Antiparasitic Veterinary Medicinal Products
On 13 February 2019, the HPRA’s Advisory Committee for Veterinary Medicines (ACVM) established a Task Force to review the position of antiparasitic and anti-coccidial veterinary medicinal products for food-producing animals against the criteria in Regulation (EU) 2019/6 for exempting from the normal requirement of a veterinary prescription. This action was on foot of several authenticated reports of anthelmintic resistance in livestock in Ireland in recent years, as well as growing international concerns over the spread of resistance to ectoparasitic drugs.
The timely action by the HPRA to review the position of the categorisation of antiparasitic products that are indicated for use in food-producing animals, would ensure compliance with Regulation 2019/6. The Regulation, which came into effect on 28 January 2019, was applied in all Member States on 28 January 2022.
Adoption of the Report and stakeholder consultations
The Task Force held an online consultation with interested parties during 2019. Following this, the Report was finalised in October 2019. Subsequently, the Report was reviewed and adopted by the ACVM on 23 October 2019, before it was further discussed and endorsed by the Authority of the HPRA at their meeting on 5 December 2019.
The Report states that the available scientific evidence shows that antiparasitic veterinary medicines that are intended for use in food-producing species did not comply with the criteria for derogation from veterinary prescription specified in Regulation (EU) 2019/6. In order to ensure their compliance any such products that are supplied without veterinary prescription had to be upregulated to supply under veterinary prescription.
Between 13 December 2019 and 28 February 2020, the HPRA held a further public consultation on the implementation of the changes of the method of supply of the affected products. Following this, the HPRA held a (virtual) meeting with interested parties on 27 April 2020.
Changeover of affected products to prescription control
During 2021, the HPRA engaged in a process to change the antiparasitic products concerned to prescription control. All affected products now bear prescription-only-medicine supply route designation, and now comply with Regulation 2019/6.
On 24 November 2021, DAFM announced that it was deferring the implementation of the requirement for a veterinary prescription for antiparasitic veterinary medicines until 1 June 2022.
DAFM subsequently announced deferral of a deferral of this date to 1 December 2022, and on 24 November 2022 published notice of a further deferral until such time as planned new legislation for electronic prescriptions would be in place. The HPRA expects that the legislation will be passed during 2023.
In June 2020, DAFM established an Antiparasitic Resistance Stakeholder Group to ensure a holistic, multi-stakeholder approach to the issue and to foster the informed and prudent use of antiparasitics.