These Regulations amend the Human Medicines Regulations 2012 (“the 2012 Regulations”), which govern the arrangements across the United Kingdom for the licensing, manufacture, wholesale dealing and sale or supply of medicines for human use, and the Medicines for Human Use (Clinical Trials) Regulations 2004 (“the 2004 Regulations”), which govern the conduct of clinical trials of medicinal products for human use. The amendments make provision for the establishment and operation of the statutory version of the Early Access to Medicine Scheme (EAMS) – there has previously been a non-statutory version of the Scheme. The EAMS has the purpose of giving patients with life threatening or seriously debilitating conditions access to medicinal products that are either not authorised or not authorised for that use.