The European Union (EU) has published 2 new commission directives on the coding and import of tissues and cells for human application.
The coding directive establishes a coding system to ensure the traceability of all human tissue and cells intended for human application, at all stages from procurement to final use. It requires a single European code (SEC), in a specified format, to be allocated to tissue and cells distributed for human application, including those imported from third countries.
The import directive requires establishments to be approved by the national competent authority. It sets out procedures to verify that human tissue and cells imported from countries outside the EU/European Economic Area (EEA) meets the same quality and safety standards applicable to tissue and cells procured within EU/EEA Member States.
Questions 5 to 23 are about the Human Tissue (Quality and Safety for Human Application) Amendment Regulations 2017 about all other types of human tissue and cells.
Questions 25 to 38 are about The Human Fertilisation and Embryology (Quality and Safety) Regulations 2017, about reproductive cells.
Why We Are Consulting
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.
Need to add something about which set of questions you should respond to and why.
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.
Read the full consultations documents, set out by the relevant authority, for further details.