Veterinary Medicines Directorate
The term Marketing Authorisation Holder includes holders of Veterinary Homeopathic Registrations (VHR) and veterinary medicines include veterinary homeopathic remedies.
Marketing Authorisation Holders
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.
MAH location
For Centralised MAs, the MAH must be located in the EU for these products to be on the NI market.
For mutually recognised MAs (in NI), or national MAs (in GB or NI), 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.
Proof of establishment
When applying to be an MAH for the first time, as part of your MA application you must provide:
| Person | As a person wishing to be an MAH you must be a resident in GB, NI or the EU and provide proof of residency. |
|---|---|
| Limited Company | As a Limited Company you must be registered with Companies House (or EU equivalent) and must have a physical address. PO Boxes are not acceptable. The company personnel, such as Director or Secretary, do not have to be based at the registered office and can live anywhere. |
| Other bodies | As a charity you must provide proof that you are registered as such with an address in GB, NI or the EU. We will accept a letter on headed paper showing the address and registered charity number (or EU equivalent) as proof of establishment. For partnerships and other bodies, you must have a registered office in GB, NI or the EU. |
Company Numbers
An MAH will be given a unique 5-digit company number, which forms the first part of a products 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 products 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.
Changes to MAH details
Once your MA is authorised, you may wish to change the details of an MAH, such as your name and address, or transfer the MA from one company to another (change to legal entity).
To change the name and / or address of an existing MAH you will need to submit a national VRNA (Variation Not Requiring Assessment), (category A.1(a)).
Changing the legal entity of the MAH is a VRA (Variation Requiring Assessment Reduced, (category U.I.z.a) dealt with on a national basis. A change in legal entity will result in a change to the company number, which forms part of a products Vm number.
When submitting a change of legal entity variation, you must provide:
- confirmation that no other aspect of the dossier has changed
- evidence that a variation to replace or change an existing Summary of the Pharmacovigilance System Master File (PSMF) has been submitted, or an explanation as to why no variation is necessary
- formal letters of transfer from the current and proposed MAH
- proof of establishment of the company unless they already hold MAs for veterinary medicines
See Variations to MAs or VHRs and Submission of applications to an animal medicines for further guidance.
Distributors and named distributors
A distributor is authorised to be in possession of and supply veterinary medicines wholesale. They can only supply the products to which their authorisation relates and can only supply to another person who is entitled to supply that product either wholesale or retail.
You can only be a distributor if you are the holder of either:
- a marketing authorisation (MA)
- a manufacturing authorisation (ManA)
- a wholesale dealers authorisation (WDA)
An MAH may wholesale supply products for which they hold the MA without the need for a WDA; however, they must still comply with Good Distribution Practice (GDP).
Named distributor
The MAH can designate a named distributor as part of a products MA. This means that their name and address can appear on the labels instead of the MAH name and address, for example distributed by instead of Marketing Authorisation Holder A named distributor may also have its own branding.
The MAH is responsible for the marketing of the product and the designation of a representative, either named distributor or local representative, does not relieve the MAH of their legal responsibility.
If the ManA or WDA documentation is provided in support of including a named distributor, the name and address on the ManA or WDA documentation must be the same as the proposed named distributor in the application.
There can be more than one named distributor on an MA. The details of the product, including its name and Vm number, remain the same regardless of who is distributing the product. The only difference on the labels will be the name and address of the named distributor and, possibly, the package branding in which it is distributed in.
Details of named distributors will appear in an MAs memorandum document, which forms part of the authorisation documentation. If you dont provide us with the name and address of a proposed named distributor with an application for a new MA, it will be assumed that the MAH is the distributor. In this case, we will state Same as MAH on the memorandum document.
Changes to named distributor details
To add, remove or change distributor details, you will need to submit a VRA (category U.I.z.b) which will be dealt with on a national basis regardless of whether the MA is mutually recognised (where NI is a CMS) or nationally authorised in NI and GB.
If the MAH is also the distributor, and the MAH details change, you do not need to submit a separate variation to change the distributor; however, if the distributor is no longer going to be the same as the MAH, you must state this in your application.
When submitting a change of distributor variation, you must provide:
- confirmation that no other aspect of the dossier has changed
- evidence that