing Practice (GMP) + Free Sale Certificate Affidavit / Sworn Statement (Local Format)*
Cosmetics: Certificate of Good Manufacturing Practice (GMP) Affidavit / Sworn Statement (Local Format)*
Cleaning and Hygienic Products: Legal Status of Registrant Affidavit / Sworn Statement (Local Format)*
Food and Beverages: Free Sale Certificate Affidavit / Sworn Statement (Local Format)*
Pesticides for household use: Free Sale Certificate Affidavit / Sworn Statement (Local Format)*
Veterinary Products: Free Sale Certificate Authorization Letter Origin Certificate
Note: Al/ documents received from abroad must be /egalized by the Apostille or nearest Honduran Consulate.
* Contact us to request this format
13. In what language should the documentation be submitted?AII documents filed must be submitted in Spanish*.
* We offer translation services at very competitive prices. Please contact us for a quotation
14. How long in advance can a renewal application be filed?Pharmaceutical Products Up to six months in advance within the precedent year. Cosmetics Up to six months in advance within the precedent year. Cleaning and Hygienic Products Up to six months in advance within the precedent year. Food and Beverages Up to five months in advance within the precedent year. Pesticides for household use Up to six months in advance within the precedent year. Veterinary Products Up to three months in advance within the precedent year.
15. Are grace periods allowed for renewing a sanitary (health) registration?Pharmaceutical Products No Food and Beverages No Cosmetics No Pesticides for household use No Cleaning and Hygienic Products No Veterinary Products No
1. Which products must have sanitary (health) registration?Pharmaceutical Products: Simple or compound substance, natural, synthetic, or a mixturethereof, in a defined pharmaceutical farm, used to diagnose, treat, prevent diseases or modify thephysiological function of huma ns.
Cosmetics: Any substance or preparation intended to be placed in contact with the externa! parts of the human body (epidermis, hair system, nails, lips and externa! genital organs) or with the teeth and oral mucosa, with the purpose of cleaning, perfuming, modifying their appearance and / or correcting body odors and / or protecting them or keeping them in good condition.
Cleaning and Hygienic products: Products applied to dwellings, buildings and other places used far cleaning, disinfecting, deodorizing and aromatizing.
Food and Beverages: Processed, semi-processed or unprocessed substances which are intended far human consumption.
Pesticides for household use: Any substance or mixture of chemical substances intended to prevent, destroy or control any plague, including human diseases or undesirable plant and animal species.
Veterinary Products: Any substance or mixture which can be given or applied to animals.
2. Is obtaining a registered mark necessary for securing a sanitary (health) registration?Pharmaceutical Products Yes Food and Beverages No Cosmetics No Pesticides far household use No Cleaning and Hygienic Products No Veterinary Products No
3. How long does it take to get a sanitary (health) registration?Pharmaceutical Products 1 O to 12 months Food and Beverages Cosmetics 3 to 6 months Pesticides far household use Cleaning and Hygienic Products 8 to 9 months Veterinary Products
1 to 2 months 16 to 18 months 8 to 9 months
4. Are sanitary (health) registrations required for the sale of products within the country?Pharmaceutical Products Yes Food and Beverages Yes Cosmetics Yes Pesticides far household use Yes Cleaning and Hygienic Products Yes Veterinary Products Yes
S. Is a local distributor mandatory for filing and obtaining a sanitary (health) registration?Pharmaceutical Products Yes Food and Beverages Yes Cosmetics Yes Pesticides far household use No Cleaning and Hygienic Products Yes Veterinary Products Yes
NICARAGUA (Conr.)
6. How long does a sanitary (health) registration remain in effect?Pharmaceutical Products 5 years Food and Beverages Cosmetics 5 years Pesticides far household use Cleaning and Hygienic Products 5 years Veterinary Products
7. Are samples of the product required for analysis?Pharmaceutical Products Yes Food and Beverages Cosmetics No Pesticides far household use Cleaning and Hygienic Products No Veterinary Products
8. What is the minimum shelf life of the product samples for analysis and requiredquantity?
5 years 5 years 5 years
Yes Yes Yes
Pharmaceutical Products: Depending on the type of pharmaceutical farm of the product.*
Cosmetics: No standard or sample is required.
Cleaning and Hygienic Products: No standard or sample is required.
Food and Beverages: Depending on the type of faod or beverages. *
Pesticides for household use: Depending on the type of pesticide.*
Veterinary Products: Depending on the type of veterinary product.*
* Please contact us far more information.
9. What happens if the product or registration undergoes a change?The Health Authorities must be duly notified when a product undergoes a change in itsfarmulation, presentation, name, social address of the manufacturer, monograph, shelf life, storageconditions, type of packing material and ownership. A resolution from said authorities acceptingthe change will be issued.
10. Is registration homologation possible and for which products?Yes, homologation is possible far faod, cleaning products, cosmetics products, pharmaceuticalproducts that are manufactured in the fallowing countries: Guatemala, El Salvador,Honduras, and Costa Rica.
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11. What are the requisites for the la beis of products?Please visit our website www.bufetemejia.com and download the
6abelling Reguisites for Regulatory Affairs" files for detailed information.
12. Which documents submitted with the application require legalization?Pharmaceutical Products: Certificate of Good Manufacturing Practice (GMP)
+ Free Sale Certificate
Cosmetics: Certificate of Good Manufacturing Practice (GMP)
Cleaning and Hygienic Products: None
Food and Beverages:
Pesticides for household use:
Veterinary Products:
Free Sale Certificate
Free Sale Certificate + Origin Certificate
Free Sale Certificate
Note: Ali documents received from abroad must be legalized by the Apostille or nearest Nicaraguan Consu/ate.
13. In what language should the documentation be submitted?AII documents filed must be submitted in Spanish*.
* We offer translation services at very competitive prices. Please contact us for a quotation
14. How long in advance can a renewal application be filed?Pharmaceutical Products Up to twelve months in advance within the precedent year. Cosmetics Up to twelve months in advance within the precedent year. Cleaning and Hygienic Products Up to twelve months in advance within the precedent year. Food and Beverages Up to twelve months in advance within the precedent year. Pesticides for household use Up to twelve months in advance within the precedent year. Veterinary Products Up to twelve months in advance within the precedent year.
15. Are grace periods allowed for renewing a sanitary (health) registration?Pharmaceutical Products No Food and Beverages No Cosmetics No Pesticides for household use No Cleaning and Hygienic Products No Veterinary Products No
1. Which products must have sanitary (health) registration?Pharmaceutical Products: Simple or compound substance, natural, synthetic, or a mixturethereof, in a defined pharmaceutical farm, used to diagnose, treat, prevent diseases or modify thephysiological function of huma ns.
Cosmetics: Any substance or preparation intended to be placed in contact with the externa! parts of the human body (epidermis, hair system, nails, lips and externa! genital organs) or with the teeth and oral mucosa, with the purpose of cleaning, perfuming, modifying their appearance and / or correcting body odors and / or protecting them or keeping them in good condition.
Cleaning and Hygienic products: Products applied to dwellings, buildings and other places used far cleaning, disinfecting, deodorizing and aromatizing.
Food and Beverages: Processed, semi-processed or unprocessed substances which are intended far human consumption.
Pesticides for household use: Any substance or mixture of chemical substances intended to prevent, destroy or control any plague, including human diseases or undesirable plant and animal species.
Veterinary Products: Any substance or mixture which can be given or applied to animals.
2. Is obtaining a registered mark necessary for securing a sanitary (health) registration?Pharmaceutical Products No Food and Beverages No Cosmetics No Pesticides far household use No Cleaning and Hygienic Products No Veterinary Products No
3. How long does it take to get a sanitary (health) registration?Pharmaceutical Products 1 O to 12 months Food and Beverages Cosmetics 1 O to 12 months Pesticides far household use Cleaning and Hygienic Products 1 O to 12 months Veterinary Products
1 to 2 months 1 O to 12 months 5 to 6 months
4. Are sanitary (health) registrations required for the sale of products within the country?Pharmaceutical Products Yes Food and Beverages Yes* Cosmetics Yes Pesticides far household use Yes Cleaning and Hygienic Products Yes Veterinary Products Yes
* With respect to Foods and Cosmetics, there is a simplified process in which the registrations takeless time and demand less requirements (for more information, please contact us)
5. Is a local distributor mandatory for filing and obtaining a sanitary (health) registration?Pharmaceutical Products Yes Food and Beverages Yes Cosmetics Yes Pesticides far household use Yes Cleaning and Hygienic Products Yes Veterinary Products Yes
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6. How long does a sanitary (health) registration remain in effect?Pharmaceutical Products 5 years Food and Beverages Cosmetics 5 years Pesticides far household use Cleaning and Hygienic Products 5 years Veterinary Products
7. Are samples of the product required for analysis?Pharmaceutical Products Yes Food and Beverages Cosmetics Yes Pesticides far household use Cleaning and Hygienic Products Yes Veterinary Products
8. What is the minimum shelf life of the product samples for analysis and requiredquantity?Pharmaceutical Products: Depending on the type of product.*
Cosmetics: Depending on the type of product.*
Cleaning and Hygienic Products: Depending on the type of product.*
Food and Beverages:No samples or standard required.
Pesticides for household use: Depending on the type of product.*
Veterinary Products: Depending on the type of product.*
* Please contact us far more information.
9. What happens if the product or registration undergoes a change?
Lifetime 5 years 5 years
No
Yes Yes
The Health Authorities must be duly notified when a product undergoes a change in itsfarmulation, presentation, name, social address of the manufacturer, monograph, shelf life, storageconditions, type of packing material and ownership. A resolution from said authorities acceptingthe change will be issued.
10. Is registration homologation possible and for which products?Homologation is not applicable in this country.
PANAMA (Conr.)
11. What are the requisites for the labels of products?Please visit our website www.bufetemejia.com and download the�abelling Reguisites for Regulatory Affairs" files for detailed information.
12. Which documents submitted with the application require legalization?Pharmaceutical Products: Certificate of Pharmaceutical Product or Certificate of Good
Manufacturing Practice (GMP) + Free Sale Certificate
Cosmetics: Free Sale Certificate + Good Manufacturing Practice Certificate
Cleaning and Hygienic Products: Free Sale Certificate + Good Manufacturing Practice Certificate
Food and Beverages:
Pesticides for household use:
Veterinary Products:
Free Sale Certificate
Free Sale Certificate + Good Manufacturing Practice Certificate
Free Sale Certificate
Note: Ali documents received from abroad must be legalized by the Apostille or nearest Panamanian Consulate.
13. In what language should the documentation be submitted?AII documents filed must be submitted in Spanish*.
* We offer translation services at very competitive prices. Please contact us for a quotation
14. How long in advance can a renewal application be filed?Pharmaceutical Products Up to three months in advance within the precedent year. Cosmetics Up to three months in advance within the precedent year. Cleaning and Hygienic Products Up to three months in advance within the precedent year. Food and Beverages Up to three months in advance within the precedent year. Pesticides for household use Up to three months in advance within the precedent year. Veterinary Products Up to three months in advance within the precedent year.
15. Are grace periods allowed for renewing a sanitary (health) registration?Pharmaceutical Products No Food and Beverages No Cosmetics No Pesticides for household use No Cleaning and Hygienic Products No Veterinary Products No
