Monthly update on implementation of the New Veterinary Regulation — April 2021
Update of note by the EMA
Progress is continuing in the development of projects under the EMA’s veterinary regulation IT development scheme. The EMA is providing support to Member States for preparatory work ahead of mapping legacy product data, particularly through the provision of a troubleshooting helpdesk as well as training webinars. The EMA expects that training for industry stakeholders will take place during the second half of 2021.
Update of note by the CMDv
An updated QRD template, which will come into effect on 28 January 2022, contains a new structure for the summary of product characteristics and package leaflet. The updated template is open for public consultation until 14 May. Regarding the transition from existing QRD templates to the new one, it was confirmed by the CMDv that:
Where an application (new or variation) has been validated by the competent authority prior to 28 January 2022 but finalised after this date the existing version of the template may be used.
Where a variation application is submitted by a marketing authorisation holder post-January 2022, the existing template may still be used. However it becomes obligatory to use the new, updated template from January 2027.
Update of note by the European Commission
The European Commission has again stated that it remains committed to give effect to the implementation of the Regulation and the delegated and implementing acts. The Commission also hopes to achieve the objective of the Farm to Fork strategy to reduce overall EU sales of antimicrobials for farmed animals by 50% by 2030. The Commission has informed Member States that, overall, it remains on track to adopt the required secondary legislation in time. It has also stated that it is committed to ensuring the operation of the Union Product Database later this year, thus reducing the administrative burden once the NVR becomes applicable on 28 January 2022.
Update of note by the HPRA
The HPRA held a webinar for marketing authorisation holders and veterinary manufacturers in respect of changes in regulatory procedures due to the change in the EU legislation that are likely to affect them. A recording of the webinar, together with the presentations and a questions and answers document is available on the NVR Webinar webpage on the HPRA website.
The HPRA addressed the Oireachtas Joint Committee on Agriculture and the Marine on the topic of the NVR and the control of veterinary medicinal products at their meeting on 27 April 2021. A recording of the event and the HPRA opening statement are available to view.