KNOELL’S ANIMAL HEALTH REGULATORY UPDATE: JULY 2023

The EMA has posted the agenda and the meeting highlights of the CVMP's meeting of 11-13 July 2023. As well as the usual business of the CVMP relating to product authorisations and post-marketing procedures, the highlights include reference to discussions on various guidelines and concept papers, such as those relating to efficacy of veterinary ectoparasiticides, to diagnostic tests to support the responsible use of antibiotics in animals, and to quality safety and efficacy of allergen products.

EMA/CVMP

CONSULTATIONS

• EMA has published a draft Reflection paper for consultation on the use of artificial intelligence in the lifecycle of medicines - relevant to human and veterinary medicines. Comments are invited until 31st December.

GUIDELINES

• The Guideline on the SPC for VMPs containing antimicrobial substances has been updated, as has the related Q&A document;
• The Guideline on the SPC for VMPs for antiparasitic veterinary medicinal products has also been updated;
• A second revision of the VICH Guideline 18 on residual solvents in new VMPs, active substances and excipients has been adopted.

PHARMACOVIGILANCE

• A 14th revision of the call for comments on the VeDDRA standard list for EVVet was published in June. Instructions on how to comment are included in the document;
• EMA published a list of changes to combined VeDDRA list of clinical terms (for reporting SAEs in animals and humans to VMPs for 2023), and an updated VeDDRA dictionary file.

EVENTS

• The EMA will host a Veterinary Awareness Day, the first event of its kind, online on September 12-13 2023. More details can be found on the event page.
   

REFERENCE AND ADMINISTRATIVE

• EMA’s annual activity report for 2022 has been released;
• EMA and HMA have published a EU veterinary big data workplan to 2025;
• EMA has published a news item concerning the phasing-out of regulatory flexibilities introduced during the Covid-19 pandemic, including in relation to GMP inspections, importation, and labelling requirements;
• A revised version (v1.5) of the EU Implementation Guide on veterinary medicines product data in the UPD has been published.

HMA/CMDV

The latest CMDv Report for release, giving an overview of the activities of the April and May 2023 meetings, is available to view and download. The report includes amongst other items discussion of informed consent, parallel trade and EDQM standard terms.
 

• CMDv have published a Q&A document on MA exemptions for small pet animals;
• A new CMDv guidance document is available concerning actions after a Commission Decision following a CMDv Review Procedure (Article 54);
• The CMDv guidance document on MA Transfers in the Member States was updated in June;
• The CMDv meeting dates page has been updated, with dates now published up to 2026.