Guidance

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

Guidance for the pharmaceutical industry on who can be a Marketing Authorisation Holder, named distributor, or local representative of veterinary medicines.

Note:

  • this guidance does not apply to centrally authorised products
  • the term Marketing Authorisation Holder includes holders of veterinary homeopathic registrations
  • the term veterinary medicinal product includes veterinary homeopathic remedies

Marketing Authorisation Holders (MAHs)

What is a Marketing Authorisation Holder

A veterinary medicinal product may not be placed on the UK market unless it is subject of a valid marketing authorisation (MA) in the UK.

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

An applicant will need to demonstrate that it can meet the obligations of an MAH during the application process and before an MA is granted.

Who can be a Marketing Authorisation Holder

An MAH must be established in the EU and can be a natural person, limited company, or other body, e.g. partnership, charity etc.

What does ‘established’ mean

The MAH must have a registered office in the EU.

Proof of establishment

Proposed MAHs must provide the following information when applying to be an MAH for the first time.

Failure to provide the necessary information may result in your application being failed at validation.

Person

A person wishing to be an MAH must be an EU resident and provide proof of residency when applying for a marketing authorisation.

Limited Company

A limited company must be registered with Companies’ House (or EU equivalent) and must have a physical address; PO Boxes are not acceptable.

The company personnel (Director, Secretary, etc) don’t have to be based at the registered office and could reside elsewhere including overseas.

Other bodies

Charities wishing to be an MAH must provide proof that they are a registered charity with an EU address. We will accept a letter on company headed paper showing the address and registered charity number (or EU equivalent) as proof of establishment.

Partnerships and other bodies wishing to become MAHs must have a registered office in the EU.

Other Government Departments (OGDs) may be MAHs and will need to demonstrate that they can meet the obligations of an MAH during the application process.

Company Numbers

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 / or veterinary medicines.

Changes to MAH details

The MAH of a VMP can change. The changes may affect the name and / or address of the existing MAH holder (same legal entity), or include a transfer of MAH holder from one company to another (different legal entity).

To change the name and / or address of an existing MAH you will need to submit a Type IA variation (category A.1). For mutually recognised products, 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 Type IB variation (category A.z) 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.

The procedure for making this change can differ between member states. Guidance on how each member state deals with this type of change is available on the HMA website under Guidance for marketing authorisation transfer – national requirements.

Partial MAH transfer:

Following initial authorisation of a mutually recognised product, 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.

Distributors

What is a distributor

A distributor may supply veterinary medicines wholesale, or be in possession of them for that purpose.

A distributor may only supply veterinary medicines if:

  • their authorisation relates to the product, and
  • the supply is to another person who is entitled to supply that product either wholesale or retail

Who can be a distributor

Only the following can be a distributor:

  • Holder of a marketing authorisation (MA)
  • Holder of a manufacturing authorisation (ManA)
  • Holder of a wholesale dealer’s 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).

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

What is a named distributor

A named distributor is approved as part of a product’s marketing authorisation (MA), so that their name and address can appear on the labels instead of the MAH name and address, ie. ‘distributed by …’, instead of the MAH name and address, ie. ‘Marketing Authorisation Holder …’

A named distributor may also have its own livery, i.e. branding.

If a ManA or WDA is provided in support of a named distributor, the name and address on the ManA or WDA must be the same as the proposed named distributor.

An MAH must hold a WDA if they wish to wholesale supply, or be a named distributor, on another MAH’s product.

There may be more than one named distributor on an MA, but 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 livery 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. Note - if the name and address of a proposed named distributor is not provided 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 / delete / change distributors details, you will need to submit a Type IB variation (category A.z), which will be dealt with on a national basis regardless of whether the MA is mutually recognised or nationally authorised.

Whilst some member states adopt a similar approach to the UK, others deal with this change via a Type IA (C.II.6(a)) variation, which is dealt with on an EU basis for mutually recognised products.

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.

Local Representatives

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 e-mail 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. Note - if the name and address of a proposed local representative is not provided with an application for a new MA, it will be assumed that there isn’t one.

Changes to local representative details

To add or delete a local representative, or change the details of an existing local representative, you need to submit a Type IA variation (category C.II.6(a)). For mutually recognised products, the variation only needs to be submitted to the RMS and CMS(s) affected by the change.

Making Changes

You must submit a variation to make changes to a MAH, named distributor or local representative details.

  • Name and / or address of MAH (same legal entity) – Type IA (category A.1)
  • Legal entity of MAH – Type IB (category A.z)
  • Named Distributor – Type IB (category A.z)
  • Local representative – Type IA (category C.II.6(a))

Further information about how to apply for a variation can be found on Apply to change a marketing authorisation for an animal medicine.

Submission of the variation

You should complete the application form as follows:

  • tick the relevant variation category
  • include a clear, concise description of the variation under scope of change in the present and proposed sections

When submitting a change to name and / or address of MAH, or to local representative details, you must provide all the information detailed in the application form.

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

  • confirmation that no other aspect of the dossier has changed
  • evidence that a variation to replace or change an existing detailed description of the pharmacovigilance system (DDPS) 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; not applicable for companies that already hold MAs for veterinary medicines

When submitting a change of distributor variation, you must provide the following:

  • confirmation that no other aspect of the dossier has changed
  • evidence that a variation to replace or change an existing detailed description of the pharmacovigilance system (DDPS) has been submitted, or an explanation as to why no variation is necessary
  • a copy of the Wholesale Dealer’s Authorisation (WDA) or Manufacturing Authorisation (ManA)

Timetable

Details about timetables can be found on Apply to change a marketing authorisation for an animal medicine.

Grouping changes

Variations dealt with on a national basis can be grouped together in the same application, eg. a change in legal entity of MAH can be grouped with a change in named distributor.

You cannot group a change dealt with on an EU basis with a change dealt with on a national basis, eg. 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 change to the named distributor if it is changing as a result of a change to the MAH.

SPCs, QRD and Mock-Ups

You do not need to submit revised SPCs, QRD text, or mock-ups for administrative changes, or for changes to batch release site. The VMD 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 C.II.6(b) variation, 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 send a notification to the VMD.

See the SPC and Product Literature guidance page for more details.

Joint-labelled products

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.

Company mergers / take overs

The merging of companies, or the takeover of one company by another, can result in many changes to a marketing authorisation.

You will always need to submit a change of legal entity variation for each marketing authorisation affected.

You may also need to make other changes including:

  • Local representative
  • Batch release site
  • Manufacturing sites
  • DDPS

How you make / group the changes is up to you, but you need to bear in mind the following:

  • A change in legal entity will mean a new Vm number; the new number will be annotated onto the product’s mock-ups and SPC during the variation procedure
  • A change in batch release site may affect the mock-ups; however, you do not need to submit mock-ups for this change (see SPCs, QRD and Mock-Ups)
  • A change in batch release and / or manufacturing site and / or DDPS will be dealt with on an EU basis for mutually recognised products, so you cannot group these changes with change of legal entity or, distributor, which are dealt with on a national basis
  • You can have up to 12 months to implement administrative changes following approval of the variation, ie. anything QP released after the 12 month deadline must reflect the agreed changes. If you would like a 12 month implementation period you need to state this in your cover letter / email otherwise you will receive the standard 6 months
  • An MAH does not need a WDA to wholesale supply their own products, so the new company must be the named MAH, or have a WDA that covers that type of product, to be able to wholesale supply it.
  • Further information is available on the HMA website under Post marketing procedures).

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.

Fees

Once a Type IB variation has passed validation, you will be sent an invoice for the fee.

For Type IA applications, you will be sent an invoice for the fee upon receipt of the variation.

For further information about fees, see the Application fees for animal medicines guidance page.

The VMD issues all invoices electronically, so please provide a valid email address of where to send the invoice; failure to do so will result in your application being rejected.

Contact us

Email: postmaster@vmd.defra.gsi.gov.uk

For queries relating to on-going applications you should contact the relevant person stated on the email confirmation sent to you following validation of your application.

Published 19 December 2016
Last updated 23 November 2018 + show all updates
  1. Guidance reviewed & updated
  2. Reviewed with minor updates.
  3. Reviewed with minor ammendments
  4. First published.