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Adopted text

Framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest

TA-10-2026-0001 · P10_TA(2026)0001 · PE775.742

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Parliament's amended version of the proposed regulation lays down a framework to strengthen the security of supply and availability of critical medicinal products and improve access to medicinal products of common interest. It introduces strategic projects, public procurement rules favouring EU production, a Union coordination mechanism for redistribution, and a possible Union Stockpile.

Key points

  1. Strategic projects must meet criteria such as creating or increasing manufacturing capacity for critical medicinal products or their inputs, and may receive priority permitting and financial support.
  2. Member States must designate authorities to assess strategic projects within three months, and the Commission will provide guidelines and a central webpage.
  3. Strategic projects are considered in the public interest; permit processes must be fast-tracked, and administrative and technical support must be provided, including for SMEs.
  4. Member States shall prioritise financial support to strategic projects addressing supply vulnerabilities, with transparency and enforceable supply obligations.
  5. Union funding may support strategic projects, and a critical medicines security fund is to be established within the next multiannual financial framework.
  6. Public procurement for critical medicinal products must use award criteria beyond price, favouring supply resilience and EU production, with multi-winner approaches where feasible.
  7. Member States must establish national programmes supporting security of supply, including procurement measures and pricing policies, and notify them to the Commission.
  8. A Union coordination mechanism is established for monitoring and, as a last resort, binding redistribution of critical medicinal products from national stockpiles.
  9. A Union Stockpile may be established by delegated acts for critical products with supply vulnerabilities, with categories, quantities, and deployment procedures.
  10. The Commission shall facilitate collaborative procurement for medicinal products of common interest upon request of three or more Member States.
  11. The Commission shall conduct joint procurement for critical products when five or more Member States request it, applying award criteria from Article 18.
  12. The Critical Medicines Group is expanded with patient and healthcare professional representatives, and gains tasks including strategic foresight and assessing duplication.

Who is affected

  • Marketing authorisation holders and other economic operators must provide information to authorities and may face export authorisation requirements.
  • Contracting authorities in member states must apply non-price award criteria in procurement for critical medicinal products.
  • Manufacturers and wholesalers may be subject to contingency stock requirements, with common standards to be developed.
  • Member states must report on national stockpiles and comply with redistribution decisions.
  • Candidate countries may participate voluntarily in procurement procedures if bilateral agreements exist.

Figures and deadlines

  • Three months for designation of authorities and assessment of strategic project requests.
  • 45 days for environmental impact assessment conclusions, extendable by 45 days.
  • At least 50% of active substance or value must be produced in the EU to count as significant proportion.
  • Five or more Member States required for joint procurement requests.
  • Quarterly reporting on national stockpiles and contingency stocks.
  • 10 days to request review of redistribution decisions, and 10 days for Commission review decision.
  • 30 days for reimbursement after receipt of redistributed products.
  • Two months for Parliament or Council to object to delegated acts.