EMA updates August / September - antimicrobial VMPs, ectoparasitic resistance, withdrawal periods, esubmissions and Type IA variations

Committee for Medicinal Products for Veterinary Use (CVMP) meeting September 2018

The EMA has posted the press release with details of the CVMP's meeting of 11 - 13 September 2018 (Link). General news relating to regulatory affairs includes:

• A draft reflection paper on ectoparasitic resistance has been agreed for a period of public consultation. This paper seeks to give an overview of the current state of knowledge on the subject. This new document will be made available on the EMA website in due course.
• A guideline on determination of withdrawal periods for edible tissues will replace the document "Note for Guidance: Approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95 FINAL)". The new guideline and an overview of comments received during the public consultation will be published on the EMA website soon.
• Finally, in the CVMP meeting, a draft reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the EU was adopted for a period of public consultation. This document will be published on the EMA website soon.

Antimicrobial veterinary medicines

In addition to the new reflection paper on aminopenicillins, August and September has seen several other developments from the EMA regarding antimicrobials in animal health:

• On the 12th of October, the EMA will hold a focus group meeting on dose optimisation of established veterinary antibiotics in the context of SPC harmonisation (Link). This meeting will complement the public consultation on the draft reflection paper of the same name (Link) and registration closes 21st September, with places limited. The meeting will also be broadcast live for those who cannot attend.

• The CVMP's Antimicrobials Working Party is holding a focus group meeting on 19th September with stakeholders to discuss the revision of the antimicrobial VMPs risk assessment guideline (Link). This is to complement the public consultation of the revision of the antimicrobial VMPs risk assessment guideline (Link), which will end 31st October. The meeting is by invitation only, but it will be broadcast live for those who cannot attend.

eSubmissions

• The latest guideline on eSubmissions for VMPs – version 2.6 - is now in force (Link). With this, the structure of the electronic dossier now reflects Commission Implementing Regulation (EU) 2017/12 of 6 January 2017 regarding the form and content of the applications and requests for the establishment of maximum residue limits (MRLs).
• The EMA has also reminded Applicants that for procedures involving only Centrally Authorised products, submission should be done only once, via the EMA eSubmission Gateway, as the National Competent Authorities have now access to the Common repository. Further details are given on EMA website (Link).

It has also been noted that there are two new documents relating to the SPOR project's Organisation Management Services (OMS), which explicitly state that they apply to veterinary industry stakeholders: overview of OMS change request process (Link) and the OMS operating model (Link). 

Regulatory affairs and industry stakeholders

In other news, the EMA has updated its list of eligible industry stakeholder organisations, which, with respect to the animal health sector includes AnimalhealthEurope, AVC and EGGVP (Link).

Relating to general regulatory affairs, the EMA's July monthly report (July) on application procedures, guidelines and related documents for VMPs is now available (Link) and the EMA has issueda pre-notification checklist for Type IA variations for VMPs, to try and reduce requests for supplementary information (Link).