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Before submitting your application

See also Marketing authorisations for veterinary medicines.

Before you apply for a Marketing Authorisation (MA), we recommend that you discuss your proposed application with us, particularly for an exceptional MA or if you wish to submit a GB application in parallel with a new EU procedure. To arrange a meeting, please email: postmaster@vmd.gov.uk and include Request a company meeting in the subject line.

You must be registered to use the Veterinary Medicines Digital Service (VMDS).

Parallel submissions

New GB and national only NI MA applications

You can submit applications for a new GB MA and a new NI MA in parallel to facilitate UK wide coverage and to allow for efficient application management, such as a single application supported by a single data set.

National only parallel submissions must be made in one application, by selecting both GB and NI, and must be for the same/aligned product, meaning they:

• are the same pharmaceutical form
• have the same qualitative and quantitative composition
• are intended for the same target species with the same indications
• have a shared dossier. Except for certain differences that make no impact on the scientific requirements or regulatory framework such as sites of batch release

To maximise the potential for harmonised labelling, you must submit updated GB SPC/QRD documents, every time you submit updated EU SPC/QRD documents.

New GB and EU MA applications

You can submit parallel applications for a new GB MA and a new DCP MA where NI is CMS to facilitate UK wide coverage and to allow for efficient application management. This provides the opportunity for both applications to be managed within similar timeframes across regulatory jurisdictions.

Parallel submissions are not possible for EU centralised procedures (CAP/EUCE), EU Mutual Recognition procedures (MRP), Subsequent Recognition procedures (SRP) previously known as Repeat Use, or applications involving former extensions that result in a new stand-alone MA due to the different timescales and procedures used on a national basis and in the EU.

Data requirements

You should provide the information set out in Annex II to EU Regulation 2019/6 and to the Veterinary Medicines Regulations Annex 2 Requirements - Guidance.

You should provide experts reports and an overall risk:benefit assessment.

Data requirements for Limited Markets

For LMAs, you should provide justification that the proposed product falls within the definition of limited markets.

Some data may be omitted from the application package in any section of the dossier; however, these must not be critical to the safety of the product and it must be possible to mitigate any risks to an acceptable level.

The following list includes examples of the type of data gaps that may be acceptable, but these cannot be considered in isolation from other data gaps:

Quality

• Antimicrobial preservative efficacy and broached vial studies have not been conducted, but the labels indicate the product should be used immediately following first opening.

Safety

• Skin and eye toxicity data on the formulation are not available, but a scientific evaluation can be made using available data on the active substance(s) and excipients, such as Material Safety Data Sheets (MSDS), published toxicity profiles (which may need to be purchased), or published literature, to predict the potential for skin and eye irritation and skin sensitisation and propose appropriate user warnings. The labels carry the agreed user warnings.

• Residue depletion studies are not available, but a scientific evaluation can be made using the pharmacokinetic data in the target species and the data in the MRL summary report to predict the expected depletion of residues and propose appropriate withdrawal periods or support standard withdrawal periods (as defined in legislation) that include additional uncertainty factors (usually in the form of additional days) to address the absence of data. The labels clearly state the agreed withdrawal period and that residue studies have not been performed and indicate what safety margin (uncertainty factor) has been applied, where applicable.

Efficacy

• Pharmacokinetics, pharmacodynamics: new studies using the proposed formulation in the target species are not available but the PK/PD profile of the active substance is well described in published peer reviewed papers; interspecies extrapolation may be acceptable if physiologically justified.

• Safety: target species tolerance data using the proposed formulation are not available but peer reviewed papers or published toxicology profiles are available which characterise the margin of safety in the target species and the proposed product contains excipients with well known safety profiles, and field safety data for the final formulation are available for the proposed dose.

• Field trial data are not available, but sufficient relevant data generated in laboratory studies in the target species (using the final formulation to be marketed) are available to indicate that the product is likely to work and to indicate the dose regimen selected is appropriate. The labels indicate that field trials have not been undertaken.

You should explain in a covering letter accompanying your exceptional MA application how your product will fill a therapeutic gap in the market.

Dossier Documents

Applications and responses must be submitted electronically and the presentation and format of the dossier must be in accordance with VNeeS guidelines.

You must prove technical validity before submission of the electronic dossier and should include the validation report in the add-info folder of the VNeeS submission.

Summary of Product Characteristics and product literature

You will need to provide a draft of the Summary of Product Characteristics (SPC) and product literature with the application. Once the assessment phase is complete you will be asked to submit mock-ups reflecting the revised text, which will then be assessed.

See SPC and Product Literature guidance.

Active substance master files (ASMF)

ASMFs must be submitted electronically and in Common Technical Document (CTD) or Notice to Applicants (NTA) format. However, CTD format is preferred. You should ensure that the proposed active substance manufacturer has submitted the full ASMF to us before submitting your application. A full ASMF includes the open and restricted parts, including Expert Reports, or Quality Overall Summary, if submitted in CTD format.

The active substance manufacturer needs to register as a manufacturer to use the VMDS so they can submit ASMFs and use the secure messaging part of the service to receive and respond to questions during national applications.

Finished tests and specification (CAP/EUCE Biological Only)

For EU Centralised procedure biological applications, it is critical that you provide VMD with a copy of the final version of the finished product tests and specifications (at release and at the end of shelf life), in order that NI batch release activities can be completed post approval.

Application Form

Application forms to apply for a national Marketing Authorisation, or to vary or renew existing ones, are online through the VMDS. You will be asked whether the application is for GB, NI or both. You will need to insert a blank placeholder file in the dossier section 1a-admin-info in order to pass the technical validation check. This is because the online application form is completed separately to the dossier submission.

European procedure application forms are available on the European Commission website. If applying for parallel DCP application, you must include the date you submitted your EU application and the EU procedure number in the comments box in the GB MA application form.

How to submit your application

See Submission of applications to an animal medicines for guidance.

Active Substance Master Files and responses to questi

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