KNOELL’S ANIMAL HEALTH REGULATORY UPDATE FOR JUNE 2022
EMA/CVMP
The EMA has posted the meeting highlights of the CVMP's meeting of 14 – 15 June 2022 (Link). During the meeting, the Committee elected Dr Frida Hasslung Wikström from Sweden as its new Vice-Chair for a 3-year mandate.
Amongst other activities, the Committee adopted a list of questions and answers on titanium dioxide – expected to be made public shortly.
SCIENTIFIC GUIDANCE
- Revision 2 of the Guideline on requirements for the production and control of immunological VMPs has been published by EMA, as well as the overview of comments;
- A new guideline on data requirements for VMPs intended to reduce the risk of transmission of vector-borne pathogens in dogs and cats has been adopted (coming into effect 2023). Comments received during consultation are also accessible on the guideline page.
PHARMACOVIGILANCE
- The VeDDRA dictionary of adverse conditions has been updated, as has the related explanatory and procedural guidance. All linked from the relevant regulatory page on the EMA website;
- The recommended due dates for submission of the annual PV statement for non-CAPs from July to December 2022 have been published;
- The recommended due dates for CAPs for the same period have been updated.
REFERENCE AND PROCEDURAL
- An updated version of the EMA advice on the designation of antimicrobials reserved for treatment of humans was published at the end of May;
- The Agency has issued a manual for reporting antimicrobial use data per animal categories (reporting now mandatory in accordance with Article 57 of Regulation 2019/6);
- EMA has published a revised validation checklist for biologicals other than immunologicals (initial MAA);
- The list of substances out of scope for MRL requirements has been updated (Revision 52);
- The joint EMA-CMDv guidance on classification of VRAs according to Article 62 of Regulation 2019/6 and on the supporting documentation to be submitted has been updated;
- The EMA's User Guidance document for submissions via the eSubmission Gateway/Web Client using xml delivery files has been updated;
- The EMA’s SME Office Annual Report for 2021 has been published;
- The EMA’s Annual Report for 2021 was published on 10th June.
EVENTS
- A webinar for MAHs on variations not requiring assessment (VNRAs) in the Union Product Database is scheduled for 8th September 2022. Registration via the event page;
- The European veterinary Big Data strategy 2022-2027 is available via this EMA news page; note also that a second stakeholder forum is planned for 23rd November 2022 - save the date.
CONSULTATIONS
A large number of draft revised VICH guideline documents have been made public by the EMA for consultation with stakeholders, in the area of anthelmintic efficacy. These are:
- VICH GL7 Efficacy of anthelmintics: general requirements;
- VICH GL12: Specific recommendations for bovines;
- VICH GL19: Specific recommendations for canines;
- VICH GL14: Specific requirements for caprines;
- VICH GL21: Specific recommendations for chickens;
- VICH GL15: Specific recommendations for equines;
- VICH GL20: Specific recommendations for felines;
- VICH GL13: Specific requirements for ovines;
- VICH GL16: Specific recommendations for porcines.
The consultation period for all of these updated draft guidelines closes on November 1st, 2022.
HMA/CMDv
The latest CMDv Report for release, giving an overview of the activities of the March and April 2022 meetings, is available to view and download. The report includes amongst other items a summary of CMDv documents updated due to the implementation of Regulation (EU) 2019/6 in March and consultations recently closed.
- The list of CMDv Members and Alternates has been updated.
- The CMDv guidance on classification of VRAs has been updated.
EUROPEAN COMMISSION
Regulation (EU) 2022/839, formalising the ‘transition period’ for updating SPC and labelling texts for VMPs authorised before 28th January 2022 to QRD version 9, has been published.