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
