E.C. (Clinical Trials on Medicinal Products for Human Use) Regulations 2004.
Source: Iris Oifigiúl 2004/190 2004-04-29 00001-00085

num: 1
paragraphs: Citation
num: 2
paragraphs: Commencement
num: 3
paragraphs: Application of Regulations and of Control of Clinical Trials Acts, 1987 and 1990
num: 4
paragraphs: Interpretation
num: 5
paragraphs: Designation of functions under the Directive
PART 2
ETHICS COMMITTEES
num: 6
paragraphs: & 7.
Establishing, recognising and monitoring of ethics committees
num: 8
paragraphs: Revocation of recognition for ethics committee
num: 9
paragraphs: Membership and operation of ethics committees
PART 3
AUTHORISATION FOR CONDUCT OF CLINICAL TRIALS AND ETHICS COMMITTEE OPINION
num: 10
paragraphs: Requirement for authorisation and ethics committee opinion
num: 11
paragraphs: Supply of investigational medicinal products for the purpose of clinical trials
num: 12
paragraphs: Application for ethics committee opinion
num: 13
paragraphs: Ethics committee opinion
num: 14
paragraphs: Request for authorization to conduct a clinical trial
num: 15
paragraphs: Authorisation procedure for clinical trials involving general medicinal products
num: 16
paragraphs: Authorisation procedure for clinical trials involving general medicinal products for gene therapy etc .
num: 17
paragraphs: Authorisation procedure for clinical trials involving medicinal products with special characteristics
num: 18
paragraphs: Clinical trials conducted in third countries
num: 19
paragraphs: Amendments to clinical trial protocol
num: 20
paragraphs: Amendments by the Board
num: 21
paragraphs: Amendments by the sponsor
num: 22
paragraphs: Modifying or adapting rejected proposals for amendment
num: 23
paragraphs: Reference to the Advisory Committee for Human Medicines
PART 4
GOOD CLINICAL PRACTICE AND THE CONDUCT OF CLINICAL TRIALS
num: 24
paragraphs: Good clinical practice and protection of clinical trial subjects
num: 25
paragraphs: Conduct of trial in accordance with clinical trial authorization etc .
num: 26
paragraphs: Urgent safety measures
num: 27
paragraphs: Suspension or termination of clinical trial
num: 28
paragraphs: Conclusion of clinical trial
PART 5
PHARMACOVIGILANCE
num: 29
paragraphs: Notification of adverse events
num: 30
paragraphs: Notification of suspected serious unexpected adverse reactions
num: 31
paragraphs: Clinical trials conducted in third countries
num: 32
paragraphs: Annual list of suspected serious adverse reactions and safety report
PART 6
MANUFACTURE AND IMPORTATION OF INVESTIGATIONAL MEDICINAL PRODUCTS
num: 33
paragraphs: Requirement for authorisation to manufacture or import investigational medicinal products
num: 34
paragraphs: Exemption for hospitals
num: 35
paragraphs: Application for manufacturing authorisation
num: 36
paragraphs: Consideration of application for manufacturing authorisation
num: 37
paragraphs: Grant or refusal of manufacturing authorisation
num: 38
paragraphs: Application and effect of manufacturing authorisation
num: 39
paragraphs: Obligations of manufacturing authorisation holder
num: 40
paragraphs: Qualified persons
num: 41
paragraphs: Variation of manufacturing authorisation
num: 42
paragraphs: Suspension and revocation of manufacturing authorisation
PART 7
LABELLING OF INVESTIGATIONAL MEDICINAL PRODUCTS
num: 43
paragraphs: Labelling
PART 8
OFFENCES, PENALTIES AND ENFORCEMENT
num: 44
paragraphs: Offences and penalties
num: 45
paragraphs: Infringement notices
num: 46
paragraphs: False or misleading information
num: 47
paragraphs: Defence of due diligence
num: 48
paragraphs: Enforcement
num: 49
paragraphs: Prosecution of offences
num: 50
paragraphs: Evidential value of Certificate given by analyst
PART 9
TRANSITIONAL ARRANGEMENTS
num: 51
paragraphs: Transitional arrangements
num: 52
paragraphs: Fees