Although the use of equivalence standards recognizes that the requirements imposed by certain foreign agencies to approve pharmaceutical products and medical devices are equivalent to those established in the laws and regulations of Mexico, the inactivity of COFEPRIS is latent.
Recently, and at the request of one of our clients in the pharmaceutical industry, we designed a strategy with the purpose of obtaining a decision from the Specialized Court ordering the issuance of the corresponding marketing authorization.
Get to know the details of this process in the article, “Judicial Decision a First Victory for Equivalence Standards”, that our renowned lawyer in the Life Sciences Industry group, Juan Luis Serrano Leets, prepared for Mexico Business.
Read the article here.
If your company requires advice in this regard, do not hesitate to contact our experts.
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Juan Luis Serrano Leets | Partner
