Frequently Asked Questions: Revision of the Pharmaceutical Legislation

26 April 2023 – the European Commission published Q&A guidance on the revision of the pharmaceutical legislation.

The Commission is proposing an ambitious revision of the EU pharmaceutical legislation to achieve the following main objectives:

1. Create a Single Market for medicines ensuring that all patients across the EU have timely and equitable access to safe, effective, and affordable medicines;

2. Continue to offer an attractive and innovation-friendly framework for research, development, and production of medicines in Europe;

3. Reduce drastically the administrative burden by speeding up procedures significantly reducing authorization times for medicines, so they reach patients faster;

4. Enhance availability and ensure medicines can always be supplied to patients, regardless of where they live in the EU;

5. Address antimicrobial resistance (AMR) and the presence of pharmaceuticals in the environment through a One Health approach;

6. Make medicines more environmentally sustainable.

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