News updates from EMA during February and March 2018

15 March, 2018

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Draft guidance released for consultation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:


  • 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).


  • 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).


  • 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). 

Business Units: 

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