In order to receive a pilot project permit, the person responsible for the project or the pilot animal user shall submit an application to the Service in which the following shall be indicated:
- the user of experimental animals;
- the location of the pilot project (or information on the location outside the premises of the experimental animal user undertaking where the procedure will take place);
- the given name, surname and number of the permit issued by the person responsible for the project;
- the names of the persons who will carry out the activities referred to in the pilot project;
- the person responsible for the implementation of the pilot project;
- the start and end dates of the procedure.
A pilot project shall be attached to the application, specifying:
- the name of the pilot project;
- the objectives of the pilot project and procedures (including the spotlight and novelty);
- the expected scientific results and educational value of the pilot project;
- justification and justification for the use of animals, including origin, number, species and life stage;
- justification and justification for procedures;
- methods to replace, reduce and improve the use of experimental animals in procedures;
- planned anaesthetics, analgesia and other pain relief methods;
- any form of reduction, prevention and relief of suffering in experimental animals from birth to death, if necessary;
- the use of humane target parameters;
- an experimental or observation strategy and statistical information to minimise the number of animals, pain, suffering, distress and environmental effects caused to them, if necessary;
- an assessment of the cumulative effects of the re-use of experimental animals;
- the classification of the severity of the proposed procedures;
- avoiding unnecessary duplication of procedures, where appropriate;
- conditions of accommodation, rearing and rearing of experimental animals;
- methods of killing experimental animals;
- the competence of the persons involved in the pilot project;
- the list and description of the manipulations to be carried out in the procedures to which experimental animals will be subjected;
- an assessment of the damage and benefits;
- a non-technical summary of the pilot project;
- if necessary, an authorisation regarding the right to submit documents on behalf of the experimental animal user.
If an incomplete or incorrect submission and other documents have been submitted, the Service shall inform the submitter of the application of the need to submit any additional documents.
An application may also be submitted by e-mail, signed with an e-signature.
Documents may also be submitted using the institution's e-address.
The service charge is specified in the price list.
The Service shall, within 10 working days after the submission of the documents, examine whether all the documents have been submitted and notify the submitter of the application:
- that all necessary documents have been received and the application will be examined within the time period specified in regulatory enactments;
- that the necessary additional documents must be submitted within five working days of the date of notification.
A pilot project permit shall be issued within 40 working days after all the necessary documents have been received, which have been prepared in conformity with the requirements specified in regulatory enactments and which completely contain the information requested by regulatory enactments.
The term of authorisation may be extended once for a period of up to 15 working days, if justified by the complexity or multidisciplinary nature of the pilot project.
Receipt of services
If the submitter of the application does not submit the necessary additional documents, the Service shall take a decision not to issue a pilot project permit for the use of the animal in the procedure and shall notify the submitter of the submission in writing within three working days.
A pilot project permit shall be issued within 40 working days or a pilot project permit shall be issued or shall refuse to issue it.