Your Search Results
Guide 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=10226518_2Application 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_6Application 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_5Curriculum 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_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-tracked.pdf?sfvrsn=b03f6918_2Guide 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-G0113-5 2/10 CONTENTS 1 SCOPE 3 2 INTRODUCTION 3 3 DEFINITIONS 4 4 APPLYING FOR AN AMENDMENT 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 APPENDIX I DEFINITIONS 10 HPRA Guide to Amendment and Renewal Applications for Projects under Scientific Animal Protection Legislation AUT-G0113-5 3/10 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’., If the project authorisation holder is to be replaced, an ‘Application for Transfer of a Project Authorisation under Scientific Animal Protection Legislation’ 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’., 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’., 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-v5.pdf?sfvrsn=a5ab89cb_5Guide 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_3Application 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_5fin-g0007-guide-to-fees-for-scientific-animal-protection-v13-changes-tracked
FIN-G0007-12.113 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 forin scientific purposes studies 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-G0007-12.113 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., fin-g0007-guide-to-fees-for-scientific-animal-protection-v13-changes-tracked
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/fin-g0007-guide-to-fees-for-scientific-animal-protection-v13-changes-tracked.pdf?sfvrsn=52aa6015_1Guide 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_3