MEXICO

On January 24, the Secretariat of Health (SSA in Spanish) published, through the Official Gazette of the Federation (DOF in Spanish), the agreement that modifies provisions of the previous agreement that contained the procedures and services applied by the Federal Commission for the Protection against Health Risks (COFEPRIS in Spanish), registered in the Federal Registry of Procedures and Services of the CONAMER. The text allows COFEPRIS to simplify drug procedures using new electronic means. This amendment covers the procedures to be carried out by manufacturers of any type of medicines, including oncological medicines. The text will enter into force on February 23, 2022.

Among the highlights of the new agreement are:

• It establishes that COFEPRIS will be able to use electronic tools on drug procedures. It also establishes that COFEPRIS will be able to use electronic tools to process the Request for a Sanitary Verification Visit for the Certification of Good Manufacturing Practices for drugs in establishments located in Mexico and abroad, which will have a 90 working day attention period.
• In terms of the Request for Sanitary Verification Visit for Good Manufacturing Practices Certificates for pharmaceuticals, companies may request a video-verification of the establishment located abroad in proceedings that are in the process of being attended by the Administrative Unit of COFEPRIS.