Antiparasitic Veterinary Medicinal Products
On 13 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.
The membership of the Task Force is as follows:
Joe O’Flaherty (Chairman), J. Gabriel Beechinor, Theo DeWaal, Caroline Garvan, Orla Keane, James O’Shaughnessy and Aidan Moody.
Members possess specialist expertise and competence relevant to the functions of the task force. They are independent in the performance of their duties and, in accordance with their mandate, they may not be subject to the direction of any other person or body in the performance of their duties.
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 is available here.
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. A copy of the Report is available here.
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 HPRA will now move to implement the findings of the Report. The HPRA notes that 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). Mindful of previous experiences in implementing such regulatory changes and of the deadline for implementation of Regulation (EU) 2019/6 in January 2022, the HPRA proposes that:
- Full market compliance for labelling of existing products that need to be changed to prescription control must be ensured by 31 December 2021.This means that the labelling and packaging of existing relevant products on the market must comply with the requirements on or before this deadline. Any products not in the correct livery after this date will be considered non-compliant.
- Applications from marketing authorisation holders to give effect to the labelling and packaging changes must be submitted to the HPRA by 31 December 2020. The period of the year 2021 is expected to be sufficient to manage the changeover needed to allow for the manufacture and release of stock bearing the new liveries and to address any logistical issues.
- In order to avoid any potential market distortion or unfair competition from existing products that are currently available without prescription, marketing authorisation holders for new products that are to be authorised between now and 2021 can apply individually to the HPRA to defer compliance of their product labelling and packaging to the 31 December 2020 deadline. In this case, a subsequent application to vary the marketing authorisation to change the labelling and packaging will be needed.
Before implementing the proposed steps indicated above, 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. Furthermore, the HPRA would welcome any comment on logistical issues or any potential consequences that need to be considered to facilitate successful implementation of the required change and ensure market compliance. Please note that this consultation is limited to the practical aspects of implementing the findings of the report and is not a consultation on the decision in relation to the compliance with the criteria, which has been determined. The consultation is open until close of business on Friday 28 February 2020. Comments should be forwarded to the following email address email@example.com. Following consideration of the requested feedback, the HPRA expects to confirm the next steps for the implementation of the labelling and packaging changes by 31 March 2020.
The terms of reference of the Task Force is available here. The classification criteria for veterinary medicinal products intended for use in food-producing animals that may be exempted from the requirement for a veterinary prescription is available here. Note that the criteria given in Article 34 of Regulation (EU) 2019/6 are essentially the same as those given in Directive 2006/130/EC.