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Nutritional Supplements

Medical Divices


New Molecule

Vitamin Drugs

Biologic /




this product is considered the most consumer friendly in our registry section.

The key is to clearly locate the scope of each formula and ingredient. The challenge consists in giving clear messages to the end consumer as well as in providing precise indications of use and of adverse effects.

Cosmetics present an annual growth of more than 20% in our country. In the pharmacies they occupy every day more and more space and the combination of cosmetics with allopathic ingredients are the market trend.

The standard that regulates cosmetics is NOM-141-SSA1/SCFI-2012 “Health and commercial labeling”.

phase 1 

Key points of the labeling standard:

  • Avoid deceitful messages or non documented statements to the end consumer.

  • Name or brand: must not be related to the particular effect or function.

  • Clear description of the process: from the way the raw material is obtained to the supply to the public.

  • Precautionary legends.

​a. Labels in Spanish

b. Instructions for use

c. Detailed information about the formula

d. Expiration date

e. There are compatible international standards

phase 2

Once the has been accomplished according to standard, the product must be registered in the license or certificate for its distribution.

phase 3

The import permit will be the next step to start commercialization in case of being a foreign manufacturer.

phase 4

Advertisement: Each advertisement must be notified to Cofepris.

phase 5

Optional: Authorized third party

  • What is an authorized third party? These are private companies authorized by Cofepris to issue technical reports acknowledged by Cofepris for official government actions.

  • How do they help? Their services provide an important saving of time in the authorization processes. This can be up to a 50%.

  • How much do they charge? Each authorized third party has standard rates depending on the service to be applied.

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