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Terms 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_3Recall of medicinal products for human and veterinary use changes tracked
(c) Notwithstanding sub-paragraph (b), in case of urgency if public or animal health is threatened, the Board may suspend the distribution, sale and supply of an animal remedy, (8) A person who sells or supplies an animal remedy shall notify the Board of any action taken by him or her to— (a) suspend the sale or supply, or (b) recall, an animal remedy together with the reasons for the action if it concerns the efficacy or safety (including the protection of public health) of the animal remedy. 14 Recall of an animal remedy (1) The Board may, by notice (“recall notice”), order the recall of any animal remedy or a batch of an animal remedy if it is of the opinion that – (a) a circumstance referred to in Article 84(1) of the Directive applies (b) an animal remedy consists of or contains a substance the administration of which, to a class of animal for which the animal remedy is intended, is unlawful (c) the animal remedy is not manufactured in accordance with the animal remedies authorisation or in accordance with the principles and guidelines referred to in Article 50(f) of the Directive, or (d) the animal remedy is not labelled in accordance with, the animal remedies authorisation, (3) The Board may confine a recall notice to wholesaler or retailer level if it considers such action appropriate for the protection of animal or public health or environmental safety, National Legislation Animal Remedies (No. 2) Regulations, 2007 (SI No. 786 of 2007).
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/sur-g0019-recall-of-medicinal-products-for-human-and-veterinary-use-v3-changes-tracked.pdf?sfvrsn=b4b36418_2Guide to Cosmetic Products for Responsible Persons
As of 11 March 2013, a ban on all animal testing of finished products and ingredients applies, even if there are no alternative non-animal tests., Data on any animal testing performed by the manufacturer, agents or suppliers and any animal testing performed to meet the regulatory requirements of third countries should be Guide to Cosmetic Products for Responsible Persons ADV-G0010-6 7/15 included in the PIF., Where no animal testing has been conducted a statement indicating this should be included in the PIF., Therefore, where an animal test has been performed, the following information should be contained within the PIF: - identification of the animal test carried out - identification of the ingredient tested - date of the animal test - location of the animal test - information on the entity (or entities) that carried out the test and the entity that commissioned it - legislative purpose of the animal test and substantiation of the stated purpose In the case of the last point, a clear reference to the legislation in question, a short description of the scope and of the need for the testing under that legislation should be included., The manufacturing premises and equipment utilised should ensure protection of the product, efficient cleaning and minimise the risk of mix-ups, or cross-contamination.
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/adv-g0010-guide-to-cosmetic-products-for-responsible-persons-v6.pdf?sfvrsn=5abfc210_5Report of the Meeting on 21 September 2022
National Committee for the Protection of Animals Used for Scientific Purposes Report of the Meeting on 21 September 2022 1., Matters Arising It was noted that a guideline on training for Animal Welfare Bodies is being developed and will be tabled for discussion at a future meeting. 4.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/scientific-animal-protection/national-committee/report-of-the-meeting-on-21-september-2022.pdf?sfvrsn=5ee7d49b_1Fee 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)-v11.xlsx?sfvrsn=17d5d9d5_8Report of the Meeting on 15 September 2021
National Committee for the Protection of Animals Used for Scientific Purposes Report of the Meeting on 15 September 2021 1., Review of feedback from AWBs on Lessons Learned from Covid Experience Following on from the September 2020 meeting, NCPA members were asked if they had received any feedback from Animal Welfare Bodies (AWBs) in relation to this matter., Feedback at the 11th World Congress on Alternatives and Animal Use in the Life Sciences held in August 2021 suggests that there are limitations on available training for AWB members.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/scientific-animal-protection/national-committee/report-of-the-meeting-on-15-september-2021.pdf?sfvrsn=eb854aea_1Clinical field trials
Veterinary clinical field trials In legislation, a clinical trial is defined as a ‘study which aims to examine under field conditions the safety or efficacy of a veterinary medicinal product under normal conditions of animal husbandry or as part of normal veterinary practice for the purpose of obtaining a marketing authorisation or a change thereof’., By contrast, pre-clinical studies on veterinary medicine fall under the scope of the legislation on scientific animal protection (regulated by the HPRA under Directive 2010/63/EU).
https://www.hpra.ie/regulation/veterinary-medicines/veterinary-clinical-field-trialsReport of the Meeting on 16 September 2020
National Committee for the Protection of Animals Used for Scientific Purposes Report of the Meeting on 16 September 2020 1., Challenges posed by Covid The National Committee noted that the UK’s Laboratory Animal Science Association (LASA) had developed a document to help Animal Welfare and Ethical Review Bodies (AWERBs) review the impact of Covid‐19 lockdown on their establishments.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/scientific-animal-protection/national-committee/report-of-the-meeting-on-16-september-2020.pdf?sfvrsn=e75b3283_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