Medicines are a fundamental part for the health of the Mexican population, which must demonstrate quality, safety and efficacy, for which COFEPRIS requests a Sanitary Authorization (Marketing Authorization) for their commercialization in the national territory, for this it is required the submission of a dossier with all the information about of the medicine that complies with the current Sanitary Regulation.
At GMVR, we support you throughout the process of compiling and reviewing the Dossier of Medications for submission to COFEPRIS, we have the following services:
- New Register
- Conventional Submission
- Equivalence Agreement: European Union, Switzerland (Swissmedic), U.S.A. (FDA), Canada (Health Canada) and Australia (TGA).
- Technical and Administrative Variation
- Minor Variations
- Moderate Variations
- Major Variations
- Change of Sanitary Register Holder
- Renewal of the Register