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Guide to new, amendment, renewal and reactivation applications for individuals under SAP legislation
No. 543 of 2012 (hereafter referred to as the Regulations). 2 INTRODUCTION All individuals performing the following activities involving animals used for scientific purposes: - project management, - carrying out procedures on animals, and - performing euthanasia on animals; must submit the following forms to the HPRA, where applicable: - ‘Application for an Individual Authorisation under Scientific Animal Protection Legislation’, - ‘Application for an Amendment to an Individual Authorisation under Scientific Animal Protection Legislation’, - ‘Application for a Renewal of an Individual Authorisation under Scientific Animal Protection Legislation’, - ‘Application for Reactivation of an Individual Authorisation under Scientific Animal Protection Legislation’., CV and training record templates can be found on the HPRA website, under Guidance documents for Scientific Animal Protection., completion of a relevant approved animal training course., The appropriate form for completion is determined based on the following criteria: - If an existing individual authorisation is due to expire in less than six months, but more than 28 days, the ‘Application for a Renewal of an Individual Authorisation under Scientific HPRA Guide to New, Amendment, Renewal and Reactivation Applications for Individuals under Scientific Animal Protection Legislation AUT-G0097-11 8/13 Animal Protection Legislation’ form must be completed and submitted to the HPRA ( see section 6.1 of this guide ), Fees: Fees are detailed in the ‘Guide to Fees for Scientific Animal Protection’, which can be found on the HPRA website.
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/aut-g0097-guide-to-new-amendment-renewal-and-reactivation-applications-for-individuals-under-sap-legislation-v10.pdf?sfvrsn=d169db6_9Application for an amendment or renewal to a project authorisation under SAP legislation
Application for an Amendment and/or Renewal to a Project Authorisation under Scientific Animal Protection Legislation For details on completing this application form, please see the ‘Guide to Amendment and Renewal Applications for Projects under Scientific Animal Protection Legislation’., Please see the ‘Guide to Transfers of Project Authorisations under Scientific Animal Protection Legislation’ for details., SECTION H: Increase in TOTAL ANIMAL NUMBERS (if applicable) If the amendment involves an increase in animal numbers, please complete the fields below., I1: REplacement If new procedures or animal models have been added, justify why live animals are required instead of using alternative (non-animal) methods., Further information in relation to fees can be found on the HPRA website under ‘Regulation’ and ‘Scientific animal protection’.
https://assets.hpra.ie/data/docs/default-source/submission-forms/aut-f0377-application-for-an-amendment-or-renewal-to-a-project-authorisation-under-sap-legislation-v11.docx?sfvrsn=54c66c75_10Annual statistical report_SAP_2017
The Directive is among the world’s most advanced pieces of legislation concerning animal welfare., Although complete replacement of animal studies is the ultimate goal of the Directive, this is not currently possible., Where biological processes are not sufficiently understood or are very complex, non-animal research or test methods are often not available., After generating as much information as possible using non-animal alternatives, animal studies can be necessary to fill knowledge gaps in order to safeguard human, animal and environmental health., This is the fifth report to be prepared by the HPRA since it became the competent authority for the protection of animals used for scientific purposes.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/veterinary-medicines/sap-statistical-reports/annual-statistical-report_sap_2017.pdf?sfvrsn=eb0c728c_1Report of the Meeting on 18 May 2022
National Committee for the Protection of Animals Used for Scientific Purposes Report of the Meeting on 18 May 2022 1., Animal Welfare Body Training Requirement Guidance Document An update was provided on the creation of a draft guidance document for training requirements for animal welfare body (AWB) members., The revision simplifies the HPRA process and removes unnecessary bureaucracy without adversely affecting animal welfare standards. 7.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/scientific-animal-protection/national-committee/report-of-the-meeting-on-18-may-2022.pdf?sfvrsn=e55486ba_1Application for renewal or amendment to a breeder supplier user authorisation under SAP legislation
Application for Amendment/Renewal to a Breeder/Supplier/User Authorisation under Scientific Animal Protection Legislation For details on completing this application form, refer to the ‘Guide to Applications for Amendments and Renewals to Breeder/Supplier/User Authorisations under Scientific Animal Protection Legislation’., ☐ The addition or removal of a species of animal that can be kept, bred, used, supplied or euthanised by the breeder/supplier/user (enter details in Section C2), 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., oan application for renewal of authorisation is submitted if there is any significant change to the structure or function of the establishment(s) that could negatively affect animal welfare.
https://assets.hpra.ie/data/docs/default-source/submission-forms/aut-f0376-application-for-renewal-or-amendment-to-a-breeder-supplier-user-authorisation-under-sap-legislation-v4.docx?sfvrsn=aa0e6beb_13The 3Rs
The 3Rs The 3Rs represent the principles of Replacement, Reduction and Refinement, forming a compassionate framework for animal research., These principles are the foundation of EU and national legislation concerning the protection and welfare of animals used in science, encompassing domestic as well as wild animals and birds involved in research projects., Refinement Minimising suffering and enhancing animal welfare in studies., Ensuring careful animal handling by trained researchers, providing anaesthesia and pain relief during procedures, maintaining high standards of housing and husbandry, including access to toys and nesting material., Further information on the 3Rs Alternatives A look at alternative approaches to animal testing and some useful resources from EU bodies.
https://www.hpra.ie/regulation/scientific-animal-protection/the-3rsRegulation of medicines, medical devices and other health products
Medicines for human use Guidance for clinical trials, manufacturing, licensing, selling and advertising of medicines for human use Learn more Medicines for animal use Guidance for manufacturing and licensing of medicines for animal use Learn more Quick links Scientific and regulatory advice Guidance documents Submission forms Fees for human products Fees for veterinary medicines Medical devices registration Scientific animal protection Educational resources for applying the 3R principle (Replacement, Reduction and Refinement) in animal research Learn more Medical devices Guidance for complying with the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR) Learn more Cosmetics Guidance for complying with the requirements for making, importing and selling cosmetic products Learn more Blood Licensing and inspections of
https://www.hpra.ie/regulationOpinions, advice and guidance | National Committee for the Protection of Animals Used for Scientific Purposes
National Committee advice and guidance The National Committee’s primary role involves providing advice to animal welfare bodies (AWBs) and the HPRA on topics concerning the acquisition, breeding, accommodation, care and use of animals in procedures., Opinions of matters considered by the Committee are found in the hyperlink(s) below: Criteria to use to justify the conduct of the same test procedures in two species PDF : 260 KB | 22/05/2017 Advice relating to certain training courses covering bovine artificial insemination (AI) and ultrasound scanning of the bovine reproductive tract PDF : 506 KB | 07/03/2019 Information Officer Guidance documents from the National Committee are found in the hyperlinks below: Guidance on the role of the Information Officer PDF : 624 KB | 06/01/2020 Guidance on training and CPD for Information Officers PDF : 546 KB | 06/01/2020 Animal Welfare Body (AWB) A printable explanatory leaflet and poster from the National Committee intended for researchers and SAP communities, which outlines the role of AWB are available for local download and printing in the hyperlinks below., Opinions, advice and guidance | National Committee for the Protection of Animals Used for Scientific Purposes
https://www.hpra.ie/regulation/scientific-animal-protection/national-committee/opinions--advice-and-guidance-from-the-national-committeeRegister
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https://www.hpra.ie/my-alerts/registrationGuide to applications for renewals and amendments to breeder, supplier, user authorisations changes tracked
Guide to Applications for Renewals and Amendments and Renewals to Breeder/Supplier/User Authorisations under Scientific Animal Protection Legislation Guide to Applications for Renewals and Amendments and Renewals to Breeder/Supplier/User Authorisations under Scientific Animal Protection Legislation AUT-G0112-3 5 2/6/8 CONTENTS 1., MAKING AN APPLICATION 5 4.1 Administrative details 5 4.2 Fees 5 APPENDIX I DEFINITIONS 6 1 SCOPE 3 2 INTRODUCTION 3 3 APPLICATIONS FOR AN AMENDMENT OR RENEWAL OF A BREEDER/SUPPLIER/ USER AUTHORISATION 4 3.1 Amendment 4 3.2 Renewal 4 3.3 Site master file (SMF) 4 3.4 Declaration and undertaking 4 4 MAKING AN APPLICATION 5 4.1 Timeline 5 4.2 Naming convention 5 4.3 Administrative details 6 4.2 Fees 6 APPENDIX 1 DEFINITIONS 7 Guide to Applications for Renewals and Amendments and Renewals to Breeder/Supplier/User Authorisations under Scientific Animal Protection Legislation AUT-G0112-3 5 3/6/8 1 SCOPE This guidance is intended to assist applicants in completing a Health Products Regulatory Authority (HPRA) ‘Application for Renewal/Amendmentamendment/renewal to a Breeder/Supplier/User Authorisationbreeder/supplier/user authorisation under Scientific Animal Protection Legislation’scientific animal protection legislation’ form and establish conditions for renewal and, Formatted: Space Before: 0 pt, After: 0 pt Guide to Applications for Renewals and Amendments and Renewals to Breeder/Supplier/User Authorisations under Scientific Animal Protection Legislation AUT-G0112-3 5 5/6/8 4 MAKING AN APPLICATION An application for aamendment or renewal or an amendment of a breeder/supplier/user authorisation must consist of a completed renewal/amendment/renewal application form., Applications are not validated as eligible for HPRA scientific animal protection (SAP) assessment until all necessary documentation has been provided., Guide to Applications for Renewals and Amendments and Renewals to Breeder/Supplier/User Authorisations under Scientific Animal Protection Legislation AUT-G0112-3 5 7/6/8 APPENDIX I1 DEFINITIONS Compliance Officer – the person(s) indicated in Regulation 44 of the Regulations who is responsible for ensuring compliance with the provisions of the Regulations.
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/aut-g0112-guide-to-applications-for-renewals-and-amendments-to-breeder-supplier-user-authorisations-v4-changes-tracked.pdf?sfvrsn=f9a6c9b5_3