Guidance

Marketing authorisations for veterinary medicines

Guidance on applying for a marketing authorisation.

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

If your product is a veterinary medicine and does require an MA, you need to submit an application to the VMD.

The Marketing Authorisation Holder (MAH) of the product must:

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

In addition to the above, the holder of a MAPI must also:

  • be the holder, or have a contract with a holder, of a suitable UK Wholesale Dealers’ Authorisations (WDA). The WDA must be authorised to parallel import veterinary medicinal products.

  • be the holder, or have a contract with a holder, of a suitable Manufacturer’s Authorisation (ManA).

If you are unsure whether your product is considered an animal medicine, read the Legal controls on veterinary medicines page.

Some animal medicines do not need an MA, read the Exemption from authorisation for medicines for small pet animals page.

The Vm symbol

An authorised product will have an authorisation number preceded by the symbol Vm on its product literature, e.g. labels; this offers users a clear guarantee that the product has been assessed and approved in accordance with the instructions on the product literature.

A product subject to an MA issued by the European Commission (EC) will not have the Vm symbol on its product literature; instead an identifier with the following format will be used - EU/2/01/011/001.

Authorisation routes

There are four routes that can be used to get an MA:

  • National
  • Centralised
  • Mutual Recognition
  • Decentralised

These routes determine the procedures, processes and timelines used in processing an application for a new MA. Once granted, the authorisation will be nationally authorised, centrally authorised, or mutually recognised.

Nationally authorised products

A product that has been assessed and approved on a national basis only, i.e. there has been no interaction with other EU MSs.

Centrally authorised products

A centrally authorised product is one that has been assessed and approved on a community level involving all EU MSs. A pan-European authorisation is issued by the European Commission (EC) permitting the marketing, sale and supply of the product in all EU MSs including the UK.

The European Medicines Agency (EMA) organises the process of evaluation using scientific expertise from all EU MSs. If a positive opinion is given by the EMA after a product has been evaluated, it is sent to the EC. If the EC also has a favourable opinion, it makes a formal decision to authorise the product and it grants a single MA that is valid in all EU MSs. Note, whilst the EC will usually endorse a positive opinion, it has the right to reject it.

Although the VMD does not issue an MA for products authorised by the centralised procedure, the outcome is the same: the product is authorised for use in the UK.

The centralised procedure is compulsory for some products and optional for others. some products are not eligible for the centralised procedure.

Mutually recognised products

A mutually recognised product is one that has been assessed and approved on a European level involving at least two EU MSs, i.e. evaluated via the mutual recognition or decentralised procedure.

The mutual recognition procedure (MRP) is a European authorisation route resulting in a mutually recognised product.

Mutual recognition must be used when a product is already authorised in at least one EU MS on a national basis and the MAH wishes to obtain an MA for the same product in at least in one other EU MS.

The MS that has already authorised the product is known as the Reference MS (RMS). The RMS submits their evaluation of the product to the other MSs; known as a Concerned MSs (CMS). The CMS is asked to mutually recognise the MA of the RMS.

If the application is successful, the CMS will then issue an MA for that product permitting the marketing of that product in their country. Please note if the UK acts as RMS this means the product was initially authorised in the UK on a national basis; therefore, once the MRP has been successfully completed, the authorisation type of the UK MA will change from ‘National’ to ‘Mutually Recognised’.

The decentralised procedure (DCP) is a European authorisation route resulting in a mutually recognised product.

The difference between MRP and DCP is that a product must already be authorised in at least one MS on a national basis in order for MRP to be used. DCP may be used if the product is not authorised in any EU MS and a company wishes to authorise it in several or all EU MSs, but only if the centralised procedure is not mandatory, or the company does not wish to use the centralised procedure (where it is optional), or the product is not eligible for the centralised procedure.

One of the proposed MSs will be asked by the MAH to act as the RMS. The RMS does the initial evaluation of the product and issues a draft assessment report including a list of unresolved issued. The CMS either agree with the RMS’s evaluation or they ask further questions/raise objections.

If all the issues are resolved and the application is successful, each MS will then issue an MA for that product permitting it to be marketed in their country.

There are several different legal bases upon which an application for an MA may be applied for, which reflects the type and content of the data submitted in support of the application.

The data and documents required in support of an application for an MA are set out in Volumes 6a and 6b of the European Notice to Applicants and in Annex I to Directive 2001/82/EC, as amended.

This does not apply to Exceptional MAs obtained on a national basis, or Marketing Authorisations for Parallel Import (MAPI), which is a national only scheme.

Some applications for an MA will be based on a full data package where all parts of the data requirements are supported using the MAH’s proprietary data, or using bibliography, i.e. published data, or a mixture of both. These MAs are known as Full MAs.

There are some circumstances when a reduced data package may be submitted in support of a Full MA; this usually occurs:

  • for applications for an MA for Minor Use, Minor Species (MUMS)

  • when an applicant refers to one of their own already authorised UK veterinary medicines in support of an application to extend that MA. This will result in an Extension MA.

There are also some circumstances when specific data may be omitted from an application for an MA that is not considered a Full MA; this usually occurs when:

  • an applicant refers to data already submitted and assessed as part of a data package submitted in support of an application for another MA known as abridged applications; this will result in an abridged MA

  • an applicant submits a reduced data package in order to obtain an Exceptional MA

  • when an applicant refers to an already authorised UK veterinary medicine in support of an application to obtain a MAPI

Full MAs

There are a number of different ways to obtain a full MA based on the data package provided in support of the application:

  • an MA based on a full data package using the MAH’s propriety data

  • an MA based on a full data package where all parts are addressed using bibliography, i.e. published data. This is referred to as a bibliographic MA, or an MA based on well-established use. The applicant must demonstrate the active substance has been used for at least ten years in the target species for the indications applied for

  • an MA based on a full data package using a mixture of the MAH’s proprietary data and bibliography

  • an MA based on a reduced data package for Minor Use Minor Species (MUMS). Specific data may be omitted from the data package submitted in support of an application for a MUMS MA. Further information about MUMS applications is available on the EMA website

  • an MA based on a reduced data package for an Extension MA

Extension MA

An extension is a type of variation. The MAH may extend an existing MA to:

  • create a new stand-alone MA (new extension, which will be considered a full MA)
  • change an existing MA (variation extension)

Upon submission of an application you must state whether you are applying for a new extension or variation extension.

A new extension will be dealt with as a new MA application, ie. same procedures and timescales with a new MA granted at the end of the procedure.

A new-extension may be progressed via a national application procedure; or via the mutual recognition or decentralised procedures (MRP or DCP). For the extension to be considered under MRP or DCP, the parent product must already be mutually recognised, ie. authorised via MRP or DCP. The member state (MS) that acted as the reference member state (RMS) during the procedure to authorise the parent product will also act as the RMS during the procedure for the extension.

MAs based on reduced data packages

One of the most common types of abridged application is the ‘copycat’; this is an informal term used by the UK to describe an MA authorised on the basis of informed consent, which results in an MA known as a ‘copycat’.

In such cases the applicant cross-refers to specific parts of the data package for an already authorised UK veterinary medicine, which is referred to as the parent product.

For these applications, only a full Part I of the dossier needs to be submitted (including European tables of materials of human and animal origin).

Apart from the product name, the product’s authorisation number and, possibly, the MAH and pharmacovigilance systems (DDPS), all of the details of the proposed copycat are identical to the parent.

For a product to be authorised on the basis of informed consent, the MAH for the parent product must have given the VMD permission to refer to the data submitted in support of the parent product.

If the MAH of the parent product is different from the MAH of the proposed copycat, a formal letter of access from the parent MAH is required; this should be submitted as part of the application package submitted in support of the copycat. If the MAH of the parent and copycat products are the same, a formal letter of access is not required.

A copycat may be authorised via a national application procedure, or via the mutual recognition or decentralised procedures. In order for the copycat product to be considered under MRP or DCP, the parent product must already be mutually recognised, ie. authorised via MRP or DCP. The MS that acted as the RMS during the procedure to authorise the parent product will also act as the RMS during the procedure for the copycat product.

A parent MAH has a responsibility to notify a copycat holder when changes have been made to the parent MA. The parent MAH should provide the copycat holder with at least the categories used for the variation(s) (and ideally the application number). The copycat holder needs this information in order to apply for the same changes.

BioSimiliars

Where a biological product, which is similar to a reference biological product, does not meet the conditions in the definition of a generic product, owing to, in particular, differences relating to raw materials or in a manufacturing processes of the biological product and the reference biological product, the results of appropriate pre-clinical tests or clinical tests relating to these conditions must be provided.

Generics

A generic MA arises when the applicant refers to the safety and efficacy aspects of a data package submitted in support of an already authorised veterinary medicine, which is referred to as the reference product.

In addition to a full quality data package, the applicant would need to provide an environmental risk assessment for the product and a user risk assessment. The type of user risk assessment provided depends on the degree of similarity between the generic and reference products.

For generics of injectable products the submission of injection site residues data are necessary, unless a biowaiver exempts the application from the need for residues studies.

Applicants must demonstrate that the generic product is bioequivalent to the reference product, unless they are exempt from doing so under the bioequivalence guidelines. The reference product must have been authorised in accordance with the Directive for at least 10 years before the generic product can be placed on the market. For applications for generic products, which are based on reference products authorised after October 2005, the application can be submitted after eight years of authorisation, but the generic product cannot be marketed until the 10 year data protection period has expired.

In some cases the data protection period for the reference product may be extended to 13 years. For products indicated for the treatment of bees and fish the protection period of the reference product is automatically 13 years.

The SPC of the generic product should follow the SPC of the reference product.

Generics of biological products are not possible unless the Master Seed and production process are the same.

Hybrids

A hybrid MA follows the same principles as those for generic applications, but such applications are required under the following two scenarios:

  • the applicant is not able to demonstrate bioequivalence to the reference product through bioavailability studies

  • where bioequivalence can be demonstrated to the reference product, but the applicant wants to make changes, eg. in the active substance(s), or changes to the therapeutic indications, strength or pharmaceutical form or to the route of administration.

Example of a hybrid MA: The reference product is indicated for use in cats and dogs and is administered orally. The applicant wants their product to include cats and dogs, but wants an injectable product. The applicant refers to the reference product to cover some of the safety and efficacy data requirements, but produces their own data to support the change in the route of administration.

Marketing authorisations for Parallel Imports (MAPIs)

Parallel importing is when a product is bought from wholesalers in one (or more) member states (MS) and imported into another MS for distribution.

An authorisation (MAPI) granted by the VMD is needed to parallel import products into the UK.

The product to be imported must be authorised in the UK and in the MS from which it is to be imported from. Both should be authorised in accordance with Directive 2001/82/EC, as amended, and meet the criteria below.

  • For biological products; the product to be imported should be identical to the UK authorised product

  • For pharmaceutical products; the product to be imported should be identical to (for food-producing species), or therapeutically the same (for non-food producing species) to the UK authorised product.

The UK authorised product is known as the parent. The parent may be nationally authorised, or mutually recognised. The product to be imported is known as the MAPI product.

Exceptional MAs

An exceptional MA may be granted following submission of a reduced data package where specific data has been omitted.

There are 2 types of exceptional MA; provisional and limited.

You may apply for a provisional MA (PMA) when there is no fully authorised product available in the UK to prevent or treat a particular condition.

A PMA is normally granted to help address an urgent situation, e.g. as a result of a new disease. PMAs are intended to exist in the short term whilst the MA holder generates data to support a full MA.

You may apply for a limited MA (LMA) to help fill an existing therapeutic gap and where the product is not expected to be sold in vast quantities; therefore, it is unrealistic to expect MA holders to generate full data packages and incur the costs involved.

For both PMAs and LMAs, it is up to the proposed MA holder to demonstrate that the benefits of the product outweigh any risks that may arise from them not providing all the data.

Distribution categories

An authorised product will have a distribution category which relates to the retail supply of the product, eg. a product classified as Prescription Only Medicine - Veterinarian (POM-V) may only be supplied by a veterinary surgeon or a pharmacist and must be supplied in accordance with a prescription from a veterinary surgeon.

Further information about the distribution categories is in the guidance for retailers.

The distribution category of an Exceptional MA will be POM-V. It is possible to apply for a change in distribution category for PMAs from POM-V to POM-VPS once the product has been on the market for at least 12 months with a high volume of sales and the product:

  • only makes preventative claims
  • has a good record in terms of adverse events (AE) and Suspected Lack of Efficacy (SLE)

The distribution category of a MAPI product will be the same as the distribution category of the parent product.

The distribution category can also be referred to as the legal category.

Post authorisation steps

Renewals

An MA must be renewed five years following initial authorisation.

Details about how to apply for a renewal can be found on the Apply to renew a marketing authorisation for a veterinary medicine page.

Variations

If you wish to make any changes to your MA, you will need to submit a variation application to the VMD.

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

UK Public Assessment Reports (UKPARs)

For nationally authorised products, or for mutually recognised products where the UK acted as RMS, a public assessment report will be available on the Product Information Database (PID). The SPC and a post authorisation assessment (PAA) document will also be available for these products. The PAA lists all applications conducted on a product since initial authorisation.

For mutually recognised products where the UK acted as a CMS, only high level details of the product including the SPC and a PAA will be available on the PID. The public assessment report will be available from the member state that acted as the RMS for the procedure.

For centrally authorised products, only high level details of the product will be available on the PID. The SPC and public assessment report will be available on the EMA website.

Exceptional MAs

Once an Exceptional MA has been granted, it may not be mutually recognised at a later date.

UK Public Assessment Reports (UKPARs): A public assessment report will be available on the Product Information Database (PID). The SPC and a post authorisation assessment (PAA) document will also be available for these products. The PAA list all applications conducted on a product since initial authorisation.

Changes to Exceptional MAs: Exceptional MAs are subject to the same variation procedures as other types of MA. For further information about variations, click here

Renewal of Exceptional MAs: Exceptional MAs are reassessed on an annual basis. A formal renewal may be required if this is specified as a condition on the initial authorisation.

If a full MA is granted that replaces the need for the Exceptional MA, the Exceptional MA will be expired and you will be notified of this.

MAPIs

Once a MAPI has been granted, it may not be mutually recognised at a later date. UK Public Assessment Reports (UKPARs): There will be no UKPAR for MAPI products due to the lack of available data. High level product details and the SPC will be available in the Product Information Database.

Renewals and Variations: MAPI products are subject to the same renewal requirements and variation procedures as other types of MA.

If the SPC or product literature of the UK authorised product, ie. the parent product, is changed, you should submit a national unforeseen variation to bring the SPC and product literature of the MAPI product back into line with it. Further information about these variations is available on the Apply to change a marketing authorisation for a veterinary medicine page.

Batch Release of Biological Products: For biological products, you should provide copies of the labels for the MAPI product each time you submit a batch release request to the VMD. For further information about batch release.

How to apply

Details about how to apply for a new Marketing Authorisation can be found on the Apply for a Marketing Authorisation for Veterinary Medicine page.

Contact us

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

Published 5 June 2015