Mexico amends the Health Law Regulations with impact in the approval of medicines.

June 8, 2021

Last May 31, 2021, the Ministry of Health issued a decree in the Official Gazette, amending several articles of the Health Law Regulations. The most relevant points of this decree were the following:

• COFEPRIS allows the submission of documentation in English, without translation into Spanish within sanitary approval applications. In the case of documents issued by a foreign Authority, they must be legalized.
• The labels of products destined for the public sector must now be differentiated from those of the private.
• For the approval of biocomparable medicines, the participation of the Subcommittee for the Evaluation of Biotechnological Products was eliminated, now it is sufficient the New Molecules Committee opinion.
• Clinical studies in the country of origin of biocomparable medicines can be submitted as evidence for the Marketing Authorization application. When applying for a renewal of the Marketing Authorization, clinical studies in Mexico must be submitted.
• The first extension must be requested 5 years after the approval and must be resolved within 120 days.
• To obtain the first Marketing Authorization renewal, all products will be monitored by the regulatory agency, taking into account the effects of the product during its first years in the market.
• For further renewals must be requested/ informed to COFEPRIS every five years, and no later than 150 calendar days before the expiration of the Marketing Authorization.
• The statutory terms regarding applications to modify the Marketing Authorization have changed, the regulatory agency shall issue a response within 45 days for technical modifications and 20 days for administrative modifications.
• If the modification of the Marketing Authorization is authorized, the holder will have a period up to 240 calendar days to eliminate the stock of the product.

These amendments to the Health Law Regulation, in general, are focused on improving the analysis and resolution of various processes.

OLIVARES will continue to analyze the impacts of these changes in order to guide our clients and the industry with best practice strategies.