The Mexican Ministry of Health and Ministry of Economy published on August 14, 2014 a modification to NOM-051-SCFI/SSA1-2010 establishing new specifications for the labeling of pre-packed food and non-alcoholic beverages. This modification is aimed at aligning the content of NOM 051 with the new sanitary rules part of the National Strategy for the Prevention and Control of Overweight, Obesity and Diabetes. The idea is to offer the consumers with more information concerning sugar, fat and salt content in pre-packed food and non-alcoholic beverages.
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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.
In order to expand the supply of innovative medicines for Mexican patients and strengthen the competitiveness of the economy, the Ministry of Health through the Federal Commission for Protection against Health Risks (COFEPRIS) announced on October 9 the next entry in force of an important Agreement on the Promotion of Pharmaceutical Innovation.
Commissioner Mikel Arriola explained that in order to support innovation, new molecules that are manufactured in Mexico – which also encourages health research – will be approved quickly and within 60 working days. At present, a new molecule registration takes up to 360 days on average.
Similarly, in order that locals have access to innovative medicines that are sold in developed countries and are not available in Mexico, COFEPRIS will recognize the registration of new molecules that have been granted by foreign agencies in the United States, Canada, Switzerland, Australia and the European Union, and approve the registrations in 60 business days.
The commissioner said that in both cases, the Mexican health agency will review and approve new drugs without neglecting the quality, safety and efficacy of drug products.