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Public consultation – Proposed fees for 2025: Veterinary Medicinal Products – October 2024
While the HPRA’s Veterinary Science department successfully defended a judicial review running over a number of years, the result of this is increased costs and resources dedicated solely to work which delivers nothing under our animal health remit. 2.1 Regulation (EU) 2019/6 (NVR) There continued to be significant work on the NVR and extensive consultation with the Department of Agriculture, Food and the Marine (DAFM) in 2024., While the HPRA is well positioned to pivot to centralised applications, the full effect of the change in legislation on veterinary medicines is still being internalised by the animal health industry and might yet change again due to the impact of the EMA fees review which will be implemented by 2025., Strategic goal 1 - Strengthen and increase the scientific animal protection inspections programme, enhancing the role the HPRA as an advocate for the 3R principles., However, the overall effect of these fees on the animal health sector will be small as few clinical trials are conducted in Ireland.
https://assets.hpra.ie/data/docs/default-source/corporate/consultations/public-consultation-proposed-fees-for-2025-veterinary-medicinal-products-october-2024.pdf?sfvrsn=23b199a2_5Annual pharmacovigilance report 2020
Our mission is to protect and enhance public and animal health through the regulation of medicines, medical devices and other health products., Reports may also be received from veterinary health professionals and animal owners directly., Reports of SAEs are assessed by the relevant MAH and the HPRA for any association between the event and the product(s) administered to the animal(s), using an established causality assignment system as shown in Table 3., Veterinary Surgeon/Veterinary Nurse, Pharmacist, animal owner) animal/human details: species, age, sex the name and veterinary product authorisation (VPA) number of the product in question details of the adverse event While the above outlines the minimum requirements for a valid SAE report, the reporter should endeavour to provide as comprehensive an account as possible in order to facilitate a full scientific evaluation., Veterinary professionals as well as persons licensed to sell or supply animal remedies are reminded of their obligation to notify the HPRA or the relevant MAH of all suspected adverse reactions.
https://assets.hpra.ie/data/docs/default-source/product-updates/annual-pharmacovigilance-report/veterinary-medicines/annual-pharmacovigilance-report-2020.pdf?sfvrsn=1d68f71a_1Privacy notice for reporting a quality defect in a medicine for human or animal use
Legal basis for processing The legal basis for processing personal data in incident reports is Article 6(1)(c) of the General Data Protection Regulation (GDPR), which states: Processing is necessary for compliance with a legal obligation to which the controller is subject., The HPRA fully respects your right to privacy and treats all personal information with the appropriate standards of security and confidentiality, strictly in accordance with data protection legislation., What are your rights under data protection law?, Data protection law provides you with the following rights regarding the processing of your personal data: The right to request access to your data The right to request your data be rectified or erased if it is inaccurate The right to request processing of your data be restricted The right to lodge a complaint with the Data Protection Commission Further information For more information or to make a request regarding your personal data under data protection law, please submit your request in writing or via email: Data Protection OfficerHealth Products Regulatory AuthorityKevin O'Malley House,Earlsfort Centre,Earlsfort Terrace,Dublin 2 Tel: +353 (1) 676 4971Fax: +353 (1) 676 7836Email: dataprotectionofficer@hpra.ie Please provide sufficient information in your request to enable us to deal with your query., Further information regarding data protection at the HPRA can be found in our main privacy notice., Privacy notice for reporting a quality defect in a medicine for human or animal use
https://www.hpra.ie/privacy---data-protection/privacy-notice---quality-defects-reportingGuide to information held by the HPRA
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-G0016-11 18/29 - 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., The mandate of the Advisory Committee is to assist and advise the Authority and the staff in relation to any matters concerning public or animal health or the safety, quality or efficacy of veterinary medicinal products which may be referred to it., These regulations are variously made under the Irish Medicines Board 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/mgt-g0016-guide-to-information-held-by-the-hpra-v11.pdf?sfvrsn=49746261_11Terms of reference and rules of procedure of the HPRA changes tracked
(Reserved functions) 2.3 The Authority takes decisions relating to very significant and serious public and/or animal health matters except in circumstances where a meeting of the Authority cannot be convened, in which case the HPRA Leadership Team takes the decision and informs the Chairperson at the earliest opportunity and the Authority as soon as practical. 2.4 The Authority refuses applications, or suspends, revokes or terminates authorisations as set out in legislation except in circumstances where: (a) the urgency is such that a meeting of the Authority cannot be convened, or (b) the application or authorisation is subject to a binding European decision, or (c) the application or authorisation is for a clinical trial or clinical investigation; 1 The body was originally established as the Irish Medicines Board (‘the Board’); the name was changed to Health Products Regulatory Authority by the Health (Pricing and Supply of Medical Goods) Act 2013., (HPRA Leadership Team) 11.3 The11.3 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. 11.4 Subject to 11.5 below, 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, Terms of Reference and Rules of Procedure of the Health Products Regulatory Authority MGT-P0007-2021 12/18 11.5 In cases of an urgent public and/or animal health matter of a serious or significant nature, 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.
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/mgt-p0007-terms-of-reference-and-rules-of-procedure-of-the-hpra-v21-changes-tracked.pdf?sfvrsn=14076918_3HPRA Access Policy
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., HPRA Guide to Information held by the HPRA MGT-G0016-89 18/31 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 - Policies, guidelines, standard operating procedures, work instructions and forms 8.10 Department of Operational Excellence and Quality 8.10.1 Functions of the Department, 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., The mandate of the Advisory Committee is to assist and advise the Authority and the staff in relation to any matters concerning public or animal health or the safety, quality or efficacy of veterinary medicinal products which may be referred to it., These regulations are variously made under the Irish Medicines Board Act 1995 as amended, the Animal Remedies Act 1993 and the European Communities Act 1972.
https://assets.hpra.ie/data/docs/default-source/corporate/freedom-of-information/guide-to-information-held-by-the-hpra-v9.pdf?sfvrsn=659c45e0_3Annual Report 2024
The year was one of transformation and progress for the HPRA, marked by notable forward-looking strategic initiatives and a continued commitment to ensuring public and animal health through the regulation of health products., Looking forward, 2025 promises to be an exciting year as we continue to pursue initiatives that promote public and animal health, while embracing innovation and growth., These efforts reaffirm our commitment to delivering excellence in regulatory practice for the benefit of public and animal health while positioning ourselves to meet the challenges of a dynamic scientific and regulatory landscape., I am continually inspired by your commitment to public and animal health and your willingness to embrace innovation and change., • Continued focus on the application of the 3R principles in animal-based research in Ireland, with the aim of enhancing animal welfare
https://assets.hpra.ie/data/docs/default-source/corporate/annual-reports/annual-report-2024.pdf?sfvrsn=8164e07d_7Terms of Reference and Rules of Procedure of the HPRA
(Reserved functions) 2.3 The Authority takes decisions relating to very significant and serious public and/or animal health matters except in circumstances where a meeting of the Authority cannot be convened, in which case the HPRA Leadership Team takes the decision and informs the Chairperson at the earliest opportunity and the Authority as soon as practical. 2.4 The Authority refuses applications, or suspends, revokes or terminates authorisations as set out in legislation except in circumstances where: (a) the urgency is such that a meeting of the Authority cannot be convened, or (b) the application or authorisation is subject to a binding European decision, or (c) the application or authorisation is for a clinical trial or clinical investigation; 1 The body was originally established as the Irish Medicines Board (‘the Board’); the name was changed to Health Products Regulatory Authority by the Health (Pricing and Supply of Medical Goods) Act 2013., (HPRA Leadership Team) 11.3 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. 11.4 Subject to 11.5 below, 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. 11.5 In cases of an urgent public and/or animal health matter of a serious or significant nature, the HPRA Leadership Team takes decisions, including suspensions and urgent Terms of Reference and Rules of Procedure of the Health Products Regulatory Authority MGT-P0007-21 12/18 suspensions, on public and/or animal health matters where the urgency is such that the Authority cannot be convened.
https://assets.hpra.ie/data/docs/default-source/corporate/terms-of-reference/mgt-p0007-terms-of-reference-and-rules-of-procedure-of-the-hpra-v21.pdf?sfvrsn=7256d18_10Notification of a clinical investigation of a CE marked medical device (Article 74 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?, FORMCHECKBOX Clinical investigation plan (CIP) (which sets out the rationale, objectives, design, methodology, monitoring, conduct, record-keeping and the method of analysis for the clinical investigation) Version number FORMTEXT Date FORMTEXT FORMCHECKBOX Investigator’s brochure (IB) OR Instructions for use FORMCHECKBOX A copy of the opinion of the relevant Ethics Committee concerned on the details of the aspects covered by its opinion (if available) FORMCHECKBOX Documents used to obtain informed consent FORMCHECKBOX Description of arrangements for data protection and confidentiality of personal information SECTION E: Declaration Signed on behalf of FORMTEXT .
https://assets.hpra.ie/data/docs/default-source/submission-forms/aut-f0914-notification-of-a-clinical-investigation-of-a-ce-marked-medical-device-(article-74-mdr)-v2.docx?sfvrsn=dae82942_5Application for a performance study
FORMCHECKBOX Yes FORMCHECKBOX No Date: FORMTEXT 16 Payment details (please include documentary confirmation of payment with your application, where applicable): FORMCHECKBOX Cheque FORMCHECKBOX Bank transfer FORMCHECKBOX Bank draft FORMCHECKBOX Credit on account SECTION B: device information 1 Name of device: FORMTEXT 2 Nomenclature or generic name of device: FORMTEXT 3 Device description: FORMTEXT 4 Does the device incorporate tissue, cells or substances of human, animal or microbial origin?, FORMTEXT 2.6In the case of devices that include tissues, cells and substances of human, animal or microbial origins, detailed information on the tissues, cells and substances, and on the compliance with the relevant general safety and performance requirements and the specific risk management in relation to those tissues, cells and substances., FORMTEXT 4.5Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data., (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-f0982-application-for-a-performance-study-v1.docx?sfvrsn=de96027e_5