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Training 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 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_7Guide 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 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_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., 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_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_7Guide 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_6Guide to preparation of a SMF for breeder supplier users under scientific animal protection legislation changes tracked
The guidance is an addition to the HPRA ‘Guide to Applications for Breeder/Supplier/Users under Scientific Animal Protection Legislation’., HPRA Guide to Preparation of a Site Master File for Breeder/Supplier/Users under Scientific Animal Protection Legislation AUT-G0099-5.1 5/13 3 FORMAT OF SITE MASTER FILE The SMF should contain adequate information in an easily-readable format when printed., HPRA Guide to Preparation of a Site Master File for Breeder/Supplier/Users under Scientific Animal Protection Legislation AUT-G0099-5.1 10/13 How the animal welfare bodyAWB performs the tasks required of it in Regulation 50 should be outlined., The HPRA ‘Guide to Ethics Committee Assessment of Project Applications under Scientific Animal Protection Legislation’ HPRA Guide to Ethics Committee Assessment of Project Applications under Scientific Animal Protection Legislation includes guidance on what is expected from an ethics committee. 4.12 Animal health and welfare system The system for monitoring the health and welfare of animals at the breeder/supplier/user establishment should be outlined., HPRA Guide to Preparation of a Site Master File for Breeder/Supplier/Users under Scientific Animal Protection Legislation AUT-G0099-5.1 12/13 It should be indicated how any bio-security measures in place, including rodent, fly and pest control, are implemented., Guide to preparation of a SMF for breeder supplier users under scientific animal protection legislation changes tracked
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/aut-g0099-guide-to-preparation-of-a-smf-for-breeder-supplier-users-under-scientific-animal-protection-legislation-v5-changes-tracked77c10b2697826eee9b55ff00008c97d0.pdf?sfvrsn=ca4c1fb_4Application for transfer of a project authorisation under scientific animal protection legislation
Application for Transfer of a Project Authorisation under Scientific Animal Protection Legislation For details of the requirements, see the ‘Guide to Transfers of Project Authorisations under Scientific Animal Protection Legislation’., I hereby confirm that in the event of the transfer being granted, FORMTEXT will furnish to FORMTEXT : -all records and documentation including records and documentation in support of the original application for project FORMTEXT , -all records and documentation in support of any previous and ongoing amendments to the project authorisation, all animal records in relation to the project, and all correspondence with the Health Products Regulatory Authority concerning the project; and -all items (including but not limited to samples) of whatsoever nature required to be held by the holder of the project authorisation FORMTEXT ., Application for transfer of a project authorisation under scientific animal protection legislation
https://assets.hpra.ie/data/docs/default-source/submission-forms/aut-f0453-application-for-transfer-of-a-project-authorisation-under-scientific-animal-protection-legislation-v3.docx?sfvrsn=8f617b98_6Application for reactivation of an individual authorisation under scientific animal protection legislation
Application for Reactivation of 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’., A new ‘Application for an individual authorisation under Scientific Animal Protection Legislation’ must be submitted in this case., Application for reactivation of an individual authorisation under scientific animal protection legislation
https://assets.hpra.ie/data/docs/default-source/submission-forms/aut-f0865-application-for-reactivation-of-an-individual-authorisation-under-scientific-animal-protection-legislation-v1.docx?sfvrsn=636b06b8_9