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Annual statistical report_SAP_2020
16 DECEMBER 2021 Annual statistical report for animals used in Ireland under scientific animal protection legislation - 2020 Annual Statistical Report 2020 2/20 CONTENTS 1 INTRODUCTION 3 2 SUMMARY 5 3 DATA ON THE USES OF ANIMALS FOR RESEARCH AND TESTING PURPOSES 5 3.1 Species and numbers of uses of animals for research and testing purposes 5 3.2 Reuse of animals 6 3.3 Origin of animals at the first use 7 3.4 Project purposes 8 3.5 Use of animals to meet legislative requirements 11 3.6 Use by genetic status for research and testing purposes 12 3.7 Actual severity of uses of animals for research and testing purposes 12 4 DATA ON THE USES OF ANIMALS FOR THE CREATION AND MAINTENANCE OF GENETICALLY ALTERED ANIMAL LINES 13 5 TRENDS 16 6 CONCLUSION 19 7 APPENDIX: DEFINITIONS 19 3/20 1 INTRODUCTION The Health Products Regulatory Authority (HPRA) is the State agency with responsibility for the protection of animals used for scientific purposes, the regulation of human, Announced inspections are typically carried out as part of the authorisation renewal process as they allow for a comprehensive review of every aspect of the establishment’s activities and operations under the scientific animal protection legislation., This is the eighth report to be prepared by the HPRA since it became the competent authority for the protection of animals used for scientific purposes., This is due to the ongoing transition from animal tests to non-animal alternatives., The number of uses of domestic fowl has increased by 79% from 2019 as a result of a large project performed for the purpose of avian disease surveillance and the protection of the health of the national poultry flock.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/veterinary-medicines/sap-statistical-reports/annual-statistical-report_sap_2020.pdf?sfvrsn=9b273388_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18 May 2022 1., Animal Welfare Body Training Requirement Guidance Document An update was provided on the creation of a draft guidance document for training requirements for animal welfare body (AWB) members., The revision simplifies the HPRA process and removes unnecessary bureaucracy without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_1Guide 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_8Application 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’.
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-v10.docx?sfvrsn=54c66c75_5Guide to applications for renewals and amendments to breeder, supplier, user authorisations under sap legislation
Guide to Applications for Amendments and Renewals to Breeder/Supplier/User Authorisations under Scientific Animal Protection Legislation Guide to Applications for Amendments and Renewals to Breeder/Supplier/User Authorisations under Scientific Animal Protection Legislation AUT-G0112-5 2/7 CONTENTS 1 SCOPE 3 2 INTRODUCTION 3 3 APPLICATIONS FOR AN AMENDMENT OR RENEWAL OF A BREEDER/SUPPLIER/ USER AUTHORISATION 3 3.1 Amendment 3 3.2 Renewal 4 3.3 Site master file (SMF) 4 3.4 Declaration and undertaking 4 4 MAKING AN APPLICATION 4 4.1 Timeline 4 4.2 Naming convention 5 4.3 Administrative details 5 4.2 Fees 6 APPENDIX 1 DEFINITIONS 7 Guide to Applications for Amendments and Renewals to Breeder/Supplier/User Authorisations under Scientific Animal Protection Legislation AUT-G0112-5 3/7 1 SCOPE This guidance is intended to assist applicants in completing a HPRA ‘Application for amendment/renewal to a breeder/supplier/user authorisation under scientific animal protection, However, only renewal applications which are due to the expiry of an existing authorisation will result in the extension of the duration of the authorisation. 3 APPLICATIONS FOR AN AMENDMENT OR RENEWAL OF A BREEDER/SUPPLIER/ USER AUTHORISATION Provide the breeder/supplier/user authorisation holder details and complete the relevant section(s) of the form. 3.1 Amendment Guide to Applications for Amendments and Renewals to Breeder/Supplier/User Authorisations under Scientific Animal Protection Legislation AUT-G0112-5 4/7 A change to any of the designated persons (see Appendix 1 for definitions) will require an amendment., Applications are not validated as eligible Guide to Applications for Amendments and Renewals to Breeder/Supplier/User Authorisations under Scientific Animal Protection Legislation AUT-G0112-5 5/7 for HPRA scientific animal protection (SAP) assessment until all necessary documentation has been provided., Appendix (where applicable) Cover letter (where applicable) The following table shows an example of how the files should be named for a hypothetical amendment/renewal application from a hypothetical establishment with the establishment authorisation number AE12345: DOCUMENT FILE NAME Breeder/supplier/user application form AE12345_Application form The SMF AE12345_SMF The compliance officer’s CV AE12345_CVCO The DV’s CV AE12345_CVDV The animal care and welfare officer’s CV AE12345_CVACWO The information officer’s CV AE12345_CVIO The training officer’s CV AE12345_TO Cover letter AE12345_Cover letter 4.3 Administrative details Due to the possible sensitive nature of information contained in breeder/supplier/user establishment applications, the HPRA provides a secure online system to enable submission of Guide to Applications for Amendments and Renewals to Breeder/Supplier/User Authorisations under Scientific Animal Protection Legislation AUT-G0112-5 6/7 applications and, Guide to Applications for Amendments and Renewals to Breeder/Supplier/User Authorisations under Scientific Animal Protection Legislation AUT-G0112-5 7/7 APPENDIX 1 DEFINITIONS Animal care and welfare officer – the person(s) indicated in Regulation 45 of the Regulations who is responsible for overseeing the welfare and care of the animals in the establishment.
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/aut-g0112-guide-to-applications-for-renewals-and-amendments-to-breeder-supplier-user-authorisations-pdf-v4.pdf?sfvrsn=2c2f911_12Register
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https://www.hpra.ie/my-alerts/registrationRegulation 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/regulationApplication for withdrawal of a breeder, supplier, user authorisation under SAP legislation
Application for Withdrawal of a Breeder/Supplier/User Authorisation under Scientific Animal Protection Legislation For details of the requirements, please see the ‘Guide to Withdrawal of Breeder/Supplier/User Authorisations under Scientific Animal Protection Legislation’. 1Breeder/supplier/user details Breeder/supplier/user authorisation number Breeder/supplier/user authorisation holder name Name Address Eircode E-mail Telephone Expiry date of current authorisation 2withdrawal notification Date of intended withdrawal of breeder/supplier/user authorisation: Provide details on the reasons for withdrawal of breeder/supplier/user authorisation: Provide details on the fate of the animals post-withdrawal, including a proposed timeline for any necessary actions: 3signature of compliance officer(S) Signature of compliance officer: __________________________ (on behalf of the authorisation holder) Print
https://assets.hpra.ie/data/docs/default-source/submission-forms/aut-f0348-application-for-withdrawal-of-a-breeder-supplier-user-authorisation-under-sap-legislation-v2.docx?sfvrsn=523efe08_5Application 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_12Report a side effect or adverse incident for medicines used in animals
Report a side effect for a medicine for animal use Healthcare professionals and animal owners can use our online reporting form to report a side effect or an adverse incident experienced with a medicine used in animals., Report Learn more Privacy and data protection Find out how we process the information from reports in our privacy notice.
https://www.hpra.ie/report-an-issue/medicines-for-animal-use/report-a-side-effect-or-adverse-incident