Explanatory note

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”.

POC medicinal products cannot be manufactured in advance in conventional, factory-based sites and distributed to supply sites from there. They have to be manufactured in small amounts in close proximity to the patient at sites that are likely to be healthcare facilities such as pharmacies, operating theatres and clinics. The number of sites at which a product is manufactured may be comparatively high, and sites may be added or removed depending on circumstances. The regulatory framework that currently applies to medicines manufacturing, whereby each site is named on the licence and individually inspected and authorised, requires adjustment to allow for this new manufacturing structure. These Regulations make the necessary amendments to the HMRs so that the manufacture of POC medicinal products is regulated by way of an authorisation and a master file that relates to the product. Similarly, the current regulatory framework is not appropriate for manufacture in units that may be relocated, so the Regulations make equivalent amendments, where necessary, in relation to modular manufacture.

The amendments in these Regulations comprise firstly of changes to the requirements that apply to manufacturers of MM medicinal products and POC medicinal products. These are set out in regulations 5 to 15 and 34 to 36. There are also some amendments to the process of applying for a marketing authorisation for such a product. These are contained in regulations 16 to 18 and 37. The HMRs provide for certain exemptions from the requirement for a marketing authorisation. Regulations 19 to 25 amend those provisions with regard to MM and POC medicinal products. The HMRs also set out requirements with regard to the post-marketing stage of a medicinal product. Regulations 26 to 28 amend those provisions. And regulations 29 to 32 and 38 make provision with regard to the labelling and packaging of POC medicinal products.

Regulations 39 to 52 make equivalent amendments to the CTRs.

An impact assessment of the effect that this instrument will have on the costs of business, the voluntary sector and the public sector is available from the Medicines and Healthcare products Regulatory Agency, 10 South Colonnade, Canary Wharf, London, E14 4PU and is published alongside this instrument at www.legislation.gov.uk.