News Category: Regulatory news
In February 2019, the HPRA’s Advisory Committee for Veterinary Medicines (ACVM) established a Task Force to review the method of supply of antiparasitic veterinary medicinal products that are intended for food-producing animals against the criteria set out in Directive 2006/130/EC. This includes products containing all classes of antiparasitic agents and including medicines containing coccidostats.
Following finalisation of the Report by the Task Force in early October, it was discussed and adopted by the ACVM on 23 October 2019. Subsequently, the Report was discussed and endorsed by the Authority of the HPRA at their meeting on 5 December 2019 and published on the HPRA website.
The Report states that the available scientific evidence shows that antiparasitic veterinary medicines that are intended for use in food-producing species do not comply with the criteria for derogation from veterinary prescription specified in Regulation (EU) 2019/6. It also states that a consequence of this determination is that any such products that are supplied without veterinary prescription will need to be upregulated to supply under veterinary prescription.
The Task Force held an on-line consultation with interested parties between 20 May and 21 June 2019. A summary of the results of that consultation has also been published.
Consulting on implementation
The HPRA will now move to implement the findings of the Report. Prior to implementation, the HPRA invites the views of stakeholders on the time needed to give effect to the changes to the method of supply of the products concerned. The consultation is open until close of business on Friday 28 February 2020.
Further details are available from the Antiparasitic Veterinary Medicinal Products section of our website. This includes additional information on the taskforce, the findings of the Report, the proposed changes and actions required for implementation of those findings, and the consultation process concerning the implementation period.