The Medicines for Human Use (Clinical Trials) Regulations 2004

Status:

This is the original version (as it was originally made).

PART 1INTRODUCTORY 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 Act” means the Medicines Act 1968(1);

“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)

a doctor,

(b)

a dentist,

(c)

a nurse, or

(d)

a pharmacist;

“appropriate committee”, for the purpose of any provision of these Regulations under which a function falls to be performed, means such committee established under section 4 of the Act for purposes which consist of or include any of those specified in section 4(3) of the Act as the authority performing that function considers appropriate in the circumstances;

“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;

“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—

(a)

in relation to a clinical trial conducted at a single trial site, the investigator for that site, or

(b)

in relation to a clinical trial conducted at more than one trial site, the authorised health care 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—

(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 Directive 2003/94/EC” means Commission Directive 2003/94/EC(2) laying down the principles and guidelines of good manufacturing practice for medicinal products for human use and for investigational medicinal products for human use;

“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 subject 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;

“dentist” means a person registered in the dentists register under the Dentists Act 1984(3) or entered in the list of visiting EEC practitioners under Schedule 4 to that Act;

“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(4);

“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(5), as amended(6);

“doctor” means a registered medical practitioner(7);

“EEA State” means a State which is a Contracting Party to the EEA Agreement;

“EEA Agreement” means the Agreement on the European Economic Area signed at Oporto on 2nd May 1992(8) as adjusted by the Protocol signed at Brussels on 17th March 1993(9);

“electronic signature” means data in electronic form which are attached to or logically associated with other electronic data and which serve as a method of authentication;

“European Economic Area” means the European Economic Area created by the EEA Agreement;

“the European Medicines Agency” means the European Agency for the Evaluation of Medicinal Products established by Council Regulation (EEC) No. 2309/93 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products(10);

“ethics committee” means—

(a)

a committee established or recognised in accordance with Part 2,

(b)

the Ethics Committee constituted by regulations made by the Scottish Ministers under section 51(6) of the Adults with Incapacity (Scotland) Act 2000(11), or

(c)

the Gene Therapy Advisory Committee;

“export” means export to a third country from an EEA State, whether by land, sea or air;

“the Gene Therapy Advisory Committee” means the Gene Therapy Advisory Committee appointed by the Secretary of State to—

(a)

consider and advise on the acceptability of proposals for gene therapy research on human subjects, on ethical grounds, and

(b)

provide advice on developments in gene therapy research and their implications;

“Health and Social Services Board” means a Health and Social Services Board established under the Health and Personal Social Services (Northern Ireland) Order 1972(12);

“Health Board” means a Health Board established under the National Health Service (Scotland) Act 1978(13);

“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 nurse,

(d)

a pharmacist,

(e)

a person registered in a register of ophthalmic opticians maintained under section 7 of the Opticians Act 1989(14),

(f)

a person registered in a register established and maintained under article 5 of Health Professions Order 2001(15),

(g)

a registered osteopath as defined by section 41 of the Osteopaths Act 1993(16), or

(h)

a registered chiropractor as defined by section 43 of the Chiropractors Act 1994(17);

“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)

a Strategic Health Authority, Health Board or Health and Social Services Board,

(b)

a Special Health Authority, Primary Care Trust or Local Health Board established under the National Health Service Act 1977,

(c)

a Special Health Board 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(18),

(e)

the Dental Practice Board constituted under section 37(1) of the National Health Service Act 1977,

(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 Northern Ireland Central Services Agency for the Health and Social Services established under the Health and Personal Social Services (Northern Ireland) Order 1972,

(h)

a National Health Service trust established under the National Health Service and Community Care Act 1990(19) 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(20), or

(j)

a Health and Social Services trust established under the Health and Personal Social Services (Northern Ireland) Order 1991(21);

“hospital” includes a clinic, nursing home or similar institution;

“import”, other than in regulation 13 and Schedule 3, means import into the United Kingdom from a third country, whether by land, sea or air;

“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)(22),

(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)(23), 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)(24), 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 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—

(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 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 section 6 of the Act;

“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;

“manufacturing authorisation” has the meaning given by regulation 36(1);

“marketing authorization” means—

(a)

a marketing authorization granted by the licensing authority under the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994(25),

(b)

a marketing authorization issued by the competent authority of an EEA State, other than the United Kingdom, in accordance with Directive 2001/83/EC,

(c)

a marketing authorization granted by the European Commission under Council Regulation (EEC) 2309/93(26), or

(d)

a product licence granted by the licensing authority for the purposes of section 7 of the Medicines Act 1968(27);

“medicinal product” means—

(a)

a medicinal product within the meaning given by Article 1 of Directive 2001/83/EC, or

(b)

any product which is not a medicinal product within the meaning given by Article 1 of Directive 2001/83/EC, but which is a medicinal product within the meaning given by section 130 of the Act;

“minor” means a person under the age of 16 years;

“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;

“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;

“pharmacist” means—

(a)

in relation to Great Britain, a person registered in the register of pharmaceutical chemists established in pursuance of the Pharmacy Act 1952 and maintained in pursuance of the Pharmacy Act 1954, 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 subjects of the trial;

“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;

“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 Article 49 or 50 of Directive 2001/83/EC, 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;

“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 paragraph 13 of Schedule 2 applies, the ethics committee which is the relevant ethics committee for that trial by virtue of sub-paragraph (5) of that paragraph;

(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 an appeal panel in accordance with paragraph 4(4) of Schedule 4, that committee, 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;

“sponsor” shall be construed in accordance with regulation 3;

“Strategic Health Authority” means a Strategic Health Authority established under the National Health Service Act 1977(28);

“subject” 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;

“third country” means a country or territory outside the European Economic Area;

“trial site” means a hospital, health centre, surgery or other establishment or facility at or from which a clinical trial, or any part of such a trial, is conducted;

“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 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.

Sponsor of a clinical trial

3.—(1) In these Regulations, subject to the following paragraphs, “sponsor” means, in relation to a clinical trial, the person who takes responsibility for the initiation, management and financing (or arranging the financing) of that trial.

(2) If two or more persons take responsibility for the matters specified in paragraph (1) in relation to a clinical trial, those persons may—

(a)take joint responsibility for carrying out the functions of the sponsor of that trial under these Regulations; or

(b)allocate responsibility for carrying out the functions of the sponsor of that trial in accordance with paragraphs (4) to (10).

(3) If two or more persons take joint responsibility in accordance with paragraph (2)(a)—

(a)any reference to the sponsor in these Regulations shall, in relation to that trial, be construed as a reference to those persons; and

(b)paragraphs (4) to (10) shall not apply.

(4) One of the persons referred to in paragraph (2) shall be responsible for carrying out the functions of a sponsor under Part 3 (authorisation for clinical trials and ethics committee opinion) and shall make the request for authorisation to conduct the trial in accordance with regulation 17.

(5) The request for authorisation referred to in regulation 17 shall specify—

(a)who, in accordance with paragraph (4), is responsible for carrying out the functions of the sponsor under Part 3;

(b)who is to be responsible for carrying out the functions of the sponsor under Part 4 (good clinical practice and the conduct of clinical trials); and

(c)who is to be responsible for carrying out the functions of the sponsor under Part 5 (pharmacovigilance).

(6) After the clinical trial has been authorised by the licensing authority in accordance with regulation 18, 19 or 20, a different person may be specified as responsible for carrying out the functions of the sponsor under Part 3, 4 or 5 by making a substantial amendment to the terms of a clinical trial authorisation in accordance with regulations 24 to 26.

(7) Where a person is responsible for carrying out the functions of the sponsor under Part 3 by virtue of paragraph (5), or is specified in accordance with paragraph (6) as responsible for those functions, any reference to the sponsor in—

(a)that Part, except regulation 15,

(b)Parts 2 to 4 of Schedule 3,

(c)Schedule 5, in so far as it relates to decisions of the licensing authority under Part 3, and

(d)Schedule 12,

shall, in relation to the trial, be construed as a reference to that person.

(8) Where a person is specified in accordance with paragraph (5) or (6) as responsible for carrying out the functions of the sponsor under Part 4, any reference to the sponsor in—

(a)that Part, except regulation 28(1), or

(b)Schedule 5, in so far as it relates to notices under regulation 31(1),

shall, in relation to the trial, be construed as a reference to that person.

(9) Where a person is specified in accordance with paragraph (5) or (6) as responsible for carrying out the functions of the sponsor under Part 5, any reference to the sponsor in that Part shall, in relation to the trial, be construed as a reference to that person.

(10) Any reference to the sponsor in—

(a)regulations 15 and 28(1),

(b)Parts 2 and 6 to 9, and

(c)Schedules 1 and 7, and Part 1 of Schedule 3,

shall, in relation to the trial, include a reference to a person specified in accordance with paragraph (5) or (6).

(11) A person who is a sponsor of a clinical trial in accordance with this regulation must—

(a)be established in the European Community, or

(b)have a legal representative who is so established.

Responsibility for functions under the Directive

4.—(1) For the purposes of the Directive, the competent authority of the United Kingdom shall be the licensing authority.

(2) Subject to paragraph (3), the licensing authority shall perform, as respects the United Kingdom, the functions of the Member State under the Directive.

(3) Paragraph (2) shall not apply in so far as any functions fall to be performed by the exercise of any powers or duties which are conferred by any provision of these Regulations, or by any provision of the Act as applied by these Regulations, on a person or body other than the licensing authority.

(1)

1968 c. 67.

(2)

OJ No. L262, 14.10.2003, p.22.

(3)

1984 c. 24.

(4)

OJ No. L121, 1.5.2001, p.34.

(5)

OJ No. L311, 28.11.2001, p.67.

(6)

See Article 31 of Directive 2002/98/EC (OJ No. L33, 8.2.2003, p.30) and Commission Directive 2003/63/EC (OJ No. L159, 27.6.2003, p.46).

(7)

See Schedule 1 of the Interpretation Act 1978 (c. 30), as amended by paragraph 18 of Schedule 5 to the Medical Act 1983 (c. 54).

(8)

OJ No. L1, 3.1.1994, p.3.

(9)

OJ No. L1, 3.1.1994, p.572.

(10)

OJ No. L214, 24.8.93, p.1.

(11)

2000 asp. 4; see S.S.I. 2002/190.

(12)

S.I. 1972/1265 (N.I. 14).

(13)

(14)

(15)

(16)

(17)

(18)

S.I. 1990/247 (N.I.3)

(19)

1990 c. 19.

(20)

2003 c. 43.

(21)

S.I. 1991/194 (N.I.1).

(22)

1990 c. 19; section 21 was amended by paragraph 79 of Schedule 1 to the Health Authorities Act 1995 (c. 17) and paragraph 81 of Schedule 4 to the Health Act 1999 (c. 8).

(23)

1978 c. 29; section 85 was inserted by section 41 of the National Health Service and Community Care Act 1990 (c. 19) and was amended by paragraph 56 of Schedule 4 to the Health Act 1999 (c. 8).

(24)

S.I. 1991/194 (N.I. 1).

(25)

S.I. 1994/3144, as amended by S.I. 1998/3105, 2000/292, 2001/795, 2002/236, 2002/542 and 2003/????.

(26)

OJ No. L214, 24.8.1993, p.1.

(27)

Section 7 does not apply to “relevant medicinal products” within the meaning given by S.I. 1994/3144.

(28)

See section 8 of the National Health Service Act 1977 (c. 49) as substituted by section 1(2) of the National Health Service Reform and Health Care Professions Act 2002 (c. 17).

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PART 1INTRODUCTORY PROVISIONS

Citation and commencement

Interpretation

Sponsor of a clinical trial

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