Mexico: new guidelines for the acceptance of GMP certificates

In October 2013, the Mexican health authority released a new document setting the criteria that will be used to accept GMP certificates as valid. This criteria applies to certificates of manufacturing facilities both of finished products and API.

Summary of the guidelines:

1- The following guidelines apply for new drug applications, variations and renewals of certificate of small-molecules (allopathic) products.

2- At the time of submitting the application dossier, the solicitor must have a GMP certificate of the finished product or API issued by:

  • COFEPRIS (Mexican health authority)
  • One of the health authorities recognized by COFEPRIS: FDA (USA), ANVISA (Brazil), Health Canada (Canada), EMA (EU), Pharmaceutical and Safety Bureau (Japan) and TGA (Australia) or,
  • Health authority of origin

The GMP certificate must be presented in original or notary-certified copy, be written in Spanish or have attached the Spanish translation by an authorized translator (perito traductor autorizado). It must be apostilled or legalized. If the validity period is not specified in the certificate, it will be considered of 30 months.

3- If the solicitor presents a GMP certificate issued by the health authority of origin, and this health authority is not any of those recognized by COFEPRIS, an analysis with focus on risk assessment will be performed to assess the compliance with GMP standards. This analysis will consider the record of the manufacturing site, its pharmacovigilance reports, other GMP certificates issued by COFEPRIS or other health authorities, sanitary alerts, and any other information that the authority might consider relevant.

4- If, as a result of the above-mentioned analysis, it is decided that there is not enough information of reason to consider the foreign GMP certificate proposed by the solicitor as valid, it will be necessary for the COFEPRIS to visit and inspect the manufacturing site to verify the compliance with GMP guidelines. This inspection will have to be requested by the solicitor via the established administrative processes, and the receipt for the application for inspection has to be evidenced to the Commission of Sanitary Authorization.

5- COFEPRIS will publish the list of GMP certificates that have been accepted by it, which can be considered as a reference for the above-mentioned analysis. The solicitors will then be able to request to COFEPRIS a note (constancia) stating that a certain GMP certificate has been recognized as acceptable, which will be attached to the submission dossier.

If you want a copy of the original guidelines (in Spanish) just send me an email: inesitag@hotmail.com

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About Maria I. Guaia

www.latampharmara.com
This entry was posted in Mexico and tagged , , , , , , , , . Bookmark the permalink.

6 Responses to Mexico: new guidelines for the acceptance of GMP certificates

  1. Ajay says:

    Please let me know, how to conduct risk assessment for compliance with GMP, as suggested in point no 3 of above article.

    • Maria says:

      Dear Ajay,

      The risk assessment is performed by the health authority (COFEPRIS) which will decide if the documental information and experience available is enough to determine GMP compliance or if it is worth inspecting.

      Thank you!

  2. Ajay says:

    Dear,

    Thank you for the information.
    is documental information sufficient for risk assessment by COFEPRIS?
    if yes, what are list of documents required and how to initiate the process?

    Regards,
    Ajay

  3. Sarita says:

    Dear Maria.

    Please guide me how can we obtain drug approval/ marketing date in Mexico. Is there is any link please share me.

  4. Bhavana says:

    Please let me know whether GMP issued by Poland (one of the EU country) is acceptable by COFEPRIS. We filed our dossier though National procedure in Poland.

  5. bhavana says:

    Dear Maria,

    COFEPRIS requires the apostilled GMP of API manufacturer. Is the apostillation of GMP done by the inspecting country is mandatory for registration or the apostillation can be done at the submitting country.

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