Executive Branch moves forward in simplifying procedures, agrees to streamline sanitary registrations with the industry and announces public procurement
6 enero 2022


On January 6, the Secretariat of Health (SSA in Spanish) published, through the National Commission for Regulatory Improvement (CONAMER in Spanish), a new version of the draft bill that proposes modifications to the agreement by which the procedures and services applied by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS in Spanish), registered in the Federal Registry of Procedures and Services of CONAMER, are disclosed. The text is still open for comments through the following link. On the other hand, on January 5, the Institute of Health for Wellbeing (INSABI in Spanish) held a working meeting with COFEPRIS and representatives of the pharmaceutical industry to devise measures to streamline procedures to obtain sanitary registrations where they agreed to work together on measures to facilitate the process of purchasing state medicines, as well as to review operations related to the importation of medical supplies and customs procedures for the same. It is expected that the stakeholders will hold more meetings on this matter in the medium term.

As for the draft bill, its objective is that COFEPRIS may carry out simplifications of the aforementioned procedures for medicines, by electronic means. The new version does not modify the spirit of the original text. It should be recalled that the text proposes that COFEPRIS may use electronic tools on drug procedures, for example in the Request for Sanitary Verification Visit for the Certification of Good Manufacturing Practices of drugs in establishments located in Mexico and abroad. It also proposes that companies may request the performance of the sanitary verification in the modality of video-verification on that establishment located abroad.

In the meeting between INSABI and COFEPRIS, it was decided to extend the term of the market research for the state purchase of medicines corresponding to the second semester of 2022, which will allow companies with the intention of participating in the bids to reevaluate whether they have the possibility of offering their medical supplies or not. On the other hand, INSABI announced that it initiated the process for the purchase of 280 keys of medicines that were not tendered at international level in the purchase that the agency concluded in December through the call LA-012M7B998-E165-2021. The entity decided to receive again quotations from national and foreign pharmaceutical laboratories, alleging that in the initial call there was a lack of business proposals.

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