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Guide 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_4Guide to training education and competency requirements under scientific animal protection legislation changes tracked
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-G0118-78 2/12/13 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 10 8 CONTINUOUS PROFESSIONAL DEVELOPMENT 10 APPENDIX I THE LEARNING PROCESS 12 APPENDIX II DEFINITIONS 13 HPRA Guide to Training, Education and Competency Requirements under Scientific Animal Protection Legislation AUT-G0118-78 3/12/13 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., HPRA Guide to Training, Education and Competency Requirements under Scientific Animal Protection Legislation AUT-G0118-78 4/12/13 To ensure compliance with the legislation, and to minimise any pain, suffering, distress or lasting harm to animals, proper training of staff at breeder/supplier/user establishments is essential., Proper training also facilitates good animal welfare and good science., It is not a mandatory requirement that such HPRA Guide to Training, Education and Competency Requirements under Scientific Animal Protection Legislation AUT-G0118-78 9/12/13 persons have been educated to third level but they must have the necessary experience for the role., HPRA Guide to Training, Education and Competency Requirements under Scientific Animal Protection Legislation AUT-G0118-78 12/12/13 APPENDIX I THE LEARNING PROCESS HPRA Guide to Training, Education and Competency Requirements under Scientific Animal Protection Legislation AUT-G0118-78 13/12/13 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 changes tracked
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/aut-g0118-guide-to-training-education-and-competency-requirements-under-scientific-animal-protection-legislation-v8-changes-tracked.pdf?sfvrsn=27922570_3Application 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 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 fees for scientific animal protection changes tracked
FIN-G0007-1314 1/2 Guide to Fees for Scientific Animal Protection INTRODUCTION The Health Products Regulatory Authority (HPRA) is the competent authority for the protection of animals used for scientific purposes under S.I., It follows the order of the fees in the ‘Fee Application Form (Scientific Animal Protection)’ and uses the fee code numbers in that form., HPRA Guide to Fees for Scientific Animal Protection FIN-G0007-1314 2/2 1.3 Short-term individual authorisation for a period of two months or less Code 812 is a reduced fee which applies to a once-off short-term individual authorisation, for example, for the purposes of demonstrating a procedure or for training in a procedure, where the authorisations are for a period of two months or less. 2 BREEDER/SUPPLIER/USER AUTHORISATION FEES (ESTABLISHMENT) Fee codes 830-838 are annual fees payable for each establishment based on the number of individual authorisations in place at the establishment., Guide to fees for scientific animal protection changes tracked
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/fin-g0007-guide-to-fees-for-scientific-animal-protection-v14-changes-tracked.pdf?sfvrsn=52aa6015_7Classification 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_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_10Curriculum 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 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 applications for breeder-supplier-users under scientific animal protection legislation changes tracked
In particular, the compliance officer is a key figure who bears ultimate responsibility for compliance with scientific animal protection legislation., Guide to Applications for Breeder/Supplier/User Authorisations under Scientific Animal Protection Legislation AUT-G0096-45 10/11/14 7 SECTION C - ANIMAL WELFARE BODY This section relates exclusively to the animal welfare body., The scientific animal protection legislation requires an animal welfare bodyAWB to operate in each breeder/supplier/user establishment, in accordance with Article 26 of the Directive and Regulation 50., Separate guidance on the format and content of the site master fileSMF for breeder/supplier/users authorised under scientific animal protection can be found at www.hpra.ie/publicationson 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 aboveof 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 the SAP GuidesRegulation and Forms section at www.hpra.ie.Scientific Animal Protection., Guide to applications for breeder-supplier-users under scientific animal protection legislation changes tracked
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/guide-to-applications-for-breeder-supplier-users-under-scientific-animal-protection-legislation-v5_ct.pdf?sfvrsn=e3506c18_5