Guidance

Apply to change Marketing Authorisation Holder, Distributor or Local Representative details

Guidance for the pharmaceutical industry on how to apply to change a Marketing Authorisation Holder, Distributor, or Local Representative details on a Veterinary Medicinal Product

Introduction

In the UK, details of the marketing authorisation holder, named distributor and local representative are considered administrative.

Marketing Authorisation Holder

You need a marketing authorisation (MA) to place a veterinary medicinal product (VMP) on the market for sale and supply.

The holder of that MA must be established within the Community.

For companies this means they must be formed in accordance with the law of a member state and have their registered office, central administration, or principle place of business within the European Union (EU).

Changes to MA holder details

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

To change the name and / or address of an existing MA holder, 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 MA holder 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 - see ‘Guidance for marketing authorisation transfer – national requirements’.

Partial MA holder transfer:

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

Distributor

The holders of a Manufacturing Authorisation (ManA) or Wholesale Dealers’ Authorisation (WDA) may wholesale supply VMPs in accordance with the terms of their authorisation.

An MA holder may also 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).

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

Only a ManA holder, WDA holder or MA holder may be a named distributor on a product’s MA.

What is a named distributor

The difference between a wholesaler of VMPs and a named distributor of a VMP is that a named distributor is approved as part of the product’s MA and their name and address can appear on the product’s labels, ie. ‘distributed by …’, instead of the MA holder name and address, ie. ‘Marketing Authorisation Holder …’.

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

A named distributor, who is not the MA holder, may be based anywhere in the EU and should have a WDA granted by the member state in which the site is based, or a ManA that permits the holder to wholesale supply.

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

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.

New MAs

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 MA holder is the distributor. In this case, we will state ‘Same as MAH’ on the memorandum document, which forms part of the authorisation documentation.

Additions / Deletions / Changes to named distributor details

In the UK, changing distributor details is a Type IB variation (category A.z) dealt with on 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 Marketing Authorisation Holder (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 Representative

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

The details of a local representative should appear on the labels if the MA holder or named distributor is based outside of the UK. 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 on the memorandum document, which forms part of the authorisation documentation.

New MAs

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.

Additions / Deletions / 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.

How to apply

Details about how to apply for a variation can be found here Apply to change a marketing authorisation for an animal medicine.

Additional information about applying to make an administrative change is provided below.

Local representative

This change is dealt with as a Type IA variation (category C.II.6(a)). It will be dealt with on a national basis if the product(s) involved is nationally authorised, or on an EU basis if the product(s) involved is mutually recognised.

For mutually recognised products, the variation only needs to be submitted to the RMS and CMS(s) affected by the change.

When submitting this type of variation you should provide all the information detailed in the application form.

Name and / or address of existing MA holder

This change is dealt with as a Type IA variation (category A.1). It will be dealt with on a national basis if the product(s) involved is nationally authorised, or on an EU basis if the product(s) involved is mutually recognised.

For mutually recognised products, the variation only needs to be submitted to the RMS and CMS(s) affected by the change.

When submitting this type of variation you should provide all the information detailed in the application form.

In the UK, variations to change the legal entity of a MA holder, or to add / delete / change distributor details, are Type IB variations dealt with on a national basis regardless of the scope of the MA.

You should complete the application form as follows:

  • tick the relevant variation category (Administrative changes – A.z (Type IB)
  • include a clear, concise description of the variation under scope of change in the present and proposed sections

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 MA holder
  • 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

Change in MA holder details (same legal entity) and local representative details will be progressed on a normal Type IA timetable.

Change in legal entity and distributor variations will be dealt with on an administrative timetable as shown below:

Period  
Validation Validated within 10 days of receipt
Initial Assessment Approved (including issue of authorisation documentation), or refused within 30 / 60 days of passing validation

A 30 day timetable applies for applications involving 9 changes or less. A 60 day timetable applies for applications involving more than 9 changes.

Products included in grouped applications, involving administrative changes only, do not need to be related.

Grouping changes

Variations dealt with on a national basis can be grouped together in the same application, eg. a change in legal entity of MA holder can be grouped with a change in 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 MA holder (same legal entity) for a mutually recognised product cannot be grouped with a change in distributor.

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.

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 MA holder does not need a WDA to wholesale supply their own products, so the new company must be the named MA holder, 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 now 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 29 March 2018 + show all updates
  1. Reviewed with minor updates.
  2. Reviewed with minor ammendments
  3. First published.