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HPRA Strategic Plan 2021 – 2025
health products and scientific animal use Maximise the opportunity presented by new legislation to enhance regulation of health products Strengthen use of risk based approaches to regulation Respond to the globalised industry and markets Engage with stakeholders to drive improvements in regulatory activities Strengthen trust in the regulatory system through greater transparency and clarity Further develop information resources and communication platforms Promote an agile approach to appropriate regulation of innovations Contribute to Irish research through outreach and engagement Prioritise areas of innovation for organisational development Health system partnerships Strengthening our collaborations across all areas of the health system Progressive regulation Increasing our use of proportionate and adaptive approaches for better patient outcomes Communication and engagement Improving our models of engagement to strengthen, Clinical researchers have access to integrated supports and a streamlined system for clinical study approvals. 1.3 Enhance national systems to better regulate animal health products and scientific animal use Embed the application of 3R principles in animal-based research in Ireland., Strengthen the pharmacovigilance system through new methods and tools for promotion and analysis of reports and dissemination of safety information to healthcare professionals and animal owners., The pharmacovigilance system is more responsive and effective, with increased reporting by healthcare professionals and animal owners., Implementation delivers value to all stakeholders, reduces regulatory burden where appropriate, while ensuring protection for the users of health products.
https://assets.hpra.ie/data/docs/default-source/corporate/strategic-plan/strategic-plan-2021-2025.pdf?sfvrsn=1b2e6118_15Technical guidance for completion of non-technical project summaries under SAP legislation
Guide to Technical Specifications for Completion of Non-technical Project Summaries HPRA Guide to Technical Specifications for Completion of Non-technical Project Summaries AUT-G0161-2 2/6 1 SCOPE This guidance is intended to assist applicants submitting a Health Products Regulatory Authority (HPRA) 'Application for a Project Authorisation under Scientific Animal Protection Legislation’, to understand the technical specifications required for entering data in the European Commission Excel template, which must be used for submission of non-technical project summaries (NTS) as part of the project application process. 2 INTRODUCTION The protection of animals used for scientific procedures is governed by Directive 2010/63/EU which was transposed into Irish law by S.I., On this sheet, use the dropdown menu to select the animal species, and input the estimated number of animals in each severity category., On this sheet, use the dropdown menu to select the animal species, then input the numbers of animals to be re-used (in another procedure/project authorisation), returned to habitat/husbandry, or rehomed.
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/aut-g0161-technical-guidance-for-completion-of-non-technical-project-summaries-under-sap-legislation-v2.pdf?sfvrsn=ec44352b_6Technical guidance for completion of non-technical project summaries under SAP legislation changes tracked
Guide to Technical Specifications for Completion of Non-technical Project Summaries HPRA Guide to Technical Specifications for Completion of Non-technical Project Summaries AUT-G0161-12 2/6 1 SCOPE This guidance is intended to assist applicants submitting a Health Products Regulatory Authority (HPRA) 'Application for a Project Authorisation under Scientific Animal Protection Legislation’, to understand the technical specifications required for entering data in the European Commission Excel template, which must be used for submission of non-technical project summaries (NTS) as part of the project application process. 2 INTRODUCTION The protection of animals used for scientific procedures is governed by Directive 2010/63/EU which was transposed into Irish law by S.I., On this sheet, use the dropdown menu which captures expected severitiesto select the animal species, and input the estimated number of animals in each severity category (further sub-divided per., This dropdown menu captures to select the animal species, then input the numbers of animals to be re-used (in another procedure/project authorisation), returned to habitat/husbandry, or rehomed.
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/aut-g0161-technical-guidance-for-completion-of-non-technical-project-summaries-under-sap-legislation-v2-changes-tracked.pdf?sfvrsn=a488fa2b_4Joint HPRA-VMD guide to acceptable texts for joint labelling for VMPs for use in IE and the UK
x Special warnings, if necessary [Indicate any particulars essential for safety or health protection, including any special precautions relating to use and any other warnings.], x The words “For animal treatment only” For animal treatment only., O u t e r P a c k a g e I m m e d i a t e P a c k a g e S m a l l i m m e d i a t e p a c k a g i n g u n i t s B l i s t e r s P a c k a g e L e a f l e t IE POM (Prescription Only) POM(E) (Prescription Only Exempt) CAM (Companion Animal Medicine) LR (Licensed Retailer) IE Contact details Contact details for marketing authorisation holder/local representatives/manufacturer responsible for batch release/ contact details to report suspected adverse reactions.
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/aut-g0181-joint-hpra-vmd-guide-to-acceptable-texts-for-joint-labelling-for-vmps-for-use-in-ie-and-the-uk-v2.pdf?sfvrsn=73a96d23_12Authorisations
Authorisations for scientific animal protection As the competent authority, our primary goal is to ensure that procedures involving the use of scientific animals adhere to the relevant EU and national legislation.
https://www.hpra.ie/regulation/scientific-animal-protection/authorisationsJoint HPRA-VMD guide to acceptable texts for joint labelling for veterinary medicinal products for use in IE and the UK track changes
x Special warnings, if necessary [Indicate any particulars essential for safety or health protection, including any special precautions relating to use and any other warnings.], x The words “For animal treatment only” For animal treatment only., O u t e r P a c k a g e I m m e d i a t e P a c k a g e S m a l l i m m e d i a t e p a c k a g i n g u n i t s B l i s t e r s P a c k a g e L e a f l e t IE POM (prescription onlyPrescription Only) POM(E) (prescription only exemptPrescription Only Exempt) CAM (companion animal medicineCompanion Animal Medicine) LM (licensed retailer)LR (Licensed Retailer) IE Contact details Contact details for marketing authorisation holder/local representatives/manufacturer responsible for batch release/ contact details to report suspected adverse reactions.
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/aut-g0181-joint-hpra-vmd-guide-to-acceptable-texts-for-joint-labelling-for-veterinary-medicinal-products-for-use-in-ie-and-the-uk-v2-track-changes.pdf?sfvrsn=1e315e7d_3Application for a clinical investigation of non CE-marked medical devices (Article 62 MDR)
FORMCHECKBOX Yes FORMCHECKBOX No b)Has the device been manufactured using non-viable tissue or cells of human or animal origin, or their derivatives?, related to equivalent or similar devices of the same manufacturer including length of time on the market, review of performance, clinical benefit and safety-related issues and any corrective actions taken FORMTEXT 25 Comment on the overall clinical development strategy for the medical device FORMTEXT 26 Summary of risk-benefit analysis and risk management, including information on known or foreseeable risks, any undesirable effects, contraindications and warnings FORMTEXT 27 For devices where question 4 in section B is answered ‘Yes’: detailed information on the medicinal substance or tissues, cells or their derivatives and on the compliance with the relevant GSPRs and the specific risk management in relation to the substance, tissues, cells or their derivatives as well as the evidence for the added value of incorporating such constituents FORMTEXT 28 Where applicable, a statement indicating whether or not the device is manufactured utilising tissues of animal, origin as referred to in EU Regulation 722 of 2012 FORMTEXT 29 If the device is manufactured utilising tissues of animal origin as referred to in Regulation 722 of 2012, the risk management measures which have been applied to reduce the risk of infection., (Experts used will be subject to the HPRA’s procedures for protection of confidentiality and impartiality.)
https://assets.hpra.ie/data/docs/default-source/submission-forms/aut-f0191-application-for-a-clinical-investigation-of-non-ce-marked-medical-devices-(article-62-mdr)-v5.docx?sfvrsn=b0005b66_8Report from NCPA on the Forced Swim Test
As the experimental conditions mean that the animal cannot escape, the FST is considered aversive., - A maximum time that animals may be kept in the water - Details of what care will be provided after the test has been completed, specifically including drying the animal and giving warming support after it has been in the water, - The parameters (in terms of animal behaviours) that will be assessed - A robust scientific and statistical justification for the typical and maximal length of swim, which should be reduced to the minimum possible for reliable results, Protection Sent: Tuesday 8 October 2024 2:36 pm Subject: National Committee Request for Data Dear Animal Welfare Body Chairs and Establishment Compliance Officers, The HPRA has submitted a request for the advice of the National Committee for the Protection of Animals Used for Scientific Purposes on whether there is a justified case for the inclusion of the forced swim test (FST) in project applications in Ireland, and if so, the circumstances under which its use would be considered appropriate., Kind regards, The SAP Te am Veterinary Sciences Department – Scientific Animal Protection Health Products Regulatory Authority | An tÚdarás Rialála Tá irgí Sláinte Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/scientific-animal-protection/national-committee/report-from-ncpa-on-the-forced-swim-test.pdf?sfvrsn=6ba12bb3_1Guide to information held by the HPRA changes tracked
The HPRA’s responsibilities and role in the scientific evaluation of medicinal products for human and veterinary use and the regulation of medical devices have a significant impact on the protection and promotion of human and animal health., The department assesses applications submitted under scientific animal protection legislation relating to the conduct of research and regulatory studies in animals. 8.9.2 Classes of records held - Files relating to the assessments of veterinary product applications and applications submitted under Directive 2010/63/EU on scientific animal protection - Clinical field trial files - Adverse reaction reports and files (only anonymised adverse reaction data are made available to any enquirer) - Data submitted in support of applications - Records of applications for determination of medicinal status - Drug and plasma master files - National and EU legislation and guidelines - Reports from internal meetings - Documentation from external meetings HPRA Guide to Information held by the HPRA MGT-G0016-1112 19/30 - Policies, guidelines, standard operating procedures, work instructions and forms 8.10 Office of the Chief Executive 8.10.1 Functions of the Office of the Chief Executive, The system is intended to improve the protection of health and safety of patients, users and others by reducing the likelihood of the same type of adverse incident being repeated in the European Economic Area (EEA) and to correct product problems., Third country manufacturers, i.e. those located outside of the European Economic Area (EEA), are also required to meet the equivalent standard of GMP as EEA manufacturers. 12.10 Scientific animal protection Licensing Since 1 January 2013, the use of animals for scientific purposes is regulated by means of authorisation at three levels: 1 Establishments: Breeders, suppliers and establishments where procedures are performed must be authorised and are subject to HPRA inspections, including unannounced inspections. 2 Projects: Scientific procedures can only be performed on an animal following a detailed submission of the planned study and subsequent approval by the HPRA. 3 Individuals: All individuals performing scientific procedures on animals in an authorised establishment must be adequately trained and hold an individual authorisation., These regulations are variously made under the Irish Medicines BoardIMB Act 1995 as amended, the Animal Remedies Act 1993 and the European Communities Act 1972.
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/mgt-g0016-guide-to-information-held-by-the-hpra-v12-changes-tracked.pdf?sfvrsn=e6666818_10Privacy & Data Protection
What is Data Protection?, What is the difference between Data Protection and Freedom of Information?, Privacy notice Personal data are processed by the HPRA in the performance of our regulatory functions to protect and enhance public and animal health through assessing the safety, quality and effectiveness of healthcare products., What are your rights under data protection law?, The HPRA, as a data controller, adheres to the principles of data protection...., Privacy & Data Protection
https://www.hpra.ie/privacy---data-protection