The Medicines for Human Use (Clinical Trials) Regulations 2004

Made: 31st March 2004

Laid before Parliament: 1st April 2004

Coming into force: 1st May 2004

The Secretary of State, being a Minister designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to medicinal products, in exercise of the powers conferred by the said section 2(2), and of all other powers enabling him in that behalf, hereby makes the following Regulations:

PART 1 — INTRODUCTORY PROVISIONS

Citation and commencement

1

These Regulations may be cited as the Medicines for Human Use (Clinical Trials) Regulations 2004 and shall come into force on 1st May 2004.

Interpretation

2

• (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 subject 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 subject to an investigational medicinal product which is related to any dose administered to that subject;

• “authorised health professional” means—a doctor,a dentist,a nurse, ora pharmacist;

• “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— the Commission on Human Medicines; oran expert committee appointed by the licensing authority;

• “assemble”, in relation to an investigational medicinal product, means—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, orwhere 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;

• “business”, except in Schedule 2, includes a professional practice and includes any activity carried on by a body of persons, whether corporate or unincorporate;

• “chief investigator” means—in relation to a clinical trial conducted at a single trial site, the investigator for that site, orin relation to a clinical trial conducted at more than one trial site, the authorised health ... professional, whether or not he is an investigator at any particular site, who takes primary responsibility for the conduct of the trial;

• “clinical trial” means any investigation in human subjects, other than a non-interventional trial, intended—to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products,to identify any adverse reactions to one or more such products, orto 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 Directive 2003/94/EC” , 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, Great Britain—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, orif Regulations have been made under the powers in regulation B17(1) of the 2012 Regulations, and have come into force, those Regulations;in the case of an investigational medicinal product manufactured or assembled in, or imported into, Northern Ireland, 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;

• “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—administering, or giving directions for the administration of, an investigational medicinal product to a subject for the purposes of that trial,giving a prescription for an investigational medicinal product for the purposes of that trial,carrying out any other medical or nursing procedure in relation to that trial, andcarrying out any test or analysis—to discover or verify the clinical, pharmacological or other pharmacodynamic effects of the investigational medicinal products administered in the course of the trial,to identify any adverse reactions to those products, orto 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 ...;

• “the Directive” means Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use;

• “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—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; andremains 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;

• ...

• “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 committee established or recognised in accordance with Part 2,the Ethics Committee constituted by regulations made by the Scottish Ministers under section 51(6) of the Adults with Incapacity (Scotland) Act 2000 , orthe Gene Therapy Advisory Committee;

• “export” means export to another country from the United Kingdom, whether by land, sea or air;

• ...

• “the Gene Therapy Advisory Committee” means the Gene Therapy Advisory Committee appointed by the Secretary of State...;

• “Health and Social Services Board” means a Health and Social Services Board established under the Health and Personal Social Services (Northern Ireland) Order 1972 ;

• “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 doctor,a dentist,a nurse,a pharmacist, a person registered in the register of optometrists maintained under section 7(a) of the Opticians Act 1989, ... a person registered in a register established and maintained under article 5 of Health Professions Order 2001,a registered osteopath as defined by section 41 of the Osteopaths Act 1993 , ...a registered chiropractor as defined by section 43 of the Chiropractors Act 1994 , or a person registered under the Anaesthesia Associates and Physician Associates Order 2024;

• “health centre” means a health centre maintained under section 2 or 3 of the National Health Service Act 1977, 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 ... Health Board or Health and Social Services Board,a Special Health Authority, ... integrated care board or Local Health Board established under the National Health Service Act 1977, NHS England ,a Special Health Board established under the National Health Service (Scotland) Act 1978, Healthcare Improvement Scotland established under the National Health Service (Scotland) Act 1978, a special health and social services agency established under the Health and Personal Social Services (Special Agencies) (Northern Ireland) Order 1990 ,...the Scottish Dental Practice Board or the Common Services Agency for the Scottish Health Service established under the National Health Service (Scotland) Act 1978,the Northern Ireland Central Services Agency for the Health and Social Services established under the Health and Personal Social Services (Northern Ireland) Order 1972,a National Health Service trust established under the National Health Service and Community Care Act 1990 or the National Health Service (Scotland) Act 1978,an NHS foundation trust within the meaning of section 1(1) of the Health and Social Care (Community Health and Standards) Act 2003 , ora 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— into Great Britain other than from Northern Ireland, orinto 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—under a scheme established under—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) ,section 85B of the National Health Service (Scotland) Act 1978 (schemes for meeting losses and liabilities etc. of certain health service bodies in Scotland) , orArticle 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) , orin accordance with guidance issued by—the Secretary of State,the Scottish Ministers,the National Assembly for Wales, orthe Department for Health, Social Services and Public Safety,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—used or assembled (formulated or packaged) in a way different from the form of the product authorised under the authorization,used for an indication not included in the summary of product characteristics under the authorization for that product, orused 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 authorisation to conduct a trial in which that product is or is to be used, in accordance with paragraph 11 of Schedule 3;

• “investigator” means, in relation to a clinical trial, the authorised health professional responsible for the conduct of that trial at a trial site, and if the trial is conducted by a team of authorised health professionals at a trial site, the investigator is 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 subjects;

• “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 Parts 2 to 4 of 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 UK marketing authorization, an EU marketing authorisation (as defined in the 2012 Regulations), oran 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—the products are prescribed in the usual manner in accordance with the terms of that authorization,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,the decision to prescribe a particular medicinal product is clearly separated from the decision to include the patient in the study,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, andepidemiological methods are to be used for the analysis of the data arising from the study;

• “nurse” means a registered nurse or registered midwife;

• “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;