The Medicines Act of 1968
The UKSIs are not the only UK laws that apply to clinical research. Many UK laws in existence before the arrival of the UKSI 1031 governed certain aspects of clinical research.
The UKSI 1031 cross-references over 60 separate pieces of legislation. You do not need to know what these individual pieces of legislation are, although a list appears at the end of this Module. However there are two main things you need to understand.
While legally requiring compliance with Good Clinical Practice was the primary concern that prompted the development of the UKSI, the legal infrastructure in the UK is quite extensive and a large number of legal requirements exist that might apply to any one clinical trial, depending on circumstances.
The most important law by far that impacts clinical research is the Medicines Act of 1968 which governs the supply and manufacture of medicine in the UK. The Medicines Act of 1968 is referenced throughout the UKSIs such that when you see the words ‘The Act’ within the text of the UKSI 1031 or 1928, this refers to the Medicines Act of 1968.
