What information is needed in a project licence application?

5.7.1 Overview

Your application must: ●

● describe the programme of work (see below);

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● specify the regulated procedures, the descriptions of animals and the place or places you want to be specified

in the project licence; ●

● include information on the matters set out in Annex 6 of the Directive (see below and Appendix F);

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● describe the realistic likely benefits;

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● include such other information as we may reasonably require; and

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● be accompanied by a project summary written in non-technical terms.

5.7.2 Programme of work

A project licence covers a single programme of work. It must describe the programme, state its purpose and specific objectives, specify the regulated procedures to be applied and identify the adverse effects (harms) likely to be experienced by the animals and how you will avoid, recognise and alleviate them.

A project licence might cover an entire programme of work to develop a new drug involving many animals of various species, numerous protocols and a large team of personal licence holders. Or it might cover the work of one scientist researching just one part of a process, using a few animals of a single species.

5.7.3 Regulated procedures to be applied and expected adverse effects

Your application must describe the experimental or other scientific protocols you propose to follow and specify the regulated procedures you may apply within each protocol. You must describe the expected adverse effects of these procedures on the animals, their likely incidence, the control measures you will adopt to minimise their severity, and the humane end-points that will be applied as specific limits on severity. We will confirm the severity

classification in your granted licence (see Section 5.12).

5.7.4 Description of the animals to be used

Your application must specify the type (e.g. species, strain, health status) of animals you plan to use.

5.7.5 Numbers of animals to be used

Your application must provide a realistic estimate of the number of animals of each species or type that you intend to use in each protocol.

5.7.6 Place or places you want to be specified in the project licence

You must specify the place where the work will be carried out. In most cases this will be a licensed establishment. We call this the ‘primary availability’. The licence may also name other licensed establishments where the work can take place. These are called ‘additional availabilities’ and we require you to identify an individual as a ‘point of contact’ for your project at each of these establishments.

Exceptionally, when required by the nature of the programme or the regulated procedures, you may be authorised to carry out procedures at a place other than a licensed establishment (known as a POLE) – for example, an inland waterway or a farm. In this case you must notify us when the work is to be carried out so that an inspector can choose whether to be there. We may also put extra safeguards in place to protect the welfare of any animals that are to be left unattended or released into the wild (set free) once you have completed the procedures.

The manner in which a POLE is specified needs to be sufficiently detailed to allow inspection. For example, a full address of the site with grid references, post code (for a farm) or other ways of identifying it, contact names and telephone numbers (and mobiles, if appropriate). However, general information (e.g. “Farms in England and Wales where cattle have been diagnosed as suffering from tuberculosis”, “Sites where pied flycatchers are nesting”, “Tributaries of the River Dee in North Wales”, “Fish farms on West Coast of Scotland”) can be sufficient if details are to be given on notification.

5.7.7 Information on the matters set out in Annex 6 of the Directive

Your application must explain, or provide details of: ●

● the relevance of and justification for (a) the use of animals including their likely origin (i.e. animal born in the

UK or rest of the EU and whether at an authorised breeder; animal born in the rest of Europe or in the rest of the world), estimated numbers, species and life stages; and (b) procedures;

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● the application of the 3Rs;

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● the planned use of anaesthesia, analgesia and other pain-relieving methods;

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● measures proposed to reduce, avoid and alleviate any animal suffering, from birth to death where appropriate;

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● use of humane end-points;

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● the experimental or observational strategy and statistical design to minimise animal numbers, pain, suffering,

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● proposed re-use of animals and the cumulative effect on the animals;

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● the proposed severity classification of procedures;

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● measures proposed to avoid unjustified duplication of procedures;

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● the housing, husbandry and care conditions for the animals including appropriate environmental enrichment

(if those conditions will not meet in full the minimum standards set by Annex 3 or, where higher, those of the Code of Practice);

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● proposed methods of killing; and

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● the competence of the persons involved in the project.

Annex 6 is reproduced in full in Appendix F of this Guidance.

5.7.8 Other information

There may be other information that you will need to include in your application. For example, in an application for an education and training project licence we would expect the programme of work to include information about how learning outcomes would be monitored. We will advise you of this on a case-by-case basis.

5.7.9 Project summary

Your application must be accompanied by a project summary written in non-technical terms and which can be understood by a non-scientist. You should complete the project summary template, which is available on the Research and testing using animals page of the GOV.UK website.

We expect that, for all but the most complex of projects, you will be able to provide a satisfactory project summary using between 500 and 1,000 words. The project summary must:

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● describe the proposed programme of work and state the objectives of the programme;

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● state the types of animal and the estimated number of each type that you will use;

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● predict all of the likely harms to the animals that will be caused and the likely benefits that will be gained by

carrying out the programme of work; and ●

● demonstrate how you will comply with the principles of replacement, reduction and refinement throughout

the project.

Your project summary must not contain any of the following: ●

● information of a confidential nature;

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● information the publication of which may lead to the infringement of any person’s intellectual property rights;

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5.8 How quickly will my application be decided?

5.8.1 Timescales

We will acknowledge receipt of your application when we receive it. We will not start assessment until we receive a complete and correct application, including a satisfactory non-technical project summary.

Unless the application involves a complex or multidisciplinary programme, we will complete our assessment within 40 working days (about eight weeks) of receiving your correct and complete application. We will either grant your project licence or notify you of our intention to refuse your application.

For applications describing a complex or multidisciplinary programme, we may extend this period by up to 15 working days (about three weeks) and will notify you accordingly.

5.8.2 Incomplete or incorrect applications

If your application contains any errors or lacks essential information necessary for us to evaluate it, we will tell you as soon as we can and set out the additional information that needs to be provided to complete or correct it. Provided the additional information submitted to us completes or corrects the application, we will complete the assessment and grant process as described above.