There are different categories of drugs that are considered new molecules:
- Medicines that worldwide do not have a Sanitary Authorization (Marketing Authorization) and are intended to be registered in Mexico for the first time
- Medicines that have a Sanitary Authorization (Marketing Authorization) in other countries and that do not have a Sanitary Registration (Marketing Authorization) in Mexico
- Drugs that intend to make a combination of two or more drugs that does not exist in the national market
- Existing drugs on the market that intend to be marketed with another therapeutic indication
For all the categories previously described, before requesting their Sanitary Registration (Marketing Authorization) to COFEPRIS, a technical opinion or special technical opinion from the New Molecules Committee (CMN) is required.
At GMVR, we know that the process to obtain the opinion of the CMN can be complex, so we offer you our experience in compiling the electronic dossier of Consultations to the Committee on New Molecules to obtain an opinion.
Types of Opinions:
- Technical Opinion
- Special Technical Opinion