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Guide to applications for renewals and amendments to breeder, supplier, user authorisations changes tracked
Guide to Applications for Renewals and Amendments and Renewals to Breeder/Supplier/User Authorisations under Scientific Animal Protection Legislation Guide to Applications for Renewals and Amendments and Renewals to Breeder/Supplier/User Authorisations under Scientific Animal Protection Legislation AUT-G0112-3 5 2/6/8 CONTENTS 1., MAKING AN APPLICATION 5 4.1 Administrative details 5 4.2 Fees 5 APPENDIX I DEFINITIONS 6 1 SCOPE 3 2 INTRODUCTION 3 3 APPLICATIONS FOR AN AMENDMENT OR RENEWAL OF A BREEDER/SUPPLIER/ USER AUTHORISATION 4 3.1 Amendment 4 3.2 Renewal 4 3.3 Site master file (SMF) 4 3.4 Declaration and undertaking 4 4 MAKING AN APPLICATION 5 4.1 Timeline 5 4.2 Naming convention 5 4.3 Administrative details 6 4.2 Fees 6 APPENDIX 1 DEFINITIONS 7 Guide to Applications for Renewals and Amendments and Renewals to Breeder/Supplier/User Authorisations under Scientific Animal Protection Legislation AUT-G0112-3 5 3/6/8 1 SCOPE This guidance is intended to assist applicants in completing a Health Products Regulatory Authority (HPRA) ‘Application for Renewal/Amendmentamendment/renewal to a Breeder/Supplier/User Authorisationbreeder/supplier/user authorisation under Scientific Animal Protection Legislation’scientific animal protection legislation’ form and establish conditions for renewal and, Formatted: Space Before: 0 pt, After: 0 pt Guide to Applications for Renewals and Amendments and Renewals to Breeder/Supplier/User Authorisations under Scientific Animal Protection Legislation AUT-G0112-3 5 5/6/8 4 MAKING AN APPLICATION An application for aamendment or renewal or an amendment of a breeder/supplier/user authorisation must consist of a completed renewal/amendment/renewal application form., Applications are not validated as eligible for HPRA scientific animal protection (SAP) assessment until all necessary documentation has been provided., Guide to Applications for Renewals and Amendments and Renewals to Breeder/Supplier/User Authorisations under Scientific Animal Protection Legislation AUT-G0112-3 5 7/6/8 APPENDIX I1 DEFINITIONS Compliance Officer – the person(s) indicated in Regulation 44 of the Regulations who is responsible for ensuring compliance with the provisions of the Regulations.
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/aut-g0112-guide-to-applications-for-renewals-and-amendments-to-breeder-supplier-user-authorisations-v4-changes-tracked.pdf?sfvrsn=f9a6c9b5_3Application for withdrawal of a breeder, supplier, user authorisation under SAP legislation
Application for Withdrawal of a Breeder/Supplier/User Authorisation under Scientific Animal Protection Legislation For details of the requirements, please see the ‘Guide to Withdrawal of Breeder/Supplier/User Authorisations under Scientific Animal Protection Legislation’. 1Breeder/supplier/user details Breeder/supplier/user authorisation number Breeder/supplier/user authorisation holder name Name Address Eircode E-mail Telephone Expiry date of current authorisation 2withdrawal notification Date of intended withdrawal of breeder/supplier/user authorisation: Provide details on the reasons for withdrawal of breeder/supplier/user authorisation: Provide details on the fate of the animals post-withdrawal, including a proposed timeline for any necessary actions: 3signature of compliance officer(S) Signature of compliance officer: __________________________ (on behalf of the authorisation holder) Print
https://assets.hpra.ie/data/docs/default-source/submission-forms/aut-f0348-application-for-withdrawal-of-a-breeder-supplier-user-authorisation-under-sap-legislation-v2.docx?sfvrsn=523efe08_6Report of the Meeting on 15 May 2024
National Committee for the Protection of Animals Used for Scientific Purposes Report of the Meeting on 15 May 2024 1., Matters Arising The Committee noted that since the last meeting a brochure detailing ‘Tips for effective Animal Welfare Bodies’ and another ‘An introduction to Animal Welfare Bodies’ has been published in hard and soft copy., The Committee will re-engage with national Animal Welfare Bodies to review how best to address their needs in the future. 7., European network of Animal Welfare Bodies The Committee was informed about the establishment of a European network of Animal Welfare Bodies (ENAWB) in April 2024.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/scientific-animal-protection/national-committee/report-of-the-meeting-on-15-may-2024.pdf?sfvrsn=8491475f_1NCPA tips for AWB - A4 Poster
Tips fo r e ffe c t i ve Animal We l f a re Bodies Everyone’s responsibility The AWB Planning on joining the AW B ?, Read ‘A n I n t roduction to Animal We l f a re Bodies’* Get to know your AW B - who is on it and what they do!, Fa m i l i a r i s e yourself with any existing 3Rs repositories within your establishment Keep abreast of new 3Rs developments and opportunities Introduce all members and explain their background and roles Compose and implement a Culture of Care mission statement Fo ster open communication Listen to everyone – seek input from all involved, and at all levels Everyone’s voice is important and should be respected Circulate any lessons learned from ongoing and completed projects to optimise project evaluation Ta ke that tour – visit the unit(s) and speak to users and staff Attend the meetings, have your say and represent others *Issued by the National Committee for the Protection of Animals Used for Scientific Purposes
https://assets.hpra.ie/data/docs/default-source/regulatory-report/scientific-animal-protection/national-committee/3-ncpa-cnca---a4-poster-2024.pdf?sfvrsn=21c706d_3Online contact form
Category* - Select - Medicines for human use Medicines for animal use Scientific animal protection Medical devices Cosmetics Blood, tissues and organs Controlled drugs Other Topic* - Select - Clinical trials Summary of product characteristics / Product information leaflets Interchangeable substances query Manufacturer query Method of Sale and Supply of a Human Medicine Other queries Reporting an issue / side effect query Requesting a New National submission slot Requesting Ireland to act as Reference Member States (RMS) Scientific advice Shortages Submitting an application to the HPRA Wholesaler / Retailer query Topic* - Select - Regulatory query Reporting an issue / side effect / adverse incident query Safety query Veterinary clinical trials Sub-topic* - Select - Copy of GMP certificates Exempt medicines query General query Topic, * - Select - Application process Classification process Compliance query Existing authorisation holder National Committee Other queries Scientific animal welfare Sub-topic - Select - How to submit an application for authorisation How to pay a fee Sub-topic* - Select - Individual authorisation query Project authorisation query Topic* - Select - Registration query Regulatory query Reporting a safety issue query Safety query Certificates of free sale Topic*: - Select - General query Reporting an issue / side effect query Topic*: - Select - Compliance query Reporting an issue / serious adverse reaction query Vigilance query Topic* - Select - Accessibility query Finance query Careers Data protection Events at the HPRA Freedom of information General query Invoice, query Media query MyAlerts subscriptions query Parliamentary questions Protected disclosures Report an illegal activity Website administrator query ---------------- - Select - Report a side effect - medicines for human use Report a quality defect - medicines for human use Report a side effect or adverse incident – medicines for animal use Report a safety issue for a medical device Report a side effect – cosmetic product Report a serious adverse reaction/event – tissues and cells Innovation office enquiry Medical devices economic operator – registration form Please provide details of your query* Please attach file (if relevant) This field is required Complete this online form to contact the HPRA with your query.
https://www.hpra.ie/contact-us/online-contact-formMake a Submission | Application forms and other forms to send to the HPRA
View list Medicines for animal use View the list of forms and download relevant forms for completion and submission., View list Scientific animal protection View the list of forms and download relevant forms for completion and submission.
https://www.hpra.ie/make-a-submissionHPRA 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_9Terms 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_10Report of the meeting on 09 October 2024
National Committee for the Protection of Animals Used for Scientific Purposes Report of the Meeting on 09 October 2024 1., The event aims to highlight the benefits of Replacement and provide a platform for discussion between researchers and those directly involved in animal research., European network of Animal Welfare Bodies The Committee was informed that as there is not a national AWB network in Ireland.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/scientific-animal-protection/national-committee/report-of-the-meeting-on-09-october-2024.pdf?sfvrsn=f5cd8e5d_1Method 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_3