A raft of updated question and answers pages has been published on the EMA website, addressing all aspects of life-cycle management for VMPs. There has also been recent news on the use of tylosin in sheep, the development of new antibiotics and the new veterinary regulation (NVR).
Tylosin referral conclusion and AMR discussed at CVMP
The EMA has posted the press release with details of the CVMP's meeting of 18 – 20 June 2019 (Link). General news relating to regulatory affairs includes:
Article 35 referral for tylosin for intramuscular use in sheep
Following referral of the matter to the CVMP by the Netherlands, the Committee agreed that the withdrawal period, for sheep treated with VMPs containing tylosin as a solution for injection for IM use, should be amended. The maximum injection volume will also require amendment to ensure consumer safety.
Antimicrobial resistance (AMR)
A scientific advice on “preliminary risk profiling for new antimicrobials” has been adopted by CVMP and CHMP following a public consultation (Link). The overview of comments from the consultation has also been published (Link).
There have also been a number of other updates from the EMA, outside the meeting of the CVMP, as discussed below.
Post authorisation Q & A for VMPs
Further to the updates reported in the June VetMed Update, additional Q & A webpages have been extensively revised and it is recommended that any experts in the respective areas review these updated Q & As carefully, to understand the latest in best practices. The following is a complete list of all the Q & A webpages which have now been updated:
- Post authorisation Q & A introduction (Link)
- Type 1A variations (Link)
- Type 1B variations (Link)
- Type II variations (Link)
- Type II variations vs extension applications (Link)
- Extension applications (Link)
- Grouping of variations (Link)
- Worksharing of variations (Link)
- Changing the (invented) name of a centrally authorised medicinal product (Link)
- Post-authorisation measures: recommendations, conditions and specific obligations (Link)
- Renewals (Link)
- MA transfers (Link)
- Mock-ups (Link)
- Transparency (Link)
- The sunset clause (Link)
- Other (Link)
EMA veterinary medicines monthly report
The latest monthly report on application procedures guidelines and related documents for VMPs has now been published, which includes a list of the ongoing referral procedures and a list of the progress with guidelines in 2019 (Link).
New Veterinary Regulation (NVR) – implementing and delegated acts
The European Commission has started to publish its mandates to the EMA for the implementing and delegated acts (Link). At this time, mandates for four of the seven delegated acts and eight of the 18 implementing acts have been issued.
An updated version of the Q&A on PDF/A format is now available, with several new and revised Q&A (Link).