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  1. News
  2. Revision of the EU general pharmaceuticals legislation – public consultation is now open

Revision of the EU general pharmaceuticals legislation – public consultation is now open

28 September 2021
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The EU Commission opened this afternoon the public consultation on the EU general pharmaceuticals legislation on medicines for human use. This initiative is part of the EU Pharmaceutical Strategy for Europe and calls on stakeholders and members of the general public to share their views on matters such as unmet medical needs, incentives for innovation, rules for novel products, affordability of medicines and others.

The Commission is evaluating Directive 2001/83/EC on the Community code relating to medicinal products for human use and Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (together, the “EU general pharmaceuticals legislation”).

This revision proposes to address the shortcomings of the EU general pharmaceuticals legislation in previously identified areas.

Stakeholders and members of the general public may contribute to the evaluation of the legislation by filling in a questionnaire made available today in this page.

The main topics covered in the questionnaire are:

  • The performance of the current EU general pharmaceuticals legislation;
  • Unmet medical needs (a definition or set of principles for “unmet medical needs” is under discussion);
  • Incentives for innovation (including views on regulatory data and market protections);
  • Antimicrobial resistance;
  • Adapted, agile and predictable regulatory framework for novel products (future proofing);
  • Improved access to medicines (rewards and obligations);
  • Affordability of medicines (including views on measures to support patients’ access to affordable medicines);
  • Repurposing of medicines;
  • Security of supply of medicines;
  • Quality and manufacturing (including views on strengthening or adapting GMPs to reflect new manufacturing methods); and
  • Environmental challenges.

Next steps

The deadline for participating in the public consultation is the 21 December 2021 (midnight Brussels time). The summary of the public consultation contributions will then be published on the “Have your say” portal.

A proposal for a regulation by the EU Commission is planned for the fourth quarter of 2022.

Our team regularly advises clients on the regulation of medicinal products in the EU. Please contact us should you have any questions.

 

Authored by Fabien Roy and Claudia Mendes Pinto

Contacts
Fabien Roy
Partner
Brussels
Claudia Mendes Pinto
Associate
Brussels
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Keywords EU, european union, pharmaceutical strategy, public consultation, ema, european medicines agency
Languages English
Topics Biologics and Biosimilars, Controlled Substances, Life Cycle Management of Pharmaceuticals and Biotechnology, OTC Drugs and Cosmetics, Regulatory Exclusivities, Hatch-Waxman, and Similar Statutes, Regulatory Inspections and cGMP, Cell, Tissue, and Gene Therapies (CTGT), Clinical Trials, Combination Products, Digital Health, Life Science Government Enforcement and Compliance, Health Policy and Advocacy, Health Compliance, Fraud and Abuse
Countries Spain, Russia, Poland, Netherlands, Luxembourg, Italy, Hungary, Germany, France, Belgium
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