KNOELL’S ANIMAL HEALTH REGULATORY UPDATE: SEPTEMBER 2023

As always, there are some updated reference documents from the EMA, which those working in regulatory affairs will need to be aware of. There are also some recently-opened consultations on data guidelines for Limited Market products, that will be of interest to many. The agenda for the CVMP meeting that took place on 5-7 September 2023 is available, and the meeting highlights are here. Minutes from the meeting on 11-13 July 2023 have also now been published.

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EMA/CVMP

CONSULTATIONs and guidelineS

Three new consultations have opened:

• A new draft guideline on quality data requirements for applications for biological VMPs intended for limited markets; 
• A new draft guideline on safety and efficacy data requirements for IVMPs intended for limited markets, but not eligible under Art. 23;
• A new draft guideline on safety and residue data requirements for VMPs intended for limited markets, not eligible under Art. 23.

Comments on all three are invited until 31st January 2024.

• A revised draft guideline has been published for consultation on user safety of topically administered VMPs - comments until 30th November 2023.

EVENTS

• The third Veterinary Big Data Stakeholder Forum is scheduled for 23 November 2023. Register via this link;
• There will be a joint HMA-EMA workshop on Artificial Intelligence on 20th November 2023. The workshop will be hybrid with face-to-face, Webex, and live online broadcast options; see the event page for details and registration;
• The recording and slides from the webinar on product grouping and 3rd country product names for UPD Industry users, that took place on September 18th, are now available on the event page.

REGULATORY REFERENCE, ADMINISTRATIVE AND OTHER

• Version 1.6.34 of the UPD release notes is available for reference;
• A 'QRD Form 1 - veterinary' has been made available by the EMA, for the Applicant/MAH to use when submitting draft translations (Day +5) to the EMA, for initial applications and variations. A related checklist has also been issued;
• A ‘QRD Form 2 – veterinary’, and checklist, have been made available by the EMA, for the Applicant/MAH to use when submitting the final translations to the Agency;
• Revision 5 of the EMA reference document on the linguistic review process of product information in the Centralised Procedure has been published;
• Contacts for the Innovation offices at the NCAs for each Member State are available in this published list. Relevance to the veterinary sector may vary by remit of the individual NCAs;
• The EMA/HMA’s EU Vet Big Data work plan to 2025 has been published;
• The EMA has published a poster celebrating 20 years of EU/US collaboration on medicines regulation.

HMA/CMDV

The latest CMDv Report for release, giving an overview of the activities of the June and July 2023 meetings, is available to view and download. Topics discussed included:

• Review procedures under Art. 54 of Regulation 2019/6
• Possibilities for grouping of VNRAs
• The Annex 1 to the QRD9 template including national reporting systems in the Member States (information to be included in section 7 of the Package Leaflet).

The minutes of the Interested Parties meeting that took place on 16th June 2023 are now available. Attended by various industry-representative groups and the CMDv, discussion included:

• Information on distributors/local representatives on the product packaging
• Frequency of adverse events in the product information text
• QRD9 updates.