Secretariat of Health
On November 18th, the Secretariat of Health (SS) published this agreement in the Federal Official Gazette (DOF), by which it is reported that the Federal Commission for the Protection against Sanitary Risks (COFEPRIS ), must resolve the origin of the applications for sanitary registration of medicines and health supplies that come from abroad, within a period of 5 business days counted from the one following the one in which the applicant delivers the applicable documentation, in accordance with what is established in the equivalence agreements mentioned in the agreement.
Likewise, it is established this period will be suspended when the Federal Commission for the Protection against Sanitary Risks requires the applicant, expressly and in writing, documents, clarifications or missing information and will resume on the business day following that on which the Applicant provides such information, documents or makes the pertinent clarifications.
If the applicant does not provide the documents, clarifications or missing information within the term granted for this purpose, the application will be deemed not submitted.
This Agreement does not exempt importers, distributors and marketers of products that obtain the sanitary registration, from complying with the requirements established in article 131 of the Health Supplies Regulation, or from any other requirement or specification necessary; as well as any additional requirement to the sanitary registry that they are obliged to fulfill in order to market the medicine or input in question, in Mexican territory, in accordance with any applicable law, regulation and other provisions.
Medicines and other health supplies that are the object of this Agreement will be subject to the surveillance, sanitary control, pharmacovigilance or technovigilance actions established in the applicable legal provisions.
The Federal Commission for the Protection against Sanitary Risks shall carry out the actions it deems necessary, that allow expediting in the administrative sphere the resolution of the requests for sanitary registration of medicines and other health supplies that come from abroad, within the established deadlines in this Agreement, guaranteeing its quality, safety and efficacy, in terms of the applicable legal provisions.
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