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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 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 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 