During January and February 2018, the EMA has published updates relating to the following topics:
CMC
- Updated guidelines on active substances / new active substances, together with overview of comments (Link)
3Rs (replacement, reduction, refinement)
- Recommendation to MAHs, highlighting recent measures in the veterinary field to 3Rs measures described in the PhEur (Link)
- Guidance for individual laboratories for transfer of quality control methods validated in collaborative trials with a view to implementing 3Rs (Link)
- Announcement of veterinary innovation day, 19th April 2018 (Link)
Pharmacovigilance
- Updated: SOP for management of PSURs for centrally authorised VMPs: Annex I – contact details of NCAs for PSUR submission (Link)
Quick Response (QR) codes
- QR codes in the labelling and/or package leaflet of VMPs authorised via the CP, MRP, DCP and NP (Link)
- Member states contact points for review of national translations of QR codes of VMPs authorised via the CP, MRP, DCP and NP (Link)
- Request form for the provision of information via QR codes in the labelling and/or package leaflet of VMPs authorised via the CP, MRP, DCP and NP (Link)
Regulatory submissions
- Updated: Recommended submission dates for Centralised (initial and extension applications) and MRL procedures (Link)
- Updated: VNeeS Q&A relating to eSubmission for Veterinary Applications (Link).
