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SANITARY REGISTRATION IN PANAMA
A Sanitary Registration issued by the Department of Food Protection of the Ministry of Health must be obtained for any food product to be sold in the Republic of Panama.
REQUIREMENTS AND PROCEEDINGS FOR THE SANITARY REGISTRATION OF FOOD PRODUCTS:
- Power of Attorney duly granted to a legal counsel, empowering him or her to proceed with the presentation of a sanitary registration petition.
- Affidavit regarding the food product, which should be given by the legal representative of the corporation, the manufacturer, importer, distributor or/and dealer of specified food product.
- Original Free Sales Certificate for the product imported, issued or countersigned by the Sanitary Authority of the country of origin, with no more than six (6) months of issuance prior to the petition date. This document must be legalized.
- Sanitary Certification of the plant or manufacturer company, which must be issued by the Authority of the Department of Food Protection regarding national products according to the plant classification established by the Ministry of Health.
- Original label or design (with its complete information).
- Four (4) samples of the product of the same batch, with a minimum size of 200g.
- Declaration and interpretation of the Batch Code Number.
- Veterinary Sanitation Certificate issued by the Ministry for Farming and Animal Husbandry of the Republic of Panama, for meat products, fish products and dairy products, by means of which the country of origin of the said products is indicated.
- Once the petition is presented before the Department of Food Protection, Analysis and Registry Division of the Ministry of Health, it is verified. The petition is then provided with an invoice detailing the costs of registration and controls, so that the respective payments can be made. These payments will be made once the petition has been approved. To complete this process, the certificate of Sanitary Registration is then awarded.
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In the case of Sanitary Registration renewals, the requirements are as follows:
- Affidavit specifying the registry number of the product for which renewal is sought.
- Free Sales Certificate for foreign product.
- Four (4) samples of the product.
- Voucher of cancellation of registration and control fees.
Incoming liquidation to the National Treasury. It is the responsibility of the economic agent, whether a natural person or legal entity that imports and sells foods, as well as the manufacturer, packer, or distributor, to assure the sanitary quality and comply with the established norms for the product(s).
REQUIREMENTS AND PROCEEDINGS FOR THE SANITARY REGISTRATION OF MEDICINES:
- Petition by attorney;
- Power of attorney;
- Countersignature of suitable pharmacist;
- Countersignature of the National Bar of Pharmacists;
- Labels (primary and secondary);
- Receipt of payment for Service Charge (US$200.00 Ministry of Health)
- Receipt of payment of I.E.A. (see fees of Specialized Analysis Institute at http://www.up.ac.pa/institutos/iea/coti_med.htm)
- Analytical patterns
- Free Sale Certificate or pharmaceutical product certificate (OMS Type)
- Good Manufacturing Practices Certificate
- Cuali-quantitative formula
- Lot code
- Analysis method
- Analysis certificate
- Specifications of the finished product.
- Monograph (literature)
- Stability Studies
- Clinical Studies (if required)
Requirements as established by Decree 178 dated July 12, 2001, amended by Decree 105 as of April 15, 2003, and Decree 105 of April 15, 2003.
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