EMA is now located in Amsterdam; work continues for CVMP and CMDv

European Medicines Agency moves to Amsterdam

The EMA has posted the press release with details of the CVMP's meeting of 19 – 21 February 2019 (Link to summary). Opinions were taken on MAA procedures, renewals, referrals, MRLs and MUMS, as usual, but there was little working group activity or discussion outside of the key CVMP activities. This was because it was the final meeting held at the Canary Wharf offices before the Agency’s move to Amsterdam (Link) and at the time of publication of this update, the CVMP will be sitting in their first meeting in Amsterdam.

In view of the agency's relocation, the EMA has reminded applicants that pre-submission meetings requested after 1 October 2018, will be held remotely until the Agency is fully established in the permanent premises (Link).

Pharmacovigilance for Veterinary Medicines

During the February meeting, the CVMP adopted the latest public bulletin on veterinary pharmacovigilance, summarising the Agency’s activities regarding PV for 2018; this report will be published in the coming weeks. Also published by the EMA in February was a new Q & A page regarding veterinary pharmacovigilance inspections, providing practical guidance for marketing authorisation holders (Link).

CMDv report for release Dec 18 - Jan 19

The latest CMDv Report for release, giving an overview of the activities of the December 2018 and January 2019 meetings, is available to view and download. The report (Link) includes amongst other items:

Committee membership

Details of changes to the composition of the CMDv, with Finland and Portugal making changes to their nominated Members/Alternates in December

Brexit

it was noted that 7% of MRP/DCP authorised products still have the UK as RMS, and some ongoing procedures also have UK as RMS. Advice to MAHs on changing the RMS to an EU Member State other than UK was reiterated.

Question to CMDv

A MAH enquired as to the possibility of submitting a line extension to a Centrally Authorised product as a DCP, not including all Member States. The CMDv response was negative.

New and updated CMDv Publications and Guidance

Several key regulatory guidance and reference documents were published or updated.

New publications

• Algorithm for risk assessment for PSURs (published as Excel file, Link to PV best practice webpage)
• Minutes of the CMDv-Interested Parties meeting 25 January 2019 (Link)
• Link to national websites / contact points for pre-submission phase and booking submission slots with a RMS (Link)

Updated publications

• CMDv-CMDh joint Q&A for the Submission of Variations According to Commission Regulation (EC) 1234/2008, questions on transfer of test methods and classification of unforeseen variations updated (Link to index page)
• Q&A for QP declaration (Link)
• BPG for grouping of variations (Link), and Reduction in Administrative Burdens Relating to Variations (Link) updated to incorporate information on supergroupings
• Format and number of copies of the dossier for post-authorisation applications (Link)
• Addresses for dossier delivery and other contact points (Link to webpage, contacts published as Excel file)
• Packaging ‘blue-box’ requirements and additional information on labelling/leaflets by Member State, for products authorised via all routes (Link)
• Marketing Authorisation Transfer – National Requirements (Link)