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Union procedures for the authorisation and supervision of medicinal products for human use and rules governing the European Medicines Agency

TA-9-2024-0221 · P9_TA(2024)0221 · PE753.550

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Parliament's amended version of a proposed regulation sets out Union procedures for authorising and supervising human medicines and rules for the European Medicines Agency. It keeps the centralised procedure, simplifies the Agency's committees, and adds new rules on antimicrobial incentives, shortages and paediatric and orphan medicines. It creates a transferable data exclusivity voucher and milestone payments for priority antimicrobials, and a subscription model for their joint procurement. It requires marketing authorisation holders to keep shortage prevention plans and to notify suspensions, cessations and supply disruptions, and gives the Agency and a steering group powers to monitor and manage critical shortages. It sets rules for orphan designations, market exclusivity periods and paediatric investigation plans, waivers and deferrals. It allows the Commission to grant temporary emergency marketing authorisations during a public health emergency and to set up regulatory sandboxes for innovative products.

Key points

  1. A medicinal product listed in Annex I may be placed on the Union market only with a centralised marketing authorisation granted by the Commission.
  2. The Agency's scientific committees are reduced to the Committee for Medicinal Products for Human Use and the Pharmacovigilance Risk Assessment Committee, supported by working parties and expert pools.
  3. The Committee for Medicinal Products for Human Use must give its opinion within 180 days of a valid application, reduced to 150 days for accelerated assessment.
  4. The Commission may grant a conditional marketing authorisation, or one in exceptional circumstances, subject to specific obligations reviewed annually for the first three years.
  5. A temporary emergency marketing authorisation may be granted during a public health emergency, valid only while the emergency lasts.
  6. A transferable data exclusivity voucher gives up to 12 months of additional data protection for a priority antimicrobial, may be transferred once, and is limited to 10 vouchers over 15 years.
  7. Milestone payments and a voluntary joint procurement subscription model are set up to reward development of priority antimicrobials.
  8. Marketing authorisation holders must keep an up-to-date shortage prevention plan and notify permanent cessation, withdrawal, temporary suspension or supply disruption.
  9. The MSSG adopts a list of critical shortages and a Union list of critical medicinal products, and may recommend measures including a voluntary solidarity mechanism.
  10. An orphan designation is valid for seven years, and market exclusivity lasts nine years, eleven years for high unmet need, or four years for well-established use products.
  11. Paediatric investigation plans, waivers and deferrals are required, with free scientific advice and a paediatric use marketing authorisation available.
  12. The Commission may set up regulatory sandboxes for innovative products that cannot be developed under existing rules, with targeted derogations.

Who is affected

  • Marketing authorisation holders: must keep shortage prevention plans, notify supply changes, and comply with post-authorisation obligations.
  • Small and medium-sized enterprises and not-for-profit entities: eligible for a support scheme with fee reductions, deferrals or waivers.
  • Patients: benefit from faster authorisation timelines, compassionate use, and access to orphan and paediatric medicines.
  • Member States: must lay down penalties for infringements and ensure adequate funding of their competent authorities.
  • The European Medicines Agency: given new tasks on inspections, shortages, antimicrobial incentives and transparency.

Figures and deadlines

  • 180 days: time for the Committee for Medicinal Products for Human Use to give an opinion on a valid application.
  • 150 days: reduced time limit for accelerated assessment.
  • 46 days: maximum time between the Committee's opinion and the final Commission decision.
  • 12 months: additional data protection from a transferable data exclusivity voucher.
  • 10 vouchers: maximum number the Commission may grant under Chapter III.
  • 15 years: period of application of the antimicrobial voucher scheme.
  • Seven years: validity of an orphan designation.
  • Five in 10 000 persons: prevalence threshold for orphan designation.

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