Minutes of CVMP Meeting 16 – 18 January published

The EMA has posted the press release with details of the CVMP's meeting of 16 – 18 January 2018 (Link). General news relating to regulatory affairs includes:

MRLs

The Committee agreed to remove diethanolamine from the list of substances considered as not falling within the scope of Regulation (EC) No 470/2009.

Draft guidance released for consultation

• SAFETY: concept paper for the revision of the guideline on safety and residue data requirements for pharmaceutical VMPs intended for MUMS/limited market (Link)

Guidance adopted

• ERAs: Q & A on the implementation of the CVMP guideline on environmental impact assessment for VMPs in support of the VICH GL6 (Phase I) and GL38 (Phase II) (Link)
• 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 (Link)