Cofepris | Mexico | Regulatory | global regulatory partners

Overview:

On August 19, 2020 The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) announced that they established new operating rules in order to promote the production of generic drugs in Mexico. The operating rules eliminated criteria that limited their production and their availability at more accessible prices for the Mexican population.

New registration procedure carried out by CIS:

 The Integral Center of Services (CIS) of the COFEPRIS will have a special registration process for generics.  Hence forth the registration procedures for generics can begin the day following the granting of the patent for the innovative medicine. This new action will effectively eliminate the previous barrier, known as the Bolar clause, that required  3 to 8 years of research for generic development. 

Second-use Patents:

According to the new rules for granting a sanitary registration to generics, second-use patents are no longer allowed.

REGULATORY CORNER:

WHAT IS THE BOLAR CLAUSE?

The Bolar Clause is part of  the “Regulation of Health Products”,  under article 167 bis. The Bolar Clause allows that BEFORE the patent expires, the manufacturers of generic drugs prepare all the studies and the required procedures so that they can leave immediately after the patent protection term ends.

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.  To learn more, please contact us at  info@globalregulatorypartners.com

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