Where the interests of the Union are involved, and in particular the interests of public or animal health or of the environment related to the quality, safety or efficacy of veterinary medicinal products, the marketing authorisation holder, one or more of the competent authorities in one or more Member States or the Commission may refer its concern to the Agency for the application of the procedure laid down in Article 83.
I gcás ina mbeidh leas an Aontais i gceist, go háirithe leas an phobail nó sláinte ainmhithe nó leas an chomhshaoil maidir le cáilíocht, sábháilteacht nó éifeachtacht táirgí íocshláinte tréidliachta, féadfaidh sealbhóir an údaraithe margaíochta, ceann amháin nó níos mó de na húdaráis inniúla i mBallstát amháin nó níos mó nó an Coimisiún a imní a chur faoi bhráid na Gníomhaireachta le go gcuirfear an nós imeachta a leagtar amach in Airteagal 83 i bhfeidhm.