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.
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.
- 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.
- 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.