The EMA has now published the following documents adopted in the July meeting of the CVMP:
Draft guidance released for consultation
- SAFETY: Draft guideline on approach towards harmonisation of withdrawal periods (Link).
- ERAs: Draft guideline on the higher tier testing of VMPs to dung fauna (Link).
- EFFICACY: concept paper for the revision of the Guideline on anticoccidials for the therapy of coccidiosis in chickens, turkeys and geese (Link).
- AMR: concept paper for revision of the current guideline on the summary of product characteristics for antimicrobial products (Link).
Guidance adopted
- ERAs: revision of the Q & A document in support of the guidance on the implementation of CVMP Guideline on Environmental Impact Assessment for VMPs in support of VICH GL6 (Phase I) and GL38 (Phase II) – Link.
- EFFICACY: revised guideline on the testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestations in dogs and cats (Link) and the overview of comments (Link).
- PHARMACOVIGILANCE: Q & A on “Expressing the frequency of adverse reactions within the product information” (Link)
- NOVEL THERAPIES: two problem statements prepared by ADVENT on stem cell-based products for veterinary use
- Specific questions to be addressed on tumorigenicity (Link)
- Specific questions to be addressed on target animal safety (Link)
- PRODUCT INFORMATION: Q & A on mentioning solvents in the product information of centrally authorised VMPs (Link).
Further documents adopted at the meeting will be published in due course.
