2021 · 2021. 1. 20. · Cosmetics: Any substance or preparation intended to be placed in contact...

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2021

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CONTENT

COSTA RICA ..................................................................................................................................... 3

DOMINICAN REPUBLIC .................................................................................................................... 6

EL SALVADOR .................................................................................................................................. 9

GUATEMALA ................................................................................................................................. 12

HONDURAS ................................................................................................................................... 15

NICARAGUA .................................................................................................................................. 19

PANAMA ....................................................................................................................................... 22

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Costa Rica 1. Which products must have sanitary (health) registration?

Pharmaceutical Products: Simple or compound substance, natural, synthetic, or a mixture thereof, in a defined pharmaceutical form, used to diagnose, treat, prevent diseases or modify the physiological function of humans.

Cosmetics: Any substance or preparation intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external 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 for cleaning, disinfecting, deodorizing and aromatizing.

Food and Beverages: Processed, semi-processed or unprocessed substances which are intended for 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 for 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 1 to 2 months Cosmetics 1 to 2 months Pesticides for household use 1 to 2 months Cleaning and Hygienic Products 2 to 3 months Veterinary Products 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 for household use Yes Cleaning and Hygienic Products Yes Veterinary Products Yes

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5. Is a local distributor mandatory for filing and obtaining a sanitary (health) registration?

Pharmaceutical Products Yes Food and Beverages Yes Cosmetics Yes Pesticides for household use Yes Cleaning and Hygienic Products Yes Veterinary Products Yes

6. How long does a sanitary (health) registration remain in effect? Pharmaceutical Products 5 years Food and Beverages 5 years Cosmetics 5 years Pesticides for household use 5 years Cleaning and Hygienic Products 5 years Veterinary Products 5 years

7. Are samples of the product required for analysis? Pharmaceutical Products Yes Food and Beverages No Cosmetics No Pesticides for household use No Cleaning and Hygienic Products No Veterinary Products No

8. What is the minimum shelf life of the product samples for analysis and required quantity? Pharmaceutical Products: The sample must have at least 1 year of shelf life.

Quantity: Five samples of the product are required and a minimum of 1 g for the standard of 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 its formulation, 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 change will be issued.

10. Is registration homologation possible and for which products? Yes, homologation is possible for food, cleaning products, cosmetics, household pesticides and veterinary products that are manufactured in the following countries: Guatemala, El Salvador, Nicaragua, and Honduras.

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11. What are the requisites for the labels of products? Please visit our website www.bufetemejia.com and download the “Labelling Requisites 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: Free Sale Certificate

Pesticides for household use: Free Sale Certificate

Veterinary Products: Certificate of Good Manufacturing Practice (GMP) + Free Sale Certificate

Note: All documents received from abroad must be legalized by the Apostille or nearest Costa Rican Consulate.

13. In what language should the documentation be submitted? All 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 Product 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

http://www.bufetemejia.com/

http://www.bufetemejia.com/index.php/en/labelling-requisites-regulatory-affairs/



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Dominican Republic 1. Which products must have sanitary (health) registration? Pharmaceutical Products: Simple or compound substance, natural, synthetic, or a mixture thereof, in a defined pharmaceutical form, used to diagnose, treat, prevent diseases or modify the physiological function of humans.




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.


3. How long does it take to get a sanitary (health) registration? Pharmaceutical Products 10 to 12 months Food and Beverages 4 to 5 months Cosmetics 8 to 9 months Pesticides for household use 10 to12 months Cleaning and Hygienic Products 10 to 12 months Veterinary Products 5 to 6 months

* There is a simplified process in which the registrations take less time and demand less requirements (for more information, please contact us).


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5. Is a local distributor mandatory for filing and obtaining a sanitary (health) registration? Pharmaceutical Products Yes Food and Beverages Yes Cosmetics Yes Pesticides for household use Yes Cleaning and Hygienic Products Yes Veterinary Products Yes


7. Are samples of the product required for analysis? Pharmaceutical Products Yes Food and Beverages Yes Cosmetics Yes Pesticides for household use Yes Cleaning and Hygienic Products No Veterinary Products Yes

8. What is the minimum shelf life of the product samples for analysis and required quantity? 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 and its content must be of a minimum of 0.5g. The quantity required depends on the type of pharmaceutical form of the product.

Cosmetics: The products must have a minimum of one year of shelf life. Three samples are required. If 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 solid 200 g or if liquid 250 ml. 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 for more information.


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10. Is registration homologation possible and for which products? Homologation is not applicable in this country.


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: Free Sale Certificate.

Pesticides for household use: Free Sale Certificate.

Veterinary Products: Certificate of Registration and Free Sale (CAMEVET model) + Certificate of Qualification of the Establishment.

*Note: All documents received from abroad must be legalized by the Apostille or nearest Dominican Consulate.

13. In what language should the documentation be submitted?

All 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




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EL SALVADOR 1. Which products must have sanitary (health) registration? Pharmaceutical Products: Simple or compound substance, natural, synthetic, or a mixture thereof, in a defined pharmaceutical form, used to diagnose, treat, prevent diseases or modify the physiological function of humans.







3. How long does it take to get a sanitary (health) registration? Pharmaceutical Products 4 to 7 months Food and Beverages 2 to 4 months Cosmetics 4 to 7 months Pesticides for household use4 to 7 months Cleaning and Hygienic Products 4 to 7 months Veterinary Products 4 to 7 months


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7. Are samples of the product required for analysis? Pharmaceutical Products No Food and Beverages Yes Cosmetics No Pesticides for household use No Cleaning and Hygienic Products No Veterinary Products No

8. What is the minimum shelf life of the product samples for analysis and required quantity? Pharmaceutical Products: Samples are not required; however, the standard of the active ingredient must have at least 1 year of shelf life.

Cosmetics: 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 for solid or 300 mL for 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.


10. Is registration homologation possible and for which products? Yes, homologation is possible for food, cleaning products, cosmetics, household pesticides, and veterinary products that are manufactured in the following countries: Guatemala, Costa Rica, Nicaragua, and Honduras.

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12. Which documents submitted with the application require legalization?

Pharmaceutical Products: Certificate of Good Manufacturing Practice (GMP) + Free Sale Certificate






*Note: All documents received from abroad must be legalized by the Apostille or nearest Salvadoran Consulate.








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Guatemala 1. Which products must have sanitary (health) registration? Pharmaceutical Products: Simple or compound substance, natural, synthetic, or a mixture thereof, in a defined pharmaceutical form, used to diagnose, treat, prevent diseases or modify the physiological function of humans.









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7. Are samples of the product required for analysis? Pharmaceutical Products Yes Food and Beverages Yes Cosmetics Yes Pesticides for household use Yes* Cleaning and Hygienic Products No Veterinary Products Yes * Depending on the type of pesticide, please contact us for more information.

8. What is the minimum shelf life of the product samples for analysis and required quantity? Pharmaceutical Products: The product sample and standard of the active ingredient must have a minimum of 1 year and minimum of 1g. The quantity required depends on the type of pharmaceutical form of the product. *

Cosmetics: Standard and samples are required for 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 for high risk food 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 1g. 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 for more information.


10. Is registration homologation possible and for which products? Yes, homologation is possible for food, cleaning products, cosmetics, pharmaceutical products that are manufactured in the following countries: El Salvador, Nicaragua, Honduras, and Costa Rica.

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Note: All documents received from abroad must be legalized by the Apostille or nearest Guatemalan Consulate


* 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 following six months once expired.




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Honduras 1. Which products must have sanitary (health) registration? Pharmaceutical Products: Simple or compound substance, natural, synthetic, or a mixture thereof, in a defined pharmaceutical form, used to diagnose, treat, prevent diseases or modify the physiological function of humans.







3. How long does it take to get a sanitary (health) registration? Pharmaceutical Products 6 to 8 months Food and Beverages 4 to 5 months Cosmetics 3 to 5 months Pesticides for household use 3 to 5 months Cleaning and Hygienic Products 3 to 5 months Veterinary Products 5 to 6 months


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7. Are samples of the product required for analysis? Pharmaceutical Products No Food and Beverages Yes* Cosmetics No Pesticides for household use Yes** Cleaning and Hygienic Products No Veterinary Products Yes

* 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 required quantity? Pharmaceutical Products: Currently, samples are not required.



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 1g. 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. *



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10. Is registration homologation possible and for which products? Yes, homologation is possible for food, pharmaceutical, cosmetics and veterinary products that are manufactured in the following countries: Guatemala, El Salvador, Nicaragua, and Costa Rica.


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: 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 (In case this document does not indicate the country of origin then a Certificate of Origin must also be submitted) Authorization Letter by the Manufacturer of Applicant to the distributor

Veterinary Products: Free Sale Certificate Authorization Letter Origin Certificate

Note: All documents received from abroad must be legalized by the Apostille or nearest Honduran Consulate.

* Contact us to request this format



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.





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16. Can a Temporary Sanitary Registration be obtained? Yes, a Temporary Sanitary Registration (PST) that is granted within a week of filing the application, can be obtained, in case there is a need to start importation and commercialization of a product in our country. The PST is granted for 6 months and is one time renewable. The documents needed to file for said PST are: Certificate of Free Sale or Sworn Affidavit signed by Legal and Technical Representative, a Proforma Invoice and the corresponding labels of the product.

17. Are medical devices subject to registration? Not all of them. There is a list of medical devices that indicate the ones that do not need registration. For the ones included in said list only a Certificate of Registration Waiver must be requested at ARSA. In case the medical device is not included in the list, it is necessary to apply for a risk classification. Once this is granted, then it is possible to proceed with the application for sanitary registration. Please note that with the Certificate of Classification issued grants a period of 6 months for the product to be imported and commercialized.

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Nicaragua 1. Which products must have sanitary (health) registration? Pharmaceutical Products: Simple or compound substance, natural, synthetic, or a mixture thereof, in a defined pharmaceutical form, used to diagnose, treat, prevent diseases or modify the physiological function of humans.






2. Is obtaining a registered mark necessary for securing a sanitary (health) registration? Pharmaceutical Products Yes Food and Beverages No Cosmetics No Pesticides for household use No Cleaning and Hygienic Products No Veterinary Products No



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5. Is a local distributor mandatory for filing and obtaining 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 Yes


7. Are samples of the product required for analysis? Pharmaceutical Products Yes Food and Beverages Yes Cosmetics No Pesticides for household use Yes Cleaning and Hygienic Products No Veterinary Products Yes

8. What is the minimum shelf life of the product samples for analysis and required quantity? Pharmaceutical Products: Depending on the type of pharmaceutical form of the product. *



Food and Beverages: Depending on the type of food or beverages. *

Pesticides for household use: Depending on the type of pesticide. *

Veterinary Products: Depending on the type of veterinary product. *



10. Is registration homologation possible and for which products? Yes, homologation is possible for food, cleaning products, cosmetics products, pharmaceutical products that are manufactured in the following countries: Guatemala, El Salvador, Honduras, and Costa Rica.

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Pesticides for household use: Free Sale Certificate + Origin Certificate

Veterinary Products: Free Sale Certificate

Note: All documents received from abroad must be legalized by the Apostille or nearest Nicaraguan Consulate.



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.





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Panama

1. Which products must have sanitary (health) registration? Pharmaceutical Products: Simple or compound substance, natural, synthetic, or a mixture thereof, in a defined pharmaceutical form, used to diagnose, treat, prevent diseases or modify the physiological function of humans.




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.




* With respect to Foods and Cosmetics, there is a simplified process in which the registrations take less time and demand less requirements (for more information, please contact us).

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5. Is a local distributor mandatory for filing and obtaining a sanitary (health) registration? Pharmaceutical Products Yes Food and Beverages Yes Cosmetics Yes Pesticides for household use Yes Cleaning and Hygienic Products Yes Veterinary Products

6. How long does a sanitary (health) registration remain in effect? Pharmaceutical Products 5 years Food and Beverages Lifetime Cosmetics 5 years Pesticides for household use 5 years Cleaning and Hygienic Products 5 years Veterinary Products 5 years

7. Are samples of the product required for analysis? Pharmaceutical Products Yes Food and Beverages No Cosmetics Yes Pesticides for household use Yes Cleaning and Hygienic Products Yes Veterinary Products Yes

8. What is the minimum shelf life of the product samples for analysis and required quantity? 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. *



10. Is registration homologation possible and for which products? Homologation is not applicable in this country.





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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


Pesticides for household use: Free Sale Certificate + Good Manufacturing Practice Certificate

Veterinary Products: Free Sale Certificate Note: All documents received from abroad must be legalized by the Apostille or nearest Panamanian Consulate.





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Date post:	06-Mar-2021
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