Documents adopted in CVMP June meeting now published

The EMA has now published the following documents adopted in the June meeting of the CVMP:

Safety guidance

A draft guideline was adopted for consultation, on user safety of topically administered VMPs (Link).

Pharmacovigilance guidance

The latest VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to VMPs was adopted, following the yearly review and update.

• Excel format of combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to VMPs (Link)
• PDF format of combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to VMPs (Link)
• List of changes to the combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to VMPs (Link)
• Guidance note of the use of VeDDRA terminology  for reporting suspected adverse reactions in animals and humans to VMPs (Link)
• Call for comments on the VeDDRA standard list for EVVet (Link)

ADVENT

A new problem statement was agreed by the CVMP Ad hoc Expert Group on Novel Therapies (ADVENT) on stem cells for veterinary use, regarding specific questions on extraneous agents (Link)

Further documents not yet published will be published on the EMA website in due course.