6. Registration Processes

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Infant, Follow-up, Young Child Formula
Mexico

This section provides information on any product notification or registration and manufacturing site registration processes.

6.1 Product Notification

Infant, Follow-up, and Young Child Formula

No product notification is required.

6.2 Product Registration

Infant, Follow-up, and Young Child Formula

Product registration does not apply [1].

6.3 Other Notes or Requirements

Imported formulas do not require product registration, but a Prior Sanitary Import Permit (PSPI in Spanish) is required. This procedure must be applied at the Federal Commission for the Protection against Sanitary Risks (COFEPRIS by its acronym in Spanish) every time the interested company wants to import a product.

The Prior Sanitary Import Permit authorizes the introduction into the national territory of foods, including infant formulas, which comply with current sanitary legislation, for their commercialization, distribution, and production processes of the industry [2].

It is worth mentioning that the importer company placed in Mexico must apply for the Notice of Operation, which is a document requested by COFEPRIS, and that refers to the physical place where the food/health supplies will be stored and distributed. For this reason, it is necessary to consider having a Legal Representative and an establishment in Mexico. Please refer to the following Section 6.4. Manufacturing Site Registration for details.

Requirements for the Prior Sanitary Import Permit [2]:

Format of Authorizations, Certificates, and Visits duly filled out (referring to the Notice of Operation).
Proof of payment of duties, in terms of the Federal Law of Duties.
Health or Sanitary Certificate or Certificate of Free Sale.
Physicochemical and microbiological analysis for each lot. For foodstuffs from countries or areas affected by nuclear accidents, in particular, Europe and Asia: certificate stating a maximum of 370 (three hundred and seventy) becquerels per kilogram of radioactive contamination for milk intended for human consumption, milk products and foodstuffs intended for infants during the first four to six months of life and a maximum of 600 (six hundred) becquerels per kilogram for all other agricultural products intended for human consumption.
Original label.
Label in Spanish with the mandatory information according to the labeling rules for infant formulas in Mexico.

Note: All documents must be submitted in original format (duly translated if from languages different from Spanish) and their corresponding copy. The originals are returned after verification. Legal documents must be legalized or apostilled, as appropriate.

The Prior Sanitary Import Permit has a cost (fees) of 5,770.79 MXN (approx. 300 USD). The maximum official response time is 15 days. However, in practice, it could take 1 month approximately.

6.4 Manufacturing Site Registration

Infant, Follow-up, and Young Child Formula

Notice of Operations for Products and Services Establishments applies for both Manufacturers, Marketers, and/or Importers check out the document requirements at: [3]

New establishments: https://www.gob.mx/cms/uploads/attachment/file/651385/COFEPRIS-05-018.pdf
Modifications to establishments: https://www.gob.mx/cms/uploads/attachment/file/651386/COFEPRIS-05-019.pdf

It is regulated by COFEPRIS.

Notice of operations has an immediate resolution once the documentation is submitted during the appointment at COFEPRIS facilities. Notice of operations has no fee and while this is a one-time process, authorization is for specific product categories indicated in the form. In addition, it applies only to National Manufacturers, Marketers, or Importers. It means that foreign companies have to be associated with a local company that will be representing them regarding the importation and commercialization of foreign products. In the case of importers, the Notice of Operations shall be for storage purposes.

6.4.1 Standard/Rules for Manufacturing Site

Infant, Follow-up, and Young Child Formula

Mexican Official Standard NOM-251-SSA1-2009 Good Manufacturing Practices for processing food, beverage and dietary supplements. / Norma Oficial Mexicana NOM-251-SSA1-2009 Prácticas de higiene para el proceso de alimentos, bebidas o suplementos alimenticios [4].

6.4.2 Other Notes or Requirements for Manufacturing Site Registration

Infant, Follow-up, and Young Child Formula

None.