HMA / CMDv updates regarding Brexit planning for VMPs, regulatory submissions, medicines for fish and the ASMF

The latest CMDv Report for release, giving an overview of the activities of the October and November 2018 meetings, is available to view and download. The report includes amongst other items a review of Community regulatory procedures ongoing and completed, an overview of the discussions at the CVMP/CMDv Presidency meeting held in October 2018, the MRP/DCP clock-start dates for 2020 (Link). The following new and updated publications from the CMDv are now available online.

Brexit planning for Veterinary Medicinal Products

A document titled ‘Practical guidance for procedures related to Brexit for veterinary medicinal products approved via MR/DC procedures’, which is supplementary to information published by the EMA and the Commission (Link). The Q&A document (Link) has been updated - to account for a possible ‘hard Brexit’ outcome;

Regulatory Submissions

• The clock start dates for MR/DC procedures, to 2020 (Link).
• A new version of the payment terms and addresses for national agencies’ fees (Link).
• Details of national procedures (including processes for booking submission slots) and relevant contacts for companies wishing to submit veterinary MAA applications through DCP have been published in a CMDv document (Link).
• A new version of the national requirements document for Marketing Authorisation Transfers, with updated information for ten Member States (Link).

VMPs for Fish

A list of VMPs intended for use in fish: published as an Excel spreadsheet and available to download from this page

Labelling and Packaging Requirements

A new version of the Labelling and Packaging of Veterinary Medicinal Products Recommendations document (Link).

Active Substance Master File training

New training presentation slides on the ASMF work-sharing procedure, developed with the CMDh, can be accessed here;

CMDv Interested Parties

The minutes of the CMDv’s Interested Parties meeting in October 2018 have been made available on the HMA/CMDv website (Link).