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Adopted text

Union code relating to medicinal products for human use

TA-9-2024-0220 · P9_TA(2024)0220 · PE753.470

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Parliament's amended version of a proposed directive on the Union code relating to medicinal products for human use, replacing Directive 2001/83/EC and Directive 2009/35/EC. It lays down rules for authorising, manufacturing, importing, distributing, supervising and using human medicines, with a marketing authorisation required before placing a product on the market. It sets out abridged routes for generic, biosimilar, hybrid and bio-hybrid medicines, and specific requirements for antimicrobials, paediatric medicines, advanced therapies and combination products. It provides for environmental risk assessments, pharmacovigilance, regulatory data and market protection periods, and rewards for paediatric and unmet-need medicines. It requires marketing authorisation holders to submit pricing and reimbursement applications on request and to report public financial support, and bans advertising of prescription medicines to the public.

Key points

  1. A medicine may be placed on a member state market only with a national or centralised marketing authorisation; applications are electronic and must include the dossier, summaries and raw data.
  2. Generic applicants need not provide non-clinical and clinical results if equivalence is shown; biosimilar applicants provide comparability tests; hybrid and bio-hybrid applicants provide data to establish a scientific bridge.
  3. Antimicrobial applications must include an antimicrobial stewardship and access plan; the holder must ensure per-unit dispensing or pack sizes matching the treatment duration.
  4. Marketing authorisation applications must include an environmental risk assessment with risk mitigation measures; an incomplete ERA can lead to refusal unless duly justified.
  5. The regulatory data protection period is seven years and six months, extendable by 24 months for supply in member states, 12 months for unmet medical need, six months for comparative trials or Union-based research, and 12 months for a significant new indication.
  6. A six-month supplementary protection certificate extension rewards completion of an agreed paediatric investigation plan; a one-year marketing protection extension applies for a new paediatric indication with significant clinical benefit.
  7. Marketing authorisation holders must, on request, submit pricing and reimbursement applications within 12 months, or 24 months for SMEs, not-for-profit entities and certain small undertakings, using the EU Access to Medicines Notification System.
  8. Holders must publicly declare direct and indirect public financial support for research and development, with an audited electronic report within 30 days of authorisation.
  9. Advertising to the general public of prescription-only medicines, including antibiotics with identified resistance risk, is prohibited; advertising must be accurate, verifiable and not misleading.
  10. Member states must operate pharmacovigilance systems; holders must record and report serious suspected adverse reactions within 15 days and non-serious ones within 90 days.
  11. The Commission may adopt delegated acts on many technical matters, including ERA monographs, master files, variations and post-authorisation efficacy studies.

Who is affected

  • Marketing authorisation holders: must ensure supply, report public support, submit pricing applications on request and operate pharmacovigilance.
  • Manufacturers and importers: need manufacturing authorisations, must follow good manufacturing practice and register decentralised sites.
  • Wholesale distributors and brokers: need authorisations or registration, must verify safety features and keep records.
  • Patients and healthcare professionals: benefit from package leaflets, reporting systems and restrictions on advertising.
  • Cyprus, Ireland, Malta and Northern Ireland: specific derogations apply for medicines supplied from or through parts of the United Kingdom other than Northern Ireland.

Figures and deadlines

  • 180 days: maximum period for granting a marketing authorisation after validation.
  • Seven years and six months: regulatory data protection period from marketing authorisation.
  • 24 months: prolongation of data protection for supply in member states.
  • 12 months: prolongation of data protection for a medicine addressing an unmet medical need.
  • Six months: prolongation for comparative clinical trials or for research and development done in the Union.
  • 12 months: prolongation for an additional therapeutic indication with significant clinical benefit.
  • 15 days: deadline to report serious suspected adverse reactions to the Eudravigilance database.
  • 90 days: deadline to report non-serious suspected adverse reactions to the Eudravigilance database.

Legal basis: Article 294(2), Article 114(1) and Article 168(4), point (c), of the Treaty on the Functioning of the European Union.