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KNOELL’S ANIMAL HEALTH REGULATORY UPDATE FOR JUNE 2022

More guidance and reference documents issued in June, and consultation has opened on several draft VICH guidelines on anthelmintic efficacy. Read on!

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

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

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.

 

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.

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