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Guide 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_5Application for an individual authorisation under scientific animal protection legislation
Application for an Individual Authorisation under Scientific Animal Protection Legislation For details on completing this application form, please see the HPRA ‘Guide to New, Amendment, Renewal and Reactivation Applications for Individuals under Scientific Animal Protection Legislation’., Have you completed a relevant approved or accredited scientific animal training course?, Select the species of animal(s) for which authorisation is sought using the table below., Where the species of animal does not clearly fit into the general categories provided, please specify the species in the relevant column., Application for an individual authorisation under scientific animal protection legislation
https://assets.hpra.ie/data/docs/default-source/submission-forms/aut-f0344-application-for-an-individual-authorisation-under-scientific-animal-protection-legislationv18.docx?sfvrsn=e33b8ac5_6Guide 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., Authorised breeders/suppliers/usersuser establishments are subject to regular inspections to ensure that they are operating the establishments are working to the required animal welfare standards, are complying with the conditions of their authorisation(s) and the requirements of the scientific animal protection legislation, as well as other applicable regulations.., Separate advice on the content and construct of the site master file is available in the HPRA ‘Guide to Preparation of a Site Master File (SMF) for Breeder/Supplier/Users under Scientific Animal Protection legislationLegislation’., The scientific animal protection legislation requires an animal welfare body to operate in each breeder/supplier/user establishment, in accordance with Article 26 and Regulation 50., Separate guidance on the format and content of the site master file for establishmentsbreeder/supplier/users authorised under scientific animal protection can be found at www.hpra.ie. 8section d - Declaration and undertaking The declaration and undertaking must be signed by the person(s) indicated in section 5.2.1 above i.e. the compliance officer(s) under scientific animal protection legislation., 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-v3_ct.docx?sfvrsn=e3506c18_2Guide to ethics committees assessment of project applications under scientific animal protection legislation pdf 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 pdf 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-tracked.pdf?sfvrsn=62296518_2Guide to practices outside the scope of scientific animal protection legislation
Guide to Practices outside the Scope of Scientific Animal Protection Legislation HPRA Guide to Practices Outside the Scope of Scientific Animal Protection Legislation AUT-G0119-4 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., Additionally, confirmation of dose studies carried out under laboratory conditions or in artificially diseased or infected animals also falls within the scope of scientific animal protection legislation., HPRA Guide to Practices Outside the Scope of Scientific Animal Protection Legislation AUT-G0119-4 7/9 3.2.1 Section A, Applicant Details Information and contact details for the applicant should be provided here., For the purposes of this guide, the HPRA concludes that the following trials, studies or practices fall within the scope of scientific animal protection legislation: HPRA Guide to Practices Outside the Scope of Scientific Animal Protection Legislation AUT-G0119-4 9/9 - Practices likely to 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 according to Good Veterinary Practice, Guide to practices outside the scope of scientific animal protection legislation
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/aut-g0119-guide-to-practices-outside-the-scope-of-scientific-animal-protection-legislation-pdf-v4.pdf?sfvrsn=64ebed45_5Guide to withdrawal of breeder,supplier,user authorisations under scientific animal protection legislation changes tracked
AUT-G0100-12 1/3 Guide to Withdrawal of Breeder/Supplier/User Authorisations under Scientific Animal Protection Legislation 1 SCOPE This guide applies to the withdrawal by the holder of a breeder/supplier/user authorisation of their authorisation for breeding, supplying and/or using animals for scientific purposes under Directive 2010/63/EU (the Directive) and S.I., Notification of the withdrawal of a breeder/supplier/user authorisation should be made using the ‘Application for Withdrawal of a Breeder/Supplier/User Authorisation under Scientific Animal Protection Legislation’ available at www.hpra.ie., HPRA Guide to Withdrawal of Breeder/Supplier/User Authorisations under Scientific Animal Protection Legislation AUT-G0100-12 2/3 3.3 Details on the fate of the animals post withdrawal In order for a breeder/supplier/user authorisation to be withdrawn, the animals kept at that the breeder/supplier/user establishment must be removed accordingly., Any projects not transferred and all project work must cease animal work immediately as of the withdrawal date of the breeder/supplier/user establishment authorisation., Breeder/supplier/user withdrawal application forms can also be submitted by standard e-mail to sapsubmit@hpra.ie or in hard copy to: Scientific Animal Protection Section Veterinary Sciences Department Health Products Regulatory Authority Kevin O’Malley House Earlsfort Centre Earlsfort Terrace Dublin 2 Queries in respect of application requirements or communications relating to applications submitted can be made by telephone or, fax, e-mail: or by post to the address above: HPRA Guide to Withdrawal of Breeder/Supplier/User Authorisations under Scientific Animal Protection Legislation AUT-G0100-12 3/3 Tel: +353 1 676 4971 Fax: +353 1 676 7836 E-mail: sap@hpra.ie Fees: Currently there are no fees for this application., Guide to withdrawal of breeder,supplier,user authorisations under scientific animal protection legislation changes tracked
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/aut-g0100-guide-to-withdrawal-of-breeder-supplier-user-authorisations-under-scientific-animal-protection-legislation-v2--changes-tracked.pdf?sfvrsn=ee226518_2Guide to retrospective assessment reports under scientific animal protection legislation change 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 change 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-tracked.pdf?sfvrsn=ed296518_2Guide to project applications under scientific animal protection legislation changes tracked
Guide to Project Applications under Scientific Animal Protection Legislation HPRA Guide to Project Applications Under Scientific Animal Protection Legislation AUT-G0098-13 2/42 CONTENTS 1 SCOPE 3 2 INTRODUCTION 3 3 DEFINITIONS 3 4 APPLICATIONS FOR A PROJECT AUTHORISATION 3 5 APPLICATION FORM: SECTION A - PROJECT TITLE AND PROPOSED PROJECT AUTHORISATION HOLDER (I.E., HPRA Guide to Project Applications Under Scientific Animal Protection Legislation AUT-G0098-13 16/42 Term Explanation of term Duration (how long will the procedure take and how long will the animal be affected for?), Food restriction should be avoided in ferrets, HPRA Guide to Project Applications Under Scientific Animal Protection Legislation AUT-G0098-13 20/42 guinea pigs and shrews., HPRA Guide to Project Applications Under Scientific Animal Protection Legislation AUT-G0098-14 39/42 5., FURTHER INFORMATION CAN BE FOUND IN THE HPRA ‘GUIDE TO NEW, RENEWAL AND AMENDMENT APPLICATIONS FOR INDIVIDUALS UNDER SCIENTIFIC ANIMAL PROTECTION LEGISLATION’ AT WWW.HPRA.IE., Guide to project applications under scientific animal protection legislation changes tracked
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/aut-g0098-guide-to-project-applications-under-scientific-animal-protection-legislation-v14-changes-tracked.pdf?sfvrsn=24badac5_8Guide to ethics committees assessment of project applications under scientific animal protection legislation
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 welfare and to improve the HPRA Guide to Ethics Committee Assessment of Project Applications under Scientific Animal Protection Legislation AUT-G0116-4 4/12 overall efficiency of the process., HPRA Guide to Ethics Committee Assessment of Project Applications under Scientific Animal Protection Legislation AUT-G0116-4 9/12 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., HPRA Guide to Ethics Committee Assessment of Project Applications under Scientific Animal Protection Legislation AUT-G0116-4 11/12 Whether the ethical reviews take place face-to-face or virtually, a record (i.e. minutes) must be taken., HPRA Guide to Ethics Committee Assessment of Project Applications under Scientific Animal Protection Legislation AUT-G0116-4 12/12 The proper conduct of a harm-benefit analysis can be quite complex with no specific mathematical formula available to deliver a decision., Guide to ethics committees assessment of project applications under scientific animal protection legislation
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/aut-g0116-guide-to-ethics-committees-assessment-of-project-applications-under-scientific-animal-protection-legislation-pdf-v4.pdf?sfvrsn=6dace401_6Guide to transfers of project authorisations under scientific animal protection legislation changes tracked
Guide to Transfers of Project Authorisations under Scientific Animal Protection Legislation HPRA Guide to Transfers of Project Authorisations under Scientific Animal Protection Legislation AUT-G0135-23 2/7 CONTENTS 1 SCOPE 3 2 INTRODUCTION 3 3 APPLICATIONS FOR A PROJECT TRANSFER 3 3.1 Existing project authorisation holder declaration 3 3.2 Proposed project authorisation holder declaration and undertaking and compliance officer/ proposed new compliance officer declaration 4 4 MAKING AN APPLICATION 4 5 ADMINISTRATIVE DETAILS 7 1 SCOPE 3 2 INTRODUCTION 3 3 APPLICATIONS FOR A PROJECT TRANSFER 3 3.1 Existing project authorisation holder declaration 3 3.2 Proposed project authorisation holder declaration and undertaking and compliance officer/ proposed new compliance officer declaration 4 3.3 Ethical approval 4 4 MAKING AN APPLICATION 4 5 ADMINISTRATIVE DETAILS 7 HPRA Guide to Transfers of Project Authorisations under Scientific Animal Protection Legislation AUT-G0135-, Therefore, please refer to the ‘Guide to Amendment and Renewal Applications for Projects under Scientific Animal Protection’., Protection Legislation’., HPRA Guide to Transfers of Project Authorisations under Scientific Animal Protection Legislation AUT-G0135-23 4/7 3.2 Proposed project authorisation holder declaration and undertaking and compliance officer/ proposed new compliance officer declaration The declaration and undertaking in Section C of the application form must be signed by the proposed (new) authorisation holder., This should be followed by an underscore and one of the following words/phrases: - Transfer application form: to be used for the transfer application form HPRA Guide to Transfers of Project Authorisations under Scientific Animal Protection Legislation AUT-G0135-23 5/7 - ECR: Ethics committee approval document, ethics committee review and/or accompanying documentation (where applicable) - Cover letter (where applicable) HPRA Guide to Transfers of Project Authorisations under Scientific Animal Protection Legislation AUT-G0135-23 6/7 See example below: DOCUMENT FILE NAME Transfer application form AE12345_P001_Transfer application form Ethics committee application AE12345_PAN_ECR1 Ethics committee approval document AE12345_PAN_ECR2 Ethics committee correspondence AE12345_PAN_ECR3 Cover letter AE12345_P001_Cover letter HPRA Guide to Transfers of Project Authorisations under Scientific Animal Protection Legislation AUT-G0135-23 7/7 5 ADMINISTRATIVE DETAILS Due to the possible, Guide to transfers of project authorisations under scientific animal protection legislation changes tracked
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/aut-g0135-guide-to-transfers-of-project-authorisations-under-scientific-animal-protection-legislation-v3--changes-tracked664d8b8e-05ef-45bb-99ad-466651e9672e.pdf?sfvrsn=30dad88_3