Requirement of GMP Certificates for Drug Applications, Renewals and/or Variations of Drug Products
COFEPRIS – Circular No. CAS/OR/01/706/2012
As from July 2012, the submission of a GMP Certificate from the manufacturing site of the finished product (dosage form) and the drug manufacturer (understood as the active ingredient manufacturer) will be required in order to grant, extend or modify the registration of a drug product manufactured in a plant outside of Mexico.
Only GMP Certificates issued by COFEPRIS or by any of the following foreign health authorities: FDA (USA) – ANVISA (Brazil) – HEALTH CANADA (Canada) – EMA (EU)-PHARMACEUTICAL – FOOD SAFETY BUREAU (Japan) and TGA (Australia) will be accepted. The documents issued abroad must be legalized or certified with The Apostille, and if they have not been issued in Spanish, a translation performed by an official translator in Mexico and certified by the Mexican College of Translators will be requested.
COFEPRIS also made express reference to the fact that the agency will not consider valid, and therefore will not accept, Certificates of Suitability instead of GMP Certificates.