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Fee application form (scientific animal protection)
Fee application form (scientific animal protection)
https://assets.hpra.ie/data/docs/default-source/submission-forms/fin-f0036-fee-application-form-(scientific-animal-protection)-v13.xlsx?sfvrsn=17d5d9d5_13Terms of Reference and Rules of Procedure of the HPRA Leadership Team
(Functions devolved from the Authority) 2.2 Other than matters reserved by the Authority, the HPRA Leadership Team is responsible for carrying out the competent authority functions for the regulation of medicinal products for human use; clinical trials on medicinal products for human and veterinary use; clinical investigations; medicinal products for veterinary use; medical devices; blood and blood components; tissues and cells; human organs; cosmetics; controlled drugs; drug precursors and protection of animals used for scientific purposes, as set out in each function’s section on the HPRA website https://www.hpra.ie/regulation. 2.3 Save for clinical trials on human medicines, clinical investigations on medical devices, and cases relating to scientific animal protection, the HPRA Leadership Team, on proposals to refuse, requests the advice of the Advisory Committee for Human Medicines, the Advisory Committee for Veterinary Medicines, or the Advisory Committee for Medical Devices, , as appropriate. 2.4 In cases of an urgent public and/or animal health matter of a serious or significant nature as deemed by the Chief Executive, the HPRA Leadership Team takes decisions, including suspensions and urgent suspensions, on public and/or animal health matters where the urgency is such that the Authority cannot be convened., centres HPRA Terms of Reference and Rules of Procedure of the HPRA Leadership Team MGT-P0008-9 9/9 VETERINARY MEDICINES - The variation of licences to conduct veterinary clinical field trials - The variation of authorisations for medicinal products for veterinary use - The variation of certificates of registration for homeopathic veterinary medicinal products - The variation of certificates of registration for veterinary medicinal products granted under Article 5(6) of Regulation 2019/6 - The variation of authorisations to manufacture medicinal products for veterinary use - The issue of certificates of free sale; certificates of manufacture and free sale; certificates of pharmaceutical product; and certificates of GMP compliance of a manufacturer - The issue of statements of non-compliance with GMP - The issue of statements of licensing status of pharmaceutical product - Annual updates/communications and immediate notifications for active substance registrations SCIENTIFIC ANIMAL, PROTECTION - Any amendments or renewals of any scientific animal protection authorisations - The issue of animal welfare or compliance notices - The approval of transfer of project authorisations CONTROLLED SUBSTANCES - The grant of licences to import and export controlled drugs - The grant of licences for the import and export of scheduled substances (precursor chemicals) COSMETICS - The issue of certificates of free sale for export purposes - The issue of compliance notices and prohibition orders for cosmetic products
https://assets.hpra.ie/data/docs/default-source/corporate/terms-of-reference/mgt-p0008-terms-of-reference-and-rules-of-procedure-of-the-hpra-leadership-team-v9.pdf?sfvrsn=a609971b_11HPRA Authority Members
Joe is currently Chief Veterinary Advisor at The Donkey Sanctuary, a UK headquartered global NGO, and teaches on animal remedies and scientific animal protection (SAP) training courses in Ireland., He has served on the National Committee for the Protection of Animals used for Scientific Purposes and the Veterinary Council of Ireland., His main interests are in animal welfare and protection, veterinary medicines and professional standards.
https://www.hpra.ie/about-us/our-structure/hpra-authority-membersReport of the Meeting on 24 September 2025
National Committee for the Protection of Animals Used for Scientific Purposes Report of the Meeting on 24 September 2025 1., Update on AWB network An update was provided in relation to the creation of a National Animal Welfare Body (AWB) Network., iii.ETPLAS modules An update was provided on the expansion of the EC funded Education and Training Platform for Laboratory Animal Science (ETPLAS) from six to twenty-three modules. 10.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/scientific-animal-protection/national-committee/report-of-the-meeting-on-24-september-2025.pdf?sfvrsn=d921b26f_1Terms of reference and rules of procedure of the HPRA Leadership Team changes tracked
(Functions devolved from the Authority) 2.2 The2.2 Other than matters reserved by the Authority, the HPRA Leadership Team is responsible for carrying out the competent authority functions for the regulation of medicinal products for human use; clinical trials on medicinal products for human and veterinary use; clinical investigations; medicinal products for veterinary use; medical devices; blood and blood components; tissues and cells; human organs; cosmetics; controlled drugs; drug precursors and protection of animals used for scientific purposes as set out in the legislation listed at http://www.hpra.ie/homepage/about- us/legislation, other than functions reserved by the Authority., as set out in each function’s section on the HPRA website https://www.hpra.ie/regulation. 2.3 Save for clinical trials on human medicines, clinical investigations on medical devices, and cases relating to scientific animal protection, the HPRA Leadership Team, on proposals to refuse, requests the, advice of the Advisory Committee for Human Medicines, the Advisory Committee for Veterinary Medicines, or the Advisory Committee for Medical Devices, as appropriate. 2.4 In cases of an urgent public and/or animal health matter of a serious or significant nature as deemed by the Chief Executive, the HPRA Leadership Team takes decisions, including suspensions and urgent suspensions, on public and/or animal health matters where the urgency is such that the Authority cannot be convened., conditions, and substantial change of authorisations for organ procurement organisations or transplantation centres VETERINARY MEDICINES The variation of licences to conduct veterinary clinical field trials The variation of authorisations for medicinal products for veterinary use The variation of certificates of registration for homeopathic veterinary medicinal products The variation of certificates of registration for veterinary medicinal products granted under Article 5(6) of Regulation 2019/6 The variation of authorisations to manufacture medicinal products for veterinary use The issue of certificates of free sale; certificates of manufacture and free sale; certificates of pharmaceutical product; and certificates of GMP compliance of a manufacturer The issue of statements of non-compliance with GMP The issue of statements of licensing status of pharmaceutical product Annual updates/communications and immediate notifications for active substance registrations SCIENTIFIC ANIMAL, PROTECTION Any amendments or renewals of any scientific animal protection authorisations The issue of animal welfare or compliance notices The approval of transfer of project authorisations CONTROLLED SUBSTANCES The grant of licences to import and export controlled drugs The grant of licences for the import and export of scheduled substances (precursor chemicals) COSMETICS The issue of certificates of free sale for export purposes The issue of compliance notices and prohibition orders for cosmetic products HUMAN MEDICINES - The modification of authorisations to conduct clinical trials on medicinal products for human use - The variation of authorisations for medicinal products for human use - The variation of certificates of registration for homeopathic medicinal products - The variation of certificates of registration for herbal medicinal products HPRA Terms of Reference and Rules of Procedure of the HPRA Leadership Team MGT-P0008-89 10/8/11 - The variation of authorisations, PROTECTION - Any amendments or renewals of any scientific animal protection authorisations - The issue of animal welfare or compliance notices - The approval of transfer of project authorisations CONTROLLED SUBSTANCES - The grant of licences to import and export controlled drugs - The grant of licences for the import and export of scheduled substances (precursor chemicals) COSMETICS - The issue of certificates of free sale for export purposes - The issue of compliance notices and prohibition orders for cosmetic products
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/mgt-p0008-terms-of-reference-and-rules-of-procedure-of-the-hpra-leadership-team-v9-changes-tracked.pdf?sfvrsn=ebd36918_6Method of supply of antiparasitic veterinary medicinal products
Risk to the target animal., In Ireland, the Environmental Protection Agency (EPA) monitors a number of pesticide-related substances in groundwater, including cypermethrin., A Report by the Environmental Protection Agency, Wexford. https://www.epa.ie/pubs/reports/waste/haz/NHWMP2008.pdf., b) Increased demand for animal protein, coupled with a drive for greenhouse gas reduction would drive animal production efficiency., Republic of Ireland animal medicines review, July 2012 data.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/methods-of-supply/method-of-supply-of-antiparasitic-veterinary-medicinal-products_2019.pdf?sfvrsn=fcb46318_3Terms of Reference and Rules of Procedure
VERSION 1 EFFECTIVE DATE 15 MAY 2024 Terms of Reference and Rules of Procedure Terms of Reference and Rules of Procedure of the National Committee for the Protection of Animals used for Scientific Purposes Version 1 2/12 CONTENTS 1 BACKGROUND 3 2 MANDATE 3 3 COMPOSITION 3 4 SECRETARIAL SUPPORT 4 5 MEETINGS 4 6 MINUTES OF MEETINGS 5 7 TRAINING EVENTS 6 8 ACCESS TO DOCUMENTS AND CONFIDENTIALITY 7 9 INDEPENDENCE AND CONFLICTS OF INTEREST 8 APPENDIX 1 PROCEDURE FOR ADVISING ANIMAL WELFARE BODIES AND THE HPRA 9 APPENDIX 2 FRAMEWORK FOR HPRA INVOLVEMENT 11 Terms of Reference and Rules of Procedure of the National Committee for the Protection of Animals used for Scientific Purposes Version 1 3/12 1 BACKGROUND 1.1 The National Committee for the Protection of Animals Used for Scientific Purposes (NCPA) is established by the European Union (Protection of Animals Used for Scientific Purposes) Regulations 2012 (SI., No. 543 of 2012, the NCPA is responsible for: 2.3 Providing advice to the HPRA and animal welfare bodies of establishments regulated by SI., - Promoting the event to its stakeholders for scientific animal protection, Terms of Reference and Rules of Procedure of the National Committee for the Protection of Animals used for Scientific Purposes Version 1 9/12 APPENDIX 1 PROCEDURE FOR ADVISING ANIMAL WELFARE BODIES AND THE HPRA Background The primary function of the NCPA is to advise the animal welfare bodies (AWBs) and HPRA on matters dealing with the acquisition, breeding, accommodation, care and use of animals in procedures and to ensure the sharing of best practice., Providing support to the Committee in its communications with Animal Welfare Bodies (AWBs) and the HPRA (e.g. sending Committee documents to the AWBs by email). 3.
https://assets.hpra.ie/data/docs/default-source/corporate/terms-of-reference/terms-of-reference-and-rules-of-procedure_sap_2024.pdf?sfvrsn=7561ff48_3Report of the Meeting on 07 May 2025
National Committee for the Protection of Animals Used for Scientific Purposes Report of the Meeting on 7 May 2025 1., This database is designed to collect and organise data on non-animal methodologies used in biomedical research, and leverages automated technologies to extract and structure information from the extensive body of published scientific literature., Update on a national Animal Welfare Body network The Committee was updated on the establishment of a national AWB network, which held its first meeting on 3 March 2025.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/scientific-animal-protection/national-committee/report-of-the-meeting-on-07-may-2025.pdf?sfvrsn=3ba20c44_1Quarter 1 2023 NTPS
1/1 Non-Technical Project Summary Period of approval: Q1 Jan – Mar 2023 REFERENCE NUMBER PROJECT TITLE KEYWORDS LINK TO NTPS V001/2023Q1 Research evaluating novel therapeutics in a model of autism using rats and mice Autism; neurodevelopmental disease; drug discovery; social behavioural cognitive deficit; rat; mouse https://hprapredocsstg.blob.core.windows.net/data/ docs/default-source/regulatory-report/scientific- animal-protection/ntps/v001_2023q1.pdf
https://assets.hpra.ie/data/docs/default-source/regulatory-report/scientific-animal-protection/ntps/q1-2023-ntps-table-for-uploading.pdf?sfvrsn=cc4fcd2_3Quarter 1 2025 NTPS
1/1 Non-Technical Project Summary Period of approval: Q1 Jan – Mar 2025 REFERENCE NUMBER PROJECT TITLE KEYWORDS LINK TO NTPS V001/2025Q1 Research project investigating innate immune regulation in infection and inflammation using mice Infectious disease; innate immunity; mice https://assets.hpra.ie/data/docs/default-source/regulatory-report/scientific-animal- protection/ntps/v001_2025q1.pdf?
https://assets.hpra.ie/data/docs/default-source/regulatory-report/scientific-animal-protection/ntps/quarter-1-2025-ntps.pdf?sfvrsn=21cf706a_1