Guidance

Apply for a Marketing Authorisation in the UK for a veterinary medicine or expiry

Guidance for the pharmaceutical industry on how to apply for an authorisation to place a veterinary medicine on the UK market or part of, or to expire one.

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 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 benefit from parallel submissions, you must only submit applications that meet the regulatory requirements of both territories. For example, a generic GB MA application can’t cite an EU reference product which would rule out the submission of such an application in GB.

New GB and EU MA applications

You can submit in parallel applications for a new GB MA and a new DCP MA where NI is CMS or for a centrally authorised product 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.

You must submit your EU application through CESP (DCP) or via the Common Repository (CAP) and then, within 2 working days at the latest, submit the GB MA application to the VMD via the Veterinary Medicines Digital Service (VMDS). As confirmation, you must include the date you submitted your EU application and the EU procedure number in the comments box in the GB MA online form. Applications must also be for the same 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 the same dossier. Except for certain differences that make no impact on the scientific requirements or regulatory framework such as sites of batch release. Both variants must be included in the dossier submitted in support of the GB MA application

As the procedure progresses it is your responsibility to ensure we are aware of information and timetables (including timetable amendments) that you wish to be considered during our assessment. You may also need to provide us with EU Lists of Questions (LOQs) and your responses in order to maximise the potential for harmonised labelling.

To benefit from parallel submissions, you must only submit applications that meet the regulatory requirements of both territories. For example, a generic GB MA application can’t cite an EU reference product which would rule out the submission of such an application in GB.

Data requirements

You should provide the information set out in Volumes 6a and 6b of the European Notice to Applicants and in Annex 1 of Directive 2001 / 82 / EC, as amended.

For exceptional MAs, the data requirements are listed below:

Therapeutic Allergen Products

Therapeutic allergen products may qualify for consideration for an LMA. A case for establishing that the proposed product falls within the definition of limited markets should be presented with the application.

In some cases, it is anticipated that the authorisation of bulk concentrated allergens will be appropriate. These may then be used to formulate dosage forms for individual animals on a case by case basis as extemporaneous preparations.

The inclusion of specific allergens in the application should be justified and its relevance to the clinical situation in UK should be explained.

All relevant data available at the time of making the submission of the application for an LMA should be included in the supporting data. As mentioned above, any gaps in the quality, safety and efficacy data must not be critical to the safety of the product and it must be possible to mitigate any risks to an acceptable level.

The allergenic active ingredients should be described in as much detail as possible and this should include specifications and control methods relating to identity and purity of the source material.

The production process for each allergen or group of allergens should be described step by step with a flow chart, with an indication of when aseptic precautions are introduced. Intermediate or bulk products in the process should be identified and the in-process controls should be described.

In certain cases, data obtained with a representative allergen product may be extrapolated to another, as long as a close relationship exists between their active components. It may be necessary to sub-divide some groups into smaller families and justification for this division should be provided.

Each family or subgroup of allergens must be described and tested separately.

Batch to batch consistency should be established by comparison with in-house reference preparations using a number of biological and analytical methods. Consistency of production must be documented on at least three production runs.

For stability data, the concept of the homologous groups may be applied and data obtained on one member of the family may be extrapolated within the same family. A shelf life longer than 12 months is only acceptable with stability studies obtained by immunological or equivalent methods that can demonstrate allergenic activity throughout the shelf life period.

The concept of the homologous groups may also be applied for the performance of clinical trials.

Measurement of total allergenic activity of individual batches of each allergen extract should be undertaken using validated immuno-assay methods.

Specific Data Requirements

You should provide the information set out in Volumes 6a and 6b of the European Notice to Applicants and in Annex 1 of Directive 2001 / 82 / EC, as amended.

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

For LMAs, you should provide justification that the proposed product falls within the definition of limited markets. To do this, you may use the headings in the template referenced in EMA paper, ‘EMA Guidance for Companies Requesting Classification as MUMS / Limited Markets’ – EMA/CVMP/370663/2009.

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.

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.

How to submit your application

See Submission of applications to an animal medicines for guidance.

Active Substance Master Files and responses to questions in relation to applications, should be submitted via the same method as the application.

Validation

Most types of applications are validated upon receipt to check that everything has been provided in order to begin the assessment.

It is up to you to identify and submit all the necessary information in support of your application. If the submission is incomplete, we may not be able to progress your application.

We will contact you if further information is needed.

Fees

Once an application has passed validation, you will be sent an invoice for the fee by email so you must provide a valid email address in your application.

You can use the fees calculator to help you work out what the fee will be or see Application fees for animal medicines.

Assessment timescales

Once the application has passed validation, it will proceed into the assessment phase. See Timetables for national applications. If you have requested parallel assessment with an EU application, these timetables will not apply.

You will receive our questions and our decision whether to approve or refuse around the same time as the corresponding EU procedure.

If during the assessment phase we need further information from you, these timescales may be suspended until the information is received.

If the assessment outcome is to approve an application and where applicable we have approved mock-ups, we will email your authorisation documentation

Expiry of a Marketing Authorisation

To expire an MA, email: s.response@vmd.gov.uk with the details.

Expiring an MA means that no more product may be released by the qualified person (QP) on or after the date of expiry. Any product already QP released may still be placed on the market for sale and supply after this date unless the MA has been expired due to safety reasons. In this case, this will be noted in the expiry letter sent to you.

Contact us

  • to request a company meeting prior to applying email: postmaster@vmd.gov.uk and include ‘Request a company meeting’ in the subject line
  • once you have applied, to discuss specific application points contact the people assigned to the application given in the validation passed email
  • for all other enquiries email: postmaster@vmd.gov.uk
Published 27 November 2014
Last updated 23 March 2021 + show all updates
  1. Exceptional MA data requirements added

  2. New section for 'Parallel submissions'.

  3. Guidance updated in accordance with end of Transition Period.

  4. Minor changes and addition of link to new timetables for national applications page

  5. Guidance reviewed and updated. Reference to MAPIs removed, see seperate guidance

  6. Updated MAPI application form

  7. Revised link to SPC and product literature guidance

  8. Inclusion of expiry procedure guidance

  9. New combined QRD template for national applications

  10. First published.