Cofepris will approve the sale of COVID vaccines for companies interested in marketing them within the national market.
The Federal Commission for the Protection against Health Risks (Cofepris) will approve the sale of COVID vaccines for marketing within the national market. The final resolution will be issued next November 29, 2023. As part of the process and prior to the final resolution, the commission informed the requesting companies that they must enter missing information, required under the regulatory prevention mechanism to obtain authorization.
In a statementCofepris declared that with the prior evaluation of the file that the laboratories entered to obtain the health record Pfizer for Comirnaty vacciney Modern (through its legal representative in Mexico, Asofarma SA de CV), for the Spikevax vaccine monovalent, missing elements were identified and pertinent clarifications were enunciated, essential for the technical integration of the dossier.
He also stated that on Wednesday, November 22, 2023, he reported the elements that must be supported before the Cofepris team of adjudicators to migrate to the authorization of health records.
Companies seeking to market vaccines must verify the quality, safety and effectiveness of the products before obtaining health registration. The evaluation process will be a regulatory exercise under the “glass box” principle, exemplary for its proactive transparency and technical efficiency. At the same time, they will have to comply with the scientific, technical and methodological criteria established by the same authority, says the Cofepris.
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Cofepris also informed the population that the vaccines that currently have emergency use authorization are quality, safe and effective products, which need to complete the route with updated technical and administrative information.
At the same time, he urged the population to do not make indiscriminate use of any vaccine against COVID-19, since it can be risky to health and reiterated that the application of vaccines outside the National Vaccination Policy must be strictly under medical recommendation.
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2023-11-24 17:45:04
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