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Terms of Reference and Rules of Procedure of the Committee for Scientific Animal Protection Appeals
MGT-P0031-2 22 DECEMBER 2015 Terms of Reference and Rules of Procedure Committee for Scientific Animal Protection Appeals HPRA Terms of Reference and Rules of Procedure of the Committee for Scientific Animal Protection Appeals MGT-P0031-2 2/6 CONTENTS 1 AUTHORITY 3 2 MANDATE 3 3 COMPOSITION 3 4 CHAIRPERSON 3 5 MEETINGS 4 6 MINUTES OF MEETINGS 5 7 ADVICE TO THE AUTHORITY 5 8 GUARANTEES OF INDEPENDENCE AND CODE OF CONDUCT 5 9 LEGAL ISSUES 6 10 GENERAL PROVISIONS 6 HPRA Terms of Reference and Rules of Procedure of the Committee for Scientific Animal Protection Appeals MGT-P0031-2 3/6 1 AUTHORITY 1.1 The Authority Committee for Scientific Animal Protection Appeals was established by the Authority on 23 April 2014. 2 MANDATE 2.1 The committee advises the Authority on appeals to an order or notice issued under Directive 2010/63/EU and S.I., The Chairperson will ordinarily be the Chairperson of the Advisory Committee for Veterinary Medicines. 4.2 The Chairperson is responsible for the efficient conduct of the business of the committee, in particular by: - planning the work of the committee together with the secretary to the subcommittee, - monitoring, together with the secretary to the committee, that the rules of procedure are respected, - ensuring that at the beginning of each meeting, any potential conflict of interest is declared regarding any particular item to be discussed by the committee, - aiming to achieve consensus on issues discussed by the committee, HPRA Terms of Reference and Rules of Procedure of the Committee for Scientific Animal Protection Appeals MGT-P0031-2 4/6 - ensuring, together with the subcommittee and the secretary to the committee, the regulatory and scientific consistency of the committee’s recommendations, - reporting on the activities of the committee as appropriate. 5 MEETINGS, HPRA Terms of Reference and Rules of Procedure of the Committee for Scientific Animal Protection Appeals MGT-P0031-2 5/6 6 MINUTES OF MEETINGS 6.1 Minutes of each meeting are prepared by the secretary to the committee. 6.2 The minutes indicate the names of the attendees, and in respect of each item on the agenda: - the documents submitted to the committee, - a summary record of the proceedings, - the decisions taken or the conclusions reached by the committee. 6.3 Draft minutes are sent to members before the next meeting., HPRA Terms of Reference and Rules of Procedure of the Committee for Scientific Animal Protection Appeals MGT-P0031-2 6/6 9 LEGAL ISSUES 9.1 The committee may avail of legal advice from the HPRA’s solicitor on any issues which may arise. 10 GENERAL PROVISIONS 10.1 These terms of reference and rules of procedure are approved by the Authority and the committee., Terms of Reference and Rules of Procedure of the Committee for Scientific Animal Protection Appeals
https://assets.hpra.ie/data/docs/default-source/corporate/terms-of-reference/mgt-p0031-committee-for-scientific-animal-protection-appeals-terms-of-reference-and-rules-of-procedure-v2.pdf?sfvrsn=ae6901b_2Guide to withdrawal of breeder,supplier,user authorisations under scientific animal protection legislation
AUT-G0100-2 1/2 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-G0100-2 2/2 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 breeder/supplier/user establishment must be removed accordingly., Any projects not transferred must cease animal work immediately as of the withdrawal date of the breeder/supplier/user establishment authorisation., Guide to withdrawal of breeder,supplier,user authorisations under scientific animal protection legislation
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/aut-g0100-guide-to-withdrawal-of-breeder-supplier-user-authorisations-under-scientific-animal-protection-legislation-pdf-v2.pdf?sfvrsn=fed97953_7Application for an amendment to an individual authorisation under scientific animal protection legislation
Application for an Amendment to an Individual Authorisation under Scientific Animal Protection Legislation 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’., Select the species of animal(s) for which authorisation is sought as part of this amendment application, using the table below., Where the species of animal does not clearly fit into the general categories provided, please specify the species in the relevant column., Application for an amendment to an individual authorisation under scientific animal protection legislation
https://assets.hpra.ie/data/docs/default-source/submission-forms/aut-f0378-application-for-an-amendment-to-an-individual-authorisation-under-scientific-animal-protection-legislationv10.docx?sfvrsn=7b79e6f8_5Report a quality defect in a medicine for animal use
Report a quality defect in a medicine for animal use Marketing authorisation holders, manufacturers and wholesalers Manufacturers must use the form below to report quality defects to us., Report online Learn more Privacy and data protection Find out how we process information from reports in our privacy notice., Report a quality defect in a medicine for animal use
https://www.hpra.ie/report-an-issue/medicines-for-animal-use/quality-defectsPrivacy notice for reporting a side effect or adverse incident from medicines for animal use
Privacy Notice - Report a side effect or adverse incident from a medicine for animal use What information do we process?, These reports are submitted to the HPRA directly by veterinary professionals, those working in the agriculture industry, and animal owners., Such changes could include recommendations to restrict use, or the addition of warnings to the product information for veterinary healthcare professionals, those who work in agriculture and animal owners., What are your rights under data protection law?, The right to lodge a complaint to the Data Protection Commission., Privacy notice for reporting a side effect or adverse incident from medicines for animal use
https://www.hpra.ie/privacy---data-protection/privacy-notice---reporting-of-adverse-events-related-to-the-use-of-veterinary-medicinal-productsAnnual statistical report_SAP_2021
16 DECEMBER 2022 Annual statistical report for animals used in Ireland under scientific animal protection legislation - 2021 Annual Statistical Report 2021 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, After generating as much information as possible using non-animal alternatives, animal studies can be necessary to fill knowledge gaps., This is the ninth report to be prepared by the HPRA since it became the competent authority for the protection of animals used for scientific purposes., g) There was a 118% increase in the number of animals (cattle, sheep, and fish) used for the purpose ‘Protection of the natural environment in the interests of the health or welfare of human beings or animals’ (6,314 uses in 2021 versus 2891 uses in 2020)., Mild: Any pain or suffering experienced by the animal is only slight, minor, or temporary and so the animal recovers in a short period of time.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/veterinary-medicines/sap-statistical-reports/annual-statistical-report_sap_2021.pdf?sfvrsn=a7a96a29_1Food-producing animals
Under this system, we review information on: The manufacture of the medicine, including raw material quality and process controls, The stability of the product during storage and use, The suitability of the product containers and other packaging materials, The overall product quality and testing carried out, The accuracy and readability of the product labelling and package leaflet, The toxicity of the product, The safety of the product for the animal, user, environment, and in the case of food-producing animals, the consumer, The efficacy of the product for the claimed indications for use., We also undertake additional measures in order to ensure the veterinary medicines perform as expected, including: Collaborating with colleagues from other European medicines agencies to ensure timely and coordinated regulatory actions, as necessary, to safeguard animal and human health, Reviewing scientific literature, reports of government and international bodies on animal health and consumer protection for potential impact on the safety and efficacy of veterinary medicines authorised in Ireland, Reviewing EU and international developments on antimicrobial resistance, Collecting information on the usage of veterinary antibiotics in Ireland, Implementing decisions of veterinary medicines which are required by the EU Commission in order to safeguard animal health and welfare in Member States., In particular, users are reminded to strictly adhere to the withdrawal periods stated on the product information, The use of a veterinary medicine at a dose above that stated on the product label is likely to prolong the time needed by the animal to clear residues of the medicine beyond that given as the withdrawal period for the product, Where a product is used in a dry-cow and that animal calves early, the withdrawal period to be observed should follow the instructions for use given on the product, that is, an adjustment to take into account the normal period before calving plus the relevant withdrawal period following calving, The administration to an animal of different veterinary medicines at the same time (or within a short period) could result in interactions between the individual medicines., In particular, the withdrawal periods might not be sufficient in situations where two or more drugs follow the same metabolic and elimination pathways from the animal, Consult your veterinary practitioner, pharmacist or licensed retailer regarding the use of veterinary medicines, Store veterinary medicines at the conditions specified on the product container., If products are not stored correctly, they are likely to degrade and may be harmful to the animal, Keep veterinary medicines out of sight and reach of children, In the case of medicines used in food-producing animals, ensure that the Animal Medicines Record is updated on each occasion that a veterinary medicine is administered.
https://www.hpra.ie/regulation/veterinary-medicines/care-in-use-of-veterinary-medicines/use-of-veterinary-medicines-in-food-producing-animalsReport of the Meeting on 27 May 2021
National Committee for the Protection of Animals Used for Scientific Purposes Report of the Meeting on 27 May 2021 1., Matters Arising It was clarified that a document from the UK setting out the impact of Covid-19 on the welfare of animals housed or used in authorised establishments, and on the functioning of animal facilities and which proposed that animal welfare bodies should review the learnings on the effect of the pandemic for their systems had been issued by the HPRA following the last meeting. 4., EURL ECVAM Recommendation on Non-Animal-Derived Antibodies The Committee considered the EURL ECVAM recommendation on the use of non animal derived antibodies., The HPRA clarified that the recommendations are to ensure NCAs and users comply with the requirements that are already stated in Directive 2010/63/EU, including Article 4 and Article 13, where if a non-animal alternative is available then it must be used in place of an animal.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/scientific-animal-protection/national-committee/report-of-the-meeting-on-27-may-2021.pdf?sfvrsn=92528c28_1Annual 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_3Guidance on the role of the Information Officer
December 2019 Page 1 of 3 NATIONAL COMMITTEE FOR THE PROTECTION OF ANIMALS USED FOR SCIENTIFIC PURPOSES: GUIDANCE ON THE ROLE OF THE INFORMATION OFFICER (IO) Background Directive 2010/63/EU as implemented by S.I., No. 553 of 2018, and local rules and information; - biology of the species used at the establishment; - provision of appropriate animal care and husbandry; - animal welfare and the 3Rs; - relevant guiding principles for good practice e.g. reports and other publications produced by organisations such as those listed in the ‘Resources’ Section below; - new scientific initiatives, technical advances and good practice relevant to types of work and species at the establishment; and - sources of further information on any of these topics., In this case, the IO can and should seek support from other experts e.g. in the establishment’s Animal Welfare Body, or from setting up a network of appropriate contacts within the establishment., It is necessary to have a good understanding of the local structure for management and responsibilities relating to animal use at their establishment to assist in forming networks and deciding how and to whom to distribute information., No. 553 of 2018 - National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) website - Federation of European Laboratory Animal Science Associations (FELASA) website - Irish Laboratory Animal Science Association (ILASA) website - Laboratory Animals Science Association (LASA) website - Norway's 3R Centre and National Consensus Platform for the Replacement, Reduction and Refinement of Animal Experiments (NORECOPA) website - ARRIVE Guidelines - The Experimental Design Assistant - 3Rs Reduction website - Humane Endpoints in Laboratory Animal Experimentation - Laboratory Animals Veterinary Association (LAVA) website - Institute of Animal Technology (IAT) website - Royal Society for the Prevention of Cruelty to Animals (RSPCA) website – research animals section - Education and Training Platform for Laboratory Animal Science (ETPLAS) - EU Reference Laboratory for Alternatives to Animal Testing
https://assets.hpra.ie/data/docs/default-source/regulatory-report/scientific-animal-protection/national-committee/role-of-io.pdf?sfvrsn=da526218_2