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Recent Issues Concerning The Pharmaceutical Industry In Argentina 

March, 2014 - Emilio N. Vogelius and Ana Andrés

As you no doubt already know, the Pharmaceutical Industry in Argentina is a strictly controlled industry. Said control is held by the ANMAT Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) and it spreads from the first authorisation of a laboratory to act as such in the country, moving through the authorisations to commercialise products, up to pharmacovigilance of products that have already been commercialised.

The general rule that regulates the pharmaceutical market is the law 16.463, issued on August 1964, but has been adapted through decrees, resolutions and dispositions. It is most accurate to suggest that the present regulation on the principal topics of the pharmaceutical market is defined by the Decree 150 issued in January 1992.

Regarding the authorisation for laboratories to commercialise theirs products in the country, it has been a long standing idea of those that  issue the political regulations to promote the local manufacturing as much as possible. The general understanding is that laboratories must perform most of the manufacturing activities in their plants, although they might sub-contract part of the process with third parties. However, it should be noted that the quality control process should be made by the laboratory authorised by the ANMAT to commercialise the corresponding pharmaceutical product.