ALBA-TCP (ALBAMED) Regulatory Center of Drugs for Human Use
The National Assembly decreed the Law Approving the Treaty that Establishes the Regulatory Center of Drugs for Human Use of the ALBA-TCP (the “Treaty”), published in Official Gazette No. 6,187 Extraordinary, dated June 10, 2015. The purpose of the Treaty is to establish the ALBA-TCP Regulatory Center of Drugs (the “Regulatory Center”), in order to contribute to the accessibility to essential drugs through the development and implementation of a grand-national and centralized system for the Health Registry of Drugs, as a mechanism of regional integration that allows access to drugs with quality, safety, efficacy, and at better prices for the ALBA-TCP member countries (Bolivia, Cuba, Ecuador, Nicaragua, and Venezuela).
The Treaty establishes that the Regulatory Center will be the highest entity for the coordination and granting of the registries of the essential drugs of the ALBA-TCP. The Grand-National Registry of Drugs (Registro Grannacional de Medicamentos) (the “Registry”) will be granted by the Regulatory Center for the essential drugs of the ALBA previously selected.
After the issue of the Registry, two forms of health authorization will coexist in the ALBA-TCP State Parties, for the commercialization, distribution, and use of drugs of human use:
1. The National Registry, with validity in the territory that granted the same and in others, as per harmonization processes or previous agreements, and
2. The Grand-National Registry of Drugs of the ALBA-TCP (Registro Grannacional de Medicamentos del ALBA-TCP), valid for all of the States Parties.
The Treaty states that the drugs requiring the Registry will be those considered in the basic lists of essential drugs of the ALBA-TCP, formed, agreed, and approved by the States Parties. In order to obtain the Registry, the drugs must comply with the following precepts:
1. To show the necessary evidence of quality, safety, and efficacy and of information to the Regulatory Center.
2. To be manufactured following “good manufacturing practice” standards, which may be verified by the Regulatory Center.
3. To be distributed, imported and exported following “good practice” standards, which may be verified by the Regulatory Center.
The Registry and its renewal will have a duration of five (5) years. Likewise, the drugs with the Registry will be subject to post-registry monitoring of their quality, safety, efficacy and information by the Regulatory Center.
The Treaty will enter into force upon the elapsing of five (5) days as from the day following that of the deposit of the second instrument of ratification and will have a duration of 25 years automatically extendible for equal periods.
In order to access the Treaty, please click here.
“NOTE: THIS INFORMATION SHOULD NOT BE CONSTRUED AS LEGAL ADVICE ON ANY SPECIFIC MATTER AND ITS CONTENT ARE INTENDED AS A MANAGEMENT ALERT AS TO CURRENT DEVELOPMENTS IN VENEZUELA, ANY SPECIFIC LEGAL QUESTIONS REGARDING THE POSSIBLE APPLICATION OF NEW OR PROPOSED LEGISLATION TO PARTICULAR SITUATIONS SHOULD BE ADDRESSED TO TRAVIESO EVANS ARRIA RENGEL & PAZ.”