COFEPRIS and Pharmaceutical sector

The formal application process starts when a pharmaceutical company takes the compilation of documents known as the application dossier to the COFEPRIS institution. 
The chemists at the COFEPRIS will read everything very thoroughly and will address any question they might have about the data on the dossier in the form of a letter, commonly called deficiency letter, officially called prevención in Mexico. 

Deficiency letters are not always issued, and most of them can be avoided by following all the guidelines, submitting complete information, and avoiding common mistakes.

Dossier

The structure of the submission dossier will depend on the type of product that it is intended to be registered.

New Molecules

Module I. Legal/Administrative information

Module II. Quality information

Module III. Preclinical studies

Module IV. Clinical studies

Generic Drugs

Module I. Legal/Administrative information

Module II. Quality information

Module III. Bioavailability and/or bioequivalence