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Guide 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_13Quarter 4 2020 NTPS
1/1 Non-Technical Project Summary Period of approval: Q4 October – December 2020 REFERENCE NUMBER PROJECT TITLE KEYWORDS LINK TO NTPS V015/2020Q4 Project to perform rumenostomy and cannulation of dairy cows to support digestibility research studies Rumen; cannula; nutrition; grass; milk production; digesta flow; rumen microbial population; dairy cows https://hprapredocsstg.blob.core.windows.net/data/ docs/default-source/regulatory-report/scientific- animal-protection/ntps/v015_2020q4.pdf V018/2020Q4 Research study investigating the role of Pellino proteins in lung inflammation and fibrosis using mice Lung; Inflammation; fibrosis; bleomycin; Pellino proteins; mice https://hprapredocsstg.blob.core.windows.net/data/ docs/default-source/regulatory-report/scientific- animal-protection/ntps/v018_2020q4.pdf
https://assets.hpra.ie/data/docs/default-source/regulatory-report/scientific-animal-protection/ntps/quarter-4-2020-ntps.pdf?sfvrsn=3b22cf47_3Annual statistical report_SAP_2023
19 DECEMBER 2024 Annual statistical report for animals used in Ireland under scientific animal protection legislation - 2023 Annual Statistical Report 2023 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, The Directive is among the world’s most advanced pieces of animal welfare legislation., After generating as much information as possible using non-animal alternatives, animal studies can sometimes be necessary to fill knowledge gaps., This is the eleventh report to be prepared by the HPRA since it became the competent authority for the protection of animals used for scientific purposes., Mice were the most commonly used species at 81% of total animal use.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/scientific-animal-protection/sap-statistical-reports/annual-statistical-report-2023.pdf?sfvrsn=b1493aa1_3NCPA Introduction to AWB - Leaflet
• Animal husbandry, c a re and health, and welfare assessment, • Ensuring best practices to protect and enhance animal welfare, Contacting your AW B Yo u c a n c o n t a c t t h e A n i m a l Welfare Body for this establishment at Introduction to Animal We l f a re Bodies By the National Committee for the Protection of Animals Used for Scientific Purposes D3-2 An Coiste Náisiúnta um Chaomhnú Ainmhithe a Úsáidtear ar Mhaithe le hEolaíocht National Committee for the Protection of Animals Used for Scientifc Purposes • Communication: Encourage open communication and provide opportunities for all stakeholders to contribute to AWB meetings, Recommended reading and further guidance Here are some resources for AWB members: • ‘Caring for Animals aiming for better science - Animal Welfare Bodies and National Committees’ issued by European Commission • Guiding principles on good practice for Animal Welfare and Ethical Review Bodies • EFPIA/RSPCA webinar on Animal Welfare Body – A catalyst for progress • EFPIA Framework document – Assessing and benchmarking ‘Culture of Care’ • NC3Rs Culture of Care resource library • NC3Rs webinar and video – Culture of Care: Creating the right environment for animal care National Committee for the Protection of Animals Used for Scientific Purposes This Committee, appointed by the Minister for Health, serves as a statutory body., • Establishment support: Ensure facilities and systems are in place for optimal animal welfare, and AWB members should be familiar with animal units’ functioning
https://assets.hpra.ie/data/docs/default-source/regulatory-report/scientific-animal-protection/national-committee/1-ncpa-cnca---online-leaflet-2024.pdf?sfvrsn=edc475a9_3Manage my alerts
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https://www.hpra.ie/my-alerts/manage-my-alertsAnnual statistical report_SAP_2022
15 DECEMBER 2023 Annual statistical report for animals used in Ireland under scientific animal protection legislation - 2022 Annual Statistical Report 2022 2/20 CONTENTS 1 INTRODUCTION 3 2SUMMARY 5 3 DATA ON THE USES OF ANIMALS FOR RESEARCH AND TESTING PURPOSES 5 3.1Speciesand numbers of uses of animals for research and testing purposes 5 3.2Reuse of animals 6 3.3Origin of animals at the first use 7 3.4Projectpurposes 8 3.5Useof animals to meet legislative requirements 11 3.6 Use by genetic status for research and testing purposes 12 3.7Actualseverityof uses of animals for research and testing purposes 12 4DATAONTHE USES OF ANIMALS FOR THE CREATION AND MAINTENANCE OF GENETICALLY ALTERED ANIMAL LINES 13 5TRENDS 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 and veterinary, The Directive is among the world’s most advanced pieces of animal welfare legislation., Although complete replacement of animal studies is the ultimate goal of the Directive, for the moment the use of live animals continues to be necessary to protect human and animal health and the environment., After generating as much information as possible using non-animal alternatives, animal studies can sometimes be necessary to fill knowledge gaps., This is the tenth 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_2022.pdf?sfvrsn=13179b12_1Guide to new, amendment and renewal applications for individuals under SAP legislation changes tracked
No. 543 of 2012 (hereafter referred to as the Regulations). 2 INTRODUCTION All individuals performing the following rolesactivities 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., However, individual authorisations can be reactivated HPRA Guide to New, Amendment, Renewal and Reactivation Applications for Individuals under Scientific Animal Protection Legislation AUT-G0097-1011 10/14/15 upon payment of the appropriate fee., under Scientific Animal Protection LegislationLegislation’ form, duly completed and signed by the applicant and the compliance officer HPRA Guide to New, Amendment, Renewal and Reactivation Applications for Individuals under Scientific Animal Protection Legislation AUT-G0097-1011 12/14/15 - Training records and a training plan should be submitted, if the purpose of the amendment is to add neuromuscular blocking agents., Tel: +353 1 676 4971 Email: sap@hpra.ie Fees: Fees are detailed in the ‘Guide to Fees for Scientific Animal Protection’, which can be found at www.hpra.ie.on the HPRA website.
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/aut-g0097-guide-to-new-amendment-and-renewal-applications-for-individuals-under-sap-legislation-v11-changes-tracked.pdf?sfvrsn=353d6518_8Annual 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_1Annual statistical report_SAP_2016
The Directive is among the world’s most advanced pieces of legislation concerning animal welfare., 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 fourth report to be prepared by the HPRA since it became the competent authority for the protection of animals used for scientific purposes., Mice were the most commonly used species at 85% of the total animal use., A single use of an animal extends from the time when the first technique is applied to the animal until the completion of data collection, or when the animal is removed from the project.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/veterinary-medicines/sap-statistical-reports/annual-statistical-report_sap_2016.pdf?sfvrsn=3f2ed12c_1Guidance on training and CPD for Information Officers
December 2019 Page 1 of 2 NATIONAL COMMITTEE FOR THE PROTECTION OF ANIMALS USED FOR SCIENTIFIC PURPOSES: GUIDANCE ON TRAINING AND CPD FOR INFORMATION OFFICERS (IOs) Some IOs will have already been involved in the HPRA regulatory system and will already have completed formal training in their previous posts, so there may be no additional training needed., It is recommended that at least the modular training in the legislation, ethics and 3Rs be completed: - EU Education and Training Framework - Module 1: Legislative framework; - EU Education and Training Framework - Module 2: Ethics, animal welfare and the 3Rs (Level 1); this will help to obtain an understanding of legal and ethical aspects of use of animals for scientific purposes and also covers the concepts and principles of the 3Rs; - EU Education and Training Framework - Module 50: Introduction to the local environment (establishment), which gives a good understanding of the local structure for management and responsibility relating to animal use at your establishment; and - EU Education and Training Framework also suggests that the IO completes aspects of Module 51 - Information provision and retrieval., You may wish to extend your skills by: - Spending time reviewing the NC3Rs website and the links within it; - Completing a suitable training module covering how to search, source, retrieve and store information; methods of searching; (e.g. see links to FRAME or SYRCLE in the Resources Section of the Guidance on the Role of the Information Officer document); - Receiving other training on information searching, storing and retrieval; - Spending time in discussion with knowledge management experts (e.g. information technologists, librarians); - Completing EU Education and Training Framework - Module 9: Ethics, Animal Welfare and the Three Rs (Level 2), a component of PPL training, which may be useful in extending the basic knowledge of ethics and legislation; - Attending a specific IO training course - if/when developed; - Visiting animal facility(s); - Attending topic specific LASA/LAVA/IAT/NC3Rs/RSPCA/UFAW meetings; and - Undertaking soft skill training; 1., Diplomacy December 2019 Page 2 of 2 Extract from EU Document – Education & Training Framework Initial training Training should include searches for information and strategies for dissemination: - LO 2.13: Describe relevant sources of information relating to ethics, animal welfare and the implementation of the 3Rs; - LO 51.1: Be aware of different search tools (e.g.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/scientific-animal-protection/national-committee/training-and-cpd-for-io.pdf?sfvrsn=d4526218_2