Cosmetics Registration in Panama
Regulatory Authority:
The Pharmacy and Drugs Department of the Ministry of Health.
Spanish name: Dirección de Farmacias y Drogas del Ministerio de Salud (MINSA)
Link for RA:
Local regulation:
Central American Technical Regulation (RTCA) 71.03.36:21 Cosmetic Products.
Who can register :
- Manufacturer
- Importer
Data to be communicated :
- Power of Attorney (POA) from the product’s owner, which contained the name and variations of the product to be registered.
- The POA must be notarised and approved by the Panamanian Consulate or the Seal of the Apostille.
- In the case of medicated items, a qualitative-quantitative formula must be signed by the manufacturing laboratory’s responsible person.
- Finished product specifications: microbiological and physicochemical specifications.
- Studies to see if the product contains biologically derived substances, vitamins, or easily decomposable components to extend the product’s shelf life.
- Documentation to back up the product’s features, such as “hypoallergenic,” “non-irritant,” and “water-resistant,” among others.
- Certificate of Good Practice (GMP) of the manufacturing laboratory, valid for two years from the date of the expedition (unless the document has a different expiration date), issued by the competent authorities of the country of origin and duly legalised by the Apostille Seal or the Panamanian Consulate.
- The appropriate authorities have issued a Certificate of Pharmaceutical Product (CPP original). & apostilled by the Panamanian Consulate or the Seal of the Apostille
- Certificate of Free Sale, also known as a Certificate for Export or a Certificate to Foreign Governments,
- Two (2) samples of the product in each of its versions as it will be commercialised in our country
- Two (2) original product labels or artwork, including the information mentioned above.
- Specifications for the product’s container and a description of the material kind.
- Product life lifespan as determined by the manufacturer’s lab certification
- Name of the product’s distributor in Panama.
Process:
There is no registration required in Panama. Only Sanitary registration and health registration.
Once the documentation is received, it is forwarded to the University of Panama’s Specialized Institute of Analysis, which will calculate the cost of the analysis to be completed. Before the application may be submitted to the Pharmacy and Drugs Department, the fee for the analysis must be paid.
When a health registration application is submitted to the Pharmacy and Drugs Department, a Pharmaceutical Examiner examines the documentation. If the Examiner determines that the technical documentation meets all of the health authorities’ requirements, the Examiner will order the issuance of the appropriate Health Registration Certificate.
The analysis of the product will be completed after the expedition of the Health Registration Certificate.
Timeframe and fees:
Validity of the Health Certificates: 10 years, counted as the expedition date and may be renewed for equal periods.
Renovation of the Health Certificate: It is recommended to start it three months before it expires.
Approximately six months as long as the documentation filed is complete and complies with the Law requirements. If the Pharmacy and Drugs Department request some clarification as to further documentation or information, a period of 6 months to file the required additional documentation will be granted.
Additional information: