The New Molecule Committee of COFEPRIS is responsible for requests and technical meetings through the Centre for Integrated Services (CIS).
The first step in the new molecule registration process is arranging a consultation meeting with COFEPRIS New Molecules Committee (NMC).
A consultation meeting is deemed mandatory before submitting the registration dossier to the New Molecule Committee (NMC) at COFEPRIS.
The consultation meeting goes through the following steps.
- A meeting request with supporting documents is submitted to NMC
- NMC notifies the applicant of the meeting request decision within 60 days after reviewing the application
- NMC notifies the applicant of the scheduled meeting day 20 business days in advance
- Applicant must confirm the scheduled meeting date with the NMC
- A presentation must be sent to NMC five (05) days prior to the confirmed meeting date
- NMC will issue a Technical Opinion twenty (20) business days after the meeting
- The applicant can submit the Technical Opinion and the complete technical dossier to COFEPRIS
Document consideration before scheduling a meeting with NMC requires the applicant to translate all documents into Spanish. The applicant must also identify the applicable evaluation route for product registration.
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