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Detailed guide: Marketing authorisations for veterinary medicines

Veterinary Medicines Directorate

January 4
08:52 2021

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

However, some animal medicines do not need an MA and some products are not considered animal medicines. For more information see Exemption from authorisation for medicines for small pet animals and Legal controls on veterinary medicines.

If your product does require an MA you will need to apply to the VMD.

To be a Marketing Authorisation Holder (MAH) you must meet the criteria set out in Marketing Authorisation Holders, Named Distributors, and Local Representatives of veterinary medicines.

Product types

Products are classed as either pharmaceutical or biological.

Biological products contain active substances produced or extracted from a biological source which needs, for its characterisation and determination of quality, a combination of physiochemical-biological testing together with the production process and its control.

The following are categorised as biological veterinary medicines:

  • immunological veterinary medicine administered to animals to produce active or passive immunity, diagnose the state of immunity to desensitise against allergens, or produce an affect based on interaction of antigens with specific antibodies
  • veterinary medicines derived from blood and plasma
  • veterinary medicines falling within the scope of Part A of the Annex to Regulation No. 2309/93

Authorisation routes

There are 5 routes that can be used to get an MA in the UK, or part of:

  • GB MA - National
  • NI MA National
  • Centralised European procedure which will include NI
  • Mutual Recognition European procedure with NI as concerned member state
  • Decentralised European procedure with NI as concerned member state

These routes determine the regulation, procedures, processes and timelines used in processing an application for a new MA. Once granted, the authorisation will only be valid in the territories applied for and will be subject to applicable regulation.

For pan-UK market coverage for national only applications you can submit your application in parallel.

For pan-UK market coverage in conjunction with EU procedures you can apply for a GB MA either in advance of submitting your application to the EU, in parallel with or following the completion of your EU application.

GB MA - national

A product with a GB MA has been approved for marketing in England, Wales and Scotland. These applications will be assessed against the requirements set out within the Veterinary Medicines Regulation 2013, as amended.

NI MA - national

A product with an NI MA has been approved for marketing in Northern Ireland. These applications will be assessed against the requirements set out within the EU Regulation.

Centrally authorised products

A centrally authorised product is one that has been approved by the EC for marketing in all EU member states, including Northern Ireland.

The centralised EU 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 approved by the EU for marketing in 2 or more EU member states. The mutual recognition EU procedure must be used when a product is already authorised in an EU member state on a national basis and the MAH wishes to obtain an MA for the same product in other EU member states.

The member state that has already authorised the product is known as the Reference Member State (RMS). The RMS submits their evaluation of the product to the other member states, known as Concerned Member States (CMS), and asks to have that MA mutually recognised.

If the application is successful, the CMS National Competent Authority will issue an MA valid in their country.

Please note that Northern Ireland cannot act as RMS and products must be first authorised in an EU member state.

Decentralised

The decentralised procedure (DCP) is a European authorisation route resulting in a mutually recognised product.The difference between MRP and DCP is:

  • for MRP, a product must already be authorised in a member state on a national basis
  • for DCP, the product is not authorised in any member state and you wish to authorise it in several or all EU member states simultaneously - but only if the centralised procedure is not mandatory, or you do not wish to use the centralised procedure (where it is optional), or the product is not eligible for the centralised procedure

You will need to ask one of the proposed member states 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 RMSs evaluation or they ask further questions/raise objections.

If all the issues are resolved and the application is successful, each member states National Competent Authority issues an MA valid in their country. Please note that Northern Ireland cannot act as RMS.

There are several legal bases upon which you can apply for an MA which reflect the type and content of the data required in support of an application.

Article references refer to Directive 2001/82/EC, as amended by 2004/28/EC.

Full - Article 12(3) Based on a full dossier using your own data or a mixture of your own data and some bibliography
Generic - Article 13(1) Referring to data of an already authorised product. Reference product authorisation requirements are given below.
Generic hybrids - Article 13(3) Combination of referring to data of an already authorised product and your own data to support differences. Reference product authorisation requirements are given below.
Biosimilars - Article 13(4) Combination of referring to data of an already authorised product and your own data to support differences, such as raw materials. Reference product authorisation requirements are given below.
Bibliographic - Article 13(a) Also known as well-established use. Based on referring to published data
Fixed combination - Article 13(b) Based on active substances already used in an authorised product but not previously used in that combination. Reference product authorisation requirements are given below.
Informed consent - Article 13(c) Also known as copycat. Combination of referring to data of an already authorised product and your own data. Reference product authorisation requirements are given below.
Extension To create a new stand-alone MA from your existing MA. Reference product authorisation requirements are given below.
Exceptional MAs Based on provisional or limited data. The data and documents required in support of these applications are provided [here].
Marketing Authorisation for Parallel Import (MAPI) The data and documents required in support these applications are provided in the

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