Veterinary medicines regulatory news updates from the European Medicines Agency

The EMA has posted the press release with details of the CVMP's meeting of 17 – 19 April 2018 (Link). General news relating to regulatory affairs includes

Community referrals and related procedure

• The Committee started an Article 30(3) procedure (requested by the Executive Director of the EMA), to prepare a scientific opinion on the need for inclusion of a maximum limit for histamine in the active substance and/or finished product specifications for gentamicin-containing VMPs for parenteral administration to horses. This is in connection with adverse reactions seen in horses. Further information will be made available in due course.

Efficacy

Draft guidance released for consultation

• Revised guideline on the SPC for VMPs containing antimicrobial substances (Link). The revision aims to improve consistency of the SPCs for antimicrobial VMPs across member states.

Safety

Guidance adopted

• User safety of topically administered VMPs, together with overview of comments (Link). This new guideline is to be used in conjunction with the ‘Guideline on user safety for pharmaceutical veterinary medicinal products’.
• Q & A on implementation of risk-based prevention of cross contamination in production related to the ‘Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’ (Link).

ERAs

Guidance adopted

• Assessing the environmental and human health risks of veterinary medicinal products in groundwater, together with overview of comments (Link).

In addition to the documents published following the April meeting of the CVMP, the following updates have also been published

Minor Use / Minor Species (MUMS) products

• Q&A - EMA guidance for companies requesting classification for products/indication as Minor Use Minor Species (MUMS)/limited market (Link).

Reduce, replace, refine (3Rs)

• The EMA has published a new webpage regarding the ethical use of animals in medicine testing, including VMPs (Link).

Chemistry manufacturing and controls (CMC)

• The draft guideline updating guidance on “Manufacture of the finished dosage form” has been published (Link).
• There is an updated Q & A on “EU GMP guide annexes: Supplementary requirements: Annex 16” (Link).

Regulatory Procedures

• The monthly report for March on application procedures and guidelines etc for VMPs has been published (Link).

Pharmacovigilance

• Clarification has been issued on the processing of PSURs for centralised VMPs by the EMA (Link).

Small and medium sized enterprises (SMEs)

• The latest news bulletin for SMEs has been published, which includes summary information regarding VMPs and Brexit (Link).