Your Search Results
HPRA Medicinal Products Newsletter - Issue Number 73 - February 2023
The objectives of amending Directive 2022/642/EC are to facilitate the continued supply of medicinal products and to maintain a high level of public health protection., In addition, the veterinary pharmacovigilance section of the HPRA website on adverse reaction/event reporting now includes three voiced- over video presentations providing useful information on: • the role of animal owners in monitoring the safety and effectiveness of veterinary medicines and the importance of reporting adverse events • pharmacovigilance and adverse event reporting for veterinarians, veterinary nurses, and animal healthcare professionals • how to report an adverse reaction/ event using the HPRA’s o n l i n e reporting form Publication of information on newly authorised centralised veterinary medicines and updating of national product data in the Union Product Database The HPRA understands that the EMA is no longer publishing information on newly authorised centralised veterinary medicines on their website., Controls other than those described in these guidelines, which the registrant has justified within its quality system to provide an equivalent level of protection for clinical trial subjects and integrity of the clinical trial data, may be acceptable.
https://assets.hpra.ie/data/docs/default-source/newsletters/medicinal-products-newsletter/hpra-medicinal-products-newsletter---issue-number-73---february-2023.pdf?sfvrsn=be592445_4Guide for manufacturers of general class in-vitro diagnostic medical devices changes tracked
The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety., In selecting the most appropriate solutions, the manufacturer must apply the following principles in the following order: - eliminate or reduce risks as far as possible (inherently safe design and construction), - where appropriate take adequate protection measures including alarms if necessary, in relation to risks that cannot be eliminated, - inform users of the residual risks due to any shortcomings of the protection measures adopted., Where appropriate, certificates of origin from suppliers of materials of animal origin that could be associated with a substantial degree of risk of infection or adverse reaction should be requested., Protection against radiation 5.1 Devices shall be designed and manufactured and packed in such a way that exposure of users and other persons to the emitted radiation is minimized., Where there are risks due to the presence of moving parts, risks due to break-up or detachment, or leakage of substances, then appropriate protection means must be incorporated.
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/sur-g0008-guide-for-manufacturers-of-general-class-in-vitro-diagnostic-medical-devices-v2-changes-tracked.pdf?sfvrsn=a325b14f_3Public consultation – Proposed fees for 2025: Human Medicines, Compliance Activities, Blood, Tissue Establishments, Organs and Medical Devices - October 2024
- Strengthen and increase the scientific animal protection inspections programme, enhancing the role the HPRA as an advocate for the 3R principles., This includes maintenance of effective working relationships with the Department of Health, HSE and the Competition and Consumer Protection Commission, and the implementation of a coordinated national approach to market surveillance and testing of cosmetics
https://assets.hpra.ie/data/docs/default-source/corporate/consultations/public-consultation-proposed-fees-for-2025-human-medicines-compliance-activities-blood-tissue-establishments-organs-an.pdf?sfvrsn=d5287b19_5Public consultation – Draft guide for health institutions who manufacture and use in-house in-vitro diagnostic medical devices in Ireland - December 2023
They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art. 2., In selecting the most appropriate solutions, manufacturers shall, in the following order of priority:` (a) eliminate or reduce risks as far as possible through safe design and manufacture; (b) where appropriate, take adequate protection measures, including alarms if necessary, in relation to risks that cannot be eliminated; and (c) provide information for safety (warnings/precautions/contra-indications) and, where appropriate, training to users., GENERAL SAFETY & PERFORMANCE REQUIREMENT COMMENTS / REFERENCES 11.3 Devices labelled as sterile shall be processed, manufactured, packaged and, sterilised by means of appropriate, validated methods. 11.4 Devices intended to be sterilised shall be manufactured and packaged in appropriate and controlled conditions and facilities. 11.5 Packaging systems for non-sterile devices shall maintain the integrity and cleanliness of the product and, where the devices are to be sterilised prior to use, minimise the risk of microbial contamination; the packaging system shall be suitable taking account of the method of sterilisation indicated by the manufacturer. 11.6 The labelling of the device shall distinguish between identical or similar devices placed on the market in both a sterile and a non-sterile condition additional to the symbol used to indicate that devices are sterile. 12 Devices incorporating materials of biological origin Where devices include tissues, cells and substances of animal, They shall be suitable to withstand stresses inherent to the foreseen working environment, and to retain this resistance during the expected lifetime of the devices, subject to any inspection and maintenance requirements as indicated by the manufacturer. 18.3 Where there are risks due to the presence of moving parts, risks due to break-up or detachment, or leakage of substances, then appropriate protection means shall be incorporated., CHAPTER II REQUIREMENTS REGARDING PERFORMANCE, DESIGN AND MANUFACTURE 29/38 GENERAL SAFETY & PERFORMANCE REQUIREMENT COMMENTS / REFERENCES The same information shall be given on moving parts and/or their housings where the direction of movement needs to be known in order to avoid a risk. 18.8 Accessible parts of devices (excluding the parts or areas intended to supply heat or reach given temperatures) and their surroundings shall not attain potentially dangerous temperatures under normal conditions of use. 19 Protection against the risks posed by devices intended for self-testing or near-patient testing 19.1 Devices intended for self-testing or near-patient testing shall be designed and manufactured in such a way that they perform appropriately for their intended purpose taking into account the skills and the means available to the intended user and the influence resulting from variation that can be reasonably anticipated in the intended user's technique and environment.
https://assets.hpra.ie/data/docs/default-source/corporate/consultations/public-consultation-draft-guide-for-health-institutions-that-manufacture-and-use-in-house-in-vitro-diagnostic-medical-devi.pdf?sfvrsn=e8cae6e2_5Guide to clinical trials conducted under the CTR in Ireland changes tracked
2 CLINICAL TRIALS UNDER THE CTR 5 3 IMPLEMENTATION OF THE CTR IN IRELAND 8 4 SAFETY REPORTING 14 5 SUPERVISION 17 6 ARCHIVING 17 7 APPEALS 18 8 GOOD CLINICAL PRACTICE (GCP) INSPECTIONS 18 9 MANUFACTURE AND/OR IMPORTATION OF INVESTIGATIONAL MEDICINAL PRODUCTS AND AUXILIARY MEDICINAL PRODUCTS 25 10 ENFORCEMENT 27 APPENDIX 1 HPRA SUPPORTS 28 APPENDIX 2 REFERENCES 30 HPRA Guide to Clinical Trials conducted under the Clinical Trials Regulations (CTR) in Ireland AUT-G0170-34 3/32 ABBREVIATIONS ACT-EU Accelerating Clinical Trials in the EU ASR Annual safety report AxMP Auxiliary medicinal products CESP Common European Submission Portal CHMP Committee for Medicinal Products for Human Use CRG Compliance Regulatory Group CTFG Clinical Trial Facilitation Group CTIS Clinical Trials Information System CTR Clinical Trials Regulation EC European Commission EEA European Economic Area (EU and Norway, Iceland and Liechtenstein) EMA European Medicines Agency EPA Environmental Protection, - Part II includes assessment of the subject information and informed consent documents, the suitability of the investigator and of the trial site, indemnity and data protection., HPRA Guide to Clinical Trials conducted under the Clinical Trials Regulations (CTR) in Ireland AUT-G0170-34 10/32 3.6 Investigational Medicinal Products and auxiliary medicinal products 3.6.1 Genetically modified organism If an investigational medicinal product (IMP) proposed to be used in a clinical trial is a genetically modified organism, a separate application for a licence must be made to the Environmental Protection Agency (EPA) in Ireland., Unexpected events may relate to safety, or may relate to other events, examples include an increase in the rate of occurrence of expected serious adverse reactions which may be clinically important, a significant hazard to the patient population, such as lack of efficacy of a medicinal product, or a major safety finding from a newly completed animal study (such as carcinogenicity). 4.5 Urgent safety measures Where an unexpected event is likely to seriously affect the benefit-risk balance, the sponsor and the investigator shall take appropriate urgent safety measures to protect the subjects (CTR, Article 54).
https://assets.hpra.ie/data/docs/default-source/external-guidance-document-(tracked)/aut-g0170-guide-to-clinical-trials-conducted-under-the-ctr-in-ireland-v4-changes-tracked.pdf?sfvrsn=7bbf7715_3Guide for health institutions who manufacture and use in-house IVDs in Ireland
Such samples must be collected and processed in line with all applicable ethical and data protection requirements, They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art., In selecting the most appropriate solutions, manufacturers shall, in the following order of priority: (a) Eliminate or reduce risks as far as possible through safe design and manufacture; (b) Where appropriate, take adequate protection measures, including alarms if necessary, in relation to risks that cannot be eliminated; and (c) Provide information for safety (warnings/precautions/contra-indications) and, where appropriate, training to users., They shall be suitable to withstand stresses inherent to the foreseen working environment, and to retain this resistance during the expected lifetime of the devices, subject to any inspection and maintenance requirements as indicated by the manufacturer. 18.3 Where there are risks due to the presence of moving parts, risks due to break-up or detachment, or leakage of substances, then appropriate protection means shall be incorporated., Note that these samples should be collected and processed in line with all applicable ethical and data protection requirements.
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/sur-g0052-guide-for-health-institutions-who-manufacture-and-use-in-house-ivds-in-ie-v1.pdf?sfvrsn=f2b38a1d_13Guide to clinical trials conducted under the CTR in Ireland
2 CLINICAL TRIALS UNDER THE CTR 5 3 IMPLEMENTATION OF THE CTR IN IRELAND 8 4 SAFETY REPORTING 14 5 SUPERVISION 17 6 ARCHIVING 17 7 APPEALS 18 8 GOOD CLINICAL PRACTICE (GCP) INSPECTIONS 18 9 MANUFACTURE AND/OR IMPORTATION OF INVESTIGATIONAL MEDICINAL PRODUCTS AND AUXILIARY MEDICINAL PRODUCTS 25 10 ENFORCEMENT 27 APPENDIX 1 HPRA SUPPORTS 28 APPENDIX 2 REFERENCES 30 HPRA Guide to Clinical Trials conducted under the Clinical Trials Regulations (CTR) in Ireland AUT-G0170-4 3/32 ABBREVIATIONS ACT-EU Accelerating Clinical Trials in the EU ASR Annual safety report AxMP Auxiliary medicinal products CESP Common European Submission Portal CHMP Committee for Medicinal Products for Human Use CRG Compliance Regulatory Group CTFG Clinical Trial Facilitation Group CTIS Clinical Trials Information System CTR Clinical Trials Regulation EC European Commission EEA European Economic Area (EU and Norway, Iceland and Liechtenstein) EMA European Medicines Agency EPA Environmental Protection, - Part II includes assessment of the subject information and informed consent documents, the suitability of the investigator and of the trial site, indemnity and data protection., HPRA Guide to Clinical Trials conducted under the Clinical Trials Regulations (CTR) in Ireland AUT-G0170-4 10/32 3.6 Investigational Medicinal Products and auxiliary medicinal products 3.6.1 Genetically modified organism If an investigational medicinal product (IMP) proposed to be used in a clinical trial is a genetically modified organism, a separate application for a licence must be made to the Environmental Protection Agency (EPA) in Ireland., Unexpected events may relate to safety, or may relate to other events, examples include an increase in the rate of occurrence of expected serious adverse reactions which may be clinically important, a significant hazard to the patient population, such as lack of efficacy of a medicinal product, or a major safety finding from a newly completed animal study (such as carcinogenicity). 4.5 Urgent safety measures Where an unexpected event is likely to seriously affect the benefit-risk balance, the sponsor and the investigator shall take appropriate urgent safety measures to protect the subjects (CTR, Article 54).
https://assets.hpra.ie/data/docs/default-source/external-guidance-document/aut-g0170-guide-to-clinical-trials-conducted-under-the-ctr-in-ireland-v4.pdf?sfvrsn=acffec7d_9