Vet Regulatory News in June 2021: Consultations opened, Delegated Regulations published, and regulatory guidance issued
The news from both the European Medicines Agency/CVMP and Heads of Medicines Agencies/CMDv in June continues to be dominated by implementation of the new veterinary medicines regulation (Regulation (EU) 2019/6). The regulatory landscape continues to evolve rapidly as we approach January 2022; several consultations are ongoing or recently concluded, with related documents open for public comment or recently finalised and adopted.
The EMA has posted highlights of the CVMP's meeting of 15 – 17 June 2021 (see the full summary here). In a busy month for the Committee, a number of documents were adopted for public consultation; these are summarised below:
CVMP adopted a new concept paper for the revision of guidelines related to residues, to align with the new definition for withdrawal periods foreseen in the new VMP-Reg. The consultation is open for comment until July 31.
A revised guideline on the SPC for veterinary medicinal products containing antimicrobial substances has been adopted, which will come into effect on 28 January 2022 (Link to PDF).
Two draft guidelines on data requirements for immunologicals were adopted by the Committee for public consultation: the first regarding multi-strain dossiers for inactivated veterinary vaccines (Link), the second regarding vaccine antigen master files (Link). A concept paper for the revision of the guideline on requirements for production and control of IVMPs was also adopted during the meeting (Link). Consultation is open for all documents until September 30, 2021.
The EMA, jointly with the Federation of Veterinarians of Europe, hosted a web seminar on 23rd June regarding the categorisation of antimicrobials for veterinary use (based on the need to use them in animals versus the risk of AMR to public health). The presentation slides are now available.
The QRD guidance on the use of approved pictograms on the packaging of VMPs authorised via the centralised, mutual recognition and decentralised procedures has been updated, with a number of new species included.
Issue 5 of the EMA’s VMP-Reg highlights was published on 31st May.
The EMA's Annual Report for 2020 was published digitally in June. The report outlines highlights of the evaluation and monitoring of human and veterinary medicines, the regulatory network’s rapid response to COVID-19, and a high-level overview of key figures. It includes an interactive timeline of EMA’s main activities in 2020, with audio-visual materials, infographics, videos and documents. A print-ready PDF can also be downloaded.
The EMA webpage on EudraVigilance Veterinary has been updated with new guidance on using the VICH standard format for reporting adverse events, which will be necessary from January 2022 in order to use the new PhV database foreseen by the VMP-Reg.
A revised version of the EudraVigilance access policy for medicines for veterinary use has been adopted following consultation. It will come into effect in 2022.
CVMP adopted the combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products; a list of changes to combined VeDDRA list of clinical terms, and non-current VeDDRA Low Level Terms and codes, following the yearly review and update. The Committee also adopted the revised guidance notes on the use of VeDDRA terminology for reporting suspected adverse reactions in animals and humans. Implementation of the revised VeDDRA list in EudraVigilance Veterinary is provisionally scheduled for 1 October 2021.
The Committee also adopted several draft veterinary good pharmacovigilance practice (VGVP) modules: collection and recording of suspected adverse events for veterinary medicinal products, signal management, veterinary PV communication, controls and PV inspections, pharmacovigilance systems, their quality management systems and pharmacovigilance system master files, and Annex Glossary for a two-month period of public consultation. Publication of the above documents is expected shortly.
UNION PRODUCT DATABASE
Documents have been issued by EMA regarding the Union Product Database (UPD) and associated use of data:
- A privacy statement regarding usability testing;
- An explanation on records of data processing activity for user research.
HMA / CMDv
The latest CMDv Report for release, giving an overview of the activities of the April and May 2021 meetings, is now available (full report available via this link). It includes amongst other items:
- HMA/CMDv have a new webpage for consultations, which can be found here. Consultation was open throughout June on four draft Best Practice Guides; although these consultations close on 30th June, future consultations from CMDv will be posted to the same page.
- CMDv has published a revised version of ‘Reduction in Administrative Burdens Relating to Variations’ (link to document), giving useful guidance to MAHs on certain scenarios whereby separate variation applications can be combined, or the number of involved agencies can be reduced, or disharmonised national product information texts in the same language can be harmonised.
- Minutes of the CMDv stakeholders’ virtual meeting on 12th May have been published. As expected, the bulk of the discussion centred around implementation of the VMP-Reg and associated ongoing work.