Exceptional authorisation of veterinary medicines
Importation and use of veterinary medicines under exceptional circumstances
In the field of veterinary medicine, the diversity of species and conditions makes it impractical to have authorised products available for each situation. Both EU and national legislation recognise the need to provide veterinary practitioners with tools to address the issue effectively.
Using medicines under the ‘Cascade’ principles
National and EU laws recognise that in exceptional situations, veterinary practitioners may need to use certain medicines off-label, which means not strictly in accordance with the medicine’s authorised conditions). This practice is commonly known as use under the ‘cascade’ provisions and applies exclusively to vets. The Department of Agriculture, Food & the Marine (DAFM) is the competent authority for providing advice on the cascade provision, including importation of veterinary medicines from another country where there is no suitable medicine authorised in Ireland.
The DAFM may grant these licences when a specific health situation arises, such as 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 EU Member State. (the so-called ‘cascade’ provisions).
Supply and use of human medicines in veterinary practice
Regulation 2019/6 allows veterinary practitioners to use certain human medicines when a suitable veterinary medicinal product is not available in Ireland. Veterinary practitioners can obtain these medicines from a retail pharmacy in Ireland, or from an Irish wholesaler authorised to supply human medicines.
Irish wholesalers of human medicines are permitted to supply human medicines to veterinary practitioners in accordance with the national legislation. The term ‘supply by wholesale’ is defined in regulation 4(1) of the Medicinal Products (Prescription and Control of Supply) Regulations 2003 covers the supply of medicinal products for various purposes, including:
- supply in the course of a pharmaceutical business,
- administration in the course of a professional practice, or
- for or in connection with a service provided by a hospital.
The HPRA interprets ‘professional practice’ as including professional practice by a registered veterinary practitioner; veterinary practitioners have an ethical and professional responsibility to treat animals in order to relieve or prevent animal suffering.
In accordance Regulation 2019/6, human medicines that are centrally authorised (following the European Medicines Agency’s recommendation), or authorised in Ireland or in another EU Member State as a human medicinal product, can exceptionally be supplied to veterinary practitioners when there is no authorised veterinary alternative available.
It is important to note that the ‘cascade’ provisions in Regulation 2019/6 do not entitle veterinary practitioners to access or use human medicines which have been supplied into Ireland without a marketing authorisation (e.g. human medicines that are imported under for specific or compassionate use for human therapy but which do not have marketing authorisations, or human medicinal products that are authorised in the UK but are not authorised in Ireland).
When veterinary practitioners order human medicines from an Irish human medicines wholesaler they should refrain from writing a prescription (which should only be filled by a retail pharmacy or licensed veterinary retailer). Instead, they should maintain records in the veterinary practitioner’s order book, specifying that the medicines sought are for use in animals under their care and in accordance with his/her professional practice.
Responsibility for exceptional licensing procedures
The DAFM is responsible for exceptional licensing procedures. For queries on the application requirements contact them at info@agriculture.gov.ie or Lo-call 1890 200 510.
Importation of veterinary medicines for which an equivalent product is already authorised
Companies have a legal option 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 applicants to seek authorisation from the HPRA under the ‘parallel veterinary product authorisation procedure’
Several conditions apply to such applications, including that the parallel-distributed product is identical to the one already authorised in Ireland and that its labelling and package leaflet are based on those in existence already. Repackaging must take place only in a manufacturing facility that has a veterinary manufacturing licence in accordance with Good Manufacturing Practice (GMP). An application fee is applicable and the product will be assigned a parallel veterinary product authorisation number. For more details, please visit our Parallel import and distribution page.