Panama Cosmetic Sector
The sanitary registration process for cosmetics in Panama is the first step to market entry.
All cosmetic products are required to be register by the Ministry of Health. This registration is performed by the Directorate of Pharmacy and Drugs of the Ministry, referred to in the law as the “Health Authority”. To start the registration process, you must fulfill the following requirements:
- Power of attorney in favor of the legal and professional representation.
- Certificate of Good Manufacturing Practices or duly legalized manufacturing authorization document, issued by the regulatory authority of the manufacturing country.
- Qualitative formula, signed by the responsible person of the manufacturing laboratory. It must indicate the quantities of the restricted substances: concentration, the name of every ingredient (must be mentioned on the formula, according to the International Nomenclature for Cosmetic Ingredients (INCI); the name of the product as well as its variations or generic names; if the product has various shades or varieties, it must be specified the names and the numbers of the colors according to the International Color Index.
- Studies of the product if it contains substances of biological origin, vitamins, or substances of easy decomposition, to support the product’s shell life.
- Certificate of Good Practice of the manufacturing laboratory with a two-year validity counted as of its expedition date, issued by the competent authorities of the country of origin and legalized by the Seal of the Apostille or the Panamanian Consulate.
- Certificate of Pharmaceutical Product duly issued by the competent authorities and legalized by the Seal of the Apostille or the Panamanian Consulate.
- Certificate of Free Sale which is sometimes called the Certificate for Export or Certificate to Foreign Governments.
Other certificates may be required in addition to the above.
All documentation must be submitted in Spanish, and official documents written in a different language must be presented with their respective official translation. In addition, any official or legal document issued abroad must be duly notarized and legalized by the Seal of the Apostille or the Panamanian Consulate.
The validity of the sanitary registration of cosmetic products will be five (5) years counted from its granting, and each registration process costs between $1,000.00 and $1,500.00 per product.
For more information, please visit the Ministry of Health webpage.