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18 October 20213 minute read

Your opinion matters: Public consultation on the revision of the EU pharmaceutical legislation is now open

On 28 September 2021, the European Commission officially opened the public consultation on the revision of EU's general pharmaceutical legislation. The consultation period will run for 12 weeks, until 21 December 2021. The general public, citizens, businesses, civil society, public authorities, healthcare providers or any other stakeholders who are interested and/or may be affected, are invited to submit their feedback on the ‘Have Your Say’ portal.

The public consultation offers a unique opportunity for concerned parties to share views on the expected changes according to their own specific needs and expectations. The European Commission will consider the feedback collected to evaluate the impact assessment and help shape the legislative proposal that it will present by the end of next year.

As discussed in our previous publication, this revision concerns the EU general pharmaceutical legislation - Directive 2001/83/EC1 and Regulation 726/20042. The changes are driven by the need to have better access to affordable medicines, foster innovation, improve security of supply, adapt to new scientific and technological developments, and reduce red tape. The European Commission welcomes views from the public on a variety of areas.

The public consultation addresses the following:

  • The performance of the EU's pharmaceutical legislation;
  • Unmet medical needs;
  • Incentives for innovation;
  • Antimicrobial resistance;
  • Future-proofing the regulatory framework for novel products;
  • Improved access to medicines;
  • Competitiveness of the European markets to ensure affordable medicines;
  • Repurposing of medicines;
  • Security of supply of medicines;
  • Quality and manufacturing of medicines;
  • Environmental challenges.

These specific points are available in all official EU languages and replies can also be submitted in any EU official language.

An ongoing study is also supporting the public consultation. Once the 12-week consultation period is over, the European Commission will analyse the feedback and expects to adopt a final legislative proposal by the fourth quarter of 2022. The type of legislative act currently envisaged is a regulation, which would have a great impact on the direct applicability, preparedness, and compliance for stakeholders.

DLA Piper can guide you through the revision process, including the public consultation. Should you need more information or require assistance with it, please do not hesitate to contact us.

1Directive 2001/83/EC on the Community code relating to medicinal products for human use.
2Regulation 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.