CRED ERP 25

01/07/2025

⚫ Regulatory bodies: CMDh and National Competent Authorities ⚫ (will be further explained in other presentations)

The Organisation for Professionals in Regulatory Affairs 31

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CMDh (article 27 of Directive 2001/83/EC (1/2)

• The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) is set up for examination of any question relating to MA of a medicinal product in two or more MSs in accordance with the MRP or DCP. In particular, tasks include: ● Examination of any question relating to MRP/ DCP, esp. solving disagree ments on grounds of ‘potential serious risk to public health’ between MS ● Examination of questions related to the pharmacovigilance of medicinal products authorised by the Member States, in accordance with Articles 107c, 107e, 107g, 107k and 107q ● CMDh takes binding decisions on PRAC recommendations for PSUSAs, article 107i and 31 safety referrals/PASS and EURD list

● Examination of questions related to variations

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The Organisation for Professionals in Regulatory Affairs

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