Labelling of veterinary medicines
Regulation 2019/6 and implementation of labelling standards for veterinary medicinal products
The implementation of Regulation 2019/6 has simplified labelling requirements of veterinary medicinal products. Only essential information is now included on the outer and immediate packaging with most of the details regarding the medicine’s safety and usage moved to the package leaflet. This change aims to facilitate the use of multilingual labelling. The labelling requirements have already been applied to products that have been authorised since January 2022 and will apply to all existing products before January 2027. Marketing authorisation holders who wish to update their product labelling in line with the provisions of Regulation 2019/6 may do so by submitting an application to vary the authorisation. The relevant variation category is a VRA G.I.18: One-off alignment of the product information with version 9 (or latest version) of the QRD templates i.e. major update of the QRD templates in accordance with Regulation (EU) 2019/6, for veterinary medicinal products authorised in accordance with Directive 2001/82/EC or Regulation (EC) No 726/2004. The variation should be submitted so that it is finalised and implemented on the printed labelling and package leaflet before 29 January 2027.
Processing of labelling and package leaflet by the HPRA
The HPRA has developed a frequently asked questions (FAQ) document explaining the process for approving changes to labelling and package leaflets for both new and existing products authorised by national, mutual recognition or decentralised procedures. The processing of labelling for centrally authorised products is exclusively managed by the EMA and is not within scope of the FAQ document. However, as for nationally-authorised products, the package leaflet of centrally-authorised products should indicate the appropriate national distribution category in Ireland using one of the designated categories indicated in the HPRA’s ‘Guide to Product Literature Standards’. In case of doubt, the HPRA should be consulted.
Creation of mock-ups
The HPRA has published a Guide to Product Literature Standard (PLS) to assist applicants with the creation of mock-ups for veterinary medicinal products. The Guidance document includes a list of general labelling requirements, which will assist applicants with the layout and design of their mock-ups along with a list of national specific information to be considered for inclusion. Mock-ups should not deviate from agreed QRD texts.
Joint labelling of veterinary medicines authorised in Ireland and Northern Ireland or United Kingdom
Joint-labelling allows for a single label/leaflet that has been agreed by the HPRA, on behalf of Ireland, and the Veterinary Medicines Directorate (VMD), on behalf of the UK, to be used on veterinary medicinal products marketed in their countries. Joint-labelling can be achieved between IE and GB, IE and UK (NI), or all three – IE, GB, and UK (NI). A joint assessment procedure allows the HPRA and VMD to coordinate the approval of final colour mock-ups for veterinary medicinal products.
Applications for joint labelling can be made via a G.I.15z variation upon completion of a new Marketing Authorisation (MA) procedure or retrospectively for existing MAs.
For veterinary medicines that share a joint label with a product authorised in Northern Ireland and/or the UK, applicants are advised to consult the UK’s VMD Product Literature Standard, regarding relevant national-specific requirements of the VMD.
For further details on using this procedure, refer to the HPRA’s Guide to Joint labelling for veterinary medicinal products for use in Ireland and the UK (see below) and to the VMD’s Joint labelling for veterinary medicines for use in the UK and Ireland.