The Medicines for Human Use (Clinical ... - …

1 STATUTORY INSTRUMENTS 2004 No. 1031 MEDICINESThe 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(a) for the purposes of section 2(2) of the European Communities Act 1972(b) in relation to medicinal products, in exercise of the powers conferred by the said section 2(2)

2 , and of all other powers enabling him in that behalf, hereby makes the following Regulations: ARRANGEMENT OF REGULATIONS PART 1 INTRODUCTORY and of a clinical for functions under the DirectivePART 2 ETHICS Kingdom Ethics Committees of ethics of ethics of and operation of ethics functions of the AuthorityPART 3 AUTHORISATION FOR CLINICAL TRIALS AND ETHICS COMMITTEE of Part for authorisation and ethics committee of investigational medicinal products for the purpose of clinical trials(a) 1972/1811.

3 (b) 1972 for ethics committee committee and appeal relating to ethics committee for authorisation to conduct a clinical procedure for clinical trials involving general medicinal procedure for clinical trials involving medicinal products for gene therapy procedure for clinical trials involving medicinal products with special trials conducted in third to clinical trial by the licensing by the or adapting rejected proposals for to the appropriate committee or the Medicines of clinical trialPART 4 GOOD CLINICAL PRACTICE AND THE CONDUCT OF CLINICAL clinical practice and protection of clinical trial of trial in accordance with clinical trial authorisation safety or termination of clinical trialPART 5 of adverse of suspected unexpected serious adverse trials conducted in third list of suspected serious adverse reactions and safety reportPART 6 MANUFACTURE AND IMPORTATION OF INVESTIGATIONAL MEDICINAL for authorisation to

4 Manufacture or import investigational medicinal for hospitals and health for manufacturing of application for manufacturing or refusal of manufacturing and effect of manufacturing of manufacturing authorisation of manufacturing and revocation of manufacturing authorisationPART 7 LABELLING OF INVESTIGATIONAL MEDICINAL 3 PART 8 ENFORCEMENT AND RELATED of enforcement provisions of the or misleading of due 9 MISCELLANEOUS of references to specified and other amendments to provisionsSCHEDULES1.

5 Conditions and principles of good clinical practice and the protection of clinical trial subjects 2. Additional provisions relating to ethics committees 3. Particulars and documents that must accompany an application for an ethics committee opinion, a request for authorisation, a notice of amendment and a notification of the conclusion of a trial 4. Appeal against unfavourable ethics committee opinion 5. Procedural provisions relating to the refusal or amendment of, or imposition of conditions relating to, clinical trial authorisations and the suspension or termination of clinical trials 6.

6 Particulars that must accompany an application for a manufacturing authorisation7. Standard provisions for manufacturing authorisations 8. Procedural provisions relating to proposals to grant, refuse to grant, vary, suspend or revoke manufacturing authorisations 9. Modification of the enforcement provisions of the Act subject to which those provisions are applied for the purposes of these Regulations 10. Consequential and other amendments of enactments 11. Revocations 12. Transitional provisions PART 1 INTRODUCTORY PROVISIONS Citation and commencement 1.

7 These Regulations may be cited as the Medicines for Human Use (Clinical Trials) Regulations 2004 and shall come into force on 1st May 2004. 4 Interpretation2. (1) In these Regulations the Act means the Medicines Act 1968 (a); 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.

8 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.

9 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.

10 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.