May - June news updates from the EMA

In addition to the CVMP’s May and June meeting reports (Link), the EMA has published updates relating to the following topics:

• New Q & A page on the “sunset clause” (Link)
• News bulletin from the SME office (Link), summarising recent developments, including those concerning VMPs.
• Documentation from the focus group on promotion of pharmacovigilance for food producing animals, 23Nov17 (Link)
• Documentation from the focus group meeting on availability of Lumpy Skin Disease (LSD) vaccines authorised to EU standards, 31Jan17 (Link)
• EMA monthly activity reports from April (Link) and May (Link)
• Q & A on regulatory guidance for industry to prepare for the UK’s withdrawal from the EU (Link) and information about EMA planning (Link)
• Updated explanatory note on general fees payable to the EMA (Link)
• Focus group announced, with invited stakeholders on field efficacy trials in the context of an EU authorisation for veterinary vaccines, 22 – 23 June 2017 (Link).
• Joint EMA/HMA Veterinary Vaccine Availability Action Plan - Analysis of industry recommendations (Link)
• Availability of veterinary vaccines – webpage updated (Link)
• Blue-box requirements update (Link)
• Updated MUMS classification list (Link) and template for requesting MUMS classification (Link)

In addition there have been a number of eSubmission updates (Link):

• Guideline on eSubmissions for Veterinary products – version 2.5 (tracked changes and clean versions published) and the eSubmission Validation checklist - version 2.5; entered into force June 2017
• VNeeS Q&A relating to eSubmission for Veterinary Applications (updated May 2017)
• Statement of intent on the stepwise implementation of VICH GL53
• Version 1.21 of the eAFs (MAAs, variations and renewals) are now available (Link).