News Category: Regulatory news
Regulation 2019/6, commonly known as the New Veterinary Regulation, legislates for the authorisation, use and monitoring of veterinary medicinal products in the European Union. The legislation came into effect on 28 January 2019 and will apply in all EU Member States (MSs) on 28 January 2022. The Regulation followed the adoption of a proposal in 2014 to develop fit-for-purpose veterinary legislation, which would no longer be based on the equivalent human medicines authorisation system.
Regulation 2019/6 may appear to the general public to represent only an incremental change in the regulatory framework for veterinary medicinal products. However, for those involved in the business of manufacturing, importation, supplying or distribution of veterinary medicinal products in Ireland, this is a generational change. It will have significant ramifications for both those already involved in the animal health business in Ireland as well as others who up to now were legally entitled to supply certain veterinary medicinal products that had been exempt from the requirements of a marketing authorisation.
To assist stakeholders in making the necessary changes to their businesses to comply with the new legislation, which takes effect from 28 January 2022, the HPRA has developed a dedicated section on our website (hpra.ie/NewVetReg) where you can follow developments. The website will be updated on a regular basis to provide stakeholders with the latest information. The website also contains links to the latest developments on the websites of the European Commission and the European Medicines Agency.
The website content will include monthly updates to communicate information on key legislative, regulatory, ICT and procedural changes relating to veterinary medicinal products. The first monthly update (January 2021) is now available.
The HPRA has commenced an internal project to ensure that any work processes, forms and guides that must be changed to facilitate the new legislation are completed expediently. The HPRA aims to ensure that the relevant forms and guides are available on our website by 30 November 2021 (two months ahead of go-live of the new system), or as soon as new national legislation is available and the final requirements are known to us.
If you have suggestions for content for our webpage, or for the provision of workshops or webinars to assist in meeting the new requirements, please contact the HPRA (vetinfo@hpra.ie).