As Brexit continues, EMA and CMDv have provided further guidance

CMDv and EMA guidance on Brexit
19 June, 2019

With the UK continuing its fight to find a way out of the Brexit political deadlock, the EMA and CMDv have provided further guidance and updates for industry.

Coordination group for mutual recognition and the decentralised procedure - veterinary (CMDv) updates

An updated version of the ‘Practical guidance for procedures related to Brexit for veterinary medicinal products approved via MR/DC procedures’ is now available (Link).

The ‘Template for request for a time-limited exemption to continue batch control testing in the United Kingdom (UK) after UK’s withdrawal from the Union for a nationally authorised medicinal product’ is also now available (Link).

Further advice has also been provided in the latest CMDv Report for Release (Link) regarding variations to transfer of the batch control site from the UK into the EU. Also in the Report for Release there is a clarifying answer to a question from an applicant regarding the repeat use MRP where there is a UK reference product.

BCP planning continues to restrict EMA activities

An update has been issued regarding business continuity planning at the EMA, stating that temporarily suspended activities remain suspended, but that some activities will start to be reinstated from June 2019 (Link). The agency still anticipates 20 – 25% staff loss following completion of the relocation project.

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