IPEC e-newsletter - Excipients Insight April/May 2018 - 15-05-18


Inside this issue


EMA, EU27 share out MHRA's rapporteur duties

The EU27 member states and the European Medicines Agency (EMA) have reallocated all the centrally authorised medicinal products for which the UK Medicines and Healthcare products Regulatory Agency (MHRA) and Veterinary Medicines Directorate (VMD) are currently rapporteur or co-rapporteur appointed by the scientific committees to coordinate the evaluation of a medicine.

The transfer affects more than 370 products that are now being handled by EU27 member states plus Iceland and Norway. The new EMA (co)-rapporteurships will be communicated to the relevant Marketing Authorisation Holders (MAHs) before the end of April but they will only take full responsibility for the re-allocated products as of 30 March, 2019, when the UK withdraws from the EU and becomes a third country




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