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, 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 can be located in GB, NI or the EU to be on the market in GB and NI.

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.

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 1 company to another (change to legal entity).

For centrally authorised MAs these variations must be submitted to the EMA and the VMD. See Submission of applications to an animal medicines for guidance.

To change the name and / or address of an existing MAH you will need to submit a VRNA (Variation Not Requiring Assessment), (category A.1a). For mutually recognised products, where NI is a CMS, the variation only needs to be submitted to the RMS and CMS(s) affected by the change.

In the UK, changing the legal entity of the MAH is a VRA (Variation Requiring Assessment – Reduced, (category U.I.z.a) dealt with on national basis regardless of whether the MA is mutually recognised or nationally authorised. A change in legal entity will result in a change to the ‘company number’, which forms part of a product’s Vm number.

Include a clear, concise description of the variation under ‘scope of change’ in the application form.

When submitting a change of legal entity variation, you must provide:

See Variations to MAs or VHRs and Submission of applications to an animal medicines for further guidance.

Guidance on how each EU member state deals with this type of change is available on the HMA website under Guidance for marketing authorisation transfer – national requirements.

Following initial authorisation of a mutually recognised product, where NI is a CMS, the MAH may change in some member states resulting in more than one MAH being responsible for the same authorisation. For further information see Guidance on post-authorisation activities after partial marketing authorisation transfer – partial MAH transfer.

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:

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).

The MAH can designate a named distributor as part of a product’s 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 it. 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 MA’s memorandum document, which forms part of the authorisation documentation. If you don’t 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.

For centrally authorised MAs these variations must be submitted to the EMA and the VMD. See Submission of applications to an animal medicines for guidance.

To add / remove / 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:

See Variations to MAs or VHRs and Submission of applications to an animal medicines for further guidance.

For centrally authorised MAs these variations must be submitted to the EMA and the VMD. See Submission of applications to an animal medicines for guidance.

Local representatives and named distributors perform different roles, although a single company may perform both roles for a specific MA.

If you intend to include the name and address of a named distributor based outside of the UK on your labels, we strongly encourage you to also include the details of a local representative. This is not a legislative requirement, but it is VMD policy and good practice to include a UK contact on the labels, so that users are able to contact someone easily to discuss any problems or concerns with the product.

The local representative may be indicated by name, telephone number and email address (optional) only. Postal address may be added space permitting. The details included on the packaging will appear in an MA’s memorandum document, which forms part of the authorisation documentation.

If local representative details are not included in an application for a new MA it will be assumed that this is not required.

To add or remove a local representative, or change the details of an existing local representative, you need to submit a VRNA (category C.10). For mutually recognised products (where NI is a CMS), the variation only needs to be submitted to the RMS and CMS(s) affected by the change.

See Variations to MAs or VHRs and Submission of applications to an animal medicines for further guidance.

The merging of companies can result in changes to the MAH details but can also include many other areas, such as batch release site, manufacturing sites, DDPS.

You will need to submit a change of legal entity variation for each MA affected and you can group changes, but you need to bear in mind:

Remember, you do not need to submit a change to the distributor if it is changing as a result of a change to the MAH.

See Variations to MAs or VHRs and Submission of applications to an animal medicines for further guidance.

Grouped variations can include more than one product or more than one change but these must be applied for on the same application form and must apply to all included products.

You cannot group a change dealt with on an EU basis with a change dealt with on a national basis, for example, a change in name of MAH (same legal entity) for a mutually recognised product cannot be grouped with a change in named distributor.

Remember, you do not need to submit a variation to change the named distributor if it is changing as a result of a change to the MAH.

You do not need to submit revised Summary of Product Characteristics, QRD text or mock-ups for administrative changes. We will annotate the agreed changes onto the latest authorised versions held on file and issue them back to you at the end of the variation procedure.

However, if you intend to make other changes to the mock-ups, you will need to submit mock-ups for assessment under a VRA G.I.15.z, or as part of a grouped variation involving the other changes.

If you are unsure if any of the other proposed changes require a variation, please email [email protected].

See the SPC and Product Literature page for more details.

If the administrative changes are country specific, you do not need to submit these variations to Ireland. We will let them know about the proposed changes and you should send them a copy of the revised labels once the variation is approved.

Details about timetables can be found on the Timetables for national applications page.

Once an application has passed validation, you will be sent an invoice for the fee by email so you must provide a valid email address in your application.

You can use the fees calculator to help you work out what the fee will be or see Application fees for animal medicines.

Once you have applied, to discuss specific application points contact the people assigned to the application given in the validation passed email.

For all other enquiries email: [email protected]