The EMA has posted the press release with details of the CVMP's meeting of 5 – 7 December 2017 (Link). General news relating to regulatory affairs includes:
Draft guidance released for consultation
- EFFICACY
- concept paper for the revision of the guideline on the SPC for anthelmintics (Link)
Guidance adopted
- QUALITY
- Guideline on the chemistry of active substances for VMPs
- Guidance on a phased implementation of requirements to control elemental impurities in VMPs (Link)
- Q & A on in-use shelf life for solid dose forms in multidose containers
- ADVENT
- Q & A on monoclonal antibodies for veterinary use (Link)
- Regulatory
- Revised guidance for companies requesting Scientific Advice
- Revised QRD guidance on the use of approved pictograms on the packaging of VMPs authorised via the CP, MRP and DCP (Link)
- QRD procedural guidance on QR codes in the labelling and package leaflet of VMPs authorised via the CP, MRP and DCP
- 3Rs
- Statement of the CVMP position on the ethical use of animals in the testing, development and manufacture of veterinary medicines
- Recommendation to MAHs, highlighting recent measures in the veterinary field to promote 3Rs measures described in the Ph. Eur.
Adopted documents not available at the time of writing this report will be published on the EMA website in the coming weeks.
