knoell's animal health regulatory update for November/December

EMA/CVMP

Meeting highlights from the CVMP meetings of 3-4 November and 7-9 December are available online, summarising the procedural and product-related activities of the CVMP. The documents discussed and adopted during these meetings are featured within this news update, where published.

CONSULTATIONS AND GUIDELINES

• Concept papers on the revision of Annex 4 of the guidelines on Good Manufacturing Practice (products other than immunologicals) and Annex 5 (immunologicals) have been published. Consultation is open until 9th January 2022
• A draft EMA/CVMP advice document for MA Applicants and MAHs on issues associated with veterinary vaccine antigen master files (VAMF) has been published; comments are invited until January 12th, 2022
• A concept paper has been published on the revision of the CVMP recommendation on evaluation of benefit-risk balance for VMPs; comments can be sent until February 28th 2022

Consultation has closed on the Good Veterinary Pharmacovigilance Practice guidance modules; these have now been adopted and final versions published, along with summaries of comments received:

• Signal Management module (comments received)
• Collection and recording of suspected adverse events module (comments received)
• Controls and PV Inspections module (comments received)
• Veterinary PV communication (comments received)
• PV systems, their quality management systems and PV system master files module (comments received)
• Glossary of terms (comments received) 

PROCEDURAL AND REFERENCE INFORMATION

• Issue 8 of the Veterinary Medicinal Products Regulation Highlights newsletter has been published, see PDF here
• The list of submission dates 2022-2024 for Veterinary Centralised applications (initial MAA, responses to LoQ, Variations, etc.), has been published
• Submission deadlines for veterinary scientific advice requests in 2022 have been published
• EMA have issued a Q&A document on the Union Product Database (UPD), which promises to be a very useful resource for all stakeholders
• Release notes and example files for the UPD were published on three occasions since the last knoell news update
• A revised reference list of EU/EEA country names in all EEA languages has been published

EVENTS UPDATES

• A recording of the EMA webinar for Industry on integration of OMS and EudraGMDP is now available on the event page. Slides and Q&A are also linked
• The slides from the EMA’s Veterinary SME Info Day, held on 28th October, are now available online
• Documents and slides from the second EMA Veterinary Info Day in 2021 (which took place on 30th November) can be accessed from this page
• The agenda and presentations from the EMA-FVE web seminar on 24th November, on data collection on sales and use of antimicrobials, are now available via the event page
• Presentation slides from the pharmacovigilance web seminar on adverse event collection and recording in the UPD that took place on 10th November have been published
• The event page for the web seminar on signal detection and analysis, that took place on 23rd-24th November, has been updated to include presentation slides
• The event page for the web seminar on veterinary pharmacovigilance (PhV) inspections and systems, their quality management systems and PhV system master files, also now has links to presentations from the day (8th December)

OTHER UPDATES

• From 2022, MAHs based in Ireland will be able to receive Commission Decisions for Centrally Authorised Products in Irish language (background and guidance here). A waiver request template, in the event that an Irish Decision document is not required by the Applicant/MAH, can be found here
• The EMA has confirmed that GMP certificates and time-limited manufacturing and import authorisations are automatically extended until the end of 2022, due to the pandemic situation and impact on inspections capability
• Antimicrobials: Reporting shows a more than 40% decrease in sales of antimicrobials for use in animals in Europe between 2011 and 2020. The EMA issued a press release to announce this; the annual report and the eleventh ESVAC report are also linked from the same news page.

HMA/CMDv

The Report for Release from the CMDv meetings in September and October is now available. The report includes summaries of procedures ongoing, as well as discussions on administrative points.

BEST PRACTICE GUIDES

Three consultations are currently in progress for CMDv Best Practice Guides (BPGs). Comments should be made by e-mail to the CMDv secretariat at cmdv@ema.europa.eu. The three open consultations are:

• Best Practice Guide on changing the Reference Member State
• BPG on handling marketing authorisations for VMPs intended for Limited Markets (National, DCP and MRP)
• BPG for validation of applications.

Another three BPGs have recently been finalised and published, in light of requirements of Articles 70-72 of the new VMP-Reg, and all coming into effect on 28th January 2022:

• BPG on the selection of products for SPC harmonisation
• BPG on harmonisation of the SPC of the reference product
• BPG for the harmonisation procedure of the SPC of generic/hybrid veterinary medicinal products