KNOELL’S ANIMAL HEALTH REGULATORY UPDATE: SEPTEMBER 2022

EMA/CVMP

If you want to catch up with the activities of the CVMP over the last few months, the highlights from the CVMP meeting of 6-8 September, and the minutes from the CVMP meeting of 12-14 July, were published this month.

Consultations

• Consultation has opened on AMR surveillance as a post-marketing authorisation commitment. The concept paper can be found via the consultation page, and comments are invited until the end of January 2023;
• A consultation has begun with the aim to establish a guideline on the development and manufacture of synthetic oligonucleotides. Comments can be submitted until 20 December;
• A consultation has begun with the aim to establish a guideline on the development and manufacture of synthetic peptides. Comments can be submitted until 20 December.

Referrals

• EMA has initiated an Article 82 referral for suspensions for injection containing procaine benzylpenicillin as a single active substance. For more information, see the relevant referral page;
• EMA has started a review of veterinary medicines containing the excipient N-methyl pyrrolidone (NMP). See the relevant referral page.

PHARMACOVIGILANCE

• The list of VeDDRA terms has been updated; the new list comes into effect on 1st October.
• The presentations from the IRIS for Good Pharmacovigilance practice (GVP) inspections webinar that took place on 7 September are now available via the event page. 

Events

• There will be a webinar on requesting access to and using EMA's SPOR application programming interface (API) on 11 October. See the event page for details and registration;
• The second Veterinary Big Data stakeholder forum will take place online on 23rd November. Details and registration via the event page;
• A refresher webinar on signal management in the Union Pharmacovigilance Database is scheduled to take place on 27th October; see the event page to register.

Reference and Administrative

• On September 8th, CVMP adopted an MRL summary opinion recommending inclusion of praziquantel in all ruminants (except bovine), Equidae and fin fish in Table 1 (allowed substances);
• Presentations from the EMA online event 'Union Product Database: webinar on VNRAs for MAHs', which took place on 8th September, are now available via the event page;
• There is now a version 3 of the guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by EMA
• The Veterinary Medicinal Products Regulation newsletter Issue 11 has been published.
• EMA has launched a communication perception survey to collect feedback on EMA’s external communication, with responses invited until 30 September.

HMA/CMDv

• HMA and EMA have published their Work programme of the HMA/EMA task force on availability of authorised medicines for human and veterinary use, and the terms of reference for this;
• CMDv and EMA have issued Procedural advice for requests for the classification of unlisted variations;
• There is a revised version of the Guidance document from CMDv on national-specific labelling/package leaflet information.

EUROPEAN COMMISSION

The Commission Mandate to the EMA, relating to Article 93(2) of Regulation 2019/6 as regards the good manufacturing practice for VMPs and active substances used as starting materials, has been published.