9 Sept 2016
Mexican Health Ministry Issues Updated Guidelines to Validate GMP Certificates for Drugs
Mexico’s Ministry of Health recently issued an updated set of guidelines that officials must follow to validate good manufacturing practices certificates for drugs and medicaments. These guidelines apply to the sanitary registration of medicines, any modifications to such registrations as well as the process to extend drug registrations. Mexico will recognise foreign GMP certificates issued by the U.S. Food and Drug Administration, Health Canada, Australia’s Therapeutic Goods Administration, the European Medicines Agency, the Swiss Agency for Therapeutic Products (Swissmedic), the Brazilian Health Agency (ANVISA), Japan’s Ministry of Health, Labour and Welfare, and South Korea’s Ministry of Food and Drug Safety. Foreign-made medicines must be accompanied by a certificate issued by one of these agencies or Mexico’s Federal Commission for the Protection against Sanitary Risk (COFEPRIS), while domestically-produced medicines must have a certificate issued by COFEPRIS.
In the case of low-risk drugs, Mexico will accept GMP certificates issued by the competent authorities in the country of origin as long as the producer undergoes an audit and the certificate complies with certain requirements. In the case of high-risk drugs, Mexico will accept GMP certificates issued by COFEPRIS or one of the foreign agencies listed above. Meanwhile, Mexico will accept foreign GMP certificates or equivalent documents for herbal, vitamin and homeopathic medicaments issued by the competent authorities in the country of origin. In the case of goods considered to be food supplements in the country of origin, an official document equivalent to a GMP certificate must be submitted.