Marketing Authorisation Holders, Named Distributors and Local Representatives of veterinary medicines

The term Marketing Authorisation Holder includes holders of Veterinary Homeopathic Registrations (VHR) and veterinary medicines include veterinary homeopathic remedies.

A veterinary medicine may not be placed on the UK market unless it is subject of a Marketing Authorisation (MA) valid in the UK. The applicant will need to demonstrate that it can meet the obligations of a Marketing Authorisation Holder (MAH) during the application process and before an MA is granted.

The MAH can be a natural person, limited company, or other body such as a partnership or charity.

The holder of the MA is responsible for the marketing of the product. The designation of a representative, such as a named distributor or local representative, does not relieve the MAH of their legal responsibility.

For Centralised MAs or for mutually recognised MAs (in NI), the MAH must be located in NI or the EU for these products to be on the NI market.

For national MAs in GB, the MAH must be located in either the UK or a country which the VMD has determined to have equivalent regulatory standards to the UK. This currently includes countries within the European Economic Area (EEA), given the similarity between the two regulatory regimes. The UK will consider the equivalence of the regulatory standards of other countries on a case-by-case basis.

When applying to be an MAH for the first time, as part of your MA application you must provide:

An MAH will be given a unique 5-digit company number, which forms the first part of a product’s authorisation number. The authorisation number will be preceded with a Vm for veterinary medicines or Vh for registered veterinary homoeopathic remedies and will appear on the product’s labels.

Company numbers are issued by the Medicines and Healthcare products Regulatory Agency (MHRA), who keep and maintain the register of company numbers for MAHs of human and veterinary medicines.