KNOELL’S ANIMAL HEALTH REGULATORY UPDATE: APRIL 2024

There have been some newly published reference documents and templates from EMA, some further information uploaded to the event pages of a couple of recent EMA events, as well as a new consultation and a new page collating information on Good Manufacturing and Good Distribution Practice (GMP and GDP). CMDv have created a new guidance document on borderline veterinary products, and FOUR new Implementing Regulations have been issued since the last update!

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EMA/CVMP

The EMA has published the agenda and the meeting highlights from the CVMP meeting that took place on 16-18 April 2024. The minutes from the meeting that took place on 12-14 March are also now available. 

EVENTS - UPCOMING and FOLLOW-UP

• There will be a joint EMA/FVE information session on 23 May 2024, on restrictions on the use of certain antimicrobials in animals. The session will take place online. Further information and registration via this page;
• The agenda and presentations from the meeting of the focus group on veterinary pharmacovigilance reporting in poultry, that took place on 11 October 2023, are now available on the event page;
• The agenda and presentations from the meeting of the focus group on veterinary pharmacovigilance reporting in aquaculture, that took place on 22 November 2023, are now available on the event page;
• A Q&A document from the Update webinar on Regulatory Procedure Management for Product Lifecycle Management on IRIS that took place on 13th February 2024 has been uploaded to the event page.

CONSULTATIONS AND GUIDANCE

• A draft concept paper has been published for consultation, with the aim of developing a guideline on the safety of nanoparticles (in the context of MRLs and veterinary MAAs). See the consultation page; comments invited until 31st July;
• There is a new Q&A page on the EMA website relating to GMP and GDP – with content tagged as relating to human and/or veterinary.

REFERENCE AND ADMINISTRATIVE

• The EMA's explanatory note on fees was revised on 11th April (in force from 1st April). A news item in relation to the change was also published;
• A new form (including checklist) is available to be used when submitting the final translated Product Information texts for CAPs;
• A template cover letter for CAP MA transfers has been made available, which includes a list of the required documentation for the dossier;
• The Annual Report of the EMA's SME Office from 2023 has been published.
• A Confidentiality arrangement between the EU and the Republic of Korea has been announced. Although applying only to human medicines at this stage, the limited agreement is expected to develop further in the future.

HMA/CMDV

• The CMDv Q&A list for the submission of variations according to Regulation (EU) 2019/6 has been updated;
• The Best Practice Guide for the Allocation of the Mutual Recognition/Decentralised Procedure Application Number has been updated (revision 2);
• CMDv have published a brief, yet comprehensive, FAQ document on veterinary borderline products;
• CMDv have published a new guidance document on the processing of generic and hybrid applications through DCP, MRP and SRP;
• A third revision of the Best Practice Guide for Subsequent Recognition Procedure was published at the end of March.
   

EUROPEAN COMMISSION

IMPLEMENTING REGULATIONS

• A further Implementing Regulation (2024/916 of 26 March 2024), amending IR 2021/17 establishing the list of VNRAs, is now in force;
• Implementing Regulation (EU) 2024/875 of 21 March 2024 has been published, concerning the list of approved pictograms and abbreviations for use on the packaging of VMPs;
• Implementing Regulation (EU) 2024/878 of 21 March 2024 has been published, setting out uniform rules on the size of small immediate packaging units of VMPs as referred to in Art. 12 of Regulation 2019/6;
• Delegated Regulation (EU) 2024/1159 of 7 February 2024, foreseen by Article 106 (6) of Regulation 2019/6 has been published - concerning measures to ensure effective and safe use of VMPs for oral administration other than via medicated feed and administered by the animal keeper to food-producing animals.