Latest info

KNOELL’S ANIMAL HEALTH REGULATORY UPDATE FOR MAY 2022

A quieter month this May, but still some useful reference documents to get acquainted with, and presentations from the Vet Info Day if you missed it.

EMA/CVMP

Meeting highlights from the CVMP's meeting on 10-12 May 2022 have been published; as have the minutes from the 15-16 March 2022 and 11-13 April 2022 meetings. A new CVMP Chair has been elected for the next 3 year term: Gerrit Johan Schefferlie.

 

EVENTS

  • The EMA and FVE will host a joint webinar on the Union Product Database, aimed at Animal Health practitioners - scheduled to take place on 27th June. Information and registration via the link.
  • The event page for the EMA's Veterinary Medicines Info Day 2022, which took place on 12-13 May,has been updated with links to the presentations.

REFERENCE AND PROCEDURAL

  • Revision 01 of the procedural advice on accelerated assessment of MAAs (in line with Art. 44(3) of Regulation 2019/6) has been published.
  • A Procedural advice document for veterinary vaccine antigen master file (VAMF) certification was adopted in April, following consultation.
  • Documents have been made available to facilitate changes of Applicant for MAAs: template letter text to notify the change of Applicant, and an Applicant's checklist.
  • An Article 82 referral was initiated in May 2022 for VMPs containing N-methyl pyrrolidone (NMP) as an excipient (Centrally and Nationally authorised products).
  • The 2021 Annual Report of the Good Manufacturing and Distribution Practice Inspectors Working Group, relevant to human and veterinary medicine, has been published.
  • Issue 10 of the Veterinary Medicinal Products Regulation Highlights newsletter has been published.
  • Issue 55 of the EMA SME Office’s Newsletter for Small and Medium-sized Enterprises is now available; the latter half being concerned with veterinary medicines regulation. 


HMA/CMDV

  • The CMDv has issued an updated Best Practice Guide (BPG) on the processing of Product Information and the preparation of multilingual/-country packaging for MRP/DCP/SRP and variations.
     
More News on
Animal Health