Glossary

A medicinal product may only be placed on the market in the European Economic Area (EEA) when a marketing authorisation has been issued by the competent authority of a Member State (or EEA country) for its own territory (national authorisation) or when an authorisation has been granted in accordance with Regulation (EC) No 726/2004 for the entire Community (a Community authorisation).

The entity that has been granted a Marketing Authorisation. Marketing Authorisation Holders must be established within the EEA.

Any instrument, apparatus, implement, machine, appliance, implant, software, material, or other similar or related article

a) intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of

1. diagnosis, prevention, monitoring, treatment or alleviation of disease,
2. diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury,
3. investigation, replacement, modification, or support of the anatomy or of a physiological process,
4. supporting or sustaining life,
5. control of conception,
6. disinfection of medical devices, and

b) which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.

The MHRA is the competent authority for the UK in relation to the Directive 2001/20/EC and the Clinical Trials Regulations, and for Medical Devices, the competent authority in relation to the Medical Devices Regulations 2002.

Provides a statutory framework to empower and protect vulnerable people who are not able to make their own decisions. It makes it clear who can take decisions, in which situations, and how they should go about this.

The research provisions of the Mental Capacity Act 2005 do not apply to the conduct of CTIMPs.

In relation to a CTIMP, defined in ‘The Medicines for Human Use (Clinical Trials) Regulations’ as a person under the age of 16.

An individual who undertakes monitoring activities for a trial.

The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted and recorded in accordance with the protocol, Standard Operating Guidelines (SOP’s), Good Clinical Practice (GCP) and the applicable regulatory requirement(s).

A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor’s SOPs.

A trial/study conducted at more than one site.