Pharmaceutical legislation

CPME WG on Pharmaceuticals – Chairperson: Prof. Dr Wolf-Dieter LUDWIG (DE)
CPME Secretariat: Mr Piotr KOLCZYŃSKI

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.

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