The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018
These Regulations amend the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (“the Principal Regulations”) to implement Directive 2015/565 of the European Commission (“the coding Directive”), laying down technical requirements for the coding of human tissues and cells. These Regulations also further amend the Principal Regulations and the Human Tissue Act 2004 (“the Act”) to implement Directive 2015/566 of the European Commission (“the fourth Directive”), setting out procedures for verifying standards of quality and safety of imported tissues and cells. The coding Directive and the fourth Directive are implemented in so far as they apply to gametes and embryos by the Human Fertilisation and Embryology (Amendment) Regulations 2018 which amend the Human Fertilisation and Embryology Act 1990.