Coding and import regulations for human tissue and cells

The European Union (EU) has published 2 new commission directives on the coding and import of tissue and cells for human application.

We would like your views on a range of questions regarding implementation, including the estimate of the likely cost of implementing both directives for establishments licensed by the Human Tissue Authority (HTA) and Human Fertilisation and Embryology Authority (HFEA), and for the authorities themselves. We would also like your views on the associated HTA guidance.

There are 2 consultation documents and 2 sets of consultation questions:

• one for the Human Fertilisation and Embryology (Quality and Safety) Regulations 2017, about reproductive cells
• one for the Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2017 about all other types of human tissue and cells

Annexes B to D are the same for both regulations. Annexes A and F are different for the 2 sets of regulations.

The quality and safety standards for the donation, procurement, testing, processing, preservation, storage and distribution of human tissue and cells intended for human application are regulated by the HTA. In the case of reproductive cells regulation is by the HFEA.

The directives sets out the information that must be provided to and the duties placed on HTA, HFEA and the UK government.