Anti Parasitic Veterinary Medicinal Products - change in route of supply

From January 2022 antiparasitic veterinary medicinal products (VMPs) will change their route of supply to 'Prescription Only Medicine.

Historical position on the derogation from requiring a veterinary prescription for antiparasitics

By way of background to the current situation, in 2004 European legislation established a requirement that all veterinary medicinal products (VMPs) 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 VMPs which did not or where not known at that time to 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 this exemption in Directive 2006/130/EC at the time and antiparasitics were allowed to continue to be available without prescription.

What has led to the position that the supply of antiparasitics must require a veterinary prescription from January 2022?

In recent years, our knowledge regarding the impact of extensive use of antiparasitics has changed. 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 website

This 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. Therefore, antiparasitic veterinary medicines must require a veterinary prescription before they can be dispensed from January 2022. Ireland has no national discretion on this issue.

Who will be permitted to dispense antiparasitics from January 2022?

In accordance with existing national legislation, antiparasitic VMPs for use in food-producing species that are required to be supplied under prescription from January 2022 may be dispensed by veterinary practitioners, pharmacists, co-op stores and licensed merchants. This means that all current stakeholders that are already permitted to supply such products will be entitled to continue to supply them but from January 2022 onwards a veterinary prescription will be needed to dispense them. A Responsible Person, employed within an agri business such as a Licensed Merchant, can not prescribe VMPs but they can supply them.

What about the derogation in Regulation 2019/6 which permits ‘Suitably Qualified Persons’ in Northern Ireland to prescribe antiparasitics?

Article 105(4) of EU Regulation 2019/6 it states that "a Member State may allow a veterinary prescription to be issued by a professional, other than a veterinarian, who is qualified to do so in accordance with applicable national law at the time of entry into force of this Regulation." This

Regulation entered into force in January 2019 and at that time Ireland's national legislation did not allow for a veterinary prescription to be issued by anyone, other than a veterinarian. Therefore, Ireland has no national discretion to now provide for a regime which would permit Responsible Persons in Licensed Merchants or pharmacists to dispense antiparasitic veterinary medicines without a veterinary prescription issued by a veterinarian.

Has the Department engaged with the EU Commission in an effort to recognise Responsible Persons and pharmacists in Ireland as professionals who can issue veterinary prescriptions?

The Department’s Chief Veterinary Officer (CVO) wrote to the Commission on 18 June highlighting the important and historic role played by Responsible Persons in Licenced Merchants (LM) and pharmacists in supplying antiparasitics within the Republic of Ireland. The letter outlined the expertise available in LMs and pharmacies throughout rural Ireland and sought a view from the Commission as to whether these professions could be considered in the context of Article 105(4) of the Regulation. DAFM received a response from the Commission on 7 September reiterating the position that "a Member State may allow a veterinary prescription to be issued by a professional, other than a veterinarian, who is qualified to do so in accordance with applicable national law at the time of entry into force of this Regulation." In Ireland, only veterinary practitioners have ever been permitted to issue veterinary prescriptions and therefore LMs and pharmacies will require the receipt of a veterinary prescription before they can dispense antiparasitics from January 2022.

What is the Department doing to address the challenges posed by the mandatory change in route of supply of antiparasitics from January 2022?

In recognition of the challenges posed to numerous stakeholders by changing the route of supply to 'Prescription Only Medicine' for these products, this Department has established an Antiparasitic Resistance Stakeholder Group chaired by the Department’s Chief Veterinary Officer (CVO). Licenced Merchants, pharmacists and Co-Op organisations are all represented on this Group. Two meetings have been held to date and a programme of work containing over 30 antiparasitic related projects is currently underway. Risk analyses of various elements of the issues are addressed within this work programme. This group will examine all the issues related to the changed route of supply with two principal objectives

o Protecting the efficacy of antiparasitics which are critical to the Irish pasture-based production model.

o Establishing a regulatory system that is pragmatic, retains a substantive role for existing stakeholders and delivers value for money for farmers.

A 5-week Public Consultation process on the Regulations, hosted this Department, closed in late July with in excess of 100 submissions received. All submissions are being analysed by DAFM officials and considered in the context of the implementation of the Regulation.

This Department is fully committed to working with all stakeholders in considering how best to implement the new EU Regulations on veterinary medicinal products.

How can interested parties engage with DAFM on the Regulations and the changed route of supply for antiparasitics?

There is a dedicated email address allowing communications on the new Regulations: vetmedregs@agricuIture.gov.ie.