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Application for a project authorisation under scientific animal protection legislation
Application for a Project Authorisation under Scientific Animal Protection Legislation For details on completing this application form, refer to the ‘Guide to Project Applications under Scientific Animal Protection Legislation’ available at www.hpra.ie., ☐ Yes ☐ No If ‘no’, complete the ‘Fee Application Form for Scientific Animal Protection’ available at www.hpra.ie., List the most relevant key references or regulatory guidelines (up to 10) supporting the need for the project: SECTION E: NON-TECHNICAL project SUMMARY Provide a completed ‘Non-Technical Project Summary for a Project under Scientific Animal Protection Legislation’ form in Excel format, using the template which is available on the Scientific Animal Protection Guides and Forms section of www.hpra.ie., G2: ANIMAL WELFARE MONITORING ARRANGEMENTS 1., SECTION h: animal information H1: ANIMALS TO BE USED 1., Application for a project authorisation under scientific animal protection legislation
https://assets.hpra.ie/data/docs/default-source/submission-forms/aut-f0339-application-for-a-project-authorisation-under-scientific-animal-protection-legislation-v11.docx?sfvrsn=c3286894_5Guide to refusals and appeals under scientific animal protection legislation changes tracked
Guide to Refusals and Appeals Under Scientific Animal Protection Legislation Guide to Refusals and Appeals Under Scientific Animal Protection Legislation AUT-G0122-12 2/9 CONTENTS 1 SCOPE 3 2 PROCEDURES 3 2.1 Introduction 3 2.2 Refusal procedure 3 2.3 Appeals 5 3 SUBMISSION OF WRITTEN INFORMATION 7 4 ORAL HEARINGS 8 5 CONTACT POINT FOR PROCEDURES 9 Guide to Refusals and Appeals Under Scientific Animal Protection Legislation AUT-G0122-12 3/9 1 SCOPE This guide provides information to applicants and appellants on refusals and appeals procedures relating to the grant of authorisations, and the issuing of orders and notices according to the provisions of S.I., Guide to Refusals and Appeals Under Scientific Animal Protection Legislation AUT-G0122-12 4/9 The procedure for refusals is shown in the flowchart below., In the case of a closure order, suspension or revocation of authorisation orders or a refusal to grant an authorisation, the Board Committee on scientific animal protection appeals will consider the appeal and advise the BoardAuthority., Appeals to orders, notices or refusals Appeals to animal welfare or compliance notice Appeals to closure order, suspension or revocation order or refusal to grant an authorisation Order lifted or authorisation granted Appeal rejected Acknowledgement, with date of Authority meeting Authority Authorisation suspended or revoked or grant of authorisation refused Appeal from applicant Notice from authorised officer Appeal from applicant Notice confirmed Order made or refusal to grant by Management Committee Management Committee Appeal accepted Acknowledgement, with date of Management Committee meeting Notice overturned Committee on Scientific Animal Protection Appeals Appeal accepted Appeal rejected Guide to Refusals and Appeals Under Scientific Animal Protection Legislation AUT-G0122-12 8/9 4 ORAL HEARINGS If applicants wish to make an oral representation at the Management Committee, Board Committee on scientific animal protection appeals or at the, Guide to Refusals and Appeals Under Scientific Animal Protection Legislation AUT-G0122-12 9/9 5 CONTACT POINT FOR PROCEDURES Secretary to the Board, Committee: Ms Amhairgín Ni Laoi,Jackie Cottell or Secretary to the Authority: Ms., Guide to refusals and appeals under scientific animal protection legislation changes tracked
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/aut-g0122-guide-to-refusals-and-appeals-under-scientific-animal-protection-legislation-v2-changes-tracked.pdf?sfvrsn=5f956418_2Classification request for a project study or technique under scientific animal protection legislation
Classification Request for a Project/Study/Technique under Scientific Animal Protection Legislation Refer to the ‘Guide to Practices outside the Scope of Scientific Animal Protection Legislation’ when completing this form., (If so, please provide the previous HPRA classification request number) Section b: Details of request Purpose of project/study/technique Species of animal to be used Number of animals to be used Which category do you propose this project/study/technique falls into?, Select all that apply ☐ Non-experimental agricultural practices ☐ Non-experimental clinical veterinary practices ☐ Veterinary clinical field trials required for the marketing authorisation of a veterinary medicinal product ☐ Practices undertaken for the purposes of recognised animal husbandry ☐ Practices undertaken for the primary purpose of identification of an animal ☐ Practices not likely to cause 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 ☐ Other In relation to the category/categories chosen above, describe your reasoning as to why this project/study/technique may fall outside the scope of scientific animal protection legislation Section c: checklist and signature of applicant Have sections A and B of this form been completed in full?, Classification request for a project study or technique under scientific animal protection legislation
https://assets.hpra.ie/data/docs/default-source/submission-forms/adv-f0050-classification-request-for-a-project-study-or-technique-under-scientific-animal-protection-legislation-v4.docx?sfvrsn=a6caee8c_5Guide to practices outside the scope of scientific animal protection legislation changes tracked
Guide to Practices Outside outside the Scope of Scientific Animal Protection Legislation HPRA Guide to Practices Outside the Scope of Scientific Animal Protection Legislation AUT-G0119-3.1 2/9 1 INTRODUCTION This guide is intended to clarify when studies or practices involving animals may fall outside the legislation governing the protection of animals used for scientific purposes i.e., The EU Commission advice is that the conduct of pre-clinical trials falls within the scope of scientific animal protection legislation and requires HPRA project authorisation., Pre clinical trials may involve safety and efficacy studies not conducted in the field, which would then fall within the scope of scientific animal protection legislation., Veterinary clinical field trials should not be confused with regulatory testing which falls within the scope of scientific animal protection legislation., Send hard copy applications to: Scientific Animal Protection Section Health Products Regulatory Authority Kevin O’Malley House Earlsfort Centre Earlsfort Terrace Dublin 2 HPRA Guide to Practices Outside the Scope of Scientific Animal Protection Legislation AUT-G0119-3.1 9/9 4 SUMMARY For the purposes of this guide, the HPRA concludes that the following trials, studies or practices fall outside the scope of scientific animal protection legislation: - General nutritional trials (which tend to be observational only) where the animals’ nutritional needs are met in full, no procedures are conducted, Guide to practices outside the scope of scientific animal protection legislation changes tracked
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/aut-g0119-guide-to-practices-outside-the-scope-of-scientific-animal-protection-legislation-v4-with-changes-tracked6bef9a5e-d1c5-4b81-a792-4c37af7b40dd.pdf?sfvrsn=c0a2afdf_3Guide to practices outside the scope of scientific animal protection legislation with changes tracked
Guide to Practices Outside outside the Scope of Scientific Animal Protection Legislation HPRA Guide to Practices Outside the Scope of Scientific Animal Protection Legislation AUT-G0119-3.1 2/9 1 INTRODUCTION This guide is intended to clarify when studies or practices involving animals may fall outside the legislation governing the protection of animals used for scientific purposes i.e., The EU Commission advice is that the conduct of pre-clinical trials falls within the scope of scientific animal protection legislation and requires HPRA project authorisation., Pre clinical trials may involve safety and efficacy studies not conducted in the field, which would then fall within the scope of scientific animal protection legislation., Veterinary clinical field trials should not be confused with regulatory testing which falls within the scope of scientific animal protection legislation., Send hard copy applications to: Scientific Animal Protection Section Health Products Regulatory Authority Kevin O’Malley House Earlsfort Centre Earlsfort Terrace Dublin 2 HPRA Guide to Practices Outside the Scope of Scientific Animal Protection Legislation AUT-G0119-3.1 9/9 4 SUMMARY For the purposes of this guide, the HPRA concludes that the following trials, studies or practices fall outside the scope of scientific animal protection legislation: - General nutritional trials (which tend to be observational only) where the animals’ nutritional needs are met in full, no procedures are conducted, Guide to practices outside the scope of scientific animal protection legislation with changes tracked
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/aut-g0119-guide-to-practices-outside-the-scope-of-scientific-animal-protection-legislation-v4-with-changes-tracked.pdf?sfvrsn=31276518_2Guide to training education and competency requirements under scientific animal protection legislation
Guide to Training, Education and Competency Requirements under Scientific Animal Protection Legislation HPRA Guide to Training, Education and Competency Requirements under Scientific Animal Protection Legislation AUT-G0118-8 2/12 CONTENTS 1 SCOPE 3 2 INTRODUCTION 3 3 DEFINITIONS 4 4 ROLES AND RESPONSIBILITIES 4 5 GENERAL TRAINING REQUIREMENTS 5 6 SPECIFIC TRAINING REQUIREMENTS 7 7 TRAINING RECORDS 9 8 CONTINUOUS PROFESSIONAL DEVELOPMENT 9 APPENDIX I THE LEARNING PROCESS 11 APPENDIX II DEFINITIONS 12 HPRA Guide to Training, Education and Competency Requirements under Scientific Animal Protection Legislation AUT-G0118-8 3/12 1 SCOPE This guidance sets out the education and training requirements for personnel involved in the use of animals for scientific or educational purposes within breeder/supplier/user establishments in accordance with Directive 2010/63/EU and S.I., Instead, applicants HPRA Guide to Training, Education and Competency Requirements under Scientific Animal Protection Legislation AUT-G0118-8 7/12 should await the availability of a suitable opportunity to train., HPRA Guide to Training, Education and Competency Requirements under Scientific Animal Protection Legislation AUT-G0118-8 8/12 An individual authorisation from the HPRA is not required for personnel engaged solely in designing procedures and projects., HPRA Guide to Training, Education and Competency Requirements under Scientific Animal Protection Legislation AUT-G0118-8 9/12 7 TRAINING RECORDS The HPRA expects that verified and accurate records of education and training, including CPD, are maintained by all persons holding HPRA individual authorisation., HPRA Guide to Training, Education and Competency Requirements under Scientific Animal Protection Legislation AUT-G0118-8 11/12 APPENDIX I THE LEARNING PROCESS HPRA Guide to Training, Education and Competency Requirements under Scientific Animal Protection Legislation AUT-G0118-8 12/12 APPENDIX II DEFINITIONS Compliance officer means a person designated by a breeder/supplier/user pursuant to Regulation 44 of the Regulations, who is responsible for ensuring compliance with the Regulations., Guide to training education and competency requirements under scientific animal protection legislation
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/aut-g0118-guide-to-training-education-and-competency-requirements-under-scientific-animal-protection-legislation-v8.pdf?sfvrsn=68ec45ac_9Training requirements and courses | Scientific animal protection
Guide to training education and competency requirements under scientific animal protection legislation PDF : 244 KB | 01/04/2025 Note that the HPRA itself does not offer training., Training requirements and courses | Scientific animal protection
https://www.hpra.ie/regulation/scientific-animal-protection/training-requirements-and-coursesGuide to ethics committees assessment of project applications under scientific animal protection legislation changes tracked
It also describes the evidence to be provided to the HPRA and included as supporting documentation as outlined in the ‘Guide to Project Applications under Scientific Animal Protection Legislation’., This is seen to be in the best interests of animal HPRA Guide to Ethics Committee Assessment of Project Applications under Scientific Animal Protection Legislation AUT-G0116-3.1 5/16 welfare and in to improve the overall efficiency of the process., The HPRA is open to the integration of the ethics committee with the animal welfare body, or to other governance HPRA Guide to Ethics Committee Assessment of Project Applications under Scientific Animal Protection Legislation AUT-G0116-3.1 6/16 arrangements such that both bodies work closely together for the benefit of animal welfare and are informed of each other’s decisions (as relevant)., Refer to the ‘Guide to Amendment and Renewal Applications for Projects under Scientific Animal Protection Legislation’ for information on submitting amendment applications., HPRA Guide to Ethics Committee Assessment of Project Applications under Scientific Animal Protection Legislation AUT-G0116-3.1 12/16 6.2 Assessment of the potential benefits being realised The HPRA notes that the criteria in section 6.1 might not be demonstrable in every case., Guide to ethics committees assessment of project applications under scientific animal protection legislation changes tracked
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/aut-g0116-guide-to-ethics-committees-assessment-of-project-applications-under-scientific-animal-protection-legislation-pdf-v4-changes-tracked6c6b4233-7ce4-41cf-8da5-7ac8b52ac9c1.pdf?sfvrsn=7cdc59d_3Application for authorisation of breeder,supplier,users under scientific animal protection legislation
Application for Authorisation of Breeder/Supplier/Users under Scientific Animal Protection Legislation Section A: breeder/supplier/user establishment Details APPLICANT DETAILS (I.E., establishments with no locations If the application is for a user establishment that does not have any animal facilities, the establishment location fields should not be completed., Title & Name Role in animal welfare body Section D: Site Master file Submit a completed site master file with this application form, providing the information outlined in the ‘Guide to Preparation of a Site Master File for Breeder/Supplier/Users under Scientific Animal Protection Legislation’ (available at www.hpra.ie)., oany restrictions on the extent to which an animal can satisfy its physiological and ethological needs are kept to a minimum., othe welfare and care of animals is appropriately overseen and that the animal welfare body is appropriately informed and consulted., Application for authorisation of breeder,supplier,users under scientific animal protection legislation
https://assets.hpra.ie/data/docs/default-source/submission-forms/aut-f0345-application-for-authorisation-of-breeder-supplier-users-under-scientific-animal-protection-legislation-v7.docx?sfvrsn=7f2e86d1_5Self-reporting of non-compliances under scientific animal protection legislation
Self-Reporting of Potential Non-Compliances under Scientific Animal Protection Legislation This form should be used by breeder/supplier/user establishment personnel to report suspected or confirmed breaches of scientific animal protection legislation (S.I., FORMTEXT 2Animal welfare (if applicable) If this incident resulted in a negative impact on animal welfare, please provide details (include species, life stage, and number of animals affected)., Self-reporting of non-compliances under scientific animal protection legislation
https://assets.hpra.ie/data/docs/default-source/submission-forms/ia-f0269-self-reporting-of-non-compliances-under-scientific-animal-protection-legislation-v1.docx?sfvrsn=183f5029_4