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Regulatory guidance documents | Scientific animal protection
Guidance documents – Scientific animal protection Guide to applications for breeder, supplier, users under scientific animal protection legislation PDF : 249 KB | 13/06/2025 Guide to applications for renewals and amendments to breeder, supplier, user authorisations under sap legislation PDF : 181 KB | 13/06/2025 Guide to new, amendment, renewal and reactivation applications for individuals under SAP legislation PDF : 225 KB | 10/04/2025 Guide to training education and competency requirements under scientific animal protection legislation PDF : 243 KB | 01/04/2025 Guide to project applications under scientific animal protection legislation PDF : 1048 KB | 14/03/2025 View tracked changes Guide to fees for scientific animal protection PDF : 85 KB | 02/01/2025 Technical guidance for completion of non-technical project summaries under SAP legislation PDF : 127 KB | 02/11/2023 View tracked changes, Guide to refusals and appeals under scientific animal protection legislation PDF : 168 KB | 04/10/2023 This document has been substantially updated so no track changed document has been provided as it would not be helpful., Guide to use of animals for educational purposes under scientific animal protection legislation PDF : 129 KB | 16/10/2022 Guide to amendment and renewal applications for projects under scientific animal protection legislation PDF : 456 KB | 05/08/2019 View tracked changes Guide to transfers of project authorisations under scientific animal protection legislation PDF : 413 KB | 05/08/2019 View tracked changes Guide to preparation of a SMF for breeder supplier users under scientific animal protection legislation PDF : 311 KB | 07/03/2019 View tracked changes Guide to retrospective assessment reports under scientific animal protection legislation PDF : 228 KB | 15/02/2019 View tracked changes Guide to ethics committees assessment of project applications under scientific animal protection legislation PDF : 516 KB | 15/02/2019 View tracked changes Guide to withdrawal of breeder,supplier,user authorisations under scientific animal protection, legislation PDF : 218 KB | 06/02/2019 View tracked changes Guide to practices outside the scope of scientific animal protection legislation PDF : 200 KB | 21/01/2016 View tracked changes Compliance with scientific animal protection legislation PDF : 205 KB | 04/08/2014, Regulatory guidance documents | Scientific animal protection
https://www.hpra.ie/regulation/scientific-animal-protection/guidance-documentsRegulation | Scientific animal protection
Scientific animal protection Legislation Overview of the legislation that protects animals used for scientific or educational purposes., Learn more Guidance documents A collection of regulatory guidance documents related to scientific animal protection., Learn more National Committee Access more information about the national committee for the protection of animals used for scientific purposes., Learn more Useful links Find more resources on scientific animal protection including statistics and non-project summaries., Learn more Animal welfare body The purpose of the Animal Welfare Body (AWB) and how it helps drive a culture of care for animals., Regulation | Scientific animal protection
https://www.hpra.ie/regulation/scientific-animal-protectionFees | Scientific animal protection
Fees for scientific animal protection The HPRA charges fees for: new applications breeder/supplier/user establishments inspections projects How to pay fees to the HPRA Identify the correct fee category in the guide to fees., Guide to fees for scientific animal protection PDF : 86 KB | 02/01/2025 Complete the fee application form., Fee application form (scientific animal protection) XLSX : 100 KB | 02/01/2025 Make a bank transfer to the HPRA's account., Fees | Scientific animal protection
https://www.hpra.ie/regulation/scientific-animal-protection/fees-for-scientific-animal-protectionLegislation | Scientific animal protection
Legislation for scientific animal protection About the legislation Overview of the legislation that protects animals used for scientific or educational purposes., Learn more Scientific animal protection legislation A full list of references to the EU legislation on scientific animal protection from 2012-2022., Legislation | Scientific animal protection
https://www.hpra.ie/regulation/scientific-animal-protection/legislationRetrospective Assessment Submission for Projects authorised under Scientific Animal Protection Legislation
Retrospective Assessment Submission for Projects authorised under Scientific Animal Protection Legislation For details on completing this submission refer to the ‘Guide to Retrospective Assessment Submissions for Projects authorised under Scientific Animal Protection Legislation’., SECTION C: ANIMAL USE AND SEVERITY C1: ANIMAL USE Species of animal Total number of animals approved for use Total number of animals used If there are any differences between the total number of animals approved for use and the total number of animals actually used during the course of the project, provide an explanation., Note that each animal should only be recorded once, i.e. for each animal, record only the highest severity experienced by that animal., Could the animal monitoring and scoring regimes used during the project be further improved in future?, Were any issues relating to animal welfare raised during the course of this project?, Retrospective Assessment Submission for Projects authorised under Scientific Animal Protection Legislation
https://assets.hpra.ie/data/docs/default-source/submission-forms/aut-f0434-retrospective-assessment-submission-for-projects-authorised-under-scientific-animal-protection-legislation-v3.docx?sfvrsn=9b304ae8_11Make a submission | Scientific animal protection
Make a submission – scientific animal protection Application for renewal or amendment to a breeder supplier user authorisation under SAP legislation DOCX : 79 KB | 13/06/2025 Application for reactivation of an individual authorisation under scientific animal protection legislation DOCX : 111 KB | 08/04/2025 Retrospective Assessment Submission for Projects authorised under Scientific Animal Protection Legislation DOCX : 75 KB | 01/04/2025 Self-reporting of non-compliances under scientific animal protection legislation DOCX : 103 KB | 19/02/2025 Non-technical summary for a project under SAP legislation XLSX : 189 KB | 19/02/2025 Fee application form (scientific animal protection) XLSX : 99 KB | 02/01/2025 Application for an amendment or renewal to a project authorisation under SAP legislation DOCX : 90 KB | 23/07/2023 Application for an individual authorisation under scientific animal protection, legislation DOCX : 127 KB | 05/09/2022 Application for an amendment to an individual authorisation under scientific animal protection legislation DOCX : 119 KB | 05/09/2022 Classification request for a project study or technique under scientific animal protection legislation DOCX : 103 KB | 04/05/2022 Individual training record for scientific animal protection DOCX : 104 KB | 22/03/2022 Application for a project authorisation under scientific animal protection legislation (no functionality) DOCX : 143 KB | 30/03/2021 Application for a project authorisation under scientific animal protection legislation DOCX : 157 KB | 27/02/2021 Application for transfer of a project authorisation under scientific animal protection legislation DOCX : 108 KB | 05/08/2019 Application for authorisation of breeder,supplier,users under scientific animal protection legislation DOCX : 64 KB | 28/05/2019 Application for withdrawal of, a breeder, supplier, user authorisation under SAP legislation DOCX : 99 KB | 07/03/2019 Application for a renewal of an individual authorisation under scientific animal protection legislation DOCX : 105 KB | 13/12/2017 Application for a clinical field trial licence under animal remedies legislation DOCX : 109 KB | 21/09/2016 Application for a variation to a veterinary clinical field trial licence under animal remedies legislation DOCX : 69 KB | 24/06/2015 Curriculum vitae for applications under scientific animal protection legislation DOCX : 61 KB | 11/06/2014, Make a submission | Scientific animal protection
https://www.hpra.ie/make-a-submission/scientific-animal-protectionLegislation for scientific animal protection
Legislation for scientific animal protection Scientific animal protection legislation European Union (Protection of Animals used for Scientific Purposes) Regulations 2012 (SI 543/2012) European Union (Protection of Animals used for Scientific Purposes) (Amendment) Regulations 2013 (SI 434/2013) European Union (Protection of Animals used for Scientific Purposes) (Amendment) Regulations 2014 (SI 174/2014) European Union (Protection of Animals used for Scientific Purposes) (Amendment) Regulations 2016 (SI 552/2016) European Union (Protection of Animals used for Scientific Purposes) Regulations 2018 (SI 553/2018) European Union (Protection of Animals used for Scientific Purposes) (Amendment) Regulations 2020 (SI 324/2020) European Union (Protection of Animals used for Scientific Purposes) (Amendment) Regulations 2022 (SI 205/2022) Establishment of the HPRA Irish Medicines Board Act 1995 Irish Medicines Board (Miscellaneous Provisions) Act 2006, Legislation for scientific animal protection
https://www.hpra.ie/regulation/scientific-animal-protection/legislation/legislation-for-scientific-animal-protectionCompliance with scientific animal protection legislation
Guide to Compliance with Scientific Animal Protection Legislation HPRA Guide to Compliance with Scientific Animal Protection Legislation SUR-G0029-3 2/8 1 INTRODUCTION The HPRA’s aim is to ensure that the requirements of Directive 2010/63/EU (the Directive) and S.I., No. 174 of 2014 (the Regulations) on the protection of animals used for scientific purposes are met, by implementing a strategy which is effective, proportionate and dissuasive., Both ‘top-down’ (management) and HPRA Guide to Compliance with Scientific Animal Protection Legislation SUR-G0029-3 3/8 ‘bottom-up’ approaches (local staff/researchers) will be applied to ensure that any necessary corrective actions are understood and implemented effectively, HPRA Guide to Compliance with Scientific Animal Protection Legislation SUR-G0029-3 7/8 e) Closure order An authorised officer, following consultations with the chief executive of the HPRA, may issue a closure order to close an establishment (or part thereof) when there is, or is likely to be, a grave and immediate danger to animal welfare., g) Power to seize and dispose of an animal HPRA Guide to Compliance with Scientific Animal Protection Legislation SUR-G0029-3 8/8 An authorised officer has the authority to seize an animal at a breeder/supplier/user when a person has failed to comply with the terms of a notice or order, or the officer believes they will not comply with a notice or order., Compliance with scientific animal protection legislation
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/sur-g0029-compliance-with-scientific-animal-protection-legislation-v3.pdf?sfvrsn=9ef93056_5Guide to retrospective assessment reports under scientific animal protection legislation
AUT-G0129-2 1/4 Guide to Retrospective Assessment Reports under Scientific Animal Protection Legislation 1 SCOPE This guidance is intended to assist authorisation holders in completing the HPRA retrospective assessment report form for projects authorised under Directive 2010/63/EU (the Directive) and S.I., Any escalation in severity should always be reported immediately to the HPRA. 3 COMPLETING A RETROSPECTIVE ASSESSMENT REPORT FOR PROJECTS Complete the required sections of the ‘Retrospective Assessment Report for Projects Authorised under Scientific Animal Protection Legislation’ form using information from the project authorisation., HPRA Guide to Retrospective Assessment Reports under Scientific Animal Protection Legislation AUT-G0129-2 2/4 3.2 Section B – Project objectives This section requires detailed information about the achievement of the project objectives and any benefits that have been accrued. 3.3 Section C – Animal use and severity 3.3.1 Animal use Enter the species and numbers of animals authorised for the project in the table provided as well as the numbers of animals that were actually used for procedures during the course of the project., HPRA Guide to Retrospective Assessment Reports under Scientific Animal Protection Legislation AUT-G0129-2 3/4 3.4 Section D – Implementation of the 3Rs 3.4.1 Replacement Provide details about any developments in the relevant scientific field which could replace the use of animals in this type of research., HPRA Guide to Retrospective Assessment Reports under Scientific Animal Protection Legislation AUT-G0129-2 4/4 4 ADMINISTRATIVE DETAILS If required, a retrospective assessment must be submitted by the date given under the terms of the project authorisation., Guide to retrospective assessment reports under scientific animal protection legislation
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/aut-g0129-guide-to-retrospective-assessment-reports-under-scientific-animal-protection-legislation-pdf-v2.pdf?sfvrsn=a2afd817_5Guide to applications for breeder, supplier, users under scientific animal protection legislation
In particular, the compliance officer is a key figure who bears ultimate responsibility for compliance with scientific animal protection legislation., Separate advice on the content and construct of the SMF is outlined in the HPRA ‘Guide to Preparation of a Site Master File (SMF) for Breeder/Supplier/Users under Scientific Animal Protection Legislation’, available on the HPRA website, under Regulation and Scientific Animal Protection (at www.hpra.ie/regulation/scientific- animal-protection/guidance-documents)., Applications are not validated as eligible for HPRA scientific animal protection (SAP) assessment until all necessary documentation has been provided., Separate guidance on the format and content of the SMF for breeder/supplier/users authorised under scientific animal protection can be found on the HPRA website, under Regulation and Scientific Animal Protection. 9 SECTION E - DECLARATION AND UNDERTAKING The declaration and undertaking must be signed by the person(s) indicated in section 6.1 of this guide, i.e. the compliance officer(s) under scientific animal protection legislation., Please see the ‘HPRA Guide to Fees for Scientific Animal Protection’, which can be found on the HPRA website under Regulation and Scientific Animal Protection., Guide to applications for breeder, supplier, users under scientific animal protection legislation
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/aut-g0096-guide-to-applications-for-breeder-supplier-users-under-scientific-animal-protection-legislation-v5.pdf?sfvrsn=f61ce0dc_12