Tissues & Cells

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.

Requirements relating to quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells for human application are regulated under Statutory Instrument No. 158 of 2006 (Quality and Safety of Human Tissues and Cells) Regulations. Certain exemptions apply including the storage of tissues and cells at sites of human application whereby a tissue establishment authorisation is not required.

These Regulations apply to ‘prescribed activities’ which are defined as follows:

‘Prescribed Activity’ means any activity consisting of the donation, procurement, testing, processing, preservation, storage for distribution of tissues or cells for human applications. Any individual or site which carries out any prescribed activity is required to be authorised by the IMB.

In order to obtain authorisation, an application must be made to the IMB for a Tissue Establishment Authorisation. Compliance with the requirements of relevant Regulations must be demonstrated by applicants.

To ensure that compliance with these requirements are maintained, Blood and Tissue inspectors monitor compliance through regular on-site inspections.

In order to make a variation to an authorisation, an application to make a variation to a tissue establishment authorisation must be completed and sent to the IMB.

Safety

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.

To read more about the safety monitoring activities in this area go to the Safety & Quality-Tissues & Cells section of the website. An on-line reporting form is also available on this website.

The Irish Medicines Board - www.imb.ie

Tissues & Cells