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COFEPRIS Sanitary License: Who Qualifies and What You Get

Learn how to obtain the legal authorization required to operate a pharmacy selling medicines and controlled substances in Mexico.

This license is the official legal authorization required to operate a business that sells medicines or controlled substances.

Who it's for

This scheme is for any establishment that sells controlled substances or medicines. If your business involves the sale of these specific types of items, you must obtain this authorization to operate legally.

What you get

Once your application is approved, you receive the formal legal authorization required to operate your business as a pharmacy. This permission allows you to conduct your business activities within the regulatory framework required for selling pharmaceutical products.

What it costs you

Obtaining this license requires both time and money. You will be responsible for paying high application fees to the issuing body. Furthermore, the process involves undergoing rigorous facility inspections conducted by the government to ensure your establishment meets the necessary requirements.

The catch to know

The most critical thing to keep in mind is the renewal process. If you miss the deadline for your renewal, it triggers immediate administrative fines. It is essential to track your expiration dates to avoid these financial penalties.

How to apply

  1. Verify that your establishment meets the requirements for selling medicines or controlled substances.
  2. Prepare the necessary documentation required for the application process.
  3. Submit your application through the official channels.
  4. Pay the required application fees.

https://www.gob.mx/cofepris