HPRA Safety Update: COVID-19 Vaccines, Overview of National Reporting Experience
| dc.contributor.author | Health Products Regulatory Authority (HPRA) | |
| dc.date.accessioned | 2024-05-20T14:44:32Z | |
| dc.date.available | 2024-05-20T14:44:32Z | |
| dc.date.issued | 2024-05-16 | |
| dc.identifier.uri | http://hdl.handle.net/10147/641598 | |
| dc.description | This guide provides an overview of the legislation on clinical investigations (CIs) involving medical devices. The guide also provides guidance on how to submit applications to carry out CIs in Ireland to the Health Products Regulatory Authority (HPRA). This guide is primarily targeted towards CI sponsors (e.g. manufacturers, academic groups, clinical research organisations), who wish to carry out CIs involving medical devices in Ireland. The information may also be useful for ethics committees and other stakeholders. This guide is not the definite interpretation of the law and/or regulations and is for guidance purposes only. You should consult the relevant legislation relating to medical devices in addition to this guide. | en_US |
| dc.language.iso | en | en_US |
| dc.publisher | Health Products Regulatory Authority (HPRA) | en_US |
| dc.relation.ispartofseries | AUT-G0095-7 | en_US |
| dc.subject | REGULATION | en_US |
| dc.subject | Medicines | en_US |
| dc.subject | safety | en_US |
| dc.subject | CLINICAL INVESTIGATIONS | en_US |
| dc.title | HPRA Safety Update: COVID-19 Vaccines, Overview of National Reporting Experience | en_US |
| dc.type | Guideline | en_US |
| refterms.dateFOA | 2024-05-20T14:44:34Z |
