Importation and use of veterinary medicines under exceptional circumstances
Given the range of species and conditions that exist in veterinary medicine it is not practical to have authorised products available for each situation. EU and national legislation recognise the need for veterinary practitioners to avail of a number of tools to improve the position.
Use of medicines under the ‘cascade’ principles
National and EU legislation recognise the need for veterinary practitioners in exceptional circumstances to be able to use certain medicines off-label (i.e. not strictly in accordance with the conditions of authorisation of the medicine). This is commonly referred to as use under the ‘cascade’ provisions of the legislation, and applies exclusively to vets. The Department of Agriculture, Food & the Marine (DAFM) is the competent authority for giving advice on the use of the cascade provision, including the importation of veterinary medicines from another country where there is no suitable medicine authorised in Ireland (the so-called AR 16 and AR 18 licensing procedures).
Such licences may be granted by the DAFM when there is a particular health situation (e.g. an outbreak of an infectious disease that normally does not occur in Ireland) or where no authorised veterinary medicinal product is available in this country but one is available in another Member State of the European Union.
Supply and use of human medicines in veterinary practice
Veterinary practitioners are entitled to use human medicines under the terms of Article 10 of the Directive 2001/82/EC (the ‘cascade’ principle) and under Regulation 18 (2) of the European Communities (Animal Remedies)(No2) Regulations, 2007 (S.I. No. 786 of 2007).
As the HPRA understands the position, the supply of human medicines from a wholesaler is covered by the Medicinal Products (content of wholesale distribution) Regulations, 2007 (S.I. No. 538 of 2007) as subsequently amended. These regulations define the ‘sale by wholesaler’ as meaning ‘the sale or supply for the purposes of sale in the course of a business or for the administration to patients in the course of a professional practice’. The HPRA interprets ‘professional practice’ as including professional practice by a registered veterinary practitioner; it is understood that veterinary practitioners have an ethical, professional obligation to relieve and prevent animal suffering. The HPRA has advised that human medicines which might include poison antidotes, large volume parenterals, certain anti‐cancer drugs as well as certain medicines used as supportive or adjunct therapy for cardiovascular and other disease in animals can be supplied to veterinary practitioners in situations where there is no authorised veterinary alternative available.
The HPRA further understands that veterinary practitioners ordering human medicines from a human medicines wholesaler should not write a prescription (which should only be filled by a pharmacy shop currently) but that the records should be kept e.g. in the veterinary practitioner’s order book. It is suggested that veterinary practitioners making such orders could confirm in his/her order that the medicines sought were for use in animals under their care in accordance with the cascade and that the use was in accordance with his/her professional practice.
Responsibility for exceptional licensing procedures rests with the DAFM and queries on the application requirements should be directed to them (email@example.com or Lo-call 1890 200 510).
Importation of veterinary medicines for which an equivalent product is already authorised
It is legally possible for a company to import a veterinary medicine that is already authorised in Ireland but is available more cheaply in another EU Member State. This procedure is governed by regulations and requires the applicant to seek authorisation from the HPRA under the so-called ‘parallel veterinary product authorisation procedure’.
There are a number of conditions which attach to such applications, including that the parallel‐distributed product must be the same as that already authorised in Ireland and that the labelling and package insert of the product are based on those approved by us for the existing product. The repackaging must be carried out in a manufacturing facility which has a veterinary manufacturing licence in accordance with Good Manufacturing Practice (GMP). An application fee applies. The product will be allocated a parallel veterinary product authorisation number. For further details please click here.
The appropriate forms are available on the Department’s website. Any further queries should be directed to firstname.lastname@example.org or by telephone on 01 615 7100.