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Guide to fees for scientific animal protection
FIN-G0007-13 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., Annual fees must not be paid in advance of annual invoices being issued by the HPRA in July. 1.3 Short-term individual authorisation for a period of two months or less HPRA Guide to Fees for Scientific Animal Protection FIN-G0007-13 2/2 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
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/fin-g0007-guide-to-fees-for-scientific-animal-protection-v12.pdf?sfvrsn=1761a6d8_17Guide to project applications under scientific animal protection legislation
Guide to Project Applications under Scientific Animal Protection Legislation HPRA Guide to Project Applications Under Scientific Animal Protection Legislation AUT-G0098-14 2/34 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-G0098-14 13/34 Term Explanation of term Duration (how long will the procedure take and how long will the animal be affected for?), Please see the ‘Guide to Fees for Scientific Animal Protection’, which can be found in the SAP Guidance documents section of the HPRA website., HPRA Guide to Project Applications Under Scientific Animal Protection Legislation AUT-G0098-14 29/34 2., HPRA Guide to Project Applications Under Scientific Animal Protection Legislation AUT-G0098-14 33/34 9., Guide to project applications under scientific animal protection legislation
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/aut-g0098-guide-to-project-applications-under-scientific-animal-protection-legislation-v14.pdf?sfvrsn=82a39815_12Guide to refusals and appeals under scientific animal protection legislation
Guide to Refusals and Appeals Under Scientific Animal Protection Legislation HPRA Guide to Refusals and Appeals Under Scientific Animal Protection Legislation AUT-G0122-3 2/10 CONTENTS 1 SCOPE 3 2 PROCEDURES 3 3 SUBMISSION OF WRITTEN INFORMATION 7 4 ORAL HEARINGS 7 5 CONTACT POINT FOR PROCEDURES 8 APPENDIX 1 ACCESSIBLE ALTERNATIVE DESCRIPTION OF FLOWCHART 1 9 APPENDIX 2 ACCESSIBLE ALTERNATIVE DESCRIPTION OF FLOWCHART 2 10 HPRA Guide to Refusals and Appeals Under Scientific Animal Protection Legislation AUT-G0122-3 3/10 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., HPRA Guide to Refusals and Appeals Under Scientific Animal Protection Legislation AUT-G0122-3 4/10 The procedure for refusals is shown in Flowchart 1., HPRA Guide to Refusals and Appeals Under Scientific Animal Protection Legislation AUT-G0122-3 7/10 Note: Applicants should note that while an appeal to an animal welfare notice is being processed, the terms of the notice remain in force., HPRA Guide to Refusals and Appeals Under Scientific Animal Protection Legislation AUT-G0122-3 8/10 Following the presentation and questions, applicants will be asked to leave the meeting., 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
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/aut-g0122-guide-to-refusals-and-appeals-under-scientific-animal-protection-legislation-v3.pdf?sfvrsn=730d3ba4_5About the legislation | Scientific animal protection
About the legislation The goal of the legislation on the protection of animals used for scientific or educational purposes is to improve animal welfare and to promote the principles of the 3Rs - Replacement, Reduction and Refinement., Where replacement is not possible, animal use must only be permitted where justified and where the expected benefits outweigh the potential adverse effects., Refinement Refinement means ensuring that any procedures carried out on an animal are done in the most humane manner possible, minimising any pain, suffering, distress or lasting harm to the animal., About the legislation | Scientific animal protection
https://www.hpra.ie/regulation/scientific-animal-protection/legislation/about-the-legislationGuide 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_3Individual training record for scientific animal protection
Individual Training Record for Scientific Animal Protection 1Procedures/Skills Trainee name: FORMTEXT Individual authorisation number (if available): FORMTEXT Procedure SPECIES Date Commenced Trainer (print name) Trainer (signature) Level of Competence Achieved* (1-4) Date Achieved * 1– Training ongoing, close supervision required 2 – Competent, procedure to be performed under supervision 3 – Competent, and can work independently, i.e. no supervision 4 – Competent and experienced, and can train others Trainee signature: Date: 2Continued Professional Development and External Training Trainee name: FORMTEXT Individual authorisation number (if available): FORMTEXT Training description Date of training Hours Outcome / certification ACHIEVED Date Trainee signature: Date:, Individual training record for scientific animal protection
https://assets.hpra.ie/data/docs/default-source/submission-forms/aut-f0351-individual-training-record-for-scientific-animal-protection-v4.docx?sfvrsn=ba35cd18_5Guide to transfers of project authorisations under scientific animal protection legislation
Guide to Transfers of Project Authorisations under Scientific Animal Protection Legislation HPRA Guide to Transfers of Project Authorisations under Scientific Animal Protection Legislation AUT-G0135-3 2/5 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 3.3 Ethical approval 4 4 MAKING AN APPLICATION 4 5 ADMINISTRATIVE DETAILS 5 HPRA Guide to Transfers of Project Authorisations under Scientific Animal Protection Legislation AUT-G0135-3 3/5 1 SCOPE This guidance is intended to assist applicants in completing a Health Products Regulatory Authority (HPRA) ‘Application for Transfer of a Project Authorisation under Scientific Animal Protection Legislation’. 2 INTRODUCTION An authorisation holder cannot transfer a project authorisation to another user unless, An authorisation holder can be a person, such as the project manager, or the breeder/supplier/user establishment, or a commercial entity. 3 APPLICATIONS FOR A PROJECT TRANSFER In order to transfer a project authorisation, the project authorisation holder must submit a completed ‘Application for Transfer of a Project Authorisation under Scientific Animal Protection Legislation’., Therefore, please refer to the ‘Guide to Amendment and Renewal Applications for Projects under Scientific Animal Protection Legislation’., HPRA Guide to Transfers of Project Authorisations under Scientific Animal Protection Legislation AUT-G0135-3 4/5 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., In the event that the project authorisation transfer is granted, by signing the confirmation, declarations and undertaking both persons are assuming the responsibility for the overall implementation and compliance of the project with the scientific animal protection legislation and with respect to fulfilment of the conditions and obligations as set out in the declarations and undertaking., Guide to transfers of project authorisations under scientific animal protection legislation
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/aut-g0135-guide-to-transfers-of-project-authorisations-under-scientific-animal-protection-legislation-v3.pdf?sfvrsn=b6a42ca4_5Application for a project authorisation under scientific animal protection legislation (no functionality)
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 in the Scientific Animal Protection Guides and Forms section of www.hpra.ie., (Please refer to the ‘Guide to Project Applications under Scientific Animal Protection Legislation’ available at www.hpra.ie for further information on genetic status.), (Please refer to the ‘Guide to Project Applications under Scientific Animal Protection Legislation’ available at www.hpra.ie for further information on genetic status.), Application for a project authorisation under scientific animal protection legislation (no functionality)
https://assets.hpra.ie/data/docs/default-source/submission-forms/aut-f0818-application-for-a-project-authorisation-under-scientific-animal-protection-legislation-v3-(no-functionality).docx?sfvrsn=28e52f2f_5Guide to preparation of a SMF for breeder supplier users under scientific animal protection legislation
Guide to Preparation of a Site Master File 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-G0099-6 2/12 CONTENTS 1 SCOPE 3 2 INTRODUCTION 3 3 FORMAT OF SITE MASTER FILE 4 4 CONTENT OF SITE MASTER FILE 4 4.1 Title page 4 4.2 Copy of any current breeder/supplier/user authorisation(s) 5 4.3 Details of animals and activities 5 4.4 Establishment locations 5 4.5 Access information 6 4.6 History 6 4.7 Site drawing and description 6 4.8 Personnel 7 4.9 Responsibilities 7 4.10 Animal welfare body 8 4.11 Ethics committees 9 4.12 Animal health and welfare system 9 4.13 Facility control and maintenance 10 4.14 Quality management system 11 4.15 Training 12 4.16 Records management 12 5 MAINTAINING THE SITE MASTER FILE 12 HPRA Guide to Preparation of a Site Master File for Breeder/Supplier/Users under Scientific Animal Protection, 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-G0099-6 4/12 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-G0099-6 9/12 An outline of the meeting schedule should be provided., The 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., Guide to preparation of a SMF for breeder supplier users under scientific animal protection legislation
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/aut-g0099-guide-to-preparation-of-a-smf-for-breeder-supplier-users-under-scientific-animal-protection-legislation-pdf-v6.pdf?sfvrsn=48c5bd67_5Guide to amendment and renewal applications for projects under scientific animal protection changes tracked
Products Regulatory Authority (HPRA) ‘Application for an amendment Amendment and/or renewalRenewal to a project authorisationProject Authorisation under scientific animal protection’., Scientific Animal Protection Legislation’., If required, further guidance for the completion of this section of the form can be found within the ‘Guide to project applications under scientific animal protection legislation’.Project Applications under Scientific Animal Protection Legislation’., If required, further guidance for the completion of this section of the form can be found within the ‘Guide to project applicationsProject Applications under scientific animal protection legislation’Scientific Animal Protection Legislation’., If required, further guidance for the completion of this section of the form can be found within the ‘Guide to project applicationsProject Applications under scientific animal protection legislation’Scientific Animal Protection Legislation’., Guide to amendment and renewal applications for projects under scientific animal protection changes tracked
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/aut-g0113-guide-to-amendment-and-renewal-applications-for-projects-under-scientific-animal-protection-v5-changes-tracked21f91053-bcfb-4c0f-92d2-3a0265652567.pdf?sfvrsn=2c7ae68e_3