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EU Vet Regulatory News April 2021: SPCs for anthelmintics, progress on Reg 2019/6, fees and big data

Update reports from the EMA, CVMP and CMDv and revised draft guidance for anthelmintic product literature.

The most recent information from the EMA, the CVMP and the CMDv largely provide updates on previously reported announcements, through the CVMP plenary highlights, the EMA monthly report and the CMDv Report for Release. In addition, the latest issue of the EMA’s VMP Regulation Highlights publication is out now and the EMA has released the agenda for their Big Data event in June. In scientific updates, a revised version of the draft guideline of anthelmintic SPCs has been released for consultation.  

CVMP plenary meeting April 2021

The EMA has posted the press release with details of the CVMP's meeting of 13-15 April 2021. Aside from the usual work relating to veterinary medicines authorisation and other regulatory procedures, there was little general news relating to regulatory affairs, apart from updated draft guidance for anthelmintic SPCs (see below).

Guidance on anthelmintic product literature

A one-month period of public consultation (closing 31st May) was opened on the revision of the current CVMP guideline EMEA/CVMP/EWP/170208/2005 for anthelmintic SPCs. The intention of the revision is to strengthen warnings regarding development of resistance in anthelmintic SPCs, and raise awareness of the problem of anthelmintic resistance for those using such products.

CVMP WORKING GROUPS

​​​​​​​Chairs were elected for 3-year terms to the Safety Working Committee and the new CVMP Novel Therapies and Technologies Working Party.

EMA reports and events

The EMA has published the fourth issue of its Veterinary Medicinal Products Regulation Highlights (March 2021), summarising progress to date on the new IT products required by the VMP-Reg, as well as change management activities, and views from stakeholders.

The EMA’s monthly report for February from the veterinary medicines division was published online on 14th April (Link to PDF). It summarises the work of the Agency since the start of 2021, and details new and ongoing consultations as well as a summary of guidelines and working documents released by the EMA (linked from the report).

Following the announcement last month of the first EMA Veterinary Big Data Stakeholder Forum, the agenda for the event, being held on 1-2 June 2021, has now been published. Registration is open via the EMA’s event page.

Fees for veterinary centralised procedures

The EMA has published an updated Explanatory Note on Fees, in effect since 1st April 2021.

CMDV Report for Release

The latest CMDv Report for release, giving an overview of the activities of the February and March 2021 meetings, is available to view and download. The report includes amongst other items:

  • A summary of the CMDv's continuing work on implementation of Regulation (EU) 2019/6 - including the new procedures for processing variations, revised Community MAA procedures, the SPC harmonisation procedure and the updated QRD template;
  • An announcement that the CMDv Annual Report for 2020 has been adopted, and is available online.
  • A template for applicants to send requests to NCAs to act as RMS in MR/DC procedures is being prepared. Use of the template is optional, but encouraged.

Links to several new versions of CMDv guidance documents are also present in the report.

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