PROJECT AUTHORISATION –

APPLICATION
Directive 2010/63/EU
Presidential Decree 56/2013, as amended by P.D. 86/2020
(Module 1: National and EU Legislation)
(Learning outcomes: 1.3, 1.8 and 1.9)

Panagiotis Andriopoulos, DVM, MSc

Directorate of Agricultural and Veterinary Policy
Region of Attica

(Fleming, 4th July 2023)

 DEFINITIONS

‘project’ means a programme of work having a defined scientific

objective and involving one or more procedures;
‘procedure’ means any use, invasive or non-invasive, of an animal for
experimental or other scientific purposes, with known or unknown
outcome, or educational purposes, which may cause the animal a level
of pain, suffering, distress or lasting harm equivalent to, or higher than,
that caused by the introduction of a needle in accordance with good
veterinary practice.
 Includes any course of action intended, or liable, to result in the birth
or hatching of an animal or the creation and maintenance of a
genetically modified animal line in any such condition
 Excludes the killing of animals solely for the use of their organs or
tissues;
 ESTABLISMENT AUTHORISATION

 Breeders (Annex I) Registered Code Number:

 Suppliers
EL 99 BIO br/sup/exp 099
 Users

Official Authorisation by the Regional Authority

Renewed every 5 years
Application Form to Regional Authority
with requirements in article 19 § 2 of P.D.
 ESTABLISMENT AUTHORISATION

Requirements
Installation description
Annex ΙΙΙ of P.D & Directive
of the establishment Requirements for establishments and for
Equipment description the Care and Accommodation of animals

Spieces & numbers of Animals housed

Form of Animal Records
Education & Training
Curriculum vitae
 The Responsible of the
Establishment
 The Designated Veterinarian
 The person/persons responsible
for the welfare and daily care of
the animals
 ESTABLISMENT AUTHORISATION

• Animal Welfare Body

(articles 25 & 26 of P.D. / articles 26 & 27 of Directive)

• Project Evaluation Committee

(article 37 § 2 of P.D.)
 PROJECT AUTHORISATION

STEP 1: Submission of Application

• The user (person responsible for project) submits an
Application Form to the Project Evaluation Committee
(different for each establishment).
• Project Evaluation Committee has been approved by the
Regional Authority and consists of:
a)a Biomedical Research Scientist, as chairman, with his deputy
b)the Designated Veterinarian responsible for the
establishment, with his deputy
c) a Biostatistician, with his deputy and
d)a representative of Regional Authority (with voting privilege)
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STEP 2: Project Evaluation
• Project Evaluation Committee evaluates and estimates:
1. that the Project
a) is justified from a scientific or educational purpose and value, or
required by law
b) justifies the use of animals, including species, animal model and number
of animals
c) is designed to reduce suffering, pain and distress to the animals used
and that it is justified by the expected outcome (harm-benefit analysis
according to ethical considerations)
d) complies with the requirement of the 3Rs (Replacement, Reduction,
Refinement) and the user has scientific knowledge of laboratory animals
2. the classification of the Severity of Procedures and the
requirement for Retrospective Assessment
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• Members of Project Evaluation Committee must

declare that:
(a)there is no benefit or personal interest in participation in the
evaluation of the project,
(b)the information referred to in the project under approval are
confidential and should be managed as such, and
(c)there is no participation in the scientific work. “Scientific
work” is defined as the publication or disclosure in Greece or
abroad
• Project Evaluation Committee prepares a meeting
practical and an opinion for the project
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STEP 3: Project Authorisation

• The user submits the corrected and final Application

Form with the meeting practical and positive opinion of
the P.E.C. to the Regional Authority
• The Regional Authority issues the Decision of Project
Authorisation, which is granted for 3 years (in Greece)
 PROJECT AUTHORISATION
PROJECT AUTHORISATION
Application Form
Application Form

1. Identification data of the user/responsible for project

2. Identification data of the responsible for the overall
implementation
3. Identification data of the responsible for the compliance
with the Project Authorisation
4. Objective of the project
5. Title and Description of the project
6. Procedures and Table of procedures
7. Overall assessment procedures Severity (Mild – Moderate –
Severe – Non-Recovery)
8. Animal Model - Justification for the choice of
 PROJECT
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Application Form

9. Total number of animals (documentation with statistical

analysis or by published literature or a pilot protocol and
retrospective assessment based on evidence from
statistical analysis of results)
10. Information on the application of anesthesia-analgesia, the
early recognition of humane endpoints and euthanasia or
any other information in relation to the fate of animals
after completion of the Project
11. Compliance with the requirement of the 3Rs (Replacement
(using alternative methods), Reduction (animal numbers),
Refinement (improvement or reduction of suffering and/or
pain)
 PROJECT
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Application Form

12. Identification of User establishment

13. Table with details of those participating in the Project,
including education and/or experience of participants
 PROJECT
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Non-technical Project
Non-technical Project Summary
Summary

Is the publication of the Project Summary with non-technical details, in very

simple language, which will be understood by people who have nothing to
do with the research, such as a 12-year-old child
Shall be anonymous and shall not contain the names and addresses of the
user establishment, its personnel and the participants
Must include:
• information on the objectives of the project, including the predicted harm
and benefits, the number and types of animals to be used and the
estimated number of animals per severity
• demonstration of compliance with the requirement of the 3Rs
(replacement, reduction and refinement).
• the obligation and the reason for a retrospective assessment and the
results of this assessment (update to the Non-technical Project Summary)
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Non-technical Project
Non-technical Project Summary
Summary

Submission of Non-Technical Project Summaries

In our Greek language

ALURES – ANIMAL USE REPORTING - EU SYSTEM

EU NTS DATABASE ON THE USE OF ANIMALS FOR SCIENTIFIC PURPOSES
UNDER DIRECTIVE 2010/63/EU

https://webgate.ec.europa.eu/envdataportal/web/resources/alures/submission/nts/list
http://www.minagric.gr/index.php/el/for-citizen-2/zoagiaepistimones
http://www.minagric.gr/index.php/el/for-citizen-2/zoagiaepistimones
COMMISSION IMPLEMENTING DECISION (EU) 2020/569
COMMISSION IMPLEMENTING DECISION (EU) 2020/569
COMMISSION IMPLEMENTING DECISION (EU) 2020/569
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Retrospective Assessment
Retrospective Assessment

• All projects using non-human primates and projects involving

procedures classified as “severe”, shall undergo a
retrospective assessment.
• P.E.C. may exempt projects involving procedures classified as
“mild”, “moderate” or “non- recovery” from the requirement
for a retrospective assessment.

Advise: In order to avoid bureaucracy (the submission of updated Non-technical

Project Summary) and because an estimated number of animals per
severity is required in Non-technical Project Summaries, it is necessary to
avoid the retrospective assessment of projects which is not mandatory by
the legislation.
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Retrospective Assessment
Retrospective Assessment

Shall be carried out by the P.E.C., on the basis of the

necessary documentation submitted by the user/responsible
for the project, evaluates the following:
(a) whether the objectives of the project were achieved
(b) the harm inflicted on animals, including the numbers and species of
animals used, and the severity of the procedures and
(c) any elements that may contribute to the further implementation of the
requirement of replacement, reduction and refinement.

In conclusion:
harm-benefit analysis and
statistical analysis
 THANK YOU
FOR YOUR ATTENTION

THANK YOU
FOR YOUR ATTENTION

http://www.theodoropoulos-surgery.gr/ερευνητικό-έργο