FAQs on processing the labelling and package leaflet for veterinary medicinal products
Starting in January 2022, EU legislation has simplified the labelling of veterinary medicines. Only essential information will remain on the label, and most details regarding the medicine’s safety and usage will be moved to the package leaflet. This change aims to facilitate multilingual labelling and enable more economic batch sizes. Before using veterinary medicines, users should consult the package leaflet. The labelling requirements already apply to products that have been authorised since January 2022 and will apply to all existing products before January 2027.
Despite the changes resulting from EU legislation, labelling for veterinary medicines may undergo periodic modification as a result of:
- Changes to requirements mandated by national and EU legislation, such as the use of pictograms,
- Updates to warnings and instructions required by the European Medicines Agency, particularly regarding antibiotics,
- Updates proposed by the marketing authorisation holder for specific products.
Below, you will find information and guidance on the requirements.
Processing labelling and package leaflet changes by the HPRA
The HPRA has published a Guide to Product Literature Standard (PLS) to assist applicant companies in developing and designing labelling of veterinary medicines that comply with the requirements, including national requirements and labelling mock-ups. Additionally, the HPRA has released a frequently asked questions (FAQ) document explaining the process for approving changes to package labelling and package leaflets for both new and existing products. However, please note centralised products are exclusively managed by the EMA are fall outside the scope of the FAQ document.
Joint labelling of veterinary medicines authorised in Ireland and Northern Ireland or United Kingdom
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 Veterinary Medicines Directorate (VMD) Product Literature Standard, regarding relevant national-specific requirements of the VMD. The procedure involves coordinating the approval of final colour mock-ups for veterinary medicines veterinary medicines between Ireland and the UK. It allows marketing authorisation holders to create a single set of mock-ups for both regions, whether between Ireland and Northern Ireland, Ireland and Great Britain or all three (Ireland, Northern Ireland and Great Britain). Application for joint labelling can be made upon completion of a new Marketing Authorisation (MA) procedure or retrospectively for existing MAs.
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 and to the VMD’s Joint labelling for veterinary medicines for use in the UK and Ireland.
Update June 2023
Recognising the challenges arising from the UK’s withdrawal from the EU and the subsequent application of EU legislation in Ireland since January 2022, the HPRA and the VMD have reached a compromise position during the ongoing review of UK legislation. This position will allow the inclusion of additional labelling and package leaflet texts specific to Great Britain on the mock-ups of joint labelled veterinary medicines. This ensures the continued availability of the medicines concerned in both Ireland and the UK.
For more information on this matter, consult the Joint HPRA/VMD Guide to Acceptable Texts for Joint Labelling for Veterinary Medicinal Products for use in Ireland and the UK.