Antimicrobial veterinary medicines high on the agenda for the CVMP in October and November

The European Medicines Agency (EMA) has posted the press release with details of the Committee for Veterinary Medicinal Products (CVMP's) meeting of 6 – 8 November 2018 (Link) and documents adopted at the October meeting are now available from the EMA website.

Antimicrobial Resistance (AMR)

The Committee adopted a reflection paper on off-label use of antimicrobial VMPs. The reflection paper will be made available on the EMA website in due course and it intends to elaborate on the risks of AMR development associated with the use of antimicrobial VMPs not in accordance with the approved Summary of Product Characteristics (SPC).

Relating to veterinary antimicrobials, presentations from the “Focus group meeting on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation” are now available online (Link). This meeting took place to allow a discussion between the regulators and stakeholders on the draft reflection paper on dose optimisation of established veterinary antibiotics. Presentations were given by various experts from national regulators, AnimalhealthEurope (AHE) and the European Group for Generic Veterinary Products (EGGVP).

Also in relation to veterinary antimicrobials, presentations from the “Risk assessment guideline focus group meeting” are now available online (Link). This meeting took place to discuss the revision of the antimicrobial VMP risk assessment guideline, with presentations from national experts, members of the CVMP’s antimicrobials working party and AHE.

Environmental Risk Assessment (ERA)

Continuing on the subject of AMR, a draft reflection paper on AMR in the environment has also been adopted for a period of public consultation. This draft reflection paper looks at the following:

• The release of antimicrobials and AMR genes into the environment from the use of VMPs
• The suitability of the current ERA processes
• Recommendations to improve the understanding of the impact of antimicrobial VMPs in the environment to animal and human health

This paper will be posted on the EMA website in the coming weeks.

Chemistry, Manufacturing and Controls (CMC) and the Active Substance Master File (ASMF)

Two CMC guidance documents have been adopted by the CVMP in November, the first of which is a revised guideline on the ASMF procedure, which seeks to clarify the responsibilities of the marketing authorisation holder in the provision of information related to active substances.

The second document is a Q & A on the requirements for selection and justification of starting materials for the manufacture of active substances in VMPs.

In addition, a draft reflection paper on risk management requirements for elemental impurities in VMPs was adopted for public consultation, which relates to the update of the European Pharmacopoeia General Monograph 2619 for pharmaceutical preparations. Revised timelines for the implementation of risk assessment requirements for the control elemental impurities in VMPs have also been adopted.

These three documents will be made available on the EMA website in the coming weeks.

Regulatory Procedures

The EMA's monthly report on application procedures, guidelines and related documents for VMPs has been updated with information from August and September (Link). Refer to the end of this document for a complete list of all the CVMP guidance and working documents of 2018 so far.

Finally, the EMA has reminded companies to submit Type I variations for 2018 by the end of November 2018 (Link).