Packaging changes to authorised veterinary medicines
Stringent legislation applies to the labelling and package leaflets of veterinary medicines authorised by the HPRA. Veterinary medicines can be supplied only in accordance with the terms of the marketing authorisation, as specified in the Summary of Product Characteristics (SPC). These terms are communicated to the user primarily be means of the package leaflet and labelling of the products concerned. It is an offence to market a medicine that is not compliant with the SPC.
Where changes are made to the SPC, the product information (the package leaflet and the labelling) must be updated as soon as possible afterwards.
Under ideal conditions, changes to the indications, contraindications, warnings, shelf-life or other parameters would be introduced immediately to new batches 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. Moreover, in many cases, the HPRA will also require a marketing authorisation holder to alert users to the changes, and we may ourselves issue a safety advisory notice.
Guidance on the implementation of packaging changes in Ireland is available here: Guide to implementation of packaging changes to authorised veterinary medicinal products.