The Ministry of Health[1] updated the restrictions for the importation of medicines and medical devices, which do not have marketing authorization in Mexico.
On September 11, 2024, an Official Amendment (hereinafter, the “Update”) was published in the Official Federal Gazette (hereinafter “DOF”) eliminating Article Three and Section IV “Importation of supplies without marketing authorization in Mexico” from the Technical Annex of the Decree published on January 28, 2020, and amended on June 22, 2021 (hereinafter, the “Decree”). These provisions established that:
- The medicines and medical devices defined in Article 262 of the General Health Law (hereinafter, the “LGS”); namely, medical equipment, prosthetics, orthotics, functional aids, diagnostic agents, dental supplies, surgical materials, dressing materials, and hygienic products that were necessary to import without a Mexican marketing authorization, had to be registered before the national Regulatory Agencies mentioned in the Decree or by Agencies Members of the Pharmaceutical Inspection Cooperation Scheme, or be prequalified by the WHO.
- Only medicines and supplies intended to meet the supply needs of public health and social security institutions could be imported into the national territory.
- The Federal Commission for the Protection against Sanitary Risks (hereinafter, “COFEPRIS”) was required to issue the corresponding import permits, review the status of the marketing authorizations of those medicines and supplies seeking to be imported, take samples for analysis, and, if necessary, exercise its powers to prevent potential health risks for those that did not hold a Mexican marketing authorization.
- Importers and medical units applying these medicines were required to conduct intensive pharmacovigilance and technovigilance in accordance with the applicable Mexican Official Standards.
- Medicines and supplies imported into Mexico without a Mexican marketing authorization that had not initiated the corresponding authorization process with COFEPRIS within 10 business days, could not obtain a second import permit under the Decree.
- To request import permits under this scheme, certain requirements had to be met under the COFEPRIS codes COFEPRIS-01-009-C, for medicines, and COFEPRIS-01-014-A, for medical devices.
In light of the above, the Update reduces the conditions and obligations for the importation of medicines and supplies covered by Article 262 of the LGS that do not have a marketing authorization in Mexico.
In this regard, the Update states that applications for marketing authorizations that, as of its effective date, September 12, 2024, are being processed under the Decree’s scheme, may continue their processing without being subject to the previously described provisions, provided that the applicant requests this in writing.
If you need additional information regarding the contents of this document or if you need legal advisory, please contact the following persons:
Luis López Linaldi – Partner
LUIS.LINALDI@S-L.MX
Phone: +52 55 50015409
Alan Osorio Aragón – Associate
ALAN.OSORIO@S-L.MXPhone: +52 55 50620074
[1] The full text of the Decree can be found at https://www.dof.gob.mx/nota_detalle.php?codigo=5738780&fecha=11/09/2024#gsc.tab=0.