Update on implementation of the new veterinary regulation March 2023
EMA update
The EMA has completed the IT work needed to develop the systems that underpin Regulation 2019/6. These include the Union Product Database (UPD), the Union Pharmacovigilance Database (EVV) and the Union Manufacturers and Wholesalers Database (MWD).
A new EMA group, called the Veterinary IT systems improvements advisory group (VSIAG) will be responsible for the further development of these IT systems going forward. The VSIAG is made up of members from Member States (MSs), industry, animal healthcare professionals, the European Commission, and the EMA itself.
In spite of this achievement, the view of the animal health industry as expressed at the EMA Info Day on 16 February 2023, was that the reduction in administrative burden is yet to be seen. As a result of this, further optimisation of the regulatory environment is needed.
Industry is particularly concerned that the requirement to submit sales data for its products in accordance with Article 58(12) of Regulation 2019/6 is proving to be challenging. The main reason for this is that industry must adapt internal IT systems to UPD requirements which are not yet available.
The pilot system for signal management of reports of suspected adverse events to veterinary medicines has been reviewed. From April 2023, where a marketing authorisation holder (MAH) considers that a signal has changed the benefit risk and the Summary of Product Characteristics (SPC) must be updated, this should be submitted as a variation requiring assessment (VRA). Therefore, signal triggering the need for SPC update will no longer be routinely reviewed prior to variation submission. This change is expected to improve the efficiency of the process.
CMDv update
The Heads of Medicines Agencies (HMA) has published new documents on the CMDv pages of their website. The documents are as follows:
The CMDv has also decided that it is not appropriate for products authorised under MRP or DCP to align the SPC to CVMP guidelines during a VRA G.I.18 procedure. However, it is possible to progress these alignments by grouping the respective variation (for example, appropriate variation in chapter G affecting the product information texts for the same product) with a VRA G.I.18.
The HMA has requested the CMDv develop a simpler approach to co-ordination and/or exchange information between Member States involved in the assessment of multi-centre clinical trials on veterinary medicines. The CMDv is developing a suite of documents that might be used to assist with this. These documents could include for example an application form, an assessment template and/or a validation checklist. It is expected that work on this area will be completed by the end of the year.
The proposed CMDv workplan for the list of national products proposed for SPC harmonisation (under Article 69 of Regulation 2019/6) was endorsed by HMA at their meeting in February.
There are 5 products concerned:
- Catosal (contains butafosphan and cyanocobalamin [Elanco])
- Finadyne (contains flunixin [Merck])
- Estrumate (contains cloprostenol [Intervet])
- Domosedan (contains detomindine hydrochloride [Orion])
- Planate (contains cloprostenol [Merck])
European Commission update
The European Commission is working to replace the Notice to Applicants with a ‘Guidance to Applicants.’ This guidance is expected to be finalised before the end of this year.
HPRA update
The HPRA is continuing efforts to upload remaining product data to the UPD. Currently, there are approximately one hundred records to be uploaded. The main delay to this progress is that the Reference Member States have not completed their tasks. As a result, the HPRA cannot complete the associated data upload, or the MAHs involved have not yet registered their organisational data with the EMA. Until the data are uploaded, the expected administrative efficiencies in processing applications won’t be recognised.
The HPRA understands that progress on the finalisation of new national legislation on veterinary medicines by the Department of Agriculture, Food, and the Marine (DAFM) is continuing. The latest indication from DAFM is that the legislation, which is now in its third stage in Parliament, is expected to be adopted and published by early summer.