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knoell’s animal health regulatory update for October

Plenty of news for regulatory affairs professionals in animal health this month, including several online training and information events in November.

EMA/CVMP

Consultations and guidelines

Three consultations have been opened with comments invited until December 17th:

A concept paper on the use of macrolides, lincosamides and streptogramins in food-producing animals, with regard to resistance and impact on human and animal health, is published for consultation; comments are invited until 31st January 2022.

A concept paper has been drafted for a scientific guideline on Limited Market products not deemed to be eligible for authorisation under Article 23 of the new VMP-Reg. Consultation is open until 15th December.

EVENTS

  • A second Veterinary Medicines Info Day has been scheduled in 2021 (30th November), which will provide the latest information to industry stakeholders before the new VMP-Reg becomes applicable in January 2022.
  • Two webinars for veterinary pharmacovigilance professionals have been scheduled: on adverse event collection and recording (10th November), and on signal detection and analysis (23rd-24th November).
  • An EMA virtual meeting has been scheduled for 24th November, aimed at representatives of patient, consumer, and healthcare professionals' organisations, to promote better understanding of how these organisations can contribute to scientific meetings at EMA.
  • A joint webinar organised by the EMA and the Federation of Veterinarians of Europe (FVE) is scheduled to take place on 24th November. It will focus on new requirements for data collection on sales volumes and on the use of antimicrobials in animals in the EU, plus the implications for animal health professionals.
  • If you missed the webinar introducing the UPD in September, a recording of the session is available online, as well as the presentation slides – see the event page.
  • Presentation slides are now available for the EMA webinar on integration of EudraGMP and OMS, which took place on 12th October.


PROCEDURAL AND REFERENCE INFORMATION

  • The EMA is advising MAHs on deadlines for submission of different variations, for validation in 2021 and/or for assessment according to the current legislation:

- Type IA and Type IAIN variations for 2021 to be submitted no later than Tuesday 30 November 2021;
- Any Type IB variations or groupings of Type IBs and Type IAs by Monday 15 November 2021 for a start of procedure in 2021. For submissions received on or after 16 November 2021, the procedure will not start until early January 2022;
- Type IB and type IA variations for assessment under Commission Regulation (EC) No 1234/2008 are to be submitted no later than 20 January 2022, to ensure that the validation is completed on or before 27 January 2022.

This procedural announcement is included in the report of the CVMP meeting that took place on 5-7 October. 

  • There is a new version of the pre-submission meeting request form to be used for veterinary products intended to be submitted for assessment under Regulation 2019/6, updated to reference eligibility criteria and legal bases in the new legislation.
  • Version 9 of the QRD Product Information template has been uploaded to the relevant EMA webpage; this includes the annotated and highlighted versions for reference use, and the Word template for use in application dossiers. The template is now available in all EU languages.
  • The EMA’s Explanatory note on fees has been updated; the new version will be in effect from January 28, 2022 and takes into account new classifications, distinctions and terminology derived from the new VMP-Reg.
  • The seventh issue of the EMA’s Veterinary Medicinal Products Regulation Highlights has been published, summarising recent progress on implementation of the VMP-Reg, and comment from stakeholders.
  • Procedural advice from the EMA is available for MAHs regarding classification of changes not listed in the Implementing Regulation or associated guidance for Variations requiring or nor requiring assessment. A form for submitting classification requests is already available. See also the main variations page.

OTHER NEWS

  • EMA’s monthly report for July on veterinary medicines for July has been published. As well as summarising ongoing procedures, the report contains links to the many consultations opened during that period.
  • Version 1.4.3-0. of the Union Product Database was released on 18th October. This version includes fixes to the previous versions, but is still only open to the Competent Authorities.
  • EMA is implementing new measures to minimise animal testing during medicines development, in line with the '3Rs' principles and the Regulatory Science Strategy to 2025. New Approach Methodologies (NAMs) for testing can be discussed with the Innovation Task Force (ITF); advice is given free of charge. See the press release for more detail.
  • Industry feedback to Quality Working Party Experts/EMA Questions on use of Titanium Dioxide as an excipient in veterinary medicines has been published.
  • A report  on progress of the Transatlantic Taskforce on Antimicrobial Resistance (TATFAR) from 2006-2020 has been published, following a conference in September. The EU and the US established TATFAR in 2009; other national agencies have joined since. A workplan to 2026 has also been drawn up.

 

HMA/CMDV

The CMDv Report for Release for the June and July 2021 meetings, is now available. It includes a summary of in-progress and completed regulatory procedures, background information on preparation and revision of Best Practice Guides (with links to some of these) – as well as other documents that have already been included in previous knoell animal health updates.

Three draft new CMDv Best Practice Guides (BPGs) will remain open for consultation until November 11th:

  • on Variations Not Requiring Assessment (VNRAs)
  • Variations Requiring Assessment (VRAs)
  • and on Worksharing.
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