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Report a side effect | Medicines used in animals
Report a side effect for a medicine for animal use Healthcare professionals and animal owners can use our online reporting form to report a side effect or an adverse incident experienced with a medicine used in animals., Report Learn more Privacy and data protection Find out how we process the information from reports in our privacy notice.
https://www.hpra.ie/report-an-issue/medicines-for-animal-use/report-a-side-effect-or-adverse-incidentReport 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_1Online 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-formAdvice relating to certain training courses covering bovine artificial insemination (AI) and ultrasound scanning of the bovine reproductive tract
Opinion from National Committee for the Protection of Animals Used for Scientific Purposes 3 October 2018 Request for advice: A request for advice relating to certain training courses covering bovine artificial insemination (AI) and ultrasound scanning of the bovine reproductive tract was submitted to the NCPAUSP from the HPRA., Advice: The Committee considered the definition of procedure under Article 3 of Directive 2010/63/EC, and also in particular to the specific practices which are exempt from such control under paragraph 5 of Article 1 of that Directive, especially subparagraphs (a) {“non- experimental agricultural practices”}, (d) {“practices undertaken for the purposes of recognised animal husbandry”}, and (f) {“practices not likely to cause pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle in accordance with good veterinary practice”}., A number of these Member States referred to the control of such practices by other legislation, such as animal welfare legislation., The remaining Member State stated that while the practices fell outside the scope of the Directive, its national legislation required such practices to have a permit due to the national definition of animal research., The Committee is also aware that protection for the welfare of such animals already exists in law, for which purpose the Animal Health and Welfare Act 2013 created a duty on the organisers of such training to protect the welfare of the animals involved.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/scientific-animal-protection/national-committee/advice-relating-to-certain-training-courses-covering-bovine-artificial-insemination-(ai)-and-ultrasound-scanning-of-the-bovine-reproductive-tract.pdf?sfvrsn=a406518_2NCPA 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_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_9Report of the Meeting on 12 September 2023
National Committee for the Protection of Animals Used for Scientific Purposes Report of the Meeting on 12 September 2023 1., Animal Welfare Body brochure and poster An update to the Brochure developed previously by the Committee for Animal Welfare Bodies (AWB) was agreed in principle., AOB The Committee noted the reports of a PARERE workshop in Italy on 30-31 March 2023 as well as a recommendation of a subgroup of EU National Committees on non-animal derived antibodies dated 7 July 2023.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/scientific-animal-protection/national-committee/report-of-the-meeting-on-12-september-2023.pdf?sfvrsn=74cc43ba_1Application 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_6Make 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-submissionReport 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_1