The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025

These Regulations amend the Human Medicines Regulations 2012 (S.I. 2012/1916) (“HMRs”) and the Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031) (“CTRs”). These Regulations make provision for medicinal products that are manufactured in a modular unit, to enable deployment from that site. This is known as modular manufacture (“MM”) and the products are referred to as “MM medicinal products”. The Regulations also make provision in relation to the manufacture and supply of medicines that are innovative and have particular characteristics such as a very short shelf life, or that are highly personalised to the recipient. These characteristics mean that the medicines have to be manufactured very close to the place where they are administered. The type of manufacture is known as point of care (“POC”) and the products are referred to in the Regulations as “POC medicinal products”.