# The Medicines for Human Use (Clinical Trials) Regulations 2004, Regulation 2: Interpretation

Extent: E+W+S+N.I.

(1) In these Regulations—
“the 2012 Regulations” means the Human Medicines Regulations 2012;
“the Act” means the Medicines Act 1968 ;
“adult” means a person who has attained the age of 16 years;
“adverse event” means any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product;
“adverse reaction” means any untoward and unintended response in a participant to an investigational medicinal product which is related to any dose administered to that participant;
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“appropriate committee” for the purposes of any provision of these Regulations under which a function falls to be performed means whichever the licensing authority considers to be appropriate of—
(a)the Commission on Human Medicines; or
(b)an expert committee appointed by the licensing authority;
“assemble”, in relation to an investigational medicinal product, means—
(a)enclosing the product (with or without other medicinal products of the same description) in a container which is labelled before the product is sold or supplied, or used in a clinical trial, or
(b)where the product (with or without other medicinal products of the same description) is already contained in the container in which it is to be sold or supplied, or used in a clinical trial, labelling the container before the product is sold or supplied, or used in a clinical trial, in that container,
and “assembly” has a corresponding meaning;
“the Authority” is to be construed in accordance with regulation 5(3);
“business”, except in regulation 9, includes a professional practice and includes any activity carried on by a body of persons, whether corporate or unincorporate;
“chief investigator” means—
(a)in relation to a clinical trial conducted at a single trial location, the investigator for that location, or
(b)in relation to a clinical trial conducted at more than one trial location, the health care professional, whether or not that health care professional is an investigator at any particular location, who takes primary responsibility for the conduct of the trial;
“clinical trial” means any investigation in human participants, other than a non-interventional trial, intended—
(a)to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products,
(b)to identify any adverse reactions to one or more such products, or
(c)to study absorption, distribution, metabolism and excretion of one or more such products,
with the object of ascertaining the safety or efficacy of those products;
“Commission Delegated Regulation 2017/1569”, other than in Parts 2 and 3 of Schedule 7, means, in the case of an investigational medicinal product manufactured or assembled in, or imported into, Northern Ireland, Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and the guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections, as that Regulation has effect in EU law;
“Commission Directive 2003/94/EC” , other than in Parts 2 and 3 of Schedule 7, means—
(a)in the case of an investigational medicinal product manufactured or assembled in, or imported into, Great Britain—
(i)Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice for medicinal products for human use and for investigational medicinal products for human use, as modified by Schedule 2A to the 2012 Regulations, or
(ii)if Regulations have been made under the powers in regulation B17(1) of the 2012 Regulations, and have come into force, those Regulations;
(b)...
“the Commission on Human Medicines” means the Commission on Human Medicines within the meaning of regulation 9 of the 2012 Regulations;
“conditions and principles of good clinical practice” means the conditions and principles specified in Schedule 1;
“conducting a clinical trial” includes—
(a)administering, or giving directions for the administration of, an investigational medicinal product to a participant for the purposes of that trial,
(b)giving a prescription for an investigational medicinal product for the purposes of that trial,
(c)carrying out any other medical or nursing procedure in relation to that trial, and
(d)carrying out any test or analysis—
(i)to discover or verify the clinical, pharmacological or other pharmacodynamic effects of the investigational medicinal products administered in the course of the trial,
(ii)to identify any adverse reactions to those products, or
(iii)to study absorption, distribution, metabolism and excretion of those products,
but does not include any activity undertaken prior to the commencement of the trial which consists of making such preparations for the trial as are necessary or expedient;
“container”, in relation to an investigational medicinal product, means the bottle, jar, box, packet or other receptacle which contains or is to contain it, not being a capsule, cachet or other article in which the product is or is to be administered, and where any such receptacle is or is to be contained in another such receptacle, includes the former but does not include the latter receptacle;
“country” means a country or territory;
“dentist” means a person registered in the dentists register under the Dentists Act 1984 ...;
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“Directive 2001/83/EC” means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use;
“doctor” means a registered medical practitioner ;
“EAMS medicinal product” means a medicinal product that—
(a)has been included in the Early Access to Medicines Scheme by means of the licensing authority issuing an EAMS scientific opinion in respect of it; and
(b)remains in the scheme by virtue of the EAMS scientific opinion not ceasing to have effect in respect of it by virtue of regulation 167D of the 2012 Regulations;
“EAMS scientific opinion” is to be construed in accordance with regulation 167C(2)(b) of the 2012 Regulations;
“Early Access to Medicines Scheme” means the scheme of that name established and operated under regulation 167C(1) of the 2012 Regulations;
“EEA State” means a Member State, Norway, Iceland or Liechtenstein;
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“electronic signature” means data in electronic form which is attached to or logically associated with other data in electronic form and which is used by the signatory to sign;
“European Economic Area” means the European Economic Area created by the EEA Agreement;
“the European Medicines Agency” means the European Medicines Agency established by Regulation (EC) No. 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency;
“ethics committee” means—
(a)a committee established ... in accordance with Part 2, or
(b)an Ethics Committee constituted by regulations made by the Scottish Ministers under section 51(6) of the Adults with Incapacity (Scotland) Act 2000 ...
(c)...
“the EU Regulation” means Regulation 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, as that Regulation has effect in EU law;
“export” means export to another country from the United Kingdom, whether by land, sea or air;
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“Health Board” means a Health Board established under the National Health Service (Scotland) Act 1978 ;
“health care” means services for or in connection with the prevention, diagnosis or treatment of illness;
“health care professional” means—
(a)a doctor,
(b)a dentist,
(c)a registered nurse as defined in regulation 8(1) of the 2012 Regulations,
(d)a pharmacist,
(e) a person registered in the register of optometrists maintained under section 7(a) of the Opticians Act 1989, ...
(f)a person registered in the Health and Care Professions Council register (as defined in regulation 8(1) of the 2012 Regulations) as a member of a relevant profession within the definition “article” 2 of, and paragraph 1 of Schedule 3 to, the Health Professions Order 2001,
(g)a registered osteopath as defined by section 41 of the Osteopaths Act 1993 , ...
(h)a registered chiropractor as defined by section 43 of the Chiropractors Act 1994 , ...
(i) a person registered under the Anaesthesia Associates and Physician Associates Order 2024; or
(j)a registered midwife as defined in regulation 8(1) of the 2012 Regulations;
“health centre” means a health centre maintained under section 2 or 3 of the National Health Service Act 2006, section 2 or 3 of the National Health Service (Wales) Act 2006, section 36 of the National Health Service (Scotland) Act 1978 or Article 5 of the Health and Personal Social Services (Northern Ireland) Order 1972;
“health service body” means—
(a)a ... Health Board or the Department of Health in Northern Ireland,
(b)a Special Health Authority, ... integrated care board or Local Health Board established under the National Health Service Act 1977,
(ba) NHS England,
(c)a Special Health Board established under the National Health Service (Scotland) Act 1978,
(ca) Healthcare Improvement Scotland established under the National Health Service (Scotland) Act 1978,
(d)a special health and social services agency established under the Health and Personal Social Services (Special Agencies) (Northern Ireland) Order 1990 ,
(e)...
(f)the Scottish Dental Practice Board or the Common Services Agency for the Scottish Health Service established under the National Health Service (Scotland) Act 1978,
(g)the Regional Business Services Organisation for the health and social care in Northern Ireland established under the Health and Social Care (Reform) Act (Northern Ireland) 2009,
(h)a National Health Service trust established under the National Health Service and Community Care Act 1990 or the National Health Service (Scotland) Act 1978,
(i)an NHS foundation trust within the meaning of section 1(1) of the Health and Social Care (Community Health and Standards) Act 2003 , or
(j)a Health and Social Services trust established under the Health and Personal Social Services (Northern Ireland) Order 1991 ;
“hospital” includes a clinic, nursing home or similar institution;
“import”, except in regulation 13 and Schedule 13, means import, or attempt to import—
(a)into Great Britain other than from Northern Ireland, or
(b)into Northern Ireland from a country other than an EEA State,
whether by land, sea or air and “imported” is to be construed accordingly;
“informed consent” shall be construed in accordance with paragraph 3 of Part 1 of Schedule 1;
“insurance or indemnity” includes provision for meeting losses or liabilities—
(a)under a scheme established under—
(i)section 21 of the National Health Service and Community Care Act 1990 (schemes for meeting losses and liabilities etc. of certain health service bodies in England and Wales) ,
(ii)section 85B of the National Health Service (Scotland) Act 1978 (schemes for meeting losses and liabilities etc. of certain health service bodies in Scotland) , or
(iii)Article 24 of the Health and Personal Social Services (Northern Ireland) Order 1991 (schemes for meeting losses and liabilities etc. of certain health service bodies in Northern Ireland) , or
(b)in accordance with guidance issued by—
(i)the Secretary of State,
(ii)the Scottish Ministers,
(iii)the National Assembly for Wales, or
(iv)the Department of Health in Northern Ireland,
as to the arrangements to be adopted by health service bodies for meeting the costs arising from clinical negligence (known as NHS Indemnity);
“investigational medicinal product” means a pharmaceutical form of an active substance or placebo being tested, or to be tested, or used, or to be used, as a reference in a clinical trial, and includes a medicinal product which has a marketing authorization but is, for the purposes of the trial—
(a)used or assembled (formulated or packaged) in a way different from the form of the product authorised under the authorization,
(b)used for an indication not included in the summary of product characteristics under the authorization for that product, or
(c)used to gain further information about the form of that product as authorised under the authorization;
“investigational medicinal product dossier” means, in relation to an investigational medicinal product, the dossier relating to that product which accompanies a request for approval to conduct a trial in which that product is or is to be used, in accordance with paragraph 5(b) of Schedule 3;
“investigator” means, in relation to a clinical trial, the health care professional who is responsible for the conduct of that trial at that trial location or, if more than one, the trial locations; and who is, if the trial is conducted by a team of health care professionals at that location or locations, the leader responsible for that team;
“investigator’s brochure” means a document containing a summary of the clinical and non-clinical data relating to an investigational medicinal product which are relevant to the study of the product in human participants;
“labelling”, in relation to an investigational medicinal product, means affixing to or otherwise displaying on it a notice describing or otherwise relating to the contents, and “label” has a corresponding meaning;
“legal representative”, other than in regulation 3 and ... Schedule 3, has the meaning given by Part 1 of Schedule 1;
“licensing authority” shall be construed in accordance with regulation 6 of the 2012 Regulations;
“manufacture”, in relation to an investigational medicinal product, includes any process carried out in the course of making the product, but does not include dissolving or dispersing the product in, or diluting it or mixing it with, some other substance used as a vehicle for the purposes of administering it;
“manufacturer’s licence (MM)” has the meaning given in regulation 8(1) of the 2012 Regulations;
“manufacturer’s licence (POC)” has the meaning given in regulation 8(1) of the 2012 Regulations;
“manufacturing authorisation” has the meaning given by regulation 36(1);
“manufacturing authorisation (MM)” means a manufacturing authorisation that authorises the manufacture or assembly of MM investigational medicinal products;
“manufacturing authorisation (POC)” means a manufacturing authorisation that authorises the manufacture or assembly of POC investigational medicinal products;
“ marketing authorization ” means—
(a) a UK marketing authorization,
(b)an EU marketing authorisation (as defined in the 2012 Regulations), or
(c)an authorization granted by a regulatory body responsible for licensing medicinal products in a country that is included in the list referred to in regulation 2A(1);
“medicinal product” means a medicinal product within the meaning of regulation 2(1) of the 2012 Regulations.
“minor” means a person under the age of 16 years;
“MM” means modular manufacture;
“MM (IMP) control site” means the premises at which the holder of a manufacturing authorisation (MM) supervises and controls the manufacture or assembly of MM investigational medicinal products;
“MM (IMP) master file” means a detailed description of the arrangements for manufacture or assembly of an MM investigational medicinal product;
“MM investigational medicinal product” means an investigational medicinal product that, for reasons relating to deployment, the licensing authority determines it necessary or expedient to be manufactured or assembled in a modular unit;
“modular unit” means a relocatable manufacturing unit;
“non-interventional trial” means a study of one or more medicinal products which have a marketing authorization, where the following conditions are met—
(a)the products are prescribed in the usual manner in accordance with the terms of that authorization,
(b)the assignment of any patient involved in the study to a particular therapeutic strategy is not decided in advance by a protocol but falls within current practice,
(c)the decision to prescribe a particular medicinal product is clearly separated from the decision to include the patient in the study,
(d)no diagnostic or monitoring procedures are applied to the patients included in the study, other than those which are ordinarily applied in the course of the particular therapeutic strategy in question, and
(e)epidemiological methods are to be used for the analysis of the data arising from the study;
“non-investigational medicinal product” means a medicinal product used or to be used in a clinical trial, as described in the protocol, but not as an investigational medicinal product;
“notifiable trial” has the meaning given in regulation 11A;
“participant” means, in relation to a clinical trial, an individual, whether a patient or not, who participates in a clinical trial—
(a)as a recipient of an investigational medicinal product or of some other treatment or product, or
(b)without receiving any treatment or product, as a control;
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“pharmaceutical form of an active substance” includes any substance or article to which these Regulations have effect by virtue of an order under section 104 or 105 of the Act (which relate to the application of Act to certain articles and substances which are not medicinal products);
“Pharmaceutical Society” in relation to Great Britain means the Royal Pharmaceutical Society of Great Britain, and in relation to Northern Ireland means the Pharmaceutical Society of Northern Ireland;
“pharmacist” means—
(a) in relation to Great Britain, a person registered as a pharmacist in Part 1 ... of the register maintained under article 19 of the Pharmacy Order 2010, and
(b)in relation to Northern Ireland, a person registered in the register of pharmaceutical chemists for Northern Ireland made out and maintained under Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976;
“Phase I trial” means a clinical trial to study the pharmacology of an investigational medicinal product when administered to humans, where the sponsor and investigator have no knowledge of any evidence that the product has effects likely to be beneficial to the participants of the trial;
“POC” means point of care;
“POC (IMP) control site” means the premises at which the holder of a manufacturing authorisation (POC) supervises and controls the manufacture or assembly of POC investigational medicinal products;
“POC (IMP) master file” means a detailed description of the arrangements for the manufacture or assembly of a POC investigational medicinal product;
“POC (IMP) site” means a site at which the manufacture or assembly of a POC investigational medicinal product takes place;
“POC investigational medicinal product” means an investigational medicinal product that, for reasons relating to method of manufacture, shelf life, constituents or method or route of administration, can only be manufactured at or near the place where the product is to be used or administered;
“the principles and guidelines of good manufacturing practice” means the principles and guidelines of good manufacturing practice set out in Commission Directive 2003/94/EC in respect of Great Britain or Commission Delegated Regulation 2017/1569 in respect of Northern Ireland;
“protocol” means a document that describes the objectives, design, methodology, statistical considerations and organisation of a clinical trial;
“qualified person” means—
(a)a person who as respects qualifications and experience satisfies the requirements of Schedule 7 to the 2012 Regulations, or
(b)a person who, without satisfying the requirements referred to in paragraph (a)—
(i)has been engaged in activities equivalent to those to be performed in accordance with regulation 43(2) in respect of investigational medicinal products for a period of at least 6 months prior to 1st May 2004,
(ii)has, in accordance with paragraph 6(1) of Schedule 6, been named as a qualified person in a valid application for a manufacturing authorisation made prior to 1st May 2006, and
(iii)is—
(aa)a member of the Institute of Biology, the Pharmaceutical Society, the Royal Society of Chemistry, or such other body as may appear to the licensing authority to be an appropriate body for the purpose of this paragraph, or
(bb)the holder of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university or other higher education course of study in pharmacy, chemistry, medicine, biology or a related life science, which the licensing authority have stated in a notice in writing to that person to be qualifications sufficient for the purpose of performing the functions of a qualified person;
“radiopharmaceutical” has the same meaning as in regulation 8(1) of the 2012 Regulations;
“relevant ethics committee”, in relation to a clinical trial, means—
(a)in a case where an ethics committee has given a favourable opinion in relation to that trial and regulation 6(3) applies, the ethics committee which is the relevant ethics committee for that trial by virtue of regulation 6(3)(b);
(b)in a case where an ethics committee has given an unfavourable opinion in relation to that trial but a favourable opinion has been given by another ethics committee in accordance with ... Schedule 4, the ethics committee which has given the favourable opinion, or
(c)in any other case, the ethics committee which has given a favourable opinion in relation to that trial in accordance with regulation 15;
“serious adverse event”, “serious adverse reaction” or “unexpected serious adverse reaction” means any adverse event, adverse reaction or unexpected adverse reaction, respectively, that—
(a)results in death,
(b)is life-threatening,
(c)requires hospitalisation or prolongation of existing hospitalisation,
(d)results in persistent or significant disability or incapacity, or
(e)consists of a congenital anomaly or birth defect;
“signatory” means a natural person who creates an electronic signature;
“sponsor” shall be construed in accordance with regulation 3;
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“trial location” means a hospital, health centre, surgery or other establishment, or facility or premises at or from which a clinical trial, or any part of such a trial, is conducted;
“ UK marketing authorization ” —
(a)has the same meaning as “UK marketing authorisation” in the 2012 Regulations (and references to “UKMA(UK)”, “UKMA(GB)” and “UKMA(NI)” in these Regulations should be construed in accordance with that definition); and
(b)includes a product licence granted by the licensing authority for the purposes of section 7 of the Medicines Act 1968;
“unexpected adverse reaction” means an adverse reaction the nature and severity of which is not consistent with the information about the medicinal product in question set out—
(a)in the case of a product with a marketing authorization, in the summary of product characteristics , or equivalent document, for that product,
(b)in the case of any other investigational medicinal product, in the investigator’s brochure relating to the trial in question.
(2) Any reference in these Regulations to the holder of a manufacturing authorisation shall be construed as a reference to the holder of such an authorisation which is for the time being in force.
(3) Any reference in these Regulations to an application, request or other document that is signed includes a reference to an application, request of other document that is signed with an electronic signature.

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Source: https://www.legislation.gov.uk/uksi/2004/1031/regulation/2 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.