All establishments in the Human Application sector must follow the HTA’s Guide to Quality and Safety Assurance for Tissue and Cells for Patient Treatment.
This guide explains the requirements for:
- licensed establishments which store and import tissues and cells for human application; and
- licensed establishments and third parties which carry out the procurement, testing, processing, distribution, or export of tissues and cells for human application.
The guide is based on the Q&S Regulations and the standards required under the Commission Directives. Establishments licensed in the Human Application sector must comply with the sections of the guide relevant to their work.
You can access the HTA’s Guide to Quality and Safety Assurance for Tissue and Cells for Patient Treatment here.
The Council of Europe have also published a Guide to the quality and safety of tissues and cells for human application. This guide has useful information and recommendations for working in this sector.
Material covered by the Q&S Regulations
We have put together a list of the types of material which fall under the Q&S Regulations. This list is not exhaustive but gives guidance on materials which we have previously given advice on.
You can access the list of material covered by the Q&S Regulations here.