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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.
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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.
Joint labelling for veterinary medicines for use in the UK and Ireland
Guidance for the veterinary pharmaceutical industry on how to apply for and maintain a joint-label for use on veterinary medicines placed on the market in the UK and Ireland.
From:
Eligible Marketing Authorisations and criteria
Joint-labelling allows for a single label/leaflet that has been agreed by the VMD, on behalf of the UK, and the Health Products Regulatory Authority (
HPRA), on behalf of Ireland, for use on veterinary medicines marketed in their countries.
Joint labelling could be achieved between GB and IE, NI and IE or all three - GB, IE and NI. You should also refer to the