Mexico City, June 07th, 2021.
On May 31st, 2021, the Decree amending, adding, and repealing various provisions of the Rules of Health Supplies («Decree») was published in the Official Gazette of the Federation, which entered into force the following day of its publication. The main provisions contained in the Decree are:
- A labeling and packaging system is established for medicines destined exclusively for public health and social security institutions differentiated from those destined for the private sector. The public sector will have a period of 180 calendar days to implement the necessary measures to acquire drugs that comply with the provisions indicated above. For their part, manufacturers, or establishments whose drugs do not comply with these provisions, will have a period of 120 business days to exhaust inventories.
- It is expected that the information to be included in the dossiers of health supplies will be presented in English.
- Regarding technical modifications to health records, COFEPRIS will have a period of 45 business days to approve technical modifications and 20 business days in the case of administrative modifications and, in the cases in which these periods elapse without issuing a response, the request will be understood as valid. When authorizing the modifications, COFEPRIS will grant the holder a period, which may not exceed 240 business days, to exhaust their inventories.
- The transfer of rights to sanitary records of health supplies must be communicated to COFEPRIS by the new owner within 30 business days from the date on which it was made, attaching the documents related to the transfer. as well as the new owner’s label projects.
- Concerning the extensions of sanitary registries, the requirements to obtain the first extension are simplified, which must be submitted 150 business days before the validity of the corresponding registry expires. COFEPRIS will have a period of 120 calendar days to approve them and, in the event that this period elapses without a response being issued, the request will be deemed appropriate. The second and subsequent extensions must be requested every 5 years, within the period indicated in the preceding paragraph. In these cases, the acknowledgment of receipt of the request will have the effects of the extension of the sanitary registry. When applications are not submitted within the deadlines established for this purpose, the sanitary registry will lose its validity on the date that has been established and its holder must request a new sanitary registry in accordance with the provisions of the Rules of Health Supplies and other applicable provisions.
COFEPRIS will have a period of 180 business days counted from the entry into force of the Decree to publish the format to request this extension in the Official Gazette of the Federation.
The Ministry of Health will have a period of 180 business days from the entry into force of the Decree to make the regulatory adjustments for its implementation.
Our health practice group is at your service to clarify any questions you may have on this subject.
S I N C E R E L Y,
Daniel Del Río