Spring Intro 2023

03/03/2023

Conclusion of changes proposed

Proposals made in 2004/27/EC saw changes to all procedures ● The addition of DCP ● Significant changes to referral procedures ● The introduction of the CMDh to replace the MRFG ● Greater harmonisation across the EU

Ref. Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, Official Journal L 136 , 30/04/2004 P. 34 – 57.

The Organisation for Professionals in Regulatory Affairs

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The role of CMDh

● Solving disagreements in MRPs and DCPs (aiming to prevent referrals to CHMP) ● Sub-group on harmonisation of SPCs, harmonisation of standards and decision-making inspections etc. ● Sub-group on variations, paediatric regulations ● Various other sub-groups (e.g. Pharmacovigilance, Homeopathics, Veterinary, etc.)

More information on the following web site: Heads of Medicines Agencies: CMD(h)

The Organisation for Professionals in Regulatory Affairs

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