The Irish Medicines Board (IMB) is the competent authority (CA) for the purpose of implementing EU and National legislation relating to Human Tissues and Cells.
In accordance with this legislation, the IMB has established a reporting system for the notification of suspected Serious Adverse Reactions (SARs) and Serious Adverse Events (SAEs) associated with human tissues and cells.
A ‘serious adverse event’ is defined as any untoward occurrence associated with the procurement, testing, processing, storage and distribution of tissues and cells that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients or which might result in, or prolong, hospitalisation or morbidity; ·
A ‘serious adverse reaction’ is defined as an unintended response, including a communicable disease, in the donor or in the recipient associated with the procurement or human application of tissues and cells that is fatal, life-threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or morbidity;
Under the legislation, all Tissue Establishments are required, through the Responsible Person (or designee), to notify the IMB of and provide a report analysing the cause of and ensuing outcome of:
- Any serious adverse events and reactions which may influence the quality and safety of tissues and cells and which may be attributed to the procurement, testing, processing, storage and distribution of tissues and cells;
- Any serious adverse reaction observed during or after clinical application which may be linked to the quality and safety of tissues and cells
The reporting requirements to the IMB are inclusive of:
- In the case of assisted reproduction, any type of gamete or embryo misidentification or mix-up, which shall be considered a serious adverse event;
- ‘Near miss’ reports where the event was detected prior to transplantation.
All reports should be submitted using the IMB Guide to Reporting Serious Adverse Reactions (SARs) and Serious Adverse Events (SAEs) associated with Human Tissues and Cells together with the IMB Adverse Reaction / Event Report Form – Human tissues and Cells
These documents may be dowloaded or submitted via the on-line forms available on this site.
Links to relevant legislation may be dowloaded on the right of this webpage.
Further Information is available from:
Irish Medicines Board,
Kevin O' Malley House,
Telephone +353 1 6764971
Fax +353 1 6762517
E-mail address: IMBPharmacovigilance@imb.ie