Antiparasitic Veterinary Medicinal Products
Background and establishment of the Task Force
At their meeting 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.
The membership of the Task Force is as follows:
Joe O’Flaherty (Chairman), Theo DeWaal (Vice-Chairman), J. Gabriel Beechinor, Caroline Garvan, Orla Keane, James O’Shaughnessy and Aidan Moody.
The criteria as set out in Regulation 2019/6 are very similar to those previously set out in Directive 2006/130/EC. Given the existence of widespread authenticated reports of anthelmintic resistance in livestock in Ireland in recent years, as well as international concerns over the spread of resistance to ectoparasitic drugs, the ACVM considered it timely to review the position of the categorisation of antiparasitic products that are indicated for use in food-producing animals, in order to ensure compliance with Regulation 2019/6. The Regulation, which came into effect on 28 January 2019, will be applied in all Member States from 28 January 2022.
Adoption of the Report and stakeholder consultations
The Task Force held an online consultation with interested parties between 20 May and 21 June 2019. A summary of the results of the consultation is available.
Following finalisation of the Report by the Task Force in early October 2019, it was reviewed 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. A copy of the Report of the Task Force
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. In accordance with existing national legislation, antiparasitic veterinary medicinal products for use in food-producing species that are supplied under prescription may be dispensed by veterinary practitioners, pharmacists and licensed merchants. This means that all current stakeholders that already supply such products will be entitled to stock them in the future (but from January 2022 onwards a veterinary prescription will be needed to dispense them).
Between 13 December 2019 and 28 February 2020, the HPRA held a further public consultation to ascertain views on the optimal timeline, logistics, and potential consequences for implementation of the changes of the method of supply of the affected products. The feedback on the public consultation is available. Following this consultation the HPRA held a (virtual) meeting with interested parties on 27 April 2020. A report of the meeting with HPRA stakeholders is available. The HPRA would like to thank all those who contributed to the consultation as well as those organisations that responded to our invitation to attend the virtual meeting.
Process underway to change to prescription control
The HPRA is now engaged in a process to change the antiparasitic products concerned to prescription control. The HPRA is conscious that notwithstanding the need for timely action to halt the development of antiparasitic resistance in food-producing animals in Ireland, given:
the Department of Agriculture, Food and the Marine’s public consultation on an amendment to the national legislation in this area;
the changes to product labelling that are required;
the opportunity that is now available to progress a multi-actor stakeholder approach to addressing antiparasitic resistance nationally;
the need for communication of developments to veterinarians, pharmacists, licensed merchants, farmers and other users;
the recommendation in the report itself, which was endorsed by the Authority, that maximum flexibility be given until 1 January 2022 to comply with the Report findings.
This process will proceed on a managed basis over the coming year, with changes becoming manifest in the labels of the products concerned between July 2021 and January 2022. The period up to 28 January 2022 is expected to allow the necessary time for any adjustments in the national legislation on the prescription and supply of the products concerned to be undertaken and for a coordinated multi-stakeholder national initiative to halt the development of resistance to be adopted.
On 24 November 2021, the Department of Agriculture, Food and the Marine announced that it has deferred the implementation of the requirement for a veterinary prescription for antiparasitic veterinary medicines until 1 June 2022. This deferral does not alter the change-over process of product labelling to display the prescription-only medicine supply category, which has already been implemented by the HPRA; relevant products in LM livery cannot be released for supply to the market by marketing authorisation holders after 28 January 2022.
The Department of Agriculture, Food and the Marine is the competent authority for monitoring market compliance, including the advertising, promotion and display of the products concerned in the retail trade.
In June 2020 the Department of Agriculture, Food and the Marine 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.