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Self-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_7Application 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_6Guide to use of animals for educational purposes under scientific animal protection legislation
Guide to Use of Animals for Educational Purposes under Scientific Animal Protection Legislation HPRA Guide to Use of Animals for Educational Purposes under Scientific Animal Protection Legislation AUT-G0117-5 2/6 1 SCOPE Directive 2010/63/EU (the Directive) and S.I., No. 324 of 2020 (hereafter referred to as the Regulations) establish measures for the protection of animals used for scientific or educational purposes., HPRA Guide to Use of Animals for Educational Purposes under Scientific Animal Protection Legislation AUT-G0117-5 4/6 4.1 Use of animals in education of agricultural, veterinary, life sciences or medical students The use of animals in education of third or fourth level students may be divided into the following categories: 4.1.1 Use of live animals for animal handling training Use of animals for training in proper animal handling does not fall under the scope of the legislation where such use does not ‘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’., Further information is provided in the Guide to project applications under Scientific Animal Protection Legislation. 4.1.3 Use of cadavers for dissection labs Animal cadavers are frequently used to train undergraduates in anatomy and physiology., HPRA Guide to Use of Animals for Educational Purposes under Scientific Animal Protection Legislation AUT-G0117-5 6/6 Training in animal handling skills does not require a project authorisation, but any procedures that are carried out as part of vocational training on live animals will require a breeder/supplier/user authorisation, project authorisation and individual authorisations for trainers and trainees., Guide to use of animals for educational purposes under scientific animal protection legislation
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/aut-g0117-guide-to-use-of-animals-for-educational-purposes-under-scientific-animal-protection-legislation-v5.pdf?sfvrsn=aefd9942_6Guide to retrospective assessment reports under scientific animal protection legislation changes tracked
AUT-G0129-1.1 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 COMPLIETING 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-G0129-1.1 2/4 3.2 Section BC – Project objectives This section requires detailed information about the achievement of the project objectives and any benefits that have been accrued. 3.3 Section CD – 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., This section should include details on issues relating to animal welfare that were raised by animal care staff, researchers, the designated veterinarian or other personnel during the course of the project., HPRA Guide to Retrospective Assessment Reports under Scientific Animal Protection Legislation AUT-G0129-1.1 4/4 Queries in respect of the retrospective assessment requirements can be made by telephone, fax, orand e-mail or by post to the following address: Scientific Animal Protection Section Veterinary Sciences Department, Health Products Regulatory Authority, Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2., Guide to retrospective assessment reports under scientific animal protection legislation changes tracked
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/aut-g0129-guide-to-retrospective-assessment-reports-under-scientific-animal-protection-legislation-v2-change-tracked01d9fbdf-be36-4d3f-9050-de72ee3ed6e1.pdf?sfvrsn=78c3520d_4Classification 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_6Curriculum vitae for applications under scientific animal protection legislation
Curriculum Vitae for Applications under Scientific Animal Protection Legislation Personal information Title: First name: Surname: Address 1: Address 2: Address 3: County: Telephone: E-mail: expertise Primary areas of expertise: work experience Dates (from – to): Name and address of employer: Occupation or position held: Main activities and responsibilities: (i) Dates (from – to): Name and address of employer: Occupation or position held: Main activities and responsibilities: Dates (from – to): Name and address of employer: Occupation or position held: Main activities and responsibilities: education Dates (from – to): Name and type of organisation providing the education: Principal subjects / occupational skills covered: Title of qualification awarded: Dates (from – to): Name and type of organisation providing, Curriculum vitae for applications under scientific animal protection legislation
https://assets.hpra.ie/data/docs/default-source/submission-forms/aut-f0350-curriculum-vitae-for-applications-under-scientific-animal-protection-legislation-v3.docx?sfvrsn=24292c0f_6Guide 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_10Guide 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_4Guide to refusals and appeals under scientific animal protection legislation changes tracked
HPRA Guide to Refusals and Appeals Under Scientific Animal Protection Legislation AUT-G0122-23 4/13 The procedure for refusals is shown in the flowchart belowFlowchart 1., HPRA Guide to Refusals and Appeals Under Scientific Animal Protection Legislation AUT-G0122-23 5/13 Flowchart 1., HPRA Guide to Refusals and Appeals Under Scientific Animal Protection Legislation AUT-G0122-23 7/13 In the case of a compliance notice, the HLT will consider the appeal., HPRA Guide to Refusals and Appeals Under Scientific Animal Protection Legislation AUT-G0122-23 8/13 Flowchart 2., A decision is made by the Authority in consultation with the special committee on scientific animal protection appeals. 4., 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_3Guide 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_4