Your Search Results
Report 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18 May 2022 1., Animal Welfare Body Training Requirement Guidance Document An update was provided on the creation of a draft guidance document for training requirements for animal welfare body (AWB) members., The revision simplifies the HPRA process and removes unnecessary bureaucracy without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_1Annual 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_1Opinions, 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-committeeRegulation 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/regulationGuidance 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_2The 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-3rsRegister
Safety notices (0 selected) Medicines for human use Product updates Direct healthcare professional communication (DHPC) Pharmacovigilance risk assessment committee (PRAC) Recall Safety update Medicines for animal use Product updates Direct healthcare professional communication (DHPC) Recall Safety update Medical devices HPRA safety notice Summary of field safety notices (FSN) Cosmetics Safety update Recall Interchangeable medicines (human use) (0 selected) Weekly update Medicine shortages (0 selected) Medicines for human use - weekly list of notified shortages News (0 selected) Regulatory news Medicines for human use Clinical trials Medicines for animal use Scientific animal protection, Medical devices Cosmetics Blood Tissues and cells Organs Controlled drugs Precursor chemicals Public health update Press release Corporate news Events (0 selected) Controlled drugs Medicines for human use Medicines for animal use Scientific animal protection Medical devices Cosmetics Blood Tissues and cells Organs Precursor chemicals Publications and Forms (0 selected) Corporate Medicines for human use Medicines for animal use Scientific animal protection Medical devices Cosmetics Blood Tissues and cells Organs Controlled drugs Precursor chemicals Newsletters (0 selected) TEST Drug Safety Newsletter
https://www.hpra.ie/my-alerts/registrationReport a side effect | 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-incidentAdvice relating to certain training courses covering bovine artificial insemination (AI) and ultrasound scanning of the bovine reproductive tract
Opinion from National Committee for the Protection of Animals Used for Scientific Purposes 3 October 2018 Request for advice: A request for advice relating to certain training courses covering bovine artificial insemination (AI) and ultrasound scanning of the bovine reproductive tract was submitted to the NCPAUSP from the HPRA., Advice: The Committee considered the definition of procedure under Article 3 of Directive 2010/63/EC, and also in particular to the specific practices which are exempt from such control under paragraph 5 of Article 1 of that Directive, especially subparagraphs (a) {“non- experimental agricultural practices”}, (d) {“practices undertaken for the purposes of recognised animal husbandry”}, and (f) {“practices not likely to cause pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle in accordance with good veterinary practice”}., A number of these Member States referred to the control of such practices by other legislation, such as animal welfare legislation., The remaining Member State stated that while the practices fell outside the scope of the Directive, its national legislation required such practices to have a permit due to the national definition of animal research., The Committee is also aware that protection for the welfare of such animals already exists in law, for which purpose the Animal Health and Welfare Act 2013 created a duty on the organisers of such training to protect the welfare of the animals involved.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/scientific-animal-protection/national-committee/advice-relating-to-certain-training-courses-covering-bovine-artificial-insemination-(ai)-and-ultrasound-scanning-of-the-bovine-reproductive-tract.pdf?sfvrsn=a406518_2Application 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_13