In brief
On 4 December 2024, Mexico's Minister of Health published in the Federal Official Gazette the Administrative regulation to secure health import permits for medical inputs destined to guarantee the supply of the public sector ("Administrative Regulation").
The Administrative Regulation allows the importation of medical products without a local market authorization exclusively for the procurement of consolidated purchases managed by Laboratorios y Reactivos Biologicos Mexicanos, S. de R. L. de C.V. (BIRMEX) destined for the public healthcare system.
After the first import, an application for the market authorization for the medical products shall be filed before the Federal Commission for the Protection Against Health Risks (COFEPRIS).
What does it mean for you?
The possibility of importing medical products without local market authorization presents both challenges and opportunities for pharmaceutical and medical devices companies doing business in Mexico, or in the process of entering the local market.
The Administrative Regulation creates a market distortion whereby certain companies may benefit from a faster access to the market eliminating the administrative backlog to resolve a market authorization application which is currently of around 18 months.
However, this expedited process carries the risk that medical products violating patents may be imported, as the patent linkage system may not be carefully observed. This could also affect third-party patent rights during the time COFEPRIS takes to analyze a market authorization application filed under the Official Decree. The unequal conditions for market access and potential violations of third-party patent rights could breach free trade agreements and may also favor the commercialization of counterfeit medical products.
At the same time, a company may benefit from accelerated market access granted by the Administrative Regulation and participate in the consolidated purchases managed by BIRMEX destined for the public healthcare system while a market authorization application is under evaluation.
In more detail
- The medical product must be destined for public procurement processes consolidated by BIRMEX, as per the tender requirements established by the Ministry of Health.
- The public tender shall be destined to IMSS, ISSSTE, IMSS-Bienestar, National Health Institutes, Federal Hospitals of Reference, and other healthcare institutions that adhere to consolidated purchases.
- The medical products shall have a market authorization issued in the regular process by:
- Medicines: Austria, Finland, Hungary, Italy, Portugal, Spain, USA, UK, Belgium, France, Island, Netherlands, Japan, Sweden, Canada, Denmark, Germany, Ireland, Norway, Singapore, Switzerland, Australia, and EMEA, if issued through centralized process.
- Medical Devices: USA, UK, Republic of Korea, Canada, Brassil, Singapore, Japan, Australia, Switzerland and EMEA, if issued through centralized process.
- An application for a market authorization shall be filed within the next 10 business days from the import of the first products.
- Vaccines, psychotropics and narcotics are excluded from this benefit.
For further information or to discuss the wider legal and commercial implications of this development, please contact Baker McKenzie's Healthcare & Life Sciences team.
