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Guide 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_5Annual statistical report_SAP_2018
The Directive is among the world’s most advanced pieces of legislation concerning animal welfare., Examples of refinement include ensuring the animals are provided with housing that allows the expression of species-specific behaviours, using appropriate anaesthesia and analgesia to minimise pain, and training animals to cooperate with procedures to minimise any distress. 1 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes Annual statistical report 2018 4/18 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 sixth 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_2018.pdf?sfvrsn=e6f0734c_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_1Annual statistical report_SAP_2019
07 DECEMBER 2020 Annual statistical report for animals used in Ireland under scientific animal protection legislation - 2019 Annual Statistical Report 2019 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 7 3.3 Origin of animals at the first use 7 3.4 Project purposes 8 3.5 Use of animals to meet legislative requirements 12 3.6 Use by genetic status for research and testing purposes 13 3.7 Actual severity of uses of animals for research and testing purposes 13 4 DATA ON THE USES OF ANIMALS FOR THE CREATION AND MAINTENANCE OF GENETICALLY ALTERED ANIMAL LINES 13 5 TRENDS 15 6 CONCLUSION 18 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 seventh report to be prepared by the HPRA since it became the competent authority for the protection of animals used for scientific purposes., The shift downwards seen in 2019 (mirroring that of 2018) is likely due to the ongoing transition from animal tests to non- animal alternatives., In addition, non-animal tests can occasionally fail or malfunction, thereby resulting in unreliable results and necessitating the use of an animal test.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/veterinary-medicines/sap-statistical-reports/annual-statistical-report_sap_2019.pdf?sfvrsn=fb9a6c04_1Annual 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_1Quarter 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_3Classification of methods of supply for veterinary vaccines_2007
Veterinary vaccines are but one of the available measures for animal owners for disease prevention; on farms other tools include the farmer’s animal purchase policy, husbandry methods and other factors., The WG recommended that for all vaccines designated LM and permitted for sale without prescription, the following advice be added to the product labelling or package leaflet: (i) the disease condition for which the vaccine induces protection; (ii) the requirement that consideration be given to herd history and (iii) the desirability of seeking veterinary advice before use., Vaccines falling into this category should have a package leaflet specifying (a) what the vaccine induces protection against, (b) the necessity for consideration of herd history and (c) the desirability of seeking advice from a veterinary practitioner when first purchased by the end-user., ‘Companion Animal Medicine (CAM)’ – refers to a companion animal medicine which may be sold or supplied only – (i) from a pharmacy, (ii) byaregistered veterinary practitioner (iii) fromapremisestowhichananimalremediesmerchant’slicence relates, or (iv) fromapremises to which a companion animal medicine seller's registration relates., In deciding the route of sale or supply for an animal remedy, the Board has due regard to the need to protect public health, animal health, animal welfare and the environment and accordingly has due regard to – (a) theneedfor prior professional diagnosis, (b) theneed for particular skill or training in the administration of the animal remedy in order to avoid unnecessary risk to the target animal or the person administering the product to the animal, and (c) theneed for professional or specialist training in relation to the storage, handling or disposal of the animal remedy. 2.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/methods-of-supply/classification-of-methods-of-supply-for-veterinary-vaccines_2007.pdf?sfvrsn=c0df9df7_2NCPA 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_3Annual 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_1Manage my alerts
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