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Application for an amendment to an individual authorisation under scientific animal protection legislation
Application for an Amendment to an Individual Authorisation under Scientific Animal Protection Legislation For details on completing this application form, please see the ‘Guide to New, Amendment, Renewal and Reactivation Applications for Individuals under Scientific Animal Protection Legislation’., Select the species of animal(s) for which authorisation is sought as part of this amendment application, 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 amendment to an individual authorisation under scientific animal protection legislation
https://assets.hpra.ie/data/docs/default-source/submission-forms/aut-f0378-application-for-an-amendment-to-an-individual-authorisation-under-scientific-animal-protection-legislationv10.docx?sfvrsn=7b79e6f8_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-tracked.pdf?sfvrsn=d1bfedc7_3Guide 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_11Guide to amendment and renewal applications for projects under scientific animal protection legislation
Guide to Amendment and Renewal Applications for Projects under Scientific Animal Protection Legislation HPRA Guide to Amendment and Renewal Applications for Projects under Scientific Animal Protection Legislation AUT-G0113-6 2/11 CONTENTS 1 SCOPE 3 2 INTRODUCTION 3 3 DEFINITIONS 4 4 APPLYING FOR AN AMENDMENT AND/OR A RENEWAL OF A PROJECT AUTHORISATION 4 4.1 Renewal 4 4.2 Amendments 4 4.3 Declaration and undertaking 8 5 MAKING AN APPLICATION 8 6 ADMINISTRATIVE DETAILS 9 7 FEES 9 APPENDIX 1 DEFINITIONS 11 HPRA Guide to Amendment and Renewal Applications for Projects under Scientific Animal Protection Legislation AUT-G0113-6 3/11 1 SCOPE This guidance is intended to assist applicants in completing a Health Products Regulatory Authority (HPRA) ‘Application for an Amendment and/or Renewal to a Project Authorisation under Scientific Animal Protection Legislation’ form., If the project authorisation holder is to be replaced, an ‘Application for Transfer of a Project Authorisation under Scientific Animal Protection Legislation’ form must be submitted to the HPRA., 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’., 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’., Please see the ‘Guide to Fees for Scientific Animal Protection’, which can be found on the HPRA website under ‘Regulation’ and ‘Scientific animal protection’., Guide to amendment and renewal applications for projects under scientific animal protection legislation
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/aut-g0113-guide-to-amendment-and-renewal-applications-for-projects-under-scientific-animal-protection-legislation-v6.pdf?sfvrsn=a5ab89cb_12Application for a renewal of an individual authorisation under scientific animal protection legislation
Application for a Renewal of an Individual Authorisation under Scientific Animal Protection Legislation Please do not complete this application form if your individual authorisation is due to expire within 28 days., For details on completing this application form, please see the ‘Guide to New, Amendment, Renewal and Reactivation Applications for Individuals under Scientific Animal Protection Legislation’., Application for a renewal of an individual authorisation under scientific animal protection legislation
https://assets.hpra.ie/data/docs/default-source/submission-forms/aut-f0754-application-for-a-renewal-of-an-individual-authorisation-under-scientific-animal-protection-legislation-v1.docx?sfvrsn=f8a5ab82_6Guide to amendment and renewal applications for projects under scientific animal protection legislation changes tracked
Guide to Amendment and Renewal Applications for Projects under Scientific Animal Protection Legislation HPRA Guide to Amendment and Renewal Applications for Projects under Scientific Animal Protection Legislation AUT-G0113-56 2/11 CONTENTS 1 SCOPE 3 2 INTRODUCTION 3 3 DEFINITIONS 4 4 APPLYING FOR AN AMENDMENT AND/OR A RENEWAL OF A PROJECT AUTHORISATION 4 4.1 Renewal 4 4.2 Amendments 4 4.3 Declaration and undertaking 8 5 MAKING AN APPLICATION 8 6 ADMINISTRATIVE DETAILS 9 7 FEES 10 APPENDIX 1 DEFINITIONS 11 HPRA Guide to Amendment and Renewal Applications for Projects under Scientific Animal Protection Legislation AUT-G0113-56 3/11 1 SCOPE This guidance is intended to assist applicants in completing a Health Products Regulatory Authority (HPRA) ‘Application for an Amendment and/or Renewal to a Project Authorisation under Scientific Animal Protection Legislation’ form., 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’., 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’., 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’., Please see the ‘Guide to Fees for Scientific Animal Protection’, which can be found on the HPRA website under ‘Regulation’ and ‘Scientific animal protection’., Guide to amendment and renewal applications for projects under scientific animal protection legislation 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-legislation-v6-changes-tracked.pdf?sfvrsn=ea907afc_3Guide to withdrawal of breeder,supplier,user authorisations under scientific animal protection legislation
AUT-G0100-2 1/2 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-G0100-2 2/2 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 breeder/supplier/user establishment must be removed accordingly., Any projects not transferred must cease animal work immediately as of the withdrawal date of the breeder/supplier/user establishment authorisation., Guide to withdrawal of breeder,supplier,user authorisations under scientific animal protection legislation
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/aut-g0100-guide-to-withdrawal-of-breeder-supplier-user-authorisations-under-scientific-animal-protection-legislation-pdf-v2.pdf?sfvrsn=fed97953_8Guide 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-tracked8df93007-be6e-493a-b8cc-55b4dc5d1254.pdf?sfvrsn=107ae040_6Terms of Reference and Rules of Procedure of the Committee for Scientific Animal Protection Appeals
MGT-P0031-2 22 DECEMBER 2015 Terms of Reference and Rules of Procedure Committee for Scientific Animal Protection Appeals HPRA Terms of Reference and Rules of Procedure of the Committee for Scientific Animal Protection Appeals MGT-P0031-2 2/6 CONTENTS 1 AUTHORITY 3 2 MANDATE 3 3 COMPOSITION 3 4 CHAIRPERSON 3 5 MEETINGS 4 6 MINUTES OF MEETINGS 5 7 ADVICE TO THE AUTHORITY 5 8 GUARANTEES OF INDEPENDENCE AND CODE OF CONDUCT 5 9 LEGAL ISSUES 6 10 GENERAL PROVISIONS 6 HPRA Terms of Reference and Rules of Procedure of the Committee for Scientific Animal Protection Appeals MGT-P0031-2 3/6 1 AUTHORITY 1.1 The Authority Committee for Scientific Animal Protection Appeals was established by the Authority on 23 April 2014. 2 MANDATE 2.1 The committee advises the Authority on appeals to an order or notice issued under Directive 2010/63/EU and S.I., The Chairperson will ordinarily be the Chairperson of the Advisory Committee for Veterinary Medicines. 4.2 The Chairperson is responsible for the efficient conduct of the business of the committee, in particular by: - planning the work of the committee together with the secretary to the subcommittee, - monitoring, together with the secretary to the committee, that the rules of procedure are respected, - ensuring that at the beginning of each meeting, any potential conflict of interest is declared regarding any particular item to be discussed by the committee, - aiming to achieve consensus on issues discussed by the committee, HPRA Terms of Reference and Rules of Procedure of the Committee for Scientific Animal Protection Appeals MGT-P0031-2 4/6 - ensuring, together with the subcommittee and the secretary to the committee, the regulatory and scientific consistency of the committee’s recommendations, - reporting on the activities of the committee as appropriate. 5 MEETINGS, HPRA Terms of Reference and Rules of Procedure of the Committee for Scientific Animal Protection Appeals MGT-P0031-2 5/6 6 MINUTES OF MEETINGS 6.1 Minutes of each meeting are prepared by the secretary to the committee. 6.2 The minutes indicate the names of the attendees, and in respect of each item on the agenda: - the documents submitted to the committee, - a summary record of the proceedings, - the decisions taken or the conclusions reached by the committee. 6.3 Draft minutes are sent to members before the next meeting., HPRA Terms of Reference and Rules of Procedure of the Committee for Scientific Animal Protection Appeals MGT-P0031-2 6/6 9 LEGAL ISSUES 9.1 The committee may avail of legal advice from the HPRA’s solicitor on any issues which may arise. 10 GENERAL PROVISIONS 10.1 These terms of reference and rules of procedure are approved by the Authority and the committee., Terms of Reference and Rules of Procedure of the Committee for Scientific Animal Protection Appeals
https://assets.hpra.ie/data/docs/default-source/corporate/terms-of-reference/mgt-p0031-committee-for-scientific-animal-protection-appeals-terms-of-reference-and-rules-of-procedure-v2.pdf?sfvrsn=ae6901b_2Privacy notice for reporting a side effect or adverse incident from medicines for animal use
Privacy Notice - Report a side effect or adverse incident from a medicine for animal use What information do we process?, These reports are submitted to the HPRA directly by veterinary professionals, those working in the agriculture industry, and animal owners., Such changes could include recommendations to restrict use, or the addition of warnings to the product information for veterinary healthcare professionals, those who work in agriculture and animal owners., What are your rights under data protection law?, The right to lodge a complaint to the Data Protection Commission., Privacy notice for reporting a side effect or adverse incident from medicines for animal use
https://www.hpra.ie/privacy---data-protection/privacy-notice---reporting-of-adverse-events-related-to-the-use-of-veterinary-medicinal-products