Packaging changes to authorised veterinary medicines
Under national legislation veterinary medicines may not be advertised or promoted in contravention of its marketing authorisation. Changes introduced to the labelling or package leaflet of an already authorised veterinary medicine must be made in a timely way and users must be educated to the changes.
Stringent national legislation applies to the labelling of veterinary medicines authorised by the HPRA. Veterinary medicines are to be supplied only in accordance with the marketing authorisation issued by the agency. The objective of the legislation is to ensure public confidence in the quality, safety and efficacy of the medicine as well as in the safety of any food produce taken from treated animals.
Under ideal conditions, changes to the indications, contraindications, warnings, shelf-life or other parameters would be introduced immediately to new products and any existing medicines would be replaced by new stock. However, this is not economically viable or practical in all cases and is unnecessary in those cases where a more favourable warning or new indication for use is authorised.
The agency has therefore provided the below guidance (information and timelines) under which changes to the product literature must be implemented in Ireland.
Guide to implementation of packaging changes to authorised veterinary medicinal products