Explainer for the pharmaceutical industry on the ongoing implementation of the Veterinary Medicines Regulation relating to applications and authorisations for veterinary medicines.
Summary of Product Characteristics and product literature for veterinary medicines
Guidance for the veterinary pharmaceutical industry on the production and submission of the Summary of Product Characteristics (SPCs) and product literature mock-ups.
From: Contents
Print this page
This guidance applies to applications for national and mutually recognised Marketing Authorisations (MAs) and Veterinary Homeopathic Remedies (VHRs). It does not apply to Centralised applications. VHRs do not have SPCs.
Product Literature Standard
Joint labelling with Ireland
Joint labelling is the term used for a single label/leaflet that has been agreed by the UK and Ireland for use on veterinary medicines marketed in their countries.