Exceptional authorisation of veterinary medicines

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

According to articles 112, 113 and 114 of European Regulation 2019/6 (the so-called ‘cascade’ provisions), when a suitable veterinary medicinal product is not available in this country, veterinary practitioners are entitled to use certain human medicines under particular circumstances. To access these medicines, veterinary practitioners may source them 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 applicable national legislation. The definition of ‘supply by wholesale’ detailed in regulation 4(1) of the Medicinal Products (Prescription and Control of Supply) Regulations 2003, as amended. It states that

‘supply by wholesale’ means the supply of a medicinal product to a person who obtains the product for one or more of the following purposes:

(a) supply in the course of a pharmaceutical business,

(b) administration in the course of a professional practice, or

(c) 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 with the ‘cascade’ provision in Regulation 2019/6, human medicines that are either authorised centrally (following the recommendation of the European Medicines Agency), or which are authorised in Ireland or in another EU Member State as a medicinal product for humans, can exceptionally be supplied  to  veterinary  practitioners  in  situations  where  there  is  not an authorised veterinary alternative available. 

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 special conditions for specific or compassionate use for human therapy but which do not have marketing authorisations, human medicinal products that are authorised in the UK but are not authorised in Ireland etc.). 

The HPRA understands that veterinary practitioners who wish to order human medicines from a human medicines wholesaler in Ireland should not write a prescription (which should only be filled by a retail pharmacy) 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 should confirm in his/her order 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 rests with the DAFM and queries on the application requirements should be directed to them (info@agriculture.gov.ie 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 veterinarymedicineswmc@agriculture.gov.ie or  by  telephone on  01 615 7100.