According to Articles 204 and 376 of the General Health Law (LGS), medicines require a Sanitary Registration for their sale or supply in Mexico.
Process Overview
To obtain the Sanitary Registration for medicines, it is necessary to prepare a dossier containing administrative-legal and technical information that meets the requirements set by the health authority, COFEPRIS (Federal Commission for the Protection against Sanitary Risks). The required documentation will depend on the characteristics of the medicine and its origin.
Key Characteristics for Registration
Nature of the Medicine: Based on Article 224 of the LGS, medicines are classified as Alopathic, Homeopathic, or Herbal. Alopathic medicines include those with pharmaceutical, biological, or biotechnology origins.
New Molecule or Generic Medicine:
New Molecule: A substance, whether natural or synthetic, that has not been used previously in the country, whose therapeutic efficacy and safety have not been fully documented in scientific literature.
Generic: A pharmaceutical specialty that is proven to be equivalent to the reference medicine in terms of pharmacopoeial specifications, dissolution profiles, or bioavailability.
Domestic or Foreign Manufacturing: For foreign-manufactured medicines, additional documents such as Certificate of Free Sale (CLV) and Representation Letter are required.
Sanitary Registration Ownership: To hold a registration, one must have a valid sanitary license for a factory or laboratory manufacturing medicines or biological products for human use. The holder can be a domestic or foreign manufacturer (with the latter requiring a legal representative in Mexico).
COFEPRIS provides a Check List with all the necessary requirements for registration requests.
Common Technical Document (CTD) Version 2.0
This document guides the integration of the registration dossier and its modifications for medicines and biological products. You can review it on COFEPRIS’s website:
Common Technical Document (CTD) Version 2.0 | COFEPRIS
Document Organization
The CTD specifies the following:
Organization of documents into five modules.
Order in which documents should appear for easy identification and accessibility.
Payment of Fees
Once the dossier is complete, the necessary fees should be paid according to COFEPRIS’s established tariffs, which vary depending on the type of medicine to be registered:
Generic Medicine
New Molecule Medicine
Homeopathic, Herbal, and Vitamin Medicines
These fees are updated annually.
COFEPRIS Review and Evaluation
Currently, applications for medicinal registration are submitted directly to COFEPRIS in printed form. The authority is working to digitalize the process through its DIGIPRIS platform.
Once submitted, the legal time for issuing a resolution ranges from 180 to 240 calendar days.