Dáil Éireann Debate, Wednesday - 13 May 2020
943. Deputy Carol Nolan asked the Minister for Agriculture, Food and the Marine the way in which veterinary medicinal products and medicated feed regulations adopted by the European Council on 26 November 2018 and due to come into effect from 28 January 2022 will impact on the points of sale of dosing products for animals and the points of sale to obtain such products by farmers; and if he will make a statement on the matter. [5246/20]
View answerEU Regulation 2019/6 on veterinary medicinal products comes into effect in January 2022. This Regulation is binding in full and has direct effect on all Member States. There is limited national discretion available to Member States in relation to a number of the Regulations articles.
In 2004, European legislation established a requirement that all veterinary medicinal products that are intended for use in food-producing animals should be subject to a veterinary prescription. However, a 2006 EU Directive allowed for the maintenance of non-prescription status for certain veterinary medicinal products which did not present a risk to human or animal health or to the environment, and which met the specified criteria for exemption from veterinary prescription. Ireland availed of the exemption in Directive 2006/130/EC at the time and anthelmintics were allowed to continue to be available without prescription.
There is a similar exemption available under the new EU Regulation 2019/6. However, since that time our knowledge regarding the impact of extensive use of anthelmintics has changed. For example, anthelmintic resistance has been widely reported in parasites of livestock species in Ireland and globally, resistance is developing year-on-year and is now a significant animal health issue.
In 2019, the Health Product Regulatory Authority’s (HPRA) 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 Regulation 2019/6. A copy of the Report is available on the HPRA’s website www.hpra.ie.
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 EU Regulation 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. Ireland and all other Member States must now comply with this regulation from January 2022.
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 are already permitted to supply such products will be entitled to continue to stock them in the future (but from January 2022 onwards a veterinary prescription will be needed to dispense them).
My Department is committed to working with all stakeholders in considering how best to implement the new EUI Regulations on veterinary medicinal products and plan to have a public consultation in Q2 2020. A dedicated email address has been set up for this purpose and I would encourage all interested parties to send their observations to vetmedregs@agriculture.gov.ie.
These changes which will take place will do so from January 2022 and, as such, are not related to or impacted by the current COVID-19 pandemic.
