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Health Law :: 

REQUIREMENTS FOR THE OBTAINMENT OF A HEALTH REGISTRATION FOR COSMETIC PRODUCTS, IN PANAMA

The procedure for the obtainment of a Health Registration of a cosmetic product is prosecuted before the Pharmacy and Drugs Department of the Ministry of Health.

Requirements:

A Power of Attorney document (from the proprietor of the product), duly notarized and legalized by the Seal of the Apostille or the Panamanian Consulate. Said Power of Attorney must mention the name of the products to be registered, including all variations.

Certificate of Good Practice of the manufacturing laboratory, issued by the competent authorities of the country of origin, and duly legalized by the Seal of the Apostille or the Panamanian Consulate. Please be advised that according to our Health Registration Law, said Certificate has a validity of two (2) years counted as of its expedition date, unless the document has another expiration date.

Certificate of Pharmaceutical Product (CPP original) duly issued by the competent authorities and legalized by the Seal of the Apostille or the Panamanian Consulate. Said document must include the name of the product that you desire to register. Please be advised that according to our Health Registration Law, said Certificate has a validity of two (2) years counted as of its expedition date, unless the document has another expedition date.

Quali-quantitative formula in case of medicated products, duly signed by the responsible person of the manufacturing laboratory. For cosmetics, it is only required the qualitative formula, duly signed by the responsible person of the manufacturing laboratory. For cosmetics containing restricted substances, said concentration must be included, as well as the name; the name of every ingredient must be mentioned on the formula, according to the International Nomenclature for Cosmetic Ingredients (INCI); must mention the name of the product as well as its variations; 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. In case of aerosols it must be mentioned the name and concentration of the propellant gases, which shall comply with our Legislations as to the protection of the ozone layer.

Two (2) samples of the product as it will be commercialized in our country, in each of its variations, and must include, the name of the product, content in weight or volume, name of the manufacturing laboratory, the country of origin, batch number, expiration date, storage conditions. Additionally, and depending on the case, must also include the precautionary legends in Spanish language.

Two (2) original labels of the product or artwork of the same, including the information mentioned above.
7.Finished product specifications, that is, microbiological and physicochemical specifications.

Studies of the product if the same contains substances of biological origin, vitamins, or substances of easy decomposition, to support the products shell life.

Documentation to support the qualities of the product, in case the same is “hypo-allergic”, “non-irritant”, “water-resistant”, among others.
10.Name of the distributer of the product in Panama.

As a matter of information, please be advised that it is possible to group in a single application, up to ten (10) variations, in relation to the characteristics of scent, color, flavor or concentration, if they are manufactured by the same laboratory, in the same country, and maintain the same pharmaceutical form, use and principal components.

With regards to the registration process, once the documentation is received at our offices, the same is sent to the Specialized Institute of Analysis of the University of Panama to request the calculation of the cost of the analysis to be performed. Said analysis must be cancelled before the application is submitted before the Pharmacy and Drugs Department.

Once the health registration application is submitted before the Pharmacy and Drugs Department, said documentation is examined by a Pharmaceutical Examiner, and if said Examiner estimates that the technical documentation complies with all the requirements of our health authorities, they will order the issuance of the correspondent Health Registration Certificate. The analysis of the product will be effectuated after the expedition of said Certificate.

The estimated timeframe for the above procedure is approximately two (2) months, as long as the documentation filed is complete and complies with our Law requirements. On the contrary, if the Pharmacy and Drugs Department requests some clarification as to further documentation or information, said entity will consent a period of 90 days to file said additional documentation.


Please be advised that the Health Registration Certificates for cosmetic products have a validity of ten (10) years, counted as of the expedition date, and may be renewed for equal periods of time.


Fees and Expenses:

Our fees for preparing, filing and prosecuting the health registration petition (each application), are US$300.00.

Additionally, the expenses to be incurred are the following:

Analysis of each product by the Specialized
Institute of Analysis
US$225.00 approx.
Expedition services for the Health Registration,
by the Pharmacy and Drugs Department
US$200.00 each
Fiscal stamps affixed to the application US$4.00 p/page
Legalizations and authentications before the
Ministry of Foreign Relations
US$10.00 each
Certificate of Registration US$14.00 each
Registry Right US$25.00 each
Countersign by a proper pharmacist US$30.00 each
Countersign by the National College of Pharmacists US$20.00 each
 Miscellaneous US$25.00 approx.
   
TOTAL US$553.00 approx.

 
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