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Health Law

  • Requirements for the obtainment of a Health Registration
    for pharmaceutical products, in Panama

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Health Law :: 

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

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

The requirements are the following:

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 product to be registered before our health authorities.

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 not be on the letter head of the company or manufacturing laboratory, and 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 expiration date.

Quali-quantitative formula of the product, duly signed in original by the responsible person of the manufacturing laboratory.

Four (4) samples of the product as it will be commercialized in our country, in each of its variations, and must include, the name of the manufacturing laboratory, the country of origin, batch number, expiration date, pharmaceutical form , way of administration, storage conditions. Must include also the phrases “Keep out of the reach of children” (Mantèngase alejado de los niños) and “Sold under prescription” (Venta bajo receta mèdica), both in Spanish. Also the Certificate of Analysis of said sample.
For your information, additional samples will be requested by the Specialized Institute of Analysis for the correspondent analysis, once the documentation is filed before said Institution.

Four (4) original labels of the product or artwork of the same. Must include also the phrases “Keep out of the reach of children” (Mantèngase alejado de los niños) and “Sold under prescription” (Venta bajo receta mèdica), in the primary and secondary labels, both in Spanish language.

Finished product specifications.

Method of Analysis of the product.

Stability Studies of the product (final product) from three (3) different batches, indicating the validity period that it is being given to the product, preferably a chart, with mention of the temperatures, the type of recipient used on the study, the duration of the study and the conclusion of the same. Also, the studies have to be effectuated at temperatures within the climatic zone IV, that is, at 30°+2°C of temperature, and 70%+ relative humidity.

Literature of the product.

Information as to the type of recipients used.

Information as to the interpretation of the batch number.

Working standard of the product (a sample), clearly identified with the name of the active ingredient, the purity percentage, expiration date, batch number and the storage conditions, with its correspondent Certificate of Analysis.

Name of the distributer of the product in Panama.


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 to 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 timeframe of this procedure is approximately six (6) months, since in the event that the Pharmacy and Drugs Department requests some clarification as to further documentation, said entity will consent a period of 120 days to file said additional documentation.

Please be advised that the Health Registration Certificates for medical products have a validity of five (5) years, counted as of the expedition date, and may be renewed for equal periods of time.

Expenses:

Analysis of each product by the Specialized
Institute of Analysis
US$750.00
1st post registration analysis (due after the
product has been approved)
US$750.00
2nd post registration analysis (due after the
product has been approved)
US$750.00
Expedition services for the Health Registration, by the Pharmacy and Drugs Department US$200.00
Fiscal stamps affixed to the application US$4.00 p/page
Legalizations and authentications before the Ministry of Foreign Relations US$10.00 p/doc.
Certificate of Registration US$14.00
Registry Right US$25.00
Countersign by a proper pharmacist US$30.00
Countersign by the National College of Pharmacists US$20.00
Miscellaneous US$25.00 approx.
   
TOTAL US$2578.00 approx.




 
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