KEY ASPECTS
- Object: Establish rules to incentivize national investment in the production chain of medicines, health supplies and medical devices, as well as in scientific research.
- Authority: Ministry of Health, with BIRMEX as the consolidating entity.
- Mechanism: Awarding of additional points in consolidated procurement procedures to bidders who demonstrate national investment.
- Application: Consolidated procurement procedures for medications scheduled for delivery from 2027.
- Entry into force: Day after its publication in the DOF (May 22, 2026).
El May 21th 2026The Ministry of Health published in the Official Gazette of the Federation the “Guidelines for the Promotion of Investment in National Territory in the Production of Medicines, Health Supplies and Medical Devices, or in the Development of Scientific Research” (the “Guidelines”), in compliance with the Decree published on June 2, 2025, which promotes investment in the national pharmaceutical industry. Its objective is to reduce dependence on imports, strengthen the Mexican pharmaceutical industry, and promote scientific research, in alignment with the 2025-2030 National Development Plan.
KEY POINTS OF THE GUIDELINES
Scope of application. The Guidelines are mandatory for BIRMEX, IMSS, ISSSTE, IMSS-Bienestar, the National Institutes of Health, the Federal Referral Hospitals and other institutions that provide health services and participate in consolidated contracting procedures. Important: They do not apply to contracts covered by international treaties that contain a chapter on purchases, so as not to violate international commitments signed by Mexico.
Points and Percentage Criteria. In applicable consolidated procurement procedures, BIRMEX must use the Points and Percentages Criteria for evaluating proposals. This system considers criteria such as the technical and economic proposals, with minimum scores that bidders must achieve in the technical evaluation to proceed to the economic evaluation. To modify criteria or ranges, BIRMEX must request prior authorization from the Public Procurement Unit of the Secretariat of Anti-Corruption and Good Governance.
Incentives for domestic investment. The central mechanism of the Guidelines consists of awarding additional points, within the category of Bidder's Capacity, to those individuals or legal entities that demonstrate investment in national territory in one of the following three dimensions:
- Infrastructure dimension: Accreditation of investment in the production chain (factories, laboratories or warehouses).
- Production process dimension: demonstration of substantive stages of the value chain, from the manufacture of active ingredients to the finished product.
- Research and development dimension: development of scientific research or innovative products in the field of health.
DOCUMENTATION REQUIRED BY DIMENSION
The Guidelines detail the documents that bidders must submit to demonstrate each dimension. The main requirements are summarized below:
| Dimension | Concept | Main Documents |
| Infrastructure / Production Plant | Factory or laboratory within national territory | Sanitary License for Factory or Laboratory; Notice of Sanitary Officer; Valid Certificate of Good Manufacturing Practices (GMP). |
| Infrastructure / Storage and distribution | Storage and distribution warehouse | Health License for Warehouse; Notice of Health Officer; Notice of Operation |
| Infrastructure / Future Investment | Investment projects in progress | Registration of the project with the Ministry of Economy or binding contracts for infrastructure development |
| Production process / Active ingredients | Raw materials manufacturing | Sanitary License for Raw Materials Factory or Laboratory; Notice of Sanitary Officer; Valid CBPF |
| Production process / Formulation and manufacturing | Product manufacturing | Sanitary License for Factory or Laboratory; Notice of Sanitary Officer; Valid CBPF |
| Production process / Filling, finishing, packaging and labeling | Final stages of production | Health License for Conditioning Warehouse; Notice of Health Officer; Valid CBPF |
| Research and Development / Basic Research | Research protocols | Approval of the protocol by CONBIOETICA with current registration, or agreements with research centers or HEIs, or auditable internal reports |
| Research and Development / Clinical Research | Studies in humans | Authorization letter for conducting the research protocol; Authorization letter for modification or amendment |
| Research and Development / R&D Fund | Resources allocated to innovation | Audited accounting documentation that proves the existence of a specific fund for a minimum of 6 months |
TRANSITORY DISPOSITIONS
The Guidelines include two particularly relevant transitional provisions:
- Entry into force: The Guidelines come into effect on the day after its publication in the Official Gazette of the Federation (DOF)That is, on May 22, 2026.
- Gradual application: The provisions relating to consolidated procurement will only apply to procedures involving medicines, health supplies and medical devices be scheduled for delivery starting in 2027.
WHY IS IT RELEVANT TO YOUR COMPANY?
The Guidelines represent a concrete opportunity for companies—both national and foreign with a presence in Mexico—to access direct competitive advantages In public procurement procedures within the health sector, which handles consolidated purchases of medicines and supplies for some of the country's largest purchasing institutions (IMSS, ISSSTE, IMSS-Bienestar), investment in infrastructure, production, and research within the national territory not only generates additional points in public tenders but also forms part of a long-term industrial policy aligned with the Mexico Plan and the 2025-2030 National Development Plan.
For more information on the Guidelines and how to prepare your company to participate in consolidated procurement procedures, please contact us:
Related articles
The Supreme Court of Justice of the Nation (SCJN) declares the current ISAI tax rate unconstitutional…
Hydrocarbons Sector Development Plan: New Fact Sheet…
