European Communities (Clinical Trials on Medicinal Products For Human Use) Regulations, 2004

• Date: 29 April 2004
• Statutory Instrument No.: 190/2004

ARRANGEMENT OF REGULATIONS
PART 1
GENERAL PROVISIONS
Regulation
1. Citation 2. Commencement 3. Application of Regulations and of Control of Clinical Trials Acts, 1987 and 1990 4. Interpretation 5. Designation of functions under the Directive
PART 2
ETHICS COMMITTEES
6. & 7. Establishing, recognising and monitoring of ethics committees 8. Revocation of recognition for ethics committee 9. Membership and operation of ethics committees
PART 3
AUTHORISATION FOR CONDUCT OF CLINICAL TRIALS AND ETHICS COMMITTEE OPINION
10. Requirement for authorisation and ethics committee opinion 11. Supply of investigational medicinal products for the purpose of clinical trials 12. Application for ethics committee opinion 13. Ethics committee opinion 14. Request for authorization to conduct a clinical trial 15. Authorisation procedure for clinical trials involving general medicinal products 16. Authorisation procedure for clinical trials involving general medicinal products for gene therapy etc . 17. Authorisation procedure for clinical trials involving medicinal products with special characteristics 18. Clinical trials conducted in third countries 19. Amendments to clinical trial protocol 20. Amendments by the Board 21. Amendments by the sponsor 22. Modifying or adapting rejected proposals for amendment 23. Reference to the Advisory Committee for Human Medicines
PART 4
GOOD CLINICAL PRACTICE AND THE CONDUCT OF CLINICAL TRIALS
24. Good clinical practice and protection of clinical trial subjects 25. Conduct of trial in accordance with clinical trial authorization etc . 26. Urgent safety measures 27. Suspension or termination of clinical trial 28. Conclusion of clinical trial
PART 5
PHARMACOVIGILANCE
29. Notification of adverse events 30. Notification of suspected serious unexpected adverse reactions 31. Clinical trials conducted in third countries 32. Annual list of suspected serious adverse reactions and safety report
PART 6
MANUFACTURE AND IMPORTATION OF INVESTIGATIONAL MEDICINAL PRODUCTS
33. Requirement for authorisation to manufacture or import investigational medicinal products 34. Exemption for hospitals 35. Application for manufacturing authorisation 36. Consideration of application for manufacturing authorisation 37. Grant or refusal of manufacturing authorisation 38. Application and effect of manufacturing authorisation 39. Obligations of manufacturing authorisation holder 40. Qualified persons 41. Variation of manufacturing authorisation 42. Suspension and revocation of manufacturing authorisation
PART 7
LABELLING OF INVESTIGATIONAL MEDICINAL PRODUCTS
43. Labelling
PART 8
OFFENCES, PENALTIES AND ENFORCEMENT
44. Offences and penalties 45. Infringement notices 46. False or misleading information 47. Defence of due diligence 48. Enforcement 49. Prosecution of offences 50. Evidential value of Certificate given by analyst
PART 9
TRANSITIONAL ARRANGEMENTS
51. Transitional arrangements 52. Fees
SCHEDULES
1. Conditions and principles for the protection of clinical trial subjects Part 1 . Application and Interpretation Part 2 . Conditions and principles that apply to all clinical trials Part 3 . Conditions which apply in relation to a subject able to consent Part 4 . Conditions and principles which apply in relation to a minor Part 5 . Conditions and principles which apply in relation to an incapacitated adult 2. Additional provisions for ethics committees 3. Part 1 Procedural provisions relating to the refusal or amendment of, or imposition of conditions relating to, clinical trials authorisations and the suspension or termination of clinical trials Part 2 Procedural provisions relating to proposals to grant, refuse to grant, vary, suspend or revoke manufacturing authorisations 4. Particulars that must accompany an application for a manufacturing authorisation 5. Standard provisions for manufacturing authorisations Part 1 . Interpretation Part 2 . Provisions which may be incorporated in an authorisation relating to the manufacture, labelling or packaging of investigational products Part 3 . Provisions which may be incorporated in an authorisation relating to the importation of investigational products 6. Qualified persons Part 1 . Minimum qualifications for qualified person Part 2 . Duties of qualified person 7. Certificate stating results of test, examination or analysis.
S.I.No. 190 of 2004
European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004
I, Micheál Martin, Minister for Health and Children, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972) and for the purpose of giving effect to Directive 2001/20/EC1 of the European Parliament and of the Council of 4 April 2001, hereby make the following regulations:-
PART 1 GENERAL PROVISIONS
	Citation	1. These Regulations may be cited as the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004.
	Commencement	2. These Regulations shall come into force on 1 May 2004.
	Scope of application of Regulations and of Control of Clinical Trials Acts 1987 and 1990	3. (1) These Regulations shall apply to the conducting of clinical trials as defined in Regulation 4(1) of these Regulations.
(2) The Control of Clinical Trials Acts 1987 and 1990 shall not apply to clinical trials that are subject to control under these Regulations.
(3) These Regulations shall not apply to non-interventional trials.
	Interpretation	4. (1) In these Regulations:-
“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 that do not necessarily have a causal relationship with this treatment;
“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;
“Advisory Committee for Human Medicines” means the Committee established under section 9 (1)(a) of the Irish Medicines Board Act 1995 (No. 29 of 1995);
“appointing authority” means the institution on whose behalf application for recognition of an ethics committee in accordance with Regulation 7(1) is made and for the purposes of this definition “institution” means a health board, a hospital, a University or other similar body involved in higher education or in the award of post-graduate specialist medical or dental qualifications or in the provision of continuing medical or dental education;
“authorised health care professional” means a registered medical practitioner or registered dentist;
“Board” means the Irish Medicines Board established by section 3 of the Irish Medicines Board Act 1995 (No. 29 of 1995);
“chief investigator” means -
(a) in the case of a clinical trial conducted at a single trial site, the investigator for that site, or
(b) in the case of a clinical trial conducted at more than one trial site, the authorised health care professional, whether or not he or she 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 investigational medicinal products, or
(b) to identify any adverse reactions to one or more such investigational medicinal products, or
(c) to study absorption, distribution, metabolism and excretion of one or more such investigational medicinal products, or
(d) to discover, verify, identify or study any combination of the matters referred to at subparagraphs (a), (b), and (c),
with the object of ascertaining the safety or efficacy of such products, or both;
“clinical trial protocol” means a document that describes the objectives, design, methodology, statistical considerations and organisation of a clinical trial and includes any successive versions of the protocol and protocol amendments;
“Commission Directive 2003/94/EC” means Commission Directive 2003/94/EC2 of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and for investigational medicinal products for human use, but only insofar as that Directive applies to investigational medicinal products;
“conditions and principles of good clinical practice” means -
(a) the principles of and guidelines for good clinical practice set out in a measure adopted pursuant to Article 1(3) of the Directive, and
(b) the conditions and principles for the protection of clinical trial subjects 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...