Every food, beverage , medicament, cosmetic, cleaning product or disinfectant that may affect human health must have a Sanitary Registration issued by the MINISTRY OF HEALTH for its manufacturing, importation or free commerce in the territory of the Republic of Panama.

THE MINISTRY OF HEALTH have two departments assigned to carry out the pertinent controls and to grant the Sanitary Registration, the FOOD PROTECTION DEPARTMENT and the BUREAU OF PHARMACIES AND DRUGS.

The obligation to obtain Sanitary Registration shall be applicable to all the above described activities that are carried out in the territory of the Republic of Panama, but it shall not be so for the import, conditioning, manufacturing and other activities that are carried out in the fiscal or special customs territories, such as free zones and processing zones, when the products are destined abroad, likewise, it shall not be applicable to the products entering the national territory and in transit or transshipment, destined abroad.

1. SANITARY REGISTRATIONS BEFORE THE FOOD PROTECTION DEPARTMENT

The procedures to opt for a Sanitary Registration for food and cleaning products are regulated by Decree 256 of June 13, 1962, amended by Decree 1195 of December 3, 1992.

To opt for the foregoing Sanitary Registration, the natural or juridical person must request the Department of Food Control of the Ministry of Health, in authorized paper and through a lawyer, the registration of its products indicating the name of the product that wishes to be registered, the name of the manufacturer and place of origin, the description of the product and the name of the representative, agent and/or distributor of the product.

With his application the interested party must submit the following:

1. Power of Attorney
2. Certificate of Free Sale, an original
3. Sanitary Certificate of the Plant or Permission to Operate
4. Quali-quantitative Formula
5. Specification of the type and material of the container
6. Original labels or art identical to the original
7. Four (4) samples of the product.
8. Declaration and interpretation of the Lot Code and the average life of the product.
9. Zoo-sanitary Certificate
10. Voucher of the cancellation of registry and control costs.

2. SANITARY REGISTRIES BEFORE THE BUREAU OF PHARMACIES AND DRUGS
Law No. 1 of January 10, 2001 published in Official Gazette No. 24,218 of January 12, 2001, regulates the administration in general of the manufacturing, import, acquisition, distribution, marketing, information, publicity, the sanitary registry and quality control, of medicaments and other products that may affect human health.

Among the products which require sanitary registration before this Bureau for its marketing in Panama, are:

1. Cosmetic, personal hygiene, products to kill plagues of domestic use and public health, antiseptics and disinfectants.
2. Vitamin supplements, dietetic and homeopathic and food supplements with therapeutic properties.
3. Finished medicaments, pharmaceutical, psycho tropics specialties, narcotics and chemical precursors of medicinal use, biological products, medicament products developed by genetic engineering, phyto medicine , radio medicine, in-puts, medical-surgical, odontological and radiological products or material for internal use, whether biological or biotechnological employ in human health.

THE REQUISITES TO OBTAIN THE SANITARY REGISTRY BEFORE THE PHARMACY AND DRUG BUREAU ARE:

1. Special Power of Attorney
2. Method of Analysis
3. Certificate of the Analysis
4. Certificate of Free Sale issued by the health authorities of the country of origin or type of the World Health Organization
5. Certificate of good manufacturing practices of the laboratory, issued by the health authority of the country of origin.
6. Clinical studies (for novelty products, new indications products and for those declaring certain properties such as " dermatological tested", "Hypo-alergenic", etc. and others that from time to time are regulated by the Health Authorities.)
7. Labels and containers.
8. Monograph of the product to be registered.
9. Samples
10. Quali-quantitative Formula
11. Stability studies for the products applying for the first time.
12. Specifications of the finished products
13. Previous control
14. Analytical models when so required.
15. Countersigned by a competent pharmacist, which may be the governing one.
16. Countersigned by the National Pharmacist Association.
Our office represents the distributing houses of very well known food and cosmetic houses in the country, transacting more than four hundred (400) sanitary registries annually. The Sanitary Registries are issued for a period of five (5) years for foods, five (5) years for medicaments, ten (10) years for cosmetic products and ten (10) years for disinfectants and plague killers.

The terms for obtaining the Sanitary Registration Certificates fluctuates between two (2) to Five (5) weeks, nevertheless, as soon as the application is submitted to the Ministry of Health, complying with the aforementioned requisites, they may be introduced into the country for their marketing.