Regulation 2019/6 (so-called New Veterinary Regulation [NVR]), regulates how veterinary medicinal products are authorised, used and monitored in the European Union (EU). It applies from 28 January, 2022. The NVR also establishes a new, centralised, database of all EU authorised medicines (whether authorised centrally or in Member States). Furthermore, it establishes new systems for monitoring adverse reactions to veterinary medicines, allowing for realtime monitoring of reports and better compliancetools. In Ireland and other Member States, the NVR will be complemented by secondary EU legislation as well as new national legislation. The secondary EU legislation takes the form of delegated and implementing acts. There are more than 25 such acts, which establish more granular details about e.g., technical requirements for application dossiers, restrictions on the use of antibiotics in veterinary practice and the operation of the 'cascade' rules governing off-label use of medicines. About half of them will be established by the date of application, with the remaining acts being elaborated in the future, as society develops. The national legislation will give effect to certain legal choices in specific areas that are provided in the NVR, e.g., whether certain medicines for specific pet species or aquarium fish are to be exempted from the requirement for marketing authorisation or not. In Ireland, some provisions of the existing national legislation conflict with the requirements of the NVR (e.g., the highest form of control in the method of supply of new medicines is under veterinary prescription rather than VPO as specified currently) and, therefore, there is a need to update the national legislation in any event.
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