The EMEA notified plaintiffs in December 1999, that the CVMP had reconfirmed its earlier recommendation to place progesterone in Annex II.
the judgment under appeal, the [CFI] referred to the fact that the CVMP entirely confirmed its first opinion, even after taking into consideration the new scientific data presented to it by the Commission and to the fact that the Commission itself had always maintained the view that progesterone should continue to be authorised for therapeutic and zootechnical treatment for the purpose of concluding that the Commission had disregarded the legitimate interests of the then applicants in a clear and serious way by failing to adopt the measures required for the continued use of progesterone, for therapeutic and zootechnical purposes, after 1 January 2000.
The [CFI] thus confined itself to referring to the second opinion of the CVMP without explaining why the Commission was obliged to follow that opinion, and disregarded the differing opinions from other sources, which, in accordance with the third recital in the preamble to [R-2377/90], had to be regarded as being relevant, such as the SCVPH, the JECFA or the International Agency for Research on Cancer (IARC) [Ed.
That sole reference, without any mention of the other opinions available, does not allow the [ECJ] to identify the link which the [CFI] established between the opinion of the CVMP and the consequences in law which it derived from that opinion.
The Committee adopted Questions and Answers on the implementation of the CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the VICH GL6 (Phase I) and GL38 (Phase II).
Following sign-off by the VICH Steering Committee, the CVMP adopted the following VICH guideline for a 5-month consultation period: VICH GL57: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: marker residue depletion studies to establish product withdrawal periods in aquatic species.
The other three revised guidelines for data requirements on quality, safety and efficacy for MUMS products were previously adopted by the CVMP in December 2016.
Revision of the guidelines is part of the CVMPs overall objective to stimulate the development of new veterinary medicines for diseases that occur infrequently or in limited geographical areas in major species and for minor species.