knoell’s animal health regulatory update for September
The EMA has posted the news release with details of the CVMP’s meeting of 7-9 September 2021.
As usual, the release summarises the Committee’s discussions and decisions relating to veterinary medicines regulatory procedures. Three reflection papers were adopted, which are mentioned elsewhere in this review.
The Committee also finalised preparation of the Presidency CVMP meeting, to be held under the Slovenian Presidency of the EU on 13 October. This meeting will focus on potential claims and data requirements for alternatives to antimicrobials, and potential for environmental impact from antiparasiticide use in companion animals.
Procedural and Reference Information
- The CVMP meeting dates for 2022-2024 have been published;
- User guidance for use of the EMA’s IRIS platform has been updated and re-issued (version 2.2);
- EMA guidance for MAHs, manufacturers and importers of human and veterinary medicines on adaptability of the European regulatory framework for GMP in light of the covid-19 pandemic, originally issued in 2020, has its validity extended until at least the end of 2021. Refer to the summary page, where the guidance Q&A documents are linked.
- The EMA guidance pages relating to Limited Markets have been updated in line with the content of the new VMP-Reg. Submissions according to the new VMP-Reg can be submitted from September 2021, for applications to be made after 28th January 2022 and using the revised request form.
- The combined VeDDRA list of clinical terms for reporting suspected adverse reactions to VMPs in animals and humans has been updated. This is available via the EMA's EudraVigilance Veterinary page.
Scientific Consultations, Papers and Opinions
- The EMA has developed a reflection paper on the interpretation of Article 18(7) of the new VMP-Reg, to provide guidance on when an ERA can be requested by authorities in the context of MAAs for generic VMPs. Comments are invited until 17th December;
- A reflection paper has been adopted on higher tier testing to investigate the effects of veterinary parasiticides on dung fauna;
- The EMA has issued an updated reflection paper on methods for demonstrating freedom from extraneous agents of the seeds used for the production of IVMPs. The revised recommendations come into effect in March 2022.
IMPLEMENTING AND DELEGATED ACTS
The Implementing Regulation on Good Distribution Practice for VMPs (2021/1248 of 29th July, foreseen by Article 99(6) of Regulation 2019/6) is now published in the EU Official Journal and available in all EU languages.
The EMA will hold a Veterinary SME Info Day on October 28th. Registration is by invite only, but it will be possible to watch the proceedings online via the event page. The agenda has also been published ahead of the event.
- The Novel Therapies and Technologies Working Party (NTWP), an expert group foreseen in the new VMP-Reg, has published its mandate, objectives and rules of procedure, and work plan for 2021-2022;
- The EMA's Big Data Steering Group has released its workplan for 2021-23, which includes a brief update of the next significant time points for actions on the veterinary side. The Big Data summary page has also been updated;
- The Union Product Database (UPD) 1.4.1-0 is live. At present this can only be used by the Competent Authorities; release notes from 6th September are publicly available.
The latest CMDv Report for release, giving an overview of the activities of the June and July 2021 meetings, is available to view and download.
The documents adopted during the meeting have since been published, and linked in earlier knoell news reviews.
Regarding CMDv work on the implementation of the new VMP-Reg, discussions have begun on the borderline procedure, the review procedure, and the procedure for parallel trade.
Procedural and Regulatory Guidance
- A guidance document on the details of classifying variations as VRAs or VNRAs (requiring or not requiring assessment), as foreseen in the relevant implementing regulation of the new VMP-Reg, has been published in September;
- Several consultations on new and updated CMDv BPGs (Best Practice Guides) have opened this month, with comments invited until October 29th. The HMA/CMDv summary page identifies all the consultations still ongoing, with links to the documents.