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).
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:
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.
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.
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:
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).
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).
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
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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
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