Institution in charge: The Pharmacy and Drugs Department of the Ministry of Health. Spanish name: Dirección de Farmacias y Drogas del Ministerio de Salud (MINSA)

Requirements:

1.Power of Attorney (POA) from the owner of the product that included the name of the products to be register and its variation. The POA must be duly notarized and legalized by the Seal of the Apostille or the Panamanian Consulate.
2.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: (1) said concentration must be included, (2) the name; (3) the name of every ingredient must be mentioned on the formula, according to the International Nomenclature for Cosmetic Ingredients (INCI); (3) the name of the product as well as its variations; (5) 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.
3.Finished product specifications: microbiological and physicochemical specifications.
4.Studies of the product if the same contains substances of biological origin, vitamins, or substances of easy decomposition, to support the products shell life.
5.Documentation to support the qualities of the product, in case the same is "hypo-allergic", "non-irritant", "water-resistant", among others.
6.Certificate of Good Practice (GMP) of the manufacturing laboratory with a two years validity counted as of its expedition date (except if the document has another expiration date), issued by the competent authorities of the country of origin and duly legalized by the Seal of the Apostille or the Panamanian Consulate.
7.Certificate of Pharmaceutical Product (CPP original) duly issued by the competent authorities. and legalized by the Seal of the Apostille or the Panamanian Consulate.
§CPP must include the name of the products.
§CPP need tos be valid for two years counted as of its expedition date, unless the document has another expedition date.
8.Certificate of Free Sale sometimes called Certificate for Export or Certificate to Foreign Governments
9.Two (2) samples of the product as it will be commercialized in our country, in each of its variations, and must include: (1) the name of the product, (2) content in weight or volume, (3) name of the manufacturing laboratory, (4) the country of origin, (5) batch number, (6) expiration date, (6) storage conditions. (7) Additionally, and depending on the case, must also include the precautionary legends in Spanish language.
10.Two (2) original labels of the product or artwork of the product, including the information mentioned above.
11.Specifications of the container of the products and description of the type of material.***
12.Lifespan of the product as per the certification of the manufacturer lab***
13.Name of the distributer of the product in Panama.

Additional Information:

1.In a single application is possible to group 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.

2.All documents issues abroad must be duly notarized and legalized by the Seal of the Apostille or the Panamanian Consulate.

3.There is an exceptional procedure for products which origin is: Canada, USA, Japan, Finland, Island, Norway, France, Spain, Sweden, Australia, Belgium, Austria, Germany, Denmark, New Zealand, UK, Netherlands, Ireland and Italy.

Registration Process:

Once the documentation is received, 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. This analysis must be paid before the application is submitted into the Pharmacy and Drugs Department.

Once the health registration application is submitted before the Pharmacy and Drugs Department, the documentation is examined by a Pharmaceutical Examiner, and if the 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.

After the expedition of the Health Registration Certificate the analysis of the product will be realized.

Process Time Frame: approximately six (6) months, as long as the documentation filed is complete and complies with the Law requirements. If the Pharmacy and Drugs Department requests some clarification as to further documentation or information, a period of six (6) months to file the required additional documentation will be granted.

Validity of the Health Certificates: ten (10) years, counted as of the expedition date, and may be renewed for equal periods of time.

Renovation of the Health Certificate: Is recommended to start it three (3) months before expires.

Approximation of Expenses:

***Additional fee may apply. Fee may change

Legal Base:

Decree 178 of July 12th, 2001, Decree 105 that modify the Decree 178, Law 1 of January 10th, 2001, Executive Decree 460 of October 4th, 2016, Resolution No. 231-2008

Executive Decree 40, February 13th, 2019

Useful Links:

Link to the government website:

https://www.panamatramita.gob.pa/tramite/registro-sanitario-para-los-cosmeticos-y-cosmeticos-medicados

https://www.minsa.gob.pa/informacion-salud/reglamentacion-sobre-cosmeticos-0

Link to the Decree No. 305 regarding toxic substance. At the bottom you can see the list of those substance.

http://www.minsa.gob.pa/sites/default/files/publicacion-general/decreto_ejecutivo_no_305_4_septiembre_de_2002.pdf

Link to the list of Forbidden Substances and/or substances with restrictions:

http://www.minsa.gob.pa/sites/default/files/publicacion-general/sustancias_prohibidas_y_con_restriciones.pdf

FINAL REMARKS: If you require specific information about the process, or specific quotations, our legal fee per consultation is USD 200 per hour or fraction, which you can pay through paypal or bank transfer. We will not answer any mail or specific inquiry if we have not received the payment for consultation. This payment may be deducted from the legal fees in case of hiring our services.

WARNING: This is not to be considered legal advice. The information herein contained is accurate to the best of our knowledge at the time of drafting of this document. We are not responsible for any changes that may occur or good faith inaccuracies. You must seek a personal consultation before you make any decisions based on the information of this brochure. We cannot give legal advise on jurisdictions other than Panama