Safety Information

Tissue - How We Monitor Safety

The implementation of legislation ensures high standards of quality and safety, nationally and across EU Member States.

Role of the Tissue Establishment            

Tissue Establishments are required to:

• Comply with the requirements laid down in relevant legislation.
• Apply to the HPRA for a Tissue Establishment Authorisation as per Regulation 6 of S.I. 158 of 2006.
• Undergo inspections by the HPRA in order to obtain authorisation and regular inspections thereafter.
• Notify the HPRA of any substantial changes it intends to make in the prescribed activities it undertakes through the submission of a variation to a Tissue Establishment Authorisation.
• Keep a record of its activities, including the types and quantities of tissues and/or cells procured, tested, preserved, processed, stored and distributed or otherwise disposed of, and on the origin and destination of the tissues and cells intended for human applications.
• Submit a Tissue Establishment Annual Report on these activities to the HPRA.
• Notify the HPRA of, and provide the HPRA with a report analyzing the cause and ensuing outcome of any serious adverse events or reactions which may influence the quality and safety of the tissues and cells. (See below)

Role of the HPRA with Tissue Establishments

The HPRA has been designated as the Competent Authority for the purposes of the Legislation.

As a result the HPRA is obliged to:

• Authorise all activities relating to the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.
• Organise inspections and appropriate control measures to ensure that the requirements of the directives are complied with.

 

Tissues and Cells - Reporting of Serious Adverse Reactions and Events (SAR/Es) 

The Health Products Regulatory Authority (HPRA) 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 HPRA 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 HPRA 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 HPRA 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. 

How do I report an adverse reaction /event

You can report an SAR/E in a number of ways:

• By using our online form
• By downloading a copy of our report form. You can e-mail completed forms to btosafety@hpra.ie. 
• By printing our report form and posting a completed copy to the HPRA by freepost at the address provided on the form

All reports should be submitted using the Guide to Reporting SAR/E in Tissues and Cells

Further Information is available from:  

Tissues and Cells
Health Products Regulatory Authority,
Pharmacovigilance Section,
Kevin O' Malley House,
Earlsfort Centre,
Earlsfort Terrace,
Dublin 2.
Ireland.  

Telephone +353 1 6764971
Fax +353 1 6762517
E-mail address: btosafety@hpra.ie