Veterinary Medicines Directorate
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 refer to 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.
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. These are only possible if same product is not already authorised or under assessment in an EU Member State
- 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.
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 and / or Northern Ireland.
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:
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for MRP, a product must already be authorised in a member state on a national basis
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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.
Legal bases
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.
References refer to the VMRs 2013 (Schedule 1).
| Section of VMRs 2013 (Schedule 1, Part 1) | Data requirement |
|---|---|
| Full Part 1 | Based on a full dossier using your own data or a mixture of your own data and some bibliography |
| Generic Para 10 | Referring to data of an already authorised product. Reference product authorisation requirements are given below. |
| Generic hybrids - Para 10a | Combination of referring to data of an already authorised product and your own data to support differences. Reference product authorisation requirements are given below. |
| Bibliographic Para 7 | Also known as well-established use. Based on referring to published data |
| Fixed combination Para 8 | 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 Para 9 | 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 is provided on our Apply for a Marketing Authorisation guidance page |
Unless otherwise stated, the data and documents required in support of these applications are set out in Annex II to EU Regulation 2019/6 and the Veterinary Medicines Regulations Annex 2 Requirements - Guidance.
Generics
You may apply for a generic MA by referring 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.
The reference product must be authorised in accordance with either Part 1 of Schedule 1 and Paragraphs 7, 8 and 9 of the Veterinary Medicines Regulation and must be authorised in:
- the UK for a GB-National MA
- the UK (subject to the reference product being originally authorised pre-Brexit January 2020) or EU for NI-National MA and European mutually recognised and decentralised procedures with NI as CMS
You cannot use a product authorised in accordance with Paragraph 10 of the VMRs, an exceptional MA or a Biological (including Immunological) veterinary medicine as a reference product.
In addition to a full quality data package, you would need to provide a user risk assessment. The type of user risk assessment provided depends on the degree of similarity between the generic and reference products.
You must also provide an environmental risk assessment as part of an application for a generic veterinary medicinal product where:
(a) the marketing authorisation for the reference veterinary medicinal product was granted before 1st October 2005, and
(b) no marketing authorisation has been granted since 1st October 2005 in respect of a veterinary medicinal product which has the same active substance and pharmaceutical form as the reference veterinary medicinal product, and which is indicated for use in the same target species when administered at the same or a higher total dose,
This does not apply, where the Secretary of State has confirmed in writing that an environmental risk assessment for the reference veterinary medicinal product in question has already been assessed.
For generics of injectable products, the submission of injection site residues data is necessary, unless a biowaiver exempts the need for residues studies.
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