Beccar Varela
  March 20, 2014 - Argentina

Recent Issues Concerning The Pharmaceutical Industry In Argentina
  by 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.

Some laboratories, acting within the scope of the Resolution 223, issued on April 1996, have been authorised to act only on commercialising pharmaceutical products; this is not manufacturing them but acting as importers and or mere sellers of products. 



Footnotes:
Emilio N. Vogelius is a partner of Estudio Beccar Varela and the head of its Life Sciences and Arbitration Department. He has extensive experience in Corporate Law, particularly in relation to the Pharmaceutical Industry, Arbitration and Litigation.

Ana Andrés is a senior associate of Estudio Beccar Varela. She focuses her practice on Corporate Law and regulatory matters involving pharmaceutical companies.



Read full article at: http://www.ebv.com.ar/images/publicaciones/eguideebv.pdf