KNOELL’S ANIMAL HEALTH REGULATORY UPDATE: MARCH 2024
The EMA has published the agenda and highlights from the CVMP meeting that took place on 12-14 March 2024. As well as progress of various EMA procedures and assessments, the highlights note that eligibility of one product for Limited Market classification according to Article 23 was agreed. The Committee also endorsed a stakeholder survey on novel therapies that aims to map the development (or intentions to develop) of novel therapies/innovative VMPs - as well as main hurdles for development and authorisation of such products.
EMA/CVMP
The minutes of the meeting on 13-14 February 2024 are also now available.
EVENTS
- EMA will host a Product Management Service (PMS) Info-Day on 16th April 2024. Details and registration via this page;
- The event page from the PMS deep-dive webinar that took place on 22nd February 2024 has also been updated with reference documents and a video recording;
- Presentations and a video recording from the EMA and Federation of Veterinarians of Europe (FVE) info session on the UPD, that took place on February 21, are available on the event page.
REGULATORY AND REFERENCE
- EMA has created a new webpage dedicated to veterinary MA transfers, and two new related document templates: for the declarations of the transferor and transferee, and the covering letter;
- Updated EVVet3 production release notes were published on 07 March 2024.
HMA/CMDV
CMDv Reports for release
- The report from the November and December 2023 meetings;
- And the January and February 2024 meetings,
are available to view and download. Giving an overview of the activities of the Committee, the reports also include an appeal to MAHs to urgently submit VRAs to update thier product information to the QRD9 template. MAHs are also encouraged to submit the G.I.18 VRAs as stand-alone applications to speed up the submission and processing.
REGULATORY AND REFERENCE
- A second revision of the CMDv procedural advice document for requests for the classification of VRAs and VNRAs not already listed, was published at the end of February.
- CMDv have published a Revision 2 of the Best Practice Guide for Article 54 review procedure.
- There is now a second revision of the Best Practice Guide for the allocation of the MRP/DCP application number; note that for VRAs this responsibility falls to the MAH.
- The CMDv Annual Report for 2023 has been published.