The Quality and Safety Regulations
The Regulations (PDF) were implemented on 5 July 2007 bringing the into UK law. The directive and it's subsequent updates are as follows:
- European Directive 2004/23/EC (Parent Directive) (pdf)
- European Directive 2006/17/EC (First technical directive) (pdf)
- European Directive 2006-86-EC (Second technical directive) (pdf)
- European Directive 2012/39/EU (Third technical directive) (pdf)
Who needs a licence?
The activity of storing human tissues and cells for human application for more than 48 hours can only take place if the establishment has an HTA licence to store. 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 the following activity/ies relating to tissue and cells for human application:
- import / export
The above activities can be carried out under a third party agreement under the following circumstances:
- when the establishment carrying out the activity is acting on behalf of a licensed establishment; and
- when the third party agreement meets the standards set out in the Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatments as implemented by HTA's Directions 003/2010.
NB: Anyone carrying out the above activities and storing materials for more than 48 hours must be in possession of an HTA licence.
Third party agreements
The Q&S Regulations allow for certain activities to be undertaken without a licence as long as the establishment has a third party agreement in place with an establishment licensed to carry out activity/ies relating to human application.
A third party agreement is an agreement in writing between a Licence Holder and another person which is made in accordance with the Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatments as implemented by Directions 003/2010. The Guide also sets out in detail the standards that must be met for third party agreements.
A licensed establishment will need to have third party agreements with anyone who carries on a licensed activity (other than 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 tissues and / or cells.
Satellite establishments are small premises that are under the same governance processes as a larger establishment (the hub) and are supervised by the same Designated Individual (DI) as the hub. The DI at the hub must have systems in place to ensure that the governance framework is properly implemented and maintained. You can find out more about satellite sites at the satellite information page.
Revoking a licence under the Q&S Regulations
If you, or a third party, are no longer conducting the activities for which you are licensed, and wish to revoke your licence, please complete the HA Revocation form and submit to email@example.com for assessment.