Changes to HPRA application forms, guidelines and general requirements associated with the implementation of Regulation 2019/6

With the implementation of Regulation 2019/6 on 28 January 2022 and the revocation of existing national legislation on animal remedies by SI No. 36 of 2022, the legal basis and framework underpinning a number of the national authorisation activities for veterinary medicinal products is changing. This has necessitated certain changes to application forms and their associated guidance notes. Furthermore, additional new national legislation is expected to be prepared by the Department of Agriculture, Food and the Marine by July 2022 and these may require further updates to HPRA forms and guidelines.

The HPRA put in place a structured implementation project to prepare the necessary changes; stakeholders should ensure that the latest versions of forms and guidelines are downloaded and used.

The forms and guidelines are available elsewhere on this site.