News updates from EMA in September and October

6 October, 2017

The EMA has posted the press release with details of the CVMP's meeting of 3 – 5 October 2017 (Link). General news relating to regulatory affairs was scarce this month, with just one draft guidance paper adopted: draft guidance on a phased implementation of requirements to control elemental impurities in VMPs. This document will be published in due course.

In other updates from the EMA during September and October, the following topics have been covered:

  • New Q & A on MA transfers (Link): Can I change the name of a medicinal product as part of a transfer application?
  • New draft guideline (Link) and Q & A (Link) on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), bluetongue (BT) and foot-and-mouth disease (FMD).
  • Update on EMA relocation preparedness (Link) and results of the EMA staff survey (Link). Related to this, the EMA’s Brexit webpage has been updated (Link) and the EMA comments on Members States’ hosting bids have been published (Link).
  • Reminder: don’t miss the submission cut-off date, 30th November, to ensure validation of Type I variations before the Christmas holiday period (Link).
  • Update: Guidance on the classification of veterinary medicinal products indicated for minor use minor species (MUMS) / limited market (Link) and Q & A document (Link).
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Unparalleled Expertise for EU Centralised Procedures

Cyton has a strong collaborative working relationship with Dr. Anja Holm of CVPC, former chair of the CVMP.

As well as providing unique insights into our clients' projects, our collaboration with Dr. Holm also includes regulatory training courses. Follow the links below for more information.
- Central VetPharma website
- Training event: Innovative VMPs