For veterinary medicinal products the active substance(s) of which has/have been in ‘well-established veterinary use’ as referred to in Article 13a, with recognised efficacy and an acceptable level of safety, the following specific rules shall apply.
I gcás táirgí íocshláinte tréidliachta a raibh a substaint ghníomhach nó a substaintí gníomhacha in “úsáid tréidliachta sheanbhunaithe” dá dtagraítear in Airteagal 13a agus éifeachtúlacht dhoiciméadaithe agus leibhéal sábháilteachta inghlactha acu, is gá na nithe seo a leanas a sholáthar: