Pharmaceutical legislation

CPME WG on Pharmaceuticals – Chairperson: Prof. Dr Wolf-Dieter LUDWIG (DE)
CPME Secretariat: Marcin RODZINKA-VERHELLE

In implementing its Pharmaceutical Strategy, the European Commission is undertaking a revision of the general pharmaceutical legislation (Directive 2001/83/EC and Regulation (EC) No 726/2004).

Similarly, EU rules on medicines for children and rare diseases (Orphan Medicinal Products Regulation and Paediatric Regulation) are currently being evaluated and will also be amended.

CPME provides its input to the revision process.

Featured Policies

Nov 2022 CPME 2022 / 130

CPME Position on the revision of the EU general pharmaceutical legislation Download

Oct 2022 CPME 2022 / 132

Joint statement on the revision of the pharmaceutical legislation Download

Nov 2021 CPME 2021 / 119

CPME response to public consultation on the revision of the general pharmaceutical legislation Download

Jul 2021 CPME 2021 / 080

CPME response to public consultation on EU rules on medicines for children and rare diseases Download

Apr 2021 CPME 2021 / 056

CPME response to the evaluation roadmap on the revision of the general pharmaceutical legislation Download