Parallel trade and distribution

Parallel import refers to the importation of a veterinary medicine into Ireland from an EU Member State by a distributor that is independent of the marketing authorisation holder. The product shares a ‘common origin’ with a veterinary medicine already authorised nationally by the HPRA. The importer involved is a wholesale distributor, distinct from the importer designated by the marketing authorisation holder for the original product on the Irish market. The HPRA evaluates the application to ensure its similarity to the already marketed product and that the labelling and package leaflet comply with the national requirements. Upon approval by the HPRA, the parallel traded product becomes eligible for distribution within Ireland.

If a parallel importer identifies a quality defect when handing the medicine in the distribution chain, the parallel importer must report this to the HPRA. Should the parallel distributor receive a notification of an adverse drug reaction from a vet, health care professional or other user, the parallel importer should inform the notifier that the reaction should be reported directly to the marketing authorisation holder of the medicinal product. The parallel importer should do the same immediately. 

To identify a parallel import product’s authorisation, look for the letters 'PVPA' preceding the authorisation number on the package leaflet of the medicine. For more details on licensing parallel traded products, refer to the HPRA Guide to parallel trade for veterinary medicines. You can find the application form for download as well. 

Please note that the HPRA cannot evaluate or address trademark or copyright issues associated with parallel importation. For information on these matters refer to guidance provided by the European Commission, which is available here.  

Parallel distribution refers to the independent importation of veterinary medicines that have been centrally authorised by the European Commission.  Centrally authorised medicines have a Community Marketing Authorisation and are marketed in all Member States under the same name. In this case, the parallel distributor must notify the European Medicines Agency. Visit the EMA website for more information.