- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Pwynt Penodol mewn Amser (30/10/2005)
- Gwreiddiol (a wnaed Fel)
The Medicines for Human Use (Clinical Trials) Regulations 2004 is up to date with all changes known to be in force on or before 23 August 2024. There are changes that may be brought into force at a future date.
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PART 3 AUTHORISATION FOR CLINICAL TRIALS AND ETHICS COMMITTEE OPINION
12.Requirement for authorisation and ethics committee opinion
13.Supply of investigational medicinal products for the purpose of clinical trials
18.Authorisation procedure for clinical trials involving general medicinal products
19.Authorisation procedure for clinical trials involving medicinal products for gene therapy etc.
20.Authorisation procedure for clinical trials involving medicinal products with special characteristics
26.Reference to the appropriate committee or the Medicines Commission
PART 4 GOOD CLINICAL PRACTICE AND THE CONDUCT OF CLINICAL TRIALS
PART 6 MANUFACTURE AND IMPORTATION OF INVESTIGATIONAL MEDICINAL PRODUCTS
PART 2 CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL TRIALS
1.Principles based on International Conference on Harmonisation GCP Guideline
2.Before the trial is initiated, foreseeable risks and inconveniences have...
3.The rights, safety, and well-being of the trial subjects are...
4.The available non-clinical and clinical information on an investigational medicinal...
5.Clinical trials shall be scientifically sound, and described in a...
6.A trial shall be conducted in compliance with the protocol...
7.The medical care given to, and medical decisions made on...
8.Each individual involved in conducting a trial shall be qualified...
9.Subject to the other provisions of this Schedule relating to...
10.All clinical trial information shall be recorded, handled, and stored...
11.The confidentiality of records that could identify subjects shall be...
12.Investigational medicinal products used in the trial shall be—
13.Systems with procedures that assure the quality of every aspect...
15.The rights of each subject to physical and mental integrity,...
16.Provision has been made for insurance or indemnity to cover...
PART 4 CONDITIONS AND PRINCIPLES WHICH APPLY IN RELATION TO A MINOR
2.That person or legal representative has been provided with a...
3.That person or legal representative has been informed of the...
4.That person or legal representative has given his informed consent...
5.That person with parental responsibility or the legal representative may,...
6.The minor has received information according to his capacity of...
9.The clinical trial relates directly to a clinical condition from...
10.Some direct benefit for the group of patients involved in...
11.The clinical trial is necessary to validate data obtained—
12.The corresponding scientific guidelines of the European Medicines Agency are...
14.The clinical trial has been designed to minimise pain, discomfort,...
16.The interests of the patient always prevail over those of...
PART 5 CONDITIONS AND PRINCIPLES WHICH APPLY IN RELATION TO AN INCAPACITATED ADULT
2.The legal representative has been provided with a contact point...
3.The legal representative has been informed of the right to...
4.The legal representative has given his informed consent to the...
5.The legal representative may, without the subject being subject to...
6.The subject has received information according to his capacity of...
8.No incentives or financial inducements are given to the subject...
9.There are grounds for expecting that administering the medicinal product...
10.The clinical trial is essential to validate data obtained—
11.The clinical trial relates directly to a life-threatening or debilitating...
13.The clinical trial has been designed to minimise pain, discomfort,...
15.The interests of the patient always prevail over those of...
ADDITIONAL PROVISIONS RELATING TO ETHICS COMMITTEES
1.In this Schedule— “appointing authority” means— in relation to an...
5.(1) The appointing authority shall appoint— (a) one of the...
6.(1) An ethics committee may— (a) appoint sub-committees consisting of...
8.(1) At any meeting of an ethics committee, the committee...
9.(1) The appointing authority shall make arrangements for the appointment...
11.The appointing authority may pay to members of ethics committees...
13.(1) This paragraph applies where— (a) recognition of an ethics...
APPEAL AGAINST UNFAVOURABLE ETHICS COMMITTEE OPINION
1.(1) Subject to the following sub-paragraphs, where the United Kingdom...
2.Where a direction is given in accordance with paragraph 1(1)(a)—...
3.(1) An appeal panel appointed pursuant to paragraph 1(1)(b) shall...
4.(1) An appeal panel shall consider an ethics committee opinion...
5.If an appeal panel gives a favourable opinion, the condition...
PARTICULARS THAT MUST ACCOMPANY AN APPLICATION FOR A MANUFACTURING AUTHORISATION
2.A statement of the types of investigational medicinal products in...
3.A statement of the manufacturing, assembling or importation operations to...
5.A statement of any manufacturing operations, other than those to...
6.(1) The name and address and qualifications and experience of...
7.A description of the arrangements for the identification and storage...
8.A description of the arrangements at each of the premises...
9.A description of the arrangements— (a) for maintaining production or...
STANDARD PROVISIONS FOR MANUFACTURING AUTHORISATIONS
1.The holder of the authorisation shall— (a) provide and maintain...
2.The holder of the authorisation shall— (a) provide and maintain...
3.The holder of the authorisation shall place the quality control...
4.The holder of the authorisation may use a contract laboratory...
5.The holder of the authorisation shall provide such information as...
6.The holder of the authorisation shall— (a) inform the licensing...
7.The holder of the authorisation shall— (a) keep readily available...
8.The holder of the authorisation shall keep readily available for...
9.Where the holder of the authorisation has been informed by...
10.The holder of the authorisation shall ensure that any tests...
11.Where the authorisation relates to the assembly of an investigational...
12.Where— (a) the manufacturing authorisation relates to the assembly of...
13.The holder of the authorisation, for the purpose of enabling...
14.The holder of the authorisation shall at all times provide...
1.The holder of the authorisation shall— (a) provide and maintain...
2.The holder of the authorisation may use a contract laboratory...
3.The holder of the authorisation shall provide such information as...
4.The holder of the authorisation shall— (a) inform the licensing...
5.The holder of the authorisation shall— (a) keep readily available...
6.Where the holder of the authorisation has been informed by...
8.The holder of the authorisation, for the purpose of enabling...
9.The holder of the authorisation shall at all times provide...
1.In this Schedule— “authorisation” means a manufacturing authorisation; and “time...
2.Subject to paragraph 6, if the licensing authority propose—
3.Any notification given under paragraph 2 shall include a statement...
4.(1) Subject to sub-paragraph (2), the applicant or holder to...
5.(1) If the applicant or holder gives notice under paragraph...
1.The modifications of the Act mentioned in regulation 47 are...
2.(1) Amendments in section 107 (validity of decisions and related...
3.For section 108 (enforcement in England and Wales) substitute—
4.In section 109 (enforcement in Scotland), for subsections (1) to...
5.For section 110 (enforcement in Northern Ireland) substitute— It shall...
6.(1) Amendments in section 111 (rights of entry) as follows....
7.(1) Amendments in section 112 (power to inspect, take samples...
8.(1) Amendments in section 115 (analysis of samples) as follows....
9.(1) Amendments in section 116 (liability to forfeiture under the...
10.In section 118(1)(b) (restrictions on disclosing of information obtained in...
11.(1) Amendments in section 119 (protection for officers of enforcement...
12.(1) Amendments in section 121 (contravention due to fault of...
13.(1) Amendments in section 122 (warranty as defence) as follows....
14.(1) Amendments in section 124 (offences by bodies corporate) as...
16.In section 127 (service of documents)— (a) for “any provision...
17.(1) Amendments in section 129 (orders and regulations) as follows....
18.(1) Amendments in section 131 (meaning of “wholesale dealing” and...
19.(1) Amendments in section 132(1) (interpretation) as follows.
CONSEQUENTIAL AND OTHER AMENDMENTS OF ENACTMENTS
2.In section 4 of the Act (establishment of committees) ,...
7.(1) Section 35 of the Act (supplementary provisions as to...
9.(1) Section 37 of the Act (transitional provisions as to...
11.In section 39 of the Act (suspension, revocation or variation...
14.In section 46 of the Act (special defences under section...
15.In section 47 of the Act (standard provisions for licences...
16.In section 50 of the Act (certificates for exporters of...
19.In section 132 of the Act (general interpretation provisions)—
21.Section 51 of the Adults with Incapacity (Scotland) Act 2000...
1.In the Medicines (Standard Provisions for Licences and Certificates) Regulations...
2.In the Medicines (Surgical Materials) Order 1971 , in article...
3.(1) In the Medicines (Exemption from Licences) (Special Cases and...
4.In the Medicines (Dental Filling Substances) Order 1975 , in...
5.In the Medicines (Specified Articles and Substances) Order 1976 ,...
6.(1) The Medicines (Labelling) Regulations 1976 shall be amended as...
7.In the Medicines (Fluted Bottles) Regulations 1978 , in regulation...
8.In Schedule 1 to the Medicines (Fixing of Fees Relating...
9.In the Medicines Act 1968 (Application to Radiopharmaceutical-Associated Products) Regulations...
10.In the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations...
11.In the Dangerous Substances and Preparations (Safety) (Consolidation) Regulations 1994...
12.In the Medicines for Human Use (Marketing Authorisations Etc.) Regulations...
13.In the Prescription Only Medicines (Human Use) Order 1997 —...
14.In the Ionising Radiation (Medical Exposure) Regulations 2000 , in...
15.In the Private and Voluntary Health Care (England) Regulations 2001...
16.In the Misuse of Drugs Regulations 2001 , in regulation...
17.In the Health Service (Control of Patient Information) Regulations 2002...
18.In the National Health Service (Functions of Strategic Health Authorities...
1.(1) This sub-paragraph applies where— (a) a clinical trial is...
2.(1) This sub-paragraph applies where a person has made an...
3.Clinical trial exemptions or notifications prior to 1st May 2004
4.(1) This sub-paragraph applies where— (a) a clinical trial is...
5.(1) This sub-paragraph applies where— (a) a clinical trial is...
6.(1) This sub-paragraph applies where— (a) a clinical trial is...
7.(1) This sub-paragraph applies where— (a) an application for a...
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