News updates from the EMA during March and April

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:

MRLs

• 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).

Pharmacovigilance

• 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.

Immunologicals

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

eSubmissions

• 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.