Application for a Project Authorisation under Scientific
Animal Protection Legislation
For details on completing this application form, please see the ‘Guide to Project Applications
under Scientific Animal Protection Legislation’.
SECTION A: PROPOSED AUTHORISATION HOLDER (I.E. USER)
Proposed authorisation holder (i.e. user):
Address 1:
Address 2:
Address 3:
Note: In the case of an academic setting, the user is usually the project manager. In the case of a
commercial setting, the user is usually the commercial entity.
SECTION B: PROJECT MANAGER AND BREEDER/SUPPLIER/USER ESTABLISHMENT
DETAILS
B1: PROJECT MANAGER
Title
First name:
Address 1:
Address 2:
Address 3:
County:
E-mail:
Surname:
Telephone:
Individual authorisation number:
If no current individual authorisation number exists, please state the date of application for an
individual authorisation:
Please append CV (setting out education, training, experience and publication history). (A
template CV is available on the HPRA website if you wish to use it.)
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B2: DEPUTY PROJECT MANAGER DETAILS (if applicable)
Title:
First name:
Address 1:
Address 2:
Address 3:
County:
E-mail:
Individual authorisation number:
Surname:
Telephone:
If no current individual authorisation number exists, please state the date of application for an
individual authorisation:
Please append CV (setting out education, training, experience and publication history). (A
template CV is available on the HPRA website if you wish to use it.)
B3: USER ESTABLISHMENT DETAILS
USER ESTABLISHMENT NAME
USER ESTABLISHMENT AUTHORISATION
NUMBER
Address where the project will be conducted:
In the case of a collaboration, list the user establishment authorisation number of each user
establishment at which the applicant will participate in project work:
USER ESTABLISHMENT NAME
USER ESTABLISHMENT AUTHORISATION
NUMBER
List any location other than the authorised user establishment(s) where procedures will be
carried out and provide a scientific justification as to why each additional location is necessary.
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SECTION C: PROJECT INFORMATION
Project title (≤ 500 characters):
Is this project being performed solely to satisfy regulatory requirements?
Is this project application solely for production or diagnostic purposes
using recognised established methods?
Has this project been approved by an ethics committee?
Yes
No
Yes
Yes
No
No
If ‘yes’ please provide a copy of the ethical review application and associated approval
documentation from the relevant ethics committee as outlined in the guide to projects.
If ‘no’ please provide a justification as to why an ethical review was not performed:
State expected duration of project work (months):
State estimated start date of project work:
State the total number of animals per species to be used for this project:
SPECIES
NUMBER OF ANIMALS
Provide details of the individuals who will be performing procedures as part of this project:
FIRST NAME
SURNAME
INDIVIDUAL
If no current individual authorisation
AUTHORISATION number is held, state the date of application
NUMBER
for an individual authorisation
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SECTION D: PROJECT PURPOSE
D1: PROJECT DETAILS
Describe the overall purpose of the project (≤ 5000 characters):
Describe the current state of scientific knowledge for the work to be performed on this project
(≤ 5000 characters):
How do the objectives of this project differ from the findings of previous studies in this area (to
include evidence of the literature research performed)? (≤ 5000 characters):
Detail the expected scientific benefit of the project (≤ 5000 characters):
Describe the feasibility and the resources available for the project (≤ 5000 characters):
D2: PURPOSE OF THE PROJECT
Provide information on the proposed purpose of this project, selecting from the list below. Please
refer to the Guide to Projects Applications Regulated by Directive 2010/63/EU and S.I. No. 543 of
2012 for expanded project purposes if required. Note: a completed application form must be
provided for each project proposed.
Basic research - select sub-field(s)
Translational and applied research - select sub-field(s)
Regulatory use and routine production - select sub-field(s)
Protection of the natural environment in the interests of the health or welfare of human
beings or animals
Preservation of species
Higher education or training for the acquisition, maintenance or improvement of vocational
skills
Maintenance of colonies of established genetically altered animals, not used in other
procedures
Forensic inquiries
SECTION E: NON-TECHNICAL PROJECT SUMMARY
Provide a completed ‘Non-Technical Project Summary for a Project Regulated by Directive
2010/63/EU and S.I. No. 543 of 2012’ form available on the ‘Publications and Forms’ section of
www.hpra.ie with each project application form.
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SECTION F: EXPERIMENTAL DESIGN
Using the table below, provide information on each of the procedures to be carried out as part
of this project in chronological order, detailing the technique involved, the severity classification
and the methods of pain relief and humane endpoints in place. For each procedure, provide a
justification as to why each procedure is required.
The table can be expanded by copying and pasting sections as many times as required
depending on the number of procedures to be conducted.
Procedure number
Species
Life stage
Technique
Duration of procedure
Frequency of procedure
Pain-relieving methods and/or anaesthesia
Proposed severity classification
Humane endpoints
Number of animals to be used
Justification/relevance of procedure
Adverse effect(s) of procedure on animal
welfare
What is the fate of the animals at the end of
the procedure?
If the fate of the animals is euthanasia, please
state the method of euthanasia
Procedure number
Species
Life stage
Technique
Duration of procedure
Frequency of procedure
Pain-relieving methods and/or anaesthesia
Proposed severity classification
Humane endpoints
Number of animals to be used
Justification/relevance of procedure
Adverse effect(s) of procedure on animal
welfare
What is the fate of the animals at the end of
the procedure?
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If the fate of the animals is euthanasia, please
state the method of euthanasia
Procedure number
Species
Life stage
Technique
Duration of procedure
Frequency of procedure
Pain-relieving methods and/or anaesthesia
Proposed severity classification
Humane endpoints
Number of animals to be used
Justification/relevance of procedure
Adverse effect(s) of procedure on animal
welfare
What is the fate of the animals at the end of
the procedure?
If the fate of the animals is euthanasia, please
state the method of euthanasia
Please append the project protocol, giving specific details for each procedure and indicating the
flow of procedures. The steps involved should be clearly numbered (from beginning to end) in
schematic or illustrative form and should correspond with the table above.
SECTION G: ANIMAL INFORMATION
G1: APPLICATION OF METHODS TO REPLACE, REDUCE AND REFINE THE USE OF ANIMALS
REPLACEMENT
Provide the reasons why the objectives of this project are not achievable through the use of
alternative methods to animal testing and indicate what sources you consulted to track possible
alternatives (≤ 5000 characters):
REDUCTION
Provide justification on the number of animals to be used in this project, specifying the
principles of experimental design used to calculate the sample group size (≤ 5000 characters):
REFINEMENT
Provide information relating to the choice of species, procedure(s) and endpoint(s) and explain
why they are the most refined for the intended purpose (≤ 5000 characters):
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For each procedure, provide details of policies in place to minimise animal suffering (≤ 5000
characters):
In the case of procedures involving moderate or severe severity classifications, provide
justification as to why these procedures are necessary (≤ 5000 characters):
Provide details about the housing, husbandry and care conditions for the animals (≤ 5000
characters):
G2: ANIMALS TO BE USED
Have the animals to be used in this project been bred for specific use in scientific procedures:
Yes
No
If ‘no’ please provide scientific justification for the reasons the animals were not specifically bred
for use in procedures?
Have the animals to be used in this project been taken from the wild?
Yes
No
If ‘yes’ please provide scientific justification for the reasons a wild animal is required?
Are the animals to be used in this project stray or feral animals of a domestic species?
Yes
No
If ‘yes’ please provide scientific justification for the reasons a stray or feral animal of a domestic
species is required?
Are the animals to be used in this project an endangered species?
Yes
No
If ‘yes’ please provide scientific justification for the reasons an endangered species is required?
G3: INFORMATION ON ANIMAL SPECIES
Please provide information on the species of animal(s) to be used in this project in the table
below.
Species
Life stage
Strain/breed
Genetic status
Genetic alteration (if GA)
Breeder/supplier establishment authorisation number
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Country of origin*
Has this animal been previously used in a scientific
study?
If yes, describe the cumulative effect of the procedures
on the animal?
Number of animals to be used
Species
Life stage
Strain/breed
Genetic status
Genetic alteration (if GA)
Breeder/supplier establishment authorisation number
Country of origin*
Has this animal been previously used in a scientific
study?
If yes, describe the cumulative effect of the procedures
on the animal?
Number of animals to be used
* If animal(s) are sourced outside of the Republic of Ireland, please indicate the source of the
animals and provide a certificate confirming authorisation and registration of the supplier
establishment (as required under Directive 2010/63/EU) where animal(s) were bred/supplied in
the country of origin.
SECTION H: DECLARATION AND UNDERTAKING
The declaration and undertaking below should be signed by or on behalf of the applicant i.e. by
the project manager (designated pursuant to Regulation 47 of S.I. No. 543 of 2012), who is
responsible for the overall implementation of the project and its compliance with the project
authorisation and the compliance officer (designated pursuant to Regulation 44 of S.I. No. 543 of
2012) responsible for ensuring compliance with the provisions of S.I. No. 543 of 2012 at the
establishment.
I hereby declare that:
- I have been designated by the user to make this application on the user’s behalf
- The information contained in this application is true and correct.
I hereby undertake that in the event of the project authorisation being granted:
- To ensure fulfilment of the obligations arising by virtue of the terms and conditions of the
project authorisation.
- To ensure fulfilment of the requirements of S.I. No. 543 of 2012, including:
- To submit an application for an amendment if any substantial changes to the project are
required.
- To ensure that the project manager has a valid individual authorisation.
- To ensure that, if appointed, the deputy project manager has a valid individual
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-
-
-
authorisation for the purpose of project management.
To ensure that all persons carrying out procedures under this project have a valid
individual authorisation.
To ensure that all persons performing euthanasia under this project have a valid
individual authorisation.
To ensure the methods of euthanasia performed are in accordance with Annex IV of
Directive 2010/63/EU unless an exemption is granted by the HPRA.
To report any project deviations that have an adverse effect on animal health or welfare,
and to report any changes to a severity classification that have an adverse effect on
animal health or welfare to the designated veterinarian and/or the animal welfare body at
the establishment.
To keep written records of all animals used under this project authorisation for a
minimum of 3 years, and to make all written records or project documentation available
to the HPRA upon request or as part of an inspection.
To provide the user establishment with an end of project report for the finished project to
be made available to the HPRA upon request.
To fulfil all reporting requirements including annual statistical returns to the HPRA.
To provide updates (if any) to the non-technical project summary (where relevant) to the
HPRA, which will be made publically available by the HPRA.
To comply with the requirements of S.I. No. 543 of 2012 for the care and accommodation
of animals.
Signature of project manager:
Print/type name:
Date:
______________________
Compliance officer (designated pursuant to regulation 44 of S.I. No. 543 of 2012) responsible
for ensuring compliance with the provisions of S.I. No. 543 of 2012 at the user
establishment.
I hereby declare that:
- The applicant is affiliated to the primary user establishment referred to in Section B3.
- I understand that if the applicant fails to uphold his/her responsibilities under S.I. No. 543 of
2012, this may have implications for the continued authorisation of the user establishment.
Signature of compliance officer: ____________________________________
(on behalf of breeder/supplier/user)
Print/type name:
Date:
CHECKLIST
Project protocol
Non-technical project summary form
Certificate confirming authorisation and registration of breeding / supplying establishment
(for animals sourced outside the Republic of Ireland)
Copy of ethical review application and associated documentation (where relevant)
Ethics approval document (where relevant
CV (setting out education, training, experience and publication history)
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APPENDIX I
LISTS OF OPTIONS FOR DROP-DOWN MENUS IN SMART FORMS
(Delete before publication)
TITLE
COUNTY
Dr.
Miss
Mr.
Mrs.
Ms.
Prof.
Carlow
Cavan
Clare
Cork
Donegal
Dublin
Galway
Kerry
Kildare
Kilkenny
Laois
Leitrim
Limerick
Roscommon
Longford
Sligo
Louth
Tipperary
Mayo
Waterford
Meath
Westmeath
Monaghan
Wexford
Offaly
Wicklow
Pigs
Birds – specify
Goats
Poultry – specify
Sheep
Zebra fish
Cattle
Cephalopods – specify
Horses
Other laboratory fish –
Donkeys
specify
Other farm species
Other fish - specify
– specify
Frogs
Other ungulates –
Toads
specify
Other amphibians – specify
Non-human
Wild animals – specify
primates - specify
species
Zoo animals –
specify
SPECIES
Rats
Mice
Guinea-pigs
Hamsters
Gerbils
Rabbits
Ferrets
Mini-pigs
Dogs
Cats
Other laboratory
animals – specify
Reptiles – specify
WHAT IS THE FATE
OF THE ANIMALS
AT THE END OF
THE PROCEDURE?
Euthanised
Rehomed
Rehabilitated and set free
Continued use under this project authorisation
Re-use in another project authorisation
Other, please provide details
NGA – not genetically altered
GANHP – genetically altered without a harmful phenotype
GAHP – genetically altered with a harmful phenotype
NGAL – animals used for the creation of a new genetically altered line /
strain
Non-recovery
Mild
Moderate
Severe
STRAIN / GENETIC
STATUS
PROPOSED
SEVERITY
CLASSIFICATION
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APPENDIX II LISTS OF OPTIONS FOR DROP-DOWN MENUS IN SMART FORM SECTION D2: PURPOSE OF THE PROJECT
(Delete before publication)
Purpose of the
project
Regulatory use and routine
production by type
Quality control
(including
batch safety
and potency
testing)
·
·
·
·
Routine
production
Basic research studies
Preservation of species
Toxicity and
other safety
testing including
pharmacology
Batch safety
testing
Pyrogenicity
testing
Batch potency
testing
Other quality
controls
Forensic
enquiries
Other efficacy
and tolerance
testing
Maintenance of
colonies of
established
genetically altered
animals, not used in
other procedures
·
·
Medical devices legislation
·
·
·
·
·
·
·
·
·
Industrial chemicals legislation
·
Legislation on medicinal products for human use
·
Oncology
Cardiovascular blood and lymphatic
system
Central nervous system
Respiratory system
Gastrointestinal system including liver
Musculoskeletal system
Immune system
Urogenital / reproductive system
Sensory organs (skin, eyes and ears)
Endocrine system / metabolism
Multisystemic (explain when to specify
multisystemic)
Ethology / animal behavious / animal
biology
Other
Legislation on medicinal products for veterinary use and their residues
Plant protection product legislation
Biocides legislation
Food legislation including food contact material
Feed legislation including legislation for the safety of target animals, workers and environment
·
·
·
Blood based products
Monoclonal antibodies
Other
Cosmetics legislation
Other
Protection of the
natural
environment in
the interest of
health or welfare
of human beings
or animals
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
·
Translational
and applied
research
Higher
education or
training for the
acquisition,
maintenance or
improvement of
vocational skills
Human cancer
Human infectious disorders
Human cardiovascular disorders
Human nervous and mental disorders
Human respiratory disorders
Human gastrointestinal disorders including liver
Human musculoskeletal disorders
Human immune disorders
Human urogenital / reproductive disorders
Human sensory organ disorders (skin, eyes and ears)
Human endocrine / metabolism disorders
Other human disorders
Animal diseases and disorders
Animal welfare
Diagnosis of diseases
Plant diseases
Non-regulatory toxicology and ecotoxicitiy
Legislation satisfying EU requirements
Legislation satisfying national requirements only (within EU)
Legislation satisfying non-EU requirements only
·
·
·
Acute (single dose) toxicity testing methods (including limit test)
Skin irritation / corrosion
LD 50, LC 50
Other lethal methods
Non-lethal methods
Skin sensitisation
Eye irritation / corrosion
Repeated dose toxicity
Carcinogenicity
·
·
·
< 28 days
28-90 days
> 90 days
Genotoxicity
Reproductive toxicity
Developmental toxicity
Neurotoxicity
Kinetics (pharmacokinetics, toxicokinetics, reside depletion
Pharmaco-dynamics (including safety pharmacology
Phototoxicity
Ecotoxicity
Safety testing in food and feed area
Target animal safety
Other
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·
·
·
·
·
Acute toxicity
Chronic toxicity
Reproductive toxicity
Endocrine toxicity
Bioaccumulation
Other
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