News updates from the EMA during March and April

17 April, 2018

The EMA has posted the press release with details of the CVMP's meeting of 13 – 15 March 2018 (Link). General news from this press release and other news items relating to regulatory affairs includes:


  • Public consultation concerning a request for CVMP opinion on the risk for the consumer resulting from the use of diethanolamine as an excipient in VMPs for food-producing species (Link).


  • The Committee adopted the public bulletin on pharmacovigilance for 2017 (Link).

Fixed combinations

  • Clarification regarding new requirements for Centralised Procedure eligibility requests for fixed combinations of known active substances (refer to main press release for details).

Regulatory Procedures

  • Updated: Dossier requirements for submission of MA and MRL applications to the EMA and to members of the CVMP (Link).
  • New fees came into force on April 1st 2018: the updated explanatory note is available to access and download online (Link).

Annual reports

  • The 2017 annual reports from the SME office (Link) and for the MUMS/limited market scheme (Link) have now been published.


  • Report on the operation of the Steering Group for the Joint EMA/HMA action plan on availability of veterinary vaccines (Link).


  • Stepwise implementation towards mandatory use of the Common Repository for veterinary submissions – deadline is 1 June 2018 (Link).
  • The newest version of the VNeeS checker, relating to the latest revisions to the e-submissions guideline entering into force on 1 September 2018, has been published (Link).

  • An updated version of the eSubmission Gateway XML delivery file user interface is now available (Link). One of the new fixtures will be introduction of Brexit Related procedure indicator; users can indicate if the change is a Brexit-related procedure.

Business Units: 

Regulatory Outsourcing Options

Cyton’s dedicated regulatory procedures team can support you with:
 - Dossier preparation, submission & regulatory procedures
 - Regulatory intelligence and strategic planning
 - Life cycle management
 - Key person cover
 - Pharmacovigilance
 - Brexit support services

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