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

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 antiā€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 (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  parallelā€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  Ms.  Breda  Meehan, DAFM, Backweston  Campus,  Young’s  Cross,  Celbridge,  Co.  Kildare  or  by  telephone on  01  505  3319.