Labelling procedure

FAQs on processing the labelling and package leaflet for veterinary medicinal products

FAQ document published by the HPRA answers questions about how the Veterinary Sciences Department will handle and process the package labelling (immediate and outer) and package leaflet for new marketing authorisation (MA) applications and variation applications to currently authorised MAs. It applies to the national phase of all procedure types and includes Mutual Recognition Procedures (MRP), Decentralised Procedures (DCP) and Subsequent Recognition Procedures (SRP) as well as variations. The processing of labelling for Centralised Procedures are outside the scope of the FAQ document as they are exclusively managed by the EMA. The document answers questions in relation to when text versions or actual mock-ups of the package labelling and package leaflet are required.

Product literature standard

The HPRA Guide to Product Literature Standard (PLS) for Veterinary Medicinal Products is a guide for applicants to assist in the creation of mock-ups for regulatory approval.

Mock-ups submitted for regulatory approval should not deviate from the agreed QRD text. The Product Literature Standard includes a list of general labelling requirements, giving guidance on the layout and design of mock-ups and an additional list of national HPRA information to be considered for inclusion.

For joint labels, applicants are also advised to consult the Product Literature Standard as published by the Veterinary Medicines Directorate (VMD), which may include relevant national-specific requirements of the VMD.

Joint labelling

The joint labelling procedure involves the coordination of approval of final colour mock-ups for veterinary medicines between Ireland and the UK. The procedure enables marketing authorisation holders to create one set of mock-ups for both countries and can be achieved between IE and UK (NI), IE and GB or all three – IE, UK (NI) and GB.

An application for joint labelling can be made either at the end of a new Marketing Authorisation (MA) procedure or retrospectively for existing MAs, whether authorised by EU or national procedures. To obtain joint labelling, the Summary of Product Characteristics (SPC) and product labelling texts must be identical in the relevant territories. To maintain joint labelling, the product information must remain harmonised.

Further information about the use of the procedure is available in the HPRA Guide to Joint labelling for veterinary medicinal products for use in Ireland and the UK and in the VMD’s Joint labelling for veterinary medicines for use in the UK and Ireland