Quality and Safety Regulations FAQs
Please see below for a number of frequently asked questions from a specific category. Simply select one of the questions of interest, the answer will then appear below. For the complete list of categories please visit the main FAQs page.
From 7 April 2006, the European Commission required that Members States bring into force the laws, regulations and administrative provisions necessary to comply with the Parent Directive (Directive 2004/23/EC). In order to comply with the European Directive the HTA commenced licensing the storage of human tissues and cells for transplantation on 7 April 2006.
Alongside the commencement of licensing the HTA issued Directions (Directions 001/2006), summarising the requirements of the Parent Directive and the first technical Directive (Directive 2006/17/EC) to licensed establishments. All establishments were required to comply with Directions 001/2006 by April 2007.
The Parent Directive, the first technical Directive and the second technical Directive (Directive 2006/86/EC) were formally adopted into UK law on 5 July 2007 via a statutory instrument called 'The Human Tissue (Quality and Safety for Human application) Regulations 2007, in short 'the Regulations'.
The HTA issued a second set of Directions (Directions 002/2007), which set out the requirements of the Regulations and the second technical Directive of the EUTCD and supplement and amend the first set of Directions.
The HTA issued a further set of Directions (Directions 004/2007) which came into force on 7 October 2007. These Directions stipulate that imports of tissues and/ or cells from non-European Economic Area (EEA) states meet standards of quality, safety and traceability equivalent to those provided in the Regulations.
The HTA issued Directions 003/2010 which came into force on 12 November 2010. These Directions consolidate and clarify the standards required under the Human Tissue (Quality and Safety of Tissues and Cells for Human Application) Regulations 2007. These Directions revoke Directions 001/2006, 002/2007 and 004/2007.
The HTA issued Directions 002/2018 which came into force on 1 April 2018. These Directions implement the HTA consolidated requirements for human application licences and third party agreements. The requirements are set out in version 2 of the “Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment” which forms the Annex to these Directions. The Guide will be the primary reference for establishments and will be subject to periodic updates. These Directions revoke Directions 003/2010.
The activity of storing human tissues and cells for human application can only lawfully take place if the establishment is licensed to carry out that activity. However, the following activities may lawfully be carried out either under a licence or under a third party agreement with an establishment licensed to carry out activity/ies relating to tissue and cells for human application:
- Testing of donor samples
- Import / export
N.B. Anyone carrying out the above activities and storing material for more than 48 hours must be in possession of a storage licence.
If an establishment held a licence to store relevant material for transplantation under the Human Tissue Act 2004, they were automatically considered to be licensed under the Regulations to carry out the activities listed below with regards to tissues and cells for human application:
- Testing of donor samples
- Import / export
This meant that establishments were no longer licensed to store tissues and cells for human application under the HT Act but are licensed to do so under the Regulations. However, establishments continue to be licensed under the HT Act for storage for scheduled purposes other than transplantation/human application e.g. establishments are still licensed under the HT Act to store human tissue for the scheduled purpose of research.
If you are procuring on behalf of an establishment that has a licence to carry out activity/ies relating to tissues and cells for human application and you have a third party agreement in place with them to carry out the activity of procurement you will not require a licence. Otherwise a licence will be required to carry out this activity.
Where the storage, processing, import, export or distribution of cells or tissues (including cell lines) for human application is for use in manufactured products and these activities are regulated by:
- the Medicines (Homeopathic Medicinal Products for Human Use) Regulations 1994
- the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994
- the Medical Devices Regulations 2002, or
- the Medicines for Human Use (Clinical Trials) Regulations 2004
these activities are not regulated by the HTA as well and a licence is not required.
You will need the third party agreements with anyone who:
- carries on a licensed activity (other than import or storage), on behalf of the licensed establishment or
- supplies to the licensed establishment any goods or services which may affect the quality or safety of tissue or cells.
The HTA has issued a Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatments as implemented by Directions (Directions 003/2010) setting the standards for third party agreements.
An EEA state is a state within the European Economic Area. These include all EU states and Iceland, Liechtenstein, Gibraltar and Norway.
Yes. The role of the Designated Individual changed under the Regulations. Under the Regulations the DI needs to possess a formal qualification in a medical or biological field or be considered appropriate by the Authority on the basis of other qualifications and experience. The DI also needs at least two years practical experience in a relevant field. There are also additional duties under the Regulations. The duties of the DI are set out in regulation 12 of the Regulations and are as follows:
- that persons to whom the licence applies are suitable persons to participate in the carrying-on of the licensed activity,
- that suitable practices are used in the course of carrying on that activity, and
- that the conditions of the licence are complied with
- that the conditions of third party agreements, in relation to the licensed activities authorised to be carried on under his supervision are complied with
- that the requirements regarding information and confidentiality (including traceability) of tissues and cells set out in regulation 13(1) are complied with
The role of Licence Holder has changed under the Regulations. The Regulations require that third party agreements are made by the Licence Holder or on his behalf by the DI meaning that the Licence Holder needs to have involvement in making these agreements. The Licence holder is also be responsible for ensuring compliance with Directions issued under the Regulations.
Through measures set out in Commission Directive (EU) 2015/565 (the coding Directive) all establishments licensed in the human application sector will be included in the EU Coding Platform.
The EU Coding Platform contains two compendia:
- the EU Tissue Establishment (TE) Compendium - this contains information on all tissue establishments authorised in the EU; and
- the EU Tissue and Cell Product Compendium – this contains categories of tissue and cell product codes.
All establishments that hold an HTA human application licence are listed in the TE compendium. This platform includes information on:
- the activities that an establishment is licensed to undertake; and
- the tissue and cell types that an establishment is authorised to undertake these activities for.
It is the HTA’s responsibility to keep the TE compendium up to date and to make any updates required. Establishments should check that their information, as listed in the TE compendium is accurate and notify the HTA if any of the information appears to be incorrect.
As a standard condition of HA licences, all establishments are required to notify the HTA of changes in licensable activity, or if they wish to start working with a new tissue type. Once these changes have been authorised, the HTA will update the TE compendium within 10 working days.
If you are only storing tissues or cells for human application and they are stored for less than 48 hours a licence is not required. Please note if you carry out any of the activities listed below then they will need to be carried out under a licence or a third party agreement with an establishment licensed to carry out activity/ies relating to tissues and cells for human application by the HTA:
- Testing of donor samples
- Import / export
Yes, the HTA regulates the procurement, processing, storing, donor testing, distribution and import / export of DLIs.