The Medicines for Human Use (Clinical Trials) Regulations 2004

JurisdictionUK Non-devolved
CitationSI 2004/1031

2004 No. 1031

MEDICINES

The Medicines for Human Use (Clinical Trials) Regulations 2004

Made 31th March 2004

Laid before Parliament 1st April 2004

Coming into force 1st May 2004

The Secretary of State, being a Minister designated1for the purposes of section 2(2) of the European Communities Act 19722in 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:

1 INTRODUCTORY PROVISIONS

PART 1

INTRODUCTORY PROVISIONS

S-1 Citation and commencement

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.

S-2 Interpretation

Interpretation

2.—(1) In these Regulations—

“the Act” means the Medicines Act 19683;

“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/EC4laying 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 19845or entered in the list of visiting EEC practitioners under Schedule 4 to that Act;

“the Directive” means Directive 2001/20/ECof 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 use6;

“Directive 2001/83/EC” means Directive 2001/83/ECof the European Parliament and of the Council on the Community code relating to medicinal products for human use7, as amended8;

“doctor” means a registered medical practitioner9;

“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 199210as adjusted by the Protocol signed at Brussels on 17th March 199311;

“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. 2309/93laying 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 Products12;

“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 200013, 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 197214;

“Health Board” means a Health Board established under the National Health Service (Scotland) Act 197815;

“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 198916,

(f) a person registered in a register established and maintained under article 5 of Health Professions Order 200117,

(g) a registered osteopath as defined by section 41 of the Osteopaths Act 199318, or

(h) a registered chiropractor as defined by section 43 of the Chiropractors Act 199419;

“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 199020,

(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 199021or 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 200322, or

(j) a Health and Social Services trust established under the Health and Personal Social Services (Northern Ireland) Order 199123;

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

“import”, other than...

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