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Developments on the implementation of Regulation 2019/6  — regular updates

Regulation 2019/6,commonly known as the New Veterinary Regulation (NVR), legislates for the authorisation, use and monitoring of veterinary medicinal products in the European Union. It applied in all EU Member States from 28 January 2022.

In the lead up to the date of application, we shared monthly updates on this webpage to communicate information on key legislative, regulatory, ICT and procedural changes relating to veterinary medicinal products. The updates are now  provided on an ‘as needed’ basis, when there are new developments to report.

The updates summarise relevant developments from the European Commission, the European Medicines Agency and the Coordination Group for Mutual Recognition and Decentralised Procedures – Veterinary (known as the CMDv). The updates also contain HPRA information about national measures that complement the implementation of the Regulation.​

Additional national legislation is being developed by the Department of Agriculture, Food and the Marine, to complement the implementation of the NVR nationally. For information on these developments, click here.

Queries relating to the HPRA’s implementation of the new Regulation may be sent to vetinfo@hpra.ie.

Please click through to each month to view the most recent highlight from the HPRA. 

January 2024 update

Highlights in the January 2024 update include:

  • Progress on the elaboration of new secondary EU implementing legislation continues, with further legislation expected early in 2024.

  • Significant new national legislation is expected in 2024, underpinning the requirements for electronic prescribing

  • An EU survey is ongoing regarding critical substances for equines and regarding the approach to amending labelling of antimicrobial medicines to remove indications for preventative use.


July 2023 update

Highlights in the July 2023 update include:

  • The EMA has closed their IT development programme for the implementation of Regulation 2019/6, which has moved to a care, maintenance, and quality improvement phase.

  • The EMA hosted a webinar in April webinar on the requirements for veterinary companies to submit annual volume of sales data for each of their products to the Union Product Database (UPD) before 30 June 2023.

  • The CMDv has published a revised version of their Best Practice Guide for Variations not Requiring Assessment (VNRAs) in relation to VRA’s submitted in a work-sharing procedure.

  • The CMDv published their report for April and May 2023. The report answers the CMDv’s query to the European Commission on the “generic extension” of a complete dossier.

  • The European Commission will be monitoring the progress of changes to product labels in accordance with the requirements of Regulation 2019/6 due to the slow progress of implementing QRD template requirements.

  • The European Commission is drafting a delegated regulation on veterinary medicinal products for oral administration to food-producing animals via routes other than medicated feed.

  • The Veterinary Medicinal Product, Medicated Feed and Fertilisers Regulation Act, was passed on 6 July 2023. It is expected to be signed into law in the coming weeks.

  • The HPRA is continuing to upload remaining national legacy product data to the Union Product Database (UPD). There have been ongoing challenges processing VNRAs and G.I. 18 variations, due to technical issues with the functionality of the UPD.


Update from the EMA

On 2 June 2023, the EMA has published the 12th issue of the Veterinary Medicines highlights with the latest updates of the Veterinary Medicines Division, ranging from stakeholder events, regulatory news, and activities in the margins of the Veterinary Big Data strategy, to notable CVMP outputs.

March 2023 update

Highlights in the March 2023 update include:

  • The EMA has finished the work to develop the IT systems needed to underpin Regulation 2019/6. These systems include the Union Product Database (UPD), the Union Pharmacovigilance Database (EVV) and the Union Manufacturers and Wholesalers Database (MWD).

  • The EMA has reviewed a pilot system for signal management of reports of suspected adverse events to veterinary medicines.

  • There are new CMDv documents that have been recently published on the HMA website relating to the classification of teat dips in Member States and borderline product classification and discussion.

  • The CMDv is developing a suite of new documents to help develop a simpler approach in the co-ordination and exchange of information between Member States involved in the assessment of multi-centre clinical trials on veterinary medicines.

  • The European Commission working to replace the Notice to Applicants with a ‘Guidance to Applicants’.

  • The HPRA is continuing to upload remaining product data to the UPD.


January 2023 update

Highlights in the January 2023 update include:

  • The EMA Steering Group for the coordination of the implementation of the ICT elements of Regulation 2019/6 has been stood down following the completion of the upload of national product data to the EMAs Union Product Database (UPD) and the delivery of the other Union ICT components.

  • An EMA guideline on the application of Article 34 of Regulation 2019/6 (method of supply of veterinary medicines) was adopted by the CVMP at their meeting in January.

  • The CMDv has published an updated version of the Best Practice Guidance for VNRAs following an increase in functionality of the UPD.

  • The CMDv has adopted a list of veterinary medicines for SPC harmonisation which will go forward for endorsement by the HMA.

  • The European Commission has given the EMA a mandate to develop scientific advice to underpin the development of a list of active substances essential to the treatment of equine species.

  • The European Commission has clarified that veterinary medicines fall within the scope of Directive 94/62/EC on Packaging and Packaging Waste and veterinary medicinal products must comply with the applicable provisions concerned.

  • The HPRA is continuing to upload remaining legacy product data to the UPD.


October 2022 update

Highlights in the October 2022 update include:

  • The EMA has reported that 95% of national legacy product data on veterinary medicines from Member State markets has been uploaded to the UPD. Variations not requiring assessment can now be processed successfully using the UPD.

  • The EMA will hold a webinar on signal management for adverse reactions to veterinary medicines on 27 October and a stakeholder forum on veterinary big data on 23 November. Attendees must register in advance.

  • The CMDv published guidance on national-specific labelling/package leaflet information.

  • The CMDv have agreed that product information alignment with revised CVMP guidelines on antimicrobials or antiparasitic cannot be completed within VRA G.I.18.

  • The European Commission has published the legal act list of antimicrobials reserved for treating certain infections in humans. Other implementing and delegated acts in fulfilment of the legislative requirements for the implementation of the Regulation are in development.

  • The HPRA has uploaded most of its legacy product data to the UPD.

  • MAHs submitting variation applications to update product information in line with the new Regulation should do so on time to finalise and implement the variation on the printed labelling and package leaflet before 29 January 2027.