The EMA has posted the press release with details of the CVMP's meeting of 13 – 15 February 2018 (Link). General news relating to regulatory affairs includes:
Community referrals
- The Committee started an Article 35 referral for VMPs containing 50 mg closantel per ml presented as solutions for injection for subcutaneous use in sheep.
- The Committee concluded the follow-up assessment procedure of the conditions on the MAs for VMPs containing enrofloxacin to be administered via the drinking water to chickens and/or turkeys. It was concluded that the indication for treatment of infections caused by E. coli susceptible to enrofloxacin in chickens and turkeys cannot remain in the product information with the currently-approved dose.
Draft guidance released for consultation
- QUALITY: guideline on manufacture of the veterinary finished dosage form (not yet published)
Also during February and March 2018, the EMA has published updates relating to the following topics:
eSubmissions
- VNeeS Q&A relating to eSubmission for Veterinary Applications updated (Link).
- Updated guideline on eSubmissions for VMPs published, together with updated eSubmission validation checklist, to enter into force on 1 September 2018 (Link – see under “Future Guidance”).
- Updated eSubmission Gateway XML delivery file user interface (Link).
- New versions of the 4 electronic Application Forms and the related release notes are now available (Link).
Replacement, reduction and refinement (3Rs)
- Recommendation to MAHs, highlighting recent measures in the veterinary field to promote 3Rs measures described in the PhEur (Link).
- Press release: Towards more ethical use of animals in medicine testing (Link).
Events
- 19 April 2018: EMA veterinary medicines innovation day (Link).
- 20 April 2018: update on Brexit regulatory preparedness activities for veterinary companies (Link).
Regulatory Procedures
- Updated user guide on how to generate PDF versions of the product information (Link).
- Webinar, 20Feb18: Substance, product, organisation and referential data (SPOR) impact on veterinary stakeholders – presentations now published (Link).
- Reminder: fees increase by 1.7% for applications to EMA from 1 April 2018 (Link).
ESVAC
- Guidance on reporting antimicrobial consumption data by animal species and an updated Q & A document (Link).
Finally, the EMA has welcomed a new Head of Veterinary Medicines, Ivo Claassen (Link).
