Your Search Results
Terms 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_10Method 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 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_3HPRA Authority Members - Declarations of Interest 2025
He has declared other interests related to his involvement with animal welfare NGOs, in animal remedy and scientific animal protection training programmes, and his occasional role as an expert witness on animal welfare, medicines and veterinary practice issues.
https://assets.hpra.ie/data/docs/default-source/corporate/declaration-of-interest/hpra-authority---declarations-of-interest-2025.pdf?sfvrsn=eb600fd5_9Recall of medicinal products for human and veterinary use
(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/sur-g0019-recall-of-medicinal-products-for-human-and-veterinary-use-v3.pdf?sfvrsn=9e07d300_5Recall 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-trackede038aaa3-0134-4dba-b3ee-59fb815cf565.pdf?sfvrsn=b76ea69_3About the National Committee
Committee for the Protection of Animals Used for Scientific Purposes In accordance with EU and national legal requirements, the functions of the National Committee are to: Advise the HPRA and institutional animal welfare bodies on matters dealing with the acquisition, breeding, accommodation, care and use of scientific animals., The procedure for advising Animal Welfare Bodies is set out in the Procedure for Advice document., Exchange information on the operation of animal welfare bodies and project evaluation.
https://www.hpra.ie/regulation/scientific-animal-protection/national-committee/about-the-national-committeeGuide to Cosmetic Products for Responsible Persons changes tracked
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-G0010-5.1 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-(tracked)/adv-g0010-guide-to-cosmetic-products-for-responsible-persons-v5-changes-tracked.pdf?sfvrsn=b05c6518_2Report 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 3 2023 NTPS
1/1 Non-Technical Project Summary Period of approval: Q3 July – Sept 2023 REFERENCE NUMBER PROJECT TITLE KEYWORDS LINK TO NTPS V001/2023Q3 Research to assess the efficacy of a novel therapy for chronic pain in knee osteoarthritis using rats Osteoarthritis; knee; hydrogel; medical device; analgesia; anxiety; depression; cognition; rat https://hprapredocsstg.blob.core.windows.net/data/ docs/default-source/regulatory-report/scientific- animal-protection/ntps/v001_2023q3.pdf
https://assets.hpra.ie/data/docs/default-source/regulatory-report/scientific-animal-protection/ntps/quarter-3-2023-ntps.pdf?sfvrsn=a15d1922_2