On May 31, the Decree amending, adding, and repealing several provisions of the Health Supplies Regulation was published in the Official Journal of the Federation. The Decree entered into force the day after its publication.
The Decree is aimed to expedite several proceedings, achieve greater health surveillance and strengthen global innovation.
The most relevant aspects of the Decree are the following:
1. Packaging and labelling
- Specific labelling and packaging are provided for products destined for public health and social security institutions, other than those in the private sector. To this end, the public sector will have 180 calendar days from the entry into force of the Decree to comply with the new requirements.
- Manufacturers whose products do not meet these requirements will have 120 calendar days to run out their stocks.
2. Applications for sanitary approvals
- Documents attached to applications for sanitary authorizations may be submitted in Spanish or English.
3. Interchangeability of biocompatible biotechnological drugs
- Longer deadlines are provided to demonstrate the interchangeability of biocompatible biotechnological drugs.
- Clinical studies from the country of origin of such drugs may be submitted as evidence for the consideration of their register.
- Such clinical studies will be reviewed by Mexican authorities to determine their quality, security, and efficacy.
- In the event of an application for the extension of registration of a biocompatible biotechnological drug, clinical studies performed in Mexico will be mandatory.
4. Extension of health registries
- Applications for first extensions shall be submitted within 150 working days before the end of the validity of the register.
- COFEPRIS will resolve on requests for extension within a maximum of 120 calendar days after their submission. If the resolution is not issued within this period, the request shall be deemed appropriate.
- In case of second and subsequent extensions, registry holders shall submit the application every 5 years, within 150 calendar days before their validity ends.
- Acknowledgement of receipt of the application shall have the effect of extension.
- COFEPRIS will have 180 calendar days to publish the format for extension requests.
- Extension requests that must be submitted or are in process before the publication of the new format, will be subject to the provisions in force at the time of their submission.
5. Technical modifications to health records
- COFEPRIS will have 45 working days to approve technical amendments and 20 working days for administrative amendments to health records.
- In the absence of approval within the prescribed limit, the request shall be deemed appropriate.
- If amendments are authorized, the holder of the registration shall be granted a maximum period of 240 working days to exhaust the existence of finished packages and products.
6. Transfer of health registration rights
- The transfer must be notified to COFEPRIS by the new holder within 30 working days of its completion.
From the entry into force of the Decree, the Ministry of Health will have 180 working days to carry out the necessary regulatory adjustments for its implementation, including the format for the request for extensions.
Juan Carlos Partida