http://www.legislation.gov.uk/uksi/2004/1031/contents/made

The Medicines for Human Use (Clinical Trials) Regulations 2004

Medical research

Community health clinics

Medicines

King's Printer of Acts of Parliament

2017-06-16

MEDICINES

These Regulations implement Directive 2001/20/EC on the approximation of 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 use (“the Directive”).

The Medicines for Human Use (Clinical Trials) Regulations 2004

reg. 2(1)

The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

reg. 3(7)

reg. 1

The Medicines for Human Use (Clinical Trials) Regulations 2004

reg. 2(1)

The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

reg. 3(9)

reg. 1

The Medicines for Human Use (Clinical Trials) Regulations 2004

reg. 13(4)

The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

reg. 7(5)(i)

reg. 1

The Medicines for Human Use (Clinical Trials) Regulations 2004

reg. 13(4)

The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

reg. 7(5)(ii)

reg. 1

The Medicines for Human Use (Clinical Trials) Regulations 2004

reg. 36(2)

The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

reg. 17

reg. 1

The Medicines for Human Use (Clinical Trials) Regulations 2004

reg. 43(2)-(2F)

The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

reg. 18

reg. 1

The Medicines for Human Use (Clinical Trials) Regulations 2004

reg. 45(1)(f)(i)

The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

reg. 20

reg. 1

The Medicines for Human Use (Clinical Trials) Regulations 2004

Sch. 3 Pt. 2

para. 7

The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

reg. 24(3)(c)(i)

reg. 1

The Medicines for Human Use (Clinical Trials) Regulations 2004

Sch. 3 Pt. 2

para. 7

The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

reg. 24(3)(c)(ii)

reg. 1

The Medicines for Human Use (Clinical Trials) Regulations 2004

Sch. 3 Pt. 2

para. 8(1)

The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

reg. 24(3)(d)(i)

reg. 1

The Medicines for Human Use (Clinical Trials) Regulations 2004

Sch. 3 Pt. 2

para. 8(2)

The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

reg. 24(3)(d)(ii)(aa)

reg. 1

The Medicines for Human Use (Clinical Trials) Regulations 2004

Sch. 3 Pt. 2

para. 8(2)

The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

reg. 24(3)(d)(ii)(bb)

reg. 1

The Medicines for Human Use (Clinical Trials) Regulations 2004

Sch. 3 Pt. 2

para. 8(2)

The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

reg. 24(3)(d)(ii)(cc)

reg. 1

The Medicines for Human Use (Clinical Trials) Regulations 2004

Sch. 3 Pt. 2

para. 8(2)(a)

The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

reg. 24(3)(d)(ii)(dd)

reg. 1

The Medicines for Human Use (Clinical Trials) Regulations 2004

Sch. 7

Pt. 1

The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

reg. 25

reg. 1

The Medicines for Human Use (Clinical Trials) Regulations 2004

reg. 2(1)

The Anaesthesia Associates and Physician Associates Order 2024

Sch. 5

para. 11(a)

art. 1(3)

The Medicines for Human Use (Clinical Trials) Regulations 2004

reg. 2(1)

The Anaesthesia Associates and Physician Associates Order 2024

Sch. 5

para. 11(b)

art. 1(3)

The Medicines for Human Use (Clinical Trials) Regulations 2004

PART 1INTRODUCTORY PROVISIONS

1Citation and commencement

2Interpretation

3Sponsor of a clinical trial

4Responsibility for functions under the Directive

PART 2ETHICS COMMITTEES

5United Kingdom Ethics Committees Authority

6Establishment of ethics committees

7Recognition of ethics committees

8Revocation of recognition

9Constitution and operation of ethics committees

10Other functions of the Authority

PART 3AUTHORISATION FOR CLINICAL TRIALS AND ETHICS COMMITTEE OPINION

11Interpretation of Part 3

12Requirement for authorisation and ethics committee opinion

13Supply of investigational medicinal products for the purpose of clinical trials

14Application for ethics committee opinion

15Ethics committee opinion

16Review and appeal relating to ethics committee opinion

17Request for authorisation to conduct a clinical trial

18Authorisation procedure for clinical trials involving general medicinal products

19Authorisation procedure for clinical trials involving medicinal products for gene therapy etc.

20Authorisation procedure for clinical trials involving medicinal products with special characteristics

21Clinical trials conducted in third countries

22Amendments to clinical trial authorisation

23Amendments by the licensing authority

24Amendments by the sponsor

25Modifying or adapting rejected proposals for amendment

26Reference to the appropriate committee or the Medicines Commission

27Conclusion of clinical trial

PART 4GOOD CLINICAL PRACTICE AND THE CONDUCT OF CLINICAL TRIALS

28Good clinical practice and protection of clinical trial subjects

29Conduct of trial in accordance with clinical trial authorisation etc.

30Urgent safety measures

31Suspension or termination of clinical trial

PART 5PHARMACOVIGILANCE

32Notification of adverse events

33Notification of suspected unexpected serious adverse reactions

34Clinical trials conducted in third countries

35Annual list of suspected serious adverse reactions and safety report

PART 6MANUFACTURE AND IMPORTATION OF INVESTIGATIONAL MEDICINAL PRODUCTS

36Requirement for authorisation to manufacture or import investigational medicinal products

37Exemption for hospitals and health centres

38Application for manufacturing authorisation

39Consideration of application for manufacturing authorisation

40Grant or refusal of manufacturing authorisation

41Application and effect of manufacturing authorisation

42Obligations of manufacturing authorisation holder

43Qualified persons

44Variation of manufacturing authorisation

45Suspension and revocation of manufacturing authorisation

PART 7LABELLING OF INVESTIGATIONAL MEDICINAL PRODUCTS

46Labelling

PART 8ENFORCEMENT AND RELATED PROVISIONS

47Application of enforcement provisions of the Act

48Infringement notices

49Offences

50False or misleading information

51Defence of due diligence

52Penalties

PART 9MISCELLANEOUS PROVISIONS

53Construction of references to specified publications

54Consequential and other amendments to enactments

55Revocations

56Transitional provisions

SCHEDULE 1CONDITIONS AND PRINCIPLES OF GOOD CLINICAL PRACTICE AND FOR THE PROTECTION OF CLINICAL TRIAL SUBJECTS

PART 1APPLICATION AND INTERPRETATION

1(1) The conditions and principles specified in Part 2 apply...

2In this Schedule— “Declaration of Helsinki” means the Declaration of...

3(1) For the purposes of this Schedule, a person gives...

PART 2CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL TRIALS

1Principles based on International Conference on Harmonisation GCP Guideline

2Before the trial is initiated, foreseeable risks and inconveniences have...

3The rights, safety, and well-being of the trial subjects are...

4The available non-clinical and clinical information on an investigational medicinal...

5Clinical trials shall be scientifically sound, and described in a...

6A trial shall be conducted in compliance with the protocol...

7The medical care given to, and medical decisions made on...

8Each individual involved in conducting a trial shall be qualified...

9Subject to the other provisions of this Schedule relating to...

10All clinical trial information shall be recorded, handled, and stored...

11The confidentiality of records that could identify subjects shall be...

12Investigational medicinal products used in the trial shall be—

13Systems with procedures that assure the quality of every aspect...

14Conditions based on Article 3 of the Directive

15The rights of each subject to physical and mental integrity,...

16Provision has been made for insurance or indemnity to cover...

PART 3CONDITIONS WHICH APPLY IN RELATION TO AN ADULT ABLE TO CONSENT OR WHO HAS GIVEN CONSENT PRIOR TO THE ONSET OF INCAPACITY

1The subject has had an interview with the investigator, or...

2The subject has been informed of his right to withdraw...

3The subject has given his informed consent to taking part...

4The subject may, without being subject to any resulting detriment,...

5The subject has been provided with a contact point where...

PART 4CONDITIONS AND PRINCIPLES WHICH APPLY IN RELATION TO A MINOR

1Conditions

2That person or legal representative has been provided with a...

3That person or legal representative has been informed of the...

4That person or legal representative has given his informed consent...

5That person with parental responsibility or the legal representative may,...

6The minor has received information according to his capacity of...

7The explicit wish of a minor who is capable of...

8No incentives or financial inducements are given—

9The clinical trial relates directly to a clinical condition from...

10Some direct benefit for the group of patients involved in...

11The clinical trial is necessary to validate data obtained—

12The corresponding scientific guidelines of the European Medicines Agency are...

13Principles

14The clinical trial has been designed to minimise pain, discomfort,...

15The risk threshold and the degree of distress have to...

16The interests of the patient always prevail over those of...

PART 5CONDITIONS AND PRINCIPLES WHICH APPLY IN RELATION TO AN INCAPACITATED ADULT

1Conditions

2The legal representative has been provided with a contact point...

3The legal representative has been informed of the right to...

4The legal representative has given his informed consent to the...

5The legal representative may, without the subject being subject to...

6The subject has received information according to his capacity of...

7The explicit wish of a subject who is capable of...

8No incentives or financial inducements are given to the subject...

9There are grounds for expecting that administering the medicinal product...

10The clinical trial is essential to validate data obtained—

11The clinical trial relates directly to a life-threatening or debilitating...

12Principles

13The clinical trial has been designed to minimise pain, discomfort,...

14The risk threshold and the degree of distress have to...

15The interests of the patient always prevail over those of...

SCHEDULE 2ADDITIONAL PROVISIONS RELATING TO ETHICS COMMITTEES

1Interpretation

2Application of provisions of the Schedule

3Membership

4A member of an ethics committee shall hold and vacate...

5Chairman, vice-chairman and alternate vice-chairman

6Committees, meetings and proceedings

7Deputies and co-opted members

8(1) At any meeting of an ethics committee, the committee...

9Staff, premises and facilities

10Expenses

11The appointing authority may pay to members of ethics committees...

12Annual report

13Transfer of functions

SCHEDULE 3PARTICULARS 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

PART 1APPLICATION FOR ETHICS COMMITTEE OPINION

1An application document including the following information or, in each...

2A document containing the particulars specified in paragraphs 1 to...

3The following documents or, in each case, an explanation of...

PART 2REQUEST FOR AUTHORISATION

1The name and address of— (a) the sponsor,

2If any person is specified as a person responsible for...

3The address of each trial site and the names and...

4Where the trial is to be conducted at trial sites...

5A copy of the ethics committee opinion in relation to...

6A description of any investigational medicinal product to be used...

7The name and address of the person responsible for the...

8(1) The address of any premises at which any batch...

9A description of the proposed clinical trial.

10The protocol for the proposed trial.

11(1) Subject to sub-paragraph (7), a dossier on each investigational...

12A description or sample of the labelling which is to...

PART 3NOTICE OF AMENDMENT

1The name and address of— (a) the sponsor,

2Particulars identifying the trial, including— (a) the title of the...

3A description of the proposed amendment.

4A statement of the reasons for proposing that amendment.

5A copy of the proposed changes to—

6Summaries of— (a) any data submitted in support of the...

PART 4NOTIFICATION OF CONCLUSION OF A CLINICAL TRIAL

1The name and address of— (a) the sponsor, and

2Particulars identifying the trial, including— (a) the title of the...

3The investigational medicinal product tested in the trial.

4(1) The date on which the trial ended in the...

5If the trial is terminated as specified in regulation 27(2),...

SCHEDULE 4APPEAL AGAINST UNFAVOURABLE ETHICS COMMITTEE OPINION

1(1) Subject to the following sub-paragraphs, where the United Kingdom...

2Where 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...

5If an appeal panel gives a favourable opinion, the condition...

6The Authority may pay to members of an appeal panel...

SCHEDULE 5PROCEDURAL PROVISIONS RELATING TO THE REFUSAL OR AMENDMENT OF, OR IMPOSITION OF CONDITIONS RELATING TO, CLINICAL TRIAL AUTHORISATION AND THE SUSPENSION OR TERMINATION OF CLINICAL TRIALS

1(1) Where the licensing authority are notified of the sponsor’s...

2(1) If a person to whom a notice is given...

3(1) If a decision notified in accordance with paragraphs 1(6)...

SCHEDULE 6PARTICULARS THAT MUST ACCOMPANY AN APPLICATION FOR A MANUFACTURING AUTHORISATION

1The name and address of the applicant, and, where the...

2A statement of the types of investigational medicinal products in...

3A statement of the manufacturing, assembling or importation operations to...

4(1) The address of each of the premises where the...

5A statement of any manufacturing operations, other than those to...

6(1) The name and address and qualifications and experience of...

7A description of the arrangements for the identification and storage...

8A description of the arrangements at each of the premises...

9A description of the arrangements— (a) for maintaining production or...

SCHEDULE 7STANDARD PROVISIONS FOR MANUFACTURING AUTHORISATIONS

PART 1INTERPRETATION

PART 2PROVISIONS WHICH MAY BE INCORPORATED IN AN AUTHORISATION RELATING TO THE MANUFACTURE OR ASSEMBLY OF INVESTIGATIONAL MEDICINAL PRODUCTS

1The holder of the authorisation shall— (a) provide and maintain...

2The holder of the authorisation shall— (a) provide and maintain...

3The holder of the authorisation shall place the quality control...

4The holder of the authorisation may use a contract laboratory...

5The holder of the authorisation shall provide such information as...

6The holder of the authorisation shall— (a) inform the licensing...

7The holder of the authorisation shall— (a) keep readily available...

8The holder of the authorisation shall keep readily available for...

9Where the holder of the authorisation has been informed by...

10The holder of the authorisation shall ensure that any tests...

11Where the authorisation relates to the assembly of an investigational...

12Where— (a) the manufacturing authorisation relates to the assembly of...

13The holder of the authorisation, for the purpose of enabling...

14The holder of the authorisation shall at all times provide...

PART 3PROVISIONS WHICH MAY BE INCORPORATED IN AN AUTHORISATION RELATING TO THE IMPORTATION OF INVESTIGATIONAL MEDICINAL PRODUCTS

1The holder of the authorisation shall— (a) provide and maintain...

2The holder of the authorisation may use a contract laboratory...

3The holder of the authorisation shall provide such information as...

4The holder of the authorisation shall— (a) inform the licensing...

5The holder of the authorisation shall— (a) keep readily available...

6Where the holder of the authorisation has been informed by...

7If the holder of the authorisation is not the sponsor...

8The holder of the authorisation, for the purpose of enabling...

9The holder of the authorisation shall at all times provide...

SCHEDULE 8PROCEDURAL PROVISIONS RELATING TO PROPOSALS TO GRANT, REFUSE TO GRANT, VARY, SUSPEND OR REVOKE MANUFACTURING AUTHORISATIONS

1In this Schedule— “authorisation” means a manufacturing authorisation; and “time...

2Subject to paragraph 6, if the licensing authority propose—

3Any notification given under paragraph 2 shall include a statement...

4A person to whom notification has been given under paragraph...

5(1) Where an applicant or the holder gives notice under...

6(1) Paragraph 2 shall not apply to the suspension of...

SCHEDULE 9MODIFICATIONS OF THE ENFORCEMENT PROVISIONS OF THE ACT SUBJECT TO WHICH THOSE PROVISIONS ARE APPLIED FOR THE PURPOSES OF THESE REGULATIONS

1The modifications of the Act mentioned in regulation 47 are...

2(1) Amendments in section 107 (validity of decisions and related...

3For section 108 (enforcement in England and Wales) substitute—

4In section 109 (enforcement in Scotland), for subsections (1) to...

5For 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...

10In 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...

15(1) Amendments in section 125 (prosecutions) as follows.

16In 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.

20(1) Amendments in Schedule 3 (sampling) as follows.

SCHEDULE 10CONSEQUENTIAL AND OTHER AMENDMENTS OF ENACTMENTS

PART 1ACTS OF PARLIAMENT

1The Act

2In section 4 of the Act (establishment of committees), in...

3In section 7 of the Act (restrictions as to dealings...

4(1) Section 8 of the Act (provisions as to manufacture...

5(1) Section 23 of the Act (special provisions as to...

6Section 31 of the Act shall be omitted

7(1) Section 35 of the Act (supplementary provisions as to...

8In section 36 of the Act (application for, and issue...

9(1) Section 37 of the Act (transitional provisions as to...

10In section 38 of the Act (duration and renewal of...

11In section 39 of the Act (suspension, revocation or variation...

12In section 44 of the Act (provision of information to...

13In section 45 of the Act (offences under Part II)—...

14In section 46 of the Act (special defences under section...

15In section 47 of the Act (standard provisions for licences...

16In section 50 of the Act (certificates for exporters of...

17In section 104 of the Act (application of Act to...

18In section 105 of the Act (application of Act to...

19In section 132 of the Act (general interpretation provisions)—

20The Medicines Act 1971

21The Adults with Incapacity (Scotland) Act 2000

PART 2ORDERS AND REGULATIONS

1In the Medicines (Standard Provisions for Licences and Certificates) Regulations...

2In the Medicines (Surgical Materials) Order 1971, in article 3,...

3(1) In the Medicines (Exemption from Licences) (Special Cases and...

4In the Medicines (Dental Filling Substances) Order 1975, in article...

5In the Medicines (Specified Articles and Substances) Order 1976, in...

6(1) The Medicines (Labelling) Regulations 1976 shall be amended as...

7In the Medicines (Fluted Bottles) Regulations 1978, in regulation 3...

8In Schedule 1 to the Medicines (Fixing of Fees Relating...

9In the Medicines Act 1968 (Application to Radiopharmaceutical-Associated Products) Regulations...

10In the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations...

11In the Dangerous Substances and Preparations (Safety) (Consolidation) Regulations 1994,...

12In the Medicines for Human Use (Marketing Authorisations Etc.) Regulations...

13In the Prescription Only Medicines (Human Use) Order 1997—

14In the Ionising Radiation (Medical Exposure) Regulations 2000, in regulation...

15In the Private and Voluntary Health Care (England) Regulations 2001,...

16In the Misuse of Drugs Regulations 2001, in regulation 18...

17In the Health Service (Control of Patient Information) Regulations 2002,...

18In the National Health Service (Functions of Strategic Health Authorities...

SCHEDULE 11REVOCATIONS

SCHEDULE 12TRANSITIONAL PROVISIONS

1Ethical approval given before 1st May 2004

2Applications for ethical approval prior to 1st May 2004

3Clinical 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...

7Applications for clinical trial exemptions or notifications prior to 1st May 2004

2004 No. 1031

MEDICINES

The Medicines for Human Use (Clinical Trials) Regulations 2004

Made31st March 2004

Laid before Parliament1st April 2004

Coming into force1st May 2004

The Secretary of State, being a Minister designated1 for the purposes of section 2(2) of the European Communities Act 19722 in 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: