In the sanitary registration process before COFEPRIS, there are several common mistakes that can delay approval or result in the rejection of the registration.
Common Mistakes
Incorrect classification of the product to be registered
Incomplete or incorrect documentation
Errors in filling out forms
Inconsistencies in the submitted information
Mistakes in administrative information
How to Avoid Them
Proper Planning and Preparation
Begin preparing the dossier well in advance to allow enough time to gather and review all required documentation. Use specific checklists tailored to each product type.Specialized Consulting
Hiring a company specialized in sanitary registrations with COFEPRIS can be a valuable investment to avoid common errors and ensure the dossier meets all requirements.Internal and External Review
Conduct thorough internal reviews and, if possible, have the dossier externally reviewed by regulatory experts before the official submission.Training and Updates
Stay updated on changes to COFEPRIS regulations and ensure that all staff involved in dossier preparation receive continuous training.Effective Communication
Maintain clear and consistent communication with all parties involved, including manufacturers, holders, and distributors, to ensure alignment with deadlines and requirements.Continuous Follow-Up
Closely monitor the COFEPRIS review process and respond promptly to any additional information requests or correction notices.
By implementing these strategies and avoiding common mistakes, you can significantly increase your chances of obtaining successful sanitary registration before COFEPRIS.
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