KNOELL’S ANIMAL HEALTH REGULATORY UPDATE: AUGUST 2022

A couple of new reference items have been published, an EMA event announced, and more guidance on pharmacovigilance from the EMA.

EMA/CMDV

PHARMACOVIGILANCE

Updated Pharmacovigilance reference resources:

• Scientific and technical recommendations: Veterinary Medicines Regulation;
• EVVet3 EVWeb Production – Release notes (Release 1.5)

Training session for industry users: IRIS for Good Pharmacovigilance practice (GVP) inspections, 7th September (online)

REFERENCE, ADMINISTRATIVE, OTHER

• The EMA’s fee list has been updated as of 1st August 2022. The key change is a reduction to the fee for a VRA in the ‘G’ category. Revised implementing rules to the Fee Regulation were also issued;
• Presentations and a video recording from the EMA and FVE webinar on the Union Product Database have been uploaded to the event page;
• There is a new page on the EMA website dedicated to Direct animal healthcare professional communications (DaHPCs);
• Issue 56 of the SME Newsletter is now out.

HMA/CMDV

• The summary of Member States’ requirements during the national phase was updated in August.
• The list of authorised medicines for fish treatment has also been updated.

EUROPEAN COMMISSION

• The Commission Implementing Regulation (EU) 2022/1255 of 19 July 2022, designating antimicrobials reserved for treatment of certain infections in humans (in accordance with Regulation (EU) 2019/6 Article 37(5), has been published in all EU languages.
• Implementing Regulation (EU) 2021/1281 of 2 August 2021 as regards good PV practice and on the format, content and summary of the PV system master file for VMPs is now adopted.