The Medicines for Human Use (Clinical Trials) Regulations 2004

• (3) In subsection (2) (defence of due diligence where contravention due to act or default of another), for “this Act in respect of a contravention of a provision to which this section applies” substitute “ the Clinical Trials Regulations in respect of a contravention of a provision of those Regulations ”.

• (4) Omit subsection (4) (provisions to which section applies).

13

• (1) Amendments in section 122 (warranty as defence) as follows.

• (2) In subsection (1), for “this Act in respect of a contravention of a provision to which this section applies” substitute “ the Clinical Trials Regulations in respect of a contravention of regulation 46 of those Regulations ”.

• (3) Omit subsection (2) (provisions to which section applies).

14

• (1) Amendments in section 124 (offences by bodies corporate) as follows.

• (2) In subsection (1), for “this Act” substitute “ the Clinical Trials Regulations, or under section 114, 118 or 123 of this Act, ”.

• (3) After subsection (2) insert—

(2A) In subsections (1) and (2) of this section “body corporate” includes a Scottish partnership and “director”, in relation to such a partnership, includes any of its partners.

15

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

• (2) In each of subsections (1) and (2) (time limits in England and Wales, and in Scotland), for “under this Act” substitute “ under the Clinical Trials Regulations, or for an offence under section 114, 118 or 123 of this Act, ”.

• (3) Omit subsections (3) to (7).

16

In section 127 (service of documents)—

• (a) for “any provision of this Act” substitute “ relevant legislation ”, and

• (b) at the end add—

In this section “relevant legislation” means any provision of the Clinical Trials Regulations or any provision of this Act applied by regulation 47 of those Regulations.

17

• (1) Amendments in section 129 (orders and regulations) as follows.

• (2) Omit subsection (1) (powers to make regulations exercisable by the Ministers where not expressed to be otherwise exercisable).

• (3) In subsection (2) (powers to make orders and regulations under the Act exercisable by statutory instrument), for the words from “this Act (other” to “section 120 of this Act)” substitute “ any provision of this Act applied by regulation 47 of the Clinical Trials Regulations ”.

• (4) In subsection (3) (instruments which are subject to negative procedure), for paragraphs (a) to (c) substitute “ an order or regulations made under any provision of this Act applied by regulation 46 of the Clinical Trials Regulations ”.

• (5) In subsection (4) (powers to make orders that include power to revoke or vary), for the words from “, other than” to 69(3), of this Act” substitute “ of this Act applied by regulation 47 of the Clinical Trials Regulations ”.

• (6) In subsection (5) (powers to make regulations include power to make differential provision etc.), for “this Act” substitute “ any provision of this Act applied by regulation 47 of the Clinical Trials Regulations ”.

• (7) In subsection (6) (duty to consult), for the words from the beginning to “effect) the Ministers” substitute— “ Before making any regulations or order under any provision of this Act applied by regulation 47 of the Clinical Trials Regulations, the persons. ”

• (8) Omit subsections (6A) and (7) (which apply only in relation to veterinary products or instruments made otherwise than under Part 8 of the Act).

18

• (1) Amendments in section 131 (meaning of “wholesale dealing” and “retail sale” etc).

• (2) Omit subsection (1) (meaning of “wholesale dealing”).

• (3) In subsection (2) (purposes referred to in subsections (1) and (3)), for “the preceding subsection” substitute “ subsection (3) of this section ”.

• (4) In subsection (3) (meaning of “retail sale”), for “In this Act” substitute “ In the provisions of this Act applied by regulation 47 of the Clinical Trials Regulations, ”.

• (5) Omit subsection (4) (meaning of “supply in circumstances corresponding to retail sale”).

19

• (1) Amendments in section 132(1) (interpretation) as follows.

• (2) At the beginning, for “In this Act,” substitute “ In the provisions of this Act applied by regulation 47 of the Clinical Trials Regulations, ”.

• (3) In the definition of “enforcement authority”, for the words from “power” to “or under” substitute “ to enforce the provisions of the Clinical Trials Regulations is imposed by ”.

• (4) After the definition of “manufacture” insert—

• “medicinal product” means—
• anything that is a medicinal product within the meaning given by Article 1 of Directive 2001/83/EC, and
• anything that is an investigational medical product for the purposes of the Clinical Trials Regulations;

• (5) Omit the definition of “offence under this Act”.

• (6) For the definition of “prescribed” substitute—

• “prescribed” means prescribed by regulations made by the Secretary of State and the Department for Health, Social Services and Public Safety, acting jointly;

20

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

• (2) In paragraph 1(1)(a), for the words from “this Act or of any regulations” onwards substitute “ the Clinical Trials Regulations, or ”.

• (3) In paragraph 1(1)(b), for the words from “of their functions” onwards substitute “ (in this Schedule referred to as “the relevant enforcement authority”) of their functions under those Regulations or under any provision of this Act applied by regulation 47 of those Regulations, ”.

• (4) In paragraph 16, omit “the relevant enforcement officer is a Minister or the Pharmaceutical Society, and”.

• (5) Omit paragraph 17.

• (6) In paragraph 19(3), for “form prescribed by the Ministers” substitute “ prescribed form ”.

• (7) Omit paragraph 20(2).

• (8) In each of paragraphs 21 and 22, for “under this Act” substitute “ under the Clinical Trials Regulations, or under section 114, 118 or 123 of this Act, ”.

• (9) In paragraph 24(1), for “under this Act,” substitute “ under the Clinical Trials Regulations or under section 114, 118 or 123 of this Act, ”.

• (10) In paragraph 27 (power to apply Schedule with modifications), for “Ministers” substitute “ Secretary of State and the Department for Health, Social Services and Public Safety, acting jointly, ”.

SCHEDULE 10 — CONSEQUENTIAL AND OTHER AMENDMENTS OF ENACTMENTS

PART 1 — ACTS OF PARLIAMENT

The Act

1

• (1) Section 3 of the Act (general functions of the Medicines Commission) is amended as follows—

• (2) In subsection (1), for the words from “advice” to “products, where” substitute—

advice on matters— (a) relating to the execution of this Act, (b) relating to the exercise of any power conferred by this Act, (c) relating to the execution of the Clinical Trials Regulations, (d) relating to the exercise of any power conferred by those regulations, or (e) otherwise relating to medicinal products, where.

• (3) In subsection (2), after “by or under this Act” insert “ or the Clinical Trials Regulations ”.

• (4) For subsection (2)(d) substitute—

(d) to advise the licensing authority in cases where the authority— (i) are required by the provisions of Part II of this Act, or by the provisions of the Clinical Trial Regulations, to consult the Commission with respect to any matter arising under those provisions; or (ii) without being required to do so, elect to consult the Commission with respect to any matter arising under any of those provisions.

2

In section 4 of the Act (establishment of committees) , in subsection (2), for the words from “connected with” onwards substitute—

connected with— (a) the execution of this Act or the Clinical Trials Regulations, or (b) the exercise of any power conferred by this Act or those regulations, either generally or in relation to any particular class of substances or articles to which any provision of this Act or those regulations applies.

3

In section 7 of the Act (restrictions as to dealings with medicinal products) , after subsection (3), insert the following subsection—

(3A) The restrictions imposed by subsections (2) and (3) of this section shall not apply where the medicinal product concerned is an investigational medicinal product within the meaning of the Clinical Trials Regulations.

4

• (1) Section 8 of the Act (provisions as to manufacture and wholesale dealing) shall be amended as follows.

• (2) At the beginning of subsection (2), insert “ Subject to subsection (2A) of this section ”.

• (3) After subsection (2) insert the following subsections—

(2A) In the case of a medicinal product that is an investigational medicinal product, the restrictions imposed by subsection (2) of this section only apply— (a) if the product has a product licence or marketing authorization, and (b) to the extent that the manufacture or assembly of the product is in accordance with the terms and conditions of that licence or authorization. (2B) In subsection (2A) of this section— “investigational medicinal product” has the meaning given by the Clinical Trials Regulations; and “marketing authorization” means— (a) a marketing authorization issued by a competent authority in accordance with Directive 2001/83/EC, or (c) a marketing authorization granted by the European Commission under Council Regulation (EEC) 2309/93 .

• (4) In subsections (3) and (3A) , for “subsection (3C)”, in both places those words appear, substitute “ subsections (3C) and (3D) ”.

• (5) After subsection (3C), insert the following subsection—

(3D) The restrictions imposed by subsections (3) and (3A) of this section do not apply where the product concerned is an investigational medicinal product within the meaning given by the Clinical Trials Regulations.

5

• (1) Section 23 of the Act (special provisions as to the effect of manufacturer’s licence) shall be amended as follows.

• (2) In subsection (1)—

• (a) omit “clinical trials and”;

• (b) for paragraph (b), substitute the following paragraph—

(b) the products are manufactured or assembled to the order of— (i) a person who is the holder of such a product licence, or (ii) if the products are to be used for the purposes of a clinical trial, the sponsor of that trial,

• (3) After subsection (5), insert the following subsection—

(6) In this section, “clinical trial” and “sponsor”, in relation to a clinical trial, have the meaning given by Clinical Trials Regulations.

6

Section 31 of the Act shall be omitted

7

• (1) Section 35 of the Act (supplementary provisions as to clinical trials and medicinal test on animals) shall be amended as follows.

• (2) In subsection (1), omit “a clinical trial certificate or”.

• (3) In subsection (2), omit paragraph (a).

• (4) In subsection (4), omit the words from the beginning to “; and”.

• (5) In subsection (5)—

• (a) omit “a clinical trial or”;

• (b) for paragraph (a), substitute the following paragraph—

(a) an animal test certificate has been issued and is for the time being in force in respect of that test, and the test is to be carried out in accordance with that certificate, and;

• (c) in paragraph (b), omit “trial or”.

• (6) In subsection (7)—

• (a) for “sections 31 and 32” substitute “ section 32 ”;

• (b) omit “of a clinical trial or”; and

• (c) in paragraph (a), omit “trial or”.

• (7) In subsection (8), omit paragraph (a).

• (8) In subsection (10), omit “any of the provisions of subsections (5) to (8) of section 31 of this Act, or”.

8

In section 36 of the Act (application for, and issue of, certificate)—

• (a) in subsection (1), omit “a clinical trial certificate or”;

• (b) in subsection (2), omit “clinical trial or”;

• (c) in subsection (3), omit “clinical trial certificates or”.

9

• (1) Section 37 of the Act (transitional provisions as to clinical trials and medicinal tests on animals) shall be amended as follows.

• (2) In subsection (1), omit “31, ”.

• (3) In subsection (2), for “sections 31 and 32” substitute “ section 32 ”.

• (4) In subsection (3)—

• (a) omit paragraph (a);

• (b) for “section 31 or section 32 of this Act do not apply to anything done in relation to medicinal products of that description or (as the case may be)” substitute “ section 32 of the Act do not apply to anything done ”.

• (5) In subsection (4)—

• (a) omit “a clinical trial certificate or”;

• (b) in paragraph (a), for the words from the beginning to “so specified” substitute “ substances or articles specified in the application ”.

10

In section 38 of the Act (duration and renewal of certificate)—

• (a) in subsections (1) and (4), omit “clinical trial certificate or”;

• (b) in subsections (5) and (6), for “a clinical trial certificate or animal test certificate” substitute “ an animal test certificate ”.

11

In section 39 of the Act (suspension, revocation or variation of certificate)—

• (a) in subsections (1), (3) and (4), for “a clinical trial certificate or animal test certificate” substitute “ an animal test certificate ”;

• (b) in subsection (2)(c) and (e), omit “clinical trial or”.

12

In section 44 of the Act (provision of information to licensing authority), in subsections (1) and (2), for “a clinical trial certificate or animal test certificate” substitute “ an animal test certificate ”.

13

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

• (a) in subsections (1) and (2), omit “section 31,”;

• (b) in subsection (3), for “a clinical trial certificate or animal test certificate” substitute “ an animal test certificate ”.

14

In section 46 of the Act (special defences under section 45), for “a clinical trial certificate or animal test certificate” (in each place) substitute “ an animal test certificate ”.

15

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

16

In section 50 of the Act (certificates for exporters of medicinal products), after paragraph (b) insert

, and (c) to the provisions of the Clinical Trials Regulations and to any authorisation granted or other thing done by virtue of those regulations.

17

In section 104 of the Act (application of Act to certain articles and substances), in subsection (1), after “such provisions of this Act” insert “ , or the Clinical Trials Regulations, ”.

18

In section 105 of the Act (application of Act to certain other substances which are not medicinal products), in subsection (1), after “such provisions of this Act” insert “ , or the Clinical Trials Regulations, ”.

19

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

• (a) in subsection (1)—

• (i) omit the entry defining “clinical trial” and “clinical trial certificate”, and

• (ii) before the definition of “the Commission” insert the following definition—

• “the Clinical Trials Regulations” means the Medicines for Human Use (Clinical Trials) Regulations 2004;

; and

in subsection (3), omit “a clinical trial certificate or”.

The Medicines Act 1971

20

In section 1 of the Medicines Act 1971 (fees payable for the purposes of Part II of the Act) after subsection (2) insert the following subsection—

(2A) In subsections (1) and (2)(b) above, any reference to a licence under Part II of the principal Act shall be taken to include a reference to a manufacturing authorisation under the Medicines for Human Use (Clinical Trials) Regulations 2004.

The Adults with Incapacity (Scotland) Act 2000

21

Section 51 of the Adults with Incapacity (Scotland) Act 2000 (authority for research) shall be amended as follows—

• (a) in subsection (2), at the beginning of paragraph (b) insert “ Subject to subsection (3A), ”;

• (b) after subsection (3), insert the following subsection—

(3A) Where the research consists of a clinical trial of a medicinal product, the research may be carried out— (a) without being approved by the Ethics Committee, if a favourable opinion on the trial has been given by an ethics committee, other than the Ethics Committee, in accordance with regulation 15 of the Medicines for Human Use (Clinical Trials) Regulations 2004; and (b) without the consent of any guardian or welfare attorney, or the adult’s nearest relative, if— (i) it has not been practicable to contact any such person before the decision to enter the adult as a subject of the clinical trial is made, and (ii) consent has been obtained from a person, other than a person connected with the conduct of the clinical trial, who is— (A) the doctor primarily responsible for the medical treatment provided to that adult, or (B) a person nominated by the relevant health care provider.

; and

• (c) at the end insert the following subsection—

(9) In this section— “clinical trial on a medicinal product” means a clinical trial as defined by regulation 2(1) of the Medicines for Human Use (Clinical Trials) Regulations 2004; “an ethics committee” has the meaning given by that regulation; “person connected with the conduct of the trial” and “relevant health care provider” have the meanings given by Schedule 1 to those regulations.

PART 2 — ORDERS AND REGULATIONS

1

In the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971 —

• (a) in regulation 2 (interpretation), in the definition of “clinical trial certificate of right”and “animal test certificate of right,”omit “ “clinical trial certificate of right” and”;

• (b) in regulation 3 (standard provisions for licences and certificates), omit paragraph (2); and

• (c) in Schedule 1, omit Part II (standard provisions for clinical trial certificates and clinical trial certificates of right).

2

In the Medicines (Surgical Materials) Order 1971 , in article 3, for the words from “, the provisions contained in Parts I and II of the Act” to the end substitute—

(a) the provisions contained in Parts I and II of the Act, sections 62, 64, 65 and 67 of Part III of the Act, and the provisions contained in Parts V, VI and VIII of the Act shall have effect in relation to the said articles or substances described in the Schedule to this Order, as those provisions have effect in relation to medicinal products; and (b) the provisions of the Clinical Trials Regulations shall have effect in relation to the said articles or substances.

3

• (1) In the Medicines (Exemption from Licences) (Special Cases and Miscellaneous Provisions) Order 1972 , article 4 shall be amended as follows.

• (2) In paragraph (1)—

• (a) for “sections 7, 31(2) and 32” substitute “ sections 7 and 32 ”;

• (b) in subparagraph (a), omit “a clinical trial, or, as the case may be,”.

• (3) In paragraph (2)—

• (a) in subparagraph (i)—

• (i) in paragraph (a), omit “a clinical trial, or, as the case may be,”,

• (ii) in paragraph (b), omit “clinical trial or”;

• (b) in subparagraph (iii)—

• (i) omit “the clinical trial or, as the case may be,”,

• (ii) omit the words from “the doctor or dentist” to “as the case may be,”;

• (c) in subparagraph (iv)—

• (i) omit the words from “that the doctor or dentist” to “as the case may be,”,

• (ii) omit the words “the trial, or, as the case may be”.

• (4) Omit paragraph (3).

4

In the Medicines (Dental Filling Substances) Order 1975 , in article 2, in paragraph (1), for the words from “the following provisions of the Act” to the end substitute—

(a) the provisions contained in Parts I, II, III, V, VI and VIII of the Act shall have effect in relation to dental filling substances as those provisions have effect in relation to medicinal products; and (b) the provisions of the Clinical Trials Regulations shall have effect in relation to those substances.

5

In the Medicines (Specified Articles and Substances) Order 1976 , in article 2, in paragraph (1), for the words from “the provisions of the Act” to the end substitute—

(a) the provisions of the Act set out in Part I of the said Schedule 2 shall have effect in relation to such articles or substances as those provisions have effect in relation to medicinal products; and (b) the provisions of the Clinical Trials Regulations shall have effect in relation to those articles or substances.

6

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

• (2) In regulation 1 (citation and scope) , after “apply”, insert “ or a medicinal product which is an investigational medicinal product within the meaning of the Medicines for Human Use (Clinical Trials) Regulations 2003 ”.

• (3) In regulation 2 (commencement), in paragraph (b), in sub-paragraph (i), omit “, clinical trial certificate”.

• (4) Omit regulation 6 (clinical trials).

• (5) In regulation 10 (surgical materials), omit the words from “, except that” to the end.

• (6) In regulation 16 (provisions in licences, clinical trial certificates and animal test certificates)—

• (a) in paragraph (1), for “a clinical trial certificate or animal test certificate ” substitute “ an animal test certificate ”;

• (b) in paragraph (2), omit “, clinical trial certificate”.

• (7) Omit Schedule 2 (particulars required in the labelling of containers and packages of medicinal products for clinical trials).

7

In the Medicines (Fluted Bottles) Regulations 1978 , in regulation 3 (exceptions)—

• (a) after paragraph (e), insert the following paragraph—

(ee) where medicinal products are investigational medicinal products within the meaning given by the Medicines for Human Use (Clinical Trials) Regulations 2004;

; and

• (b) in paragraph (g), omit “clinical trial certificate or”.

8

In Schedule 1 to the Medicines (Fixing of Fees Relating to Medicinal Products for Human Use) Order 1989 , after paragraph 9A insert the following paragraph—

(9B) Functions of the licensing authority which are functions of theirs by virtue of the Medicines for Human Use (Clinical Trials) Regulations 2004 and the functions of any person appointed under Schedule 5 or 8 to those Regulations.

9

In the Medicines Act 1968 (Application to Radiopharmaceutical-Associated Products) Regulations 1992 , in the Schedule—

• (a) in the entry relating to section 44 of the Act, for “ “, or of a clinical trial certificate or animal test certificate,”” substitute “ , or of an animal test certificate, ”;

• (b) in the entry relating to section 45 of the Act, omit “section 31,”, in both places those words appear;

• (c) in the entry relating to section 46 of the Act, for “ “or of a clinical trial certificate or animal test certificate”” substitute “ or of an animal test certificate ”; and

• (d) in the entry relating to section 47 of the Act—

• (i) for “ “any clinical trial certificate or animal test certificate”” substitute “ any animal test certificate ”, and

• (ii) for “ “, or any clinical trial certificate or animal test certificate,”” substitute “ , or any animal test certificate, ”.

10

In the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 , in Schedule 4 (application of the provisions of the Act)—

• (a) in the entry relating to section 23 of the Act, omit “clinical trials and”;

• (b) in the entry relating to section 44 of the Act, for “a clinical trial certificate or animal test certificate”, in both places those words appear, substitute “ an animal test certificate ”;

• (c) in the entry relating to section 45 of the Act—

• (i) omit “section 31,”, and

• (ii) for “ “or of a clinical trial certificate or animal test certificate”” substitute “ or of an animal test certificate ”; and

• (d) in the entry relating to section 46 of the Act, for “ “or of a clinical trial certificate or animal test certificate”” substitute “ or of an animal test certificate ”.

11

In the Dangerous Substances and Preparations (Safety) (Consolidation) Regulations 1994 , in regulation 1 (citation, commencement and interpretation), in paragraph (2), in the definition of “medicinal product”—

• (a) for sub-paragraph (ii), substitute the following sub-paragraph—

(ii) which is an “investigational medicinal product” within the meaning of regulation 2(1) of the Medicines for Human Use (Clinical Trials) Regulations 2003, or

; and

• (b) omit sub-paragraph (iii).

12

In the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 —

• (a) in regulation 1—

• (i) in paragraph (2), after the definition of “the Act” insert the following definition—

• “the Clinical Trials Directive” means Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the 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;

• (ii) in paragraph (5), omit “and except in the case of “clinical trial,””; and

• (b) in Schedule 1, in paragraph 2, for sub-paragraph (e) substitute the following sub-paragraph—

(e) the relevant medicinal product— (i) is manufactured, assembled or imported by the holder of an authorization referred to in Article 40 of the 2001 Directive which relates specifically to the manufacture, assembly or import of relevant medicinal products to which paragraph 1 applies; or (ii) has been manufactured, assembled or imported as an investigational medicinal product by the holder of an authorization referred to in Article 13 of the Clinical Trials Directive

; and.

13

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

• (a) in article 1 (citation, commencement and interpretation), in paragraph (2), for the definition of “clinical trial exemption” substitute the following definition—

• “clinical trial” has the meaning given by regulation 2(1) of the Medicines for Human Use (Clinical Trials) Regulations 2003;

; and

• (b) in article 3B (prescribing and administration by supplementary prescribers), in paragraph (3), in sub-paragraph (b), in head (ii), for the words from “and—” to the end substitute “ which has been authorised, or is to be treated as having been authorised, by the licensing authority in accordance with the Medicines for Human Use (Clinical Trials) Regulations 2003 ”.

14

In the Ionising Radiation (Medical Exposure) Regulations 2000 , in regulation 2 (interpretation), in paragraph (1), after the definition of “ionising radiation”, insert the following definition—

• “Local Research Ethics Committee” means—
• an ethics committee established or recognised in accordance with Part 2 of the Medicines for Human Use (Clinical Trials) Regulations 2004,
• the Ethics Committee constituted by regulations made by the Scottish Ministers under section 51(6) of the Adults with Incapacity (Scotland) Act 2000, or
• any other committee established to advise on the ethics of research investigations in human beings, and recognised for that purpose by or on behalf of the Secretary of State, the National Assembly for Wales or Scottish Ministers;

15

In the Private and Voluntary Health Care (England) Regulations 2001 , in regulation 24 (research), for paragraph (2) substitute the following paragraph—

(2) For the purposes of paragraph (1)(a), “appropriate Research Ethics Committee” means— (a) an ethics committee established or recognised in accordance with Part 2 of the Medicines for Human Use (Clinical Trials) Regulations 2004; or (b) any other committee established to advise on the ethics of research investigations in human beings, and recognised for that purpose by or on behalf of the Secretary of State;

16

In the Misuse of Drugs Regulations 2001 , in regulation 18 (marking of bottles and other containers), for paragraph (3) substitute the following paragraph—

(3) In this regulation— “clinical trial” has the same meaning as in the Medicines for Human Use (Clinical Trials) Regulations 2003; “medicinal test on animals” has the same meaning as in the Medicines Act 1968.

17

In the Health Service (Control of Patient Information) Regulations 2002 , in regulation 1 (citation, commencement, interpretation and extent), in paragraph (2), for the definition of “research ethics committee” substitute the following definition—

• “research ethics committee” means—
• an ethics committee established or recognised in accordance with Part 2 of the Medicines for Human Use (Clinical Trials) Regulations 2004, or
• any other committee established to advise on the ethics of research investigations in human beings, and recognised for that purpose by or on behalf of the Secretary of State or the National Assembly for Wales;

18

In the National Health Service (Functions of Strategic Health Authorities and Primary Care Trusts and Administration Arrangements) (England) Regulations 2002 , in regulation 2 (interpretation), in paragraph (1), for the definition of “research ethics committee” substitute the following definition—

• “research ethics committee” means—
• an ethics committee established or recognised in accordance with Part 2 of the Medicines for Human Use (Clinical Trials) Regulations 2004, or
• any other committee established to advise on the ethics of research investigations on human beings and recognised for that purpose by or on behalf of the Secretary of State;

SCHEDULE 11 — REVOCATIONS

Regulations and orders	S.I. number	Extent of revocation
The Medicines (Standard Provisions for Licence and Certificates) Regulations 1971	S.I. 1971/972	The whole Regulations in so far as they relate to clinical trial certificates
The Medicines (Applications for Product Licences and Clinical Trial and Animal Test Certificates) Regulations 1971	S.I. 1971/973	The whole Regulations in so far as they relate to applications for clinical trial certificates
The Medicines (Exemption from Licences) (Clinical Trials) Order 1974	S.I. 1974/498	The whole Order
The Medicines (Renewal Applications for Licences and Certificates) Regulations 1974	S.I. 1974/832	The whole Regulations in so far as they relate to renewal applications for clinical trial certificates
The Medicines (Exemption from Licences) (Clinical Trials) Order 1995	S.I. 1995/2808	The whole Order
The Medicines (Exemption from Licences and Certificates) (Clinical Trials) Order 1995	S.I. 1995/2809	The whole Order
The National Health Service Reform and Health Care Professions Act 2002 (Supplementary, Consequential Etc Provisions) Regulations 2002	S.I. 2002/2469	Schedule 1, Part 2, paragraph 67.

SCHEDULE 12 — TRANSITIONAL PROVISIONS

Ethical approval given before 1st May 2004

1

• (1) This sub-paragraph applies where—

• (a) a clinical trial is conducted after 30th April 2004;

• (b) no ethics committee has given a favourable opinion in relation to that trial in accordance with regulation 15; and

• (c) a committee established or recognised for the purpose of advising on the ethics of research investigations on human beings has before 1st May 2004 given a favourable ethical opinion in relation to that trial.

• (2) Subject to the following sub-paragraphs, where sub-paragraph (1) applies—

• (a) the trial shall be treated for the purposes of these Regulations as if an ethics committee has given a favourable opinion in relation to that trial in accordance with regulation 15;

• (b) regulations 12, 24 (4) and 29 shall apply in relation to the trial with the modification that references to the application for an ethics committee opinion shall be read as references to the application for approval made to the committee referred to in sub-paragraph (1)(c); and

• (c) regulations 24, 25, 27, 30 to 35 and 48 shall apply in relation to the trial with the modification that references to the relevant ethics committee shall be read as references to the committee referred to in sub-paragraph (1)(c).

• (3) This sub-paragraph applies where the committee referred to in sub-paragraph (1)(c) has not been recognised by the Authority in accordance with regulation 7—

• (a) for the area in which the trial sites are situated, or

• (b) for the description or class of clinical trial into which the trial falls,

before 1st September 2004.

• (4) Where sub-paragraph (3) applies—

• (a) the sponsor of the clinical trial may make an application to an ethics committee established or recognised by the Authority in accordance with Part 2—

• (i) for the area in which the trial sites are situated, or

• (ii) for the description or class of clinical trial into which the trial falls,

for an amendment to the protocol for the trial within the meaning of Part 3 of these Regulations; or

• (b) the chief investigator may make an application to an ethics committee in accordance with regulation 14.

• (5) Where an ethics committee receives an application for an amendment in accordance with sub-paragraph (4)(a), it shall consider the amendment as if it was a valid notice of amendment under regulation 24.

• (6) Where an ethics committee gives a favourable opinion in relation to an application for amendment made pursuant to sub-paragraph (4)(a)—

• (a) sub-paragraph (2)(c) shall cease to apply; and

• (b) regulations 24, 25, 27, 30 to 35 and 48 shall apply in relation to the trial with the modification that references to the relevant ethics committee shall be read as references to the committee which gave that favourable opinion.

• (7) Where an ethics committee gives a favourable opinion in relation to an application pursuant to sub-paragraph (4) (b), sub-paragraph (2) shall cease to apply in relation to that trial

• (8) Where sub-paragraph (3) applies and before 1st May 2006 no favourable opinion has been given as specified in sub-paragraphs (6) and (7), sub-paragraph (2) and (4) shall cease to apply from that date.

• (9) If the committee referred to in sub-paragraph (1)(b) is abolished or ceases operation before 1st May 2006—

• (a) the Authority shall nominate an ethics committee as responsible for the work of the committee which is abolished or which ceases operation; and

• (b) regulations 24, 25, 27, 30 to 35 and 48 shall apply in relation to the trial with the modification that references to the relevant ethics committee shall be read as references to the committee so nominated.

Applications for ethical approval prior to 1st May 2004

2

• (1) This sub-paragraph applies where a person has made an application for an ethical opinion in relation to a clinical trial before 1st May 2004 to a committee established or recognised for the purpose of advising on the ethics of research investigations on human beings.

• (2) Where—

• (a) sub-paragraph (1) applies;

• (b) the committee has not given its opinion before 1st May 2004; and

• (c) the committee has been recognised by the Authority in accordance with regulation 7 for the area in which the trial sites are situated, or for the description or class of clinical trial into which the trial falls,

the committee shall consider the application as if it had been made in accordance with regulation 14.

Clinical trial exemptions or notifications prior to 1st May 2004

3

• (1) This sub-paragraph applies where—

• (a) a clinical trial is conducted after 30th April 2004; and

• (b) immediately before 1st May 2004, a clinical trial certificate was in force and the trial was being conducted in accordance with that certificate.

• (2) Where sub-paragraph (1) applies—

• (a) the trial shall be treated for the purposes of these Regulations as having been authorised by the licensing authority;

• (b) regulations 17 to 21 shall not apply in relation to the trial; and

• (c) regulations 11, 24(2), 29, 31 and 45(1), and Schedule 7, shall apply in relation to the trial with the modification that references to the request for authorisation shall be read as references to the application for the clinical trial certificate.

4

• (1) This sub-paragraph applies where—

• (a) a clinical trial is conducted after 30th April 2004; and

• (b) immediately before 1st May 2004, the exemption conferred by article 3 of the Medicines (Exemption from Licences) (Clinical Trials) Order 1995 applied in respect of the sale or supply of medicinal products for the purposes of that trial.

• (2) Where sub-paragraph (1) applies—

• (a) the trial shall be treated for the purposes of these Regulations as having been authorised by the licensing authority;

• (b) regulations 17 to 21 shall not apply in relation to the trial; and

• (c) regulations 11, 24(2), 29, 31 and 45(1), and Schedule 7, shall apply in relation to the trial with the modification that references to the request for authorisation shall be read as references to the notice to the licensing authority specified in article 4(1)(a) of the Medicines (Exemption from Licences) (Clinical Trials) Order 1995 .

5

• (1) This sub-paragraph applies where—

• (a) a clinical trial is conducted after 30th April 2004;

• (b) the investigational medicinal product used in the trial is a product with a marketing authorization;

• (c) the trial has before 1st May 2004 been notified to the licensing authority by the person supplying the product for the purposes of that trial; and

• (d) the licensing authority has before 1st May 2004 notified that person that—

• (i) the trial appeared to fall within the terms of the Medicines (Exemption from Licences) (Clinical Trials) Order 1974 , and

• (ii) the authority agreed to the trial proceeding.

• (2) Where sub-paragraph (1) applies—

• (a) the trial shall be treated for the purposes of these Regulations as having been authorised by the licensing authority;

• (b) regulations 17 to 21 shall not apply in relation to the trial; and

• (c) regulations 11, 24(2), 29, 31 and 45(1), and Schedule 7, shall apply in relation to the trial with the modification that references to the request for authorisation shall be read as references to the notification referred to in sub-paragraph (1)(c).

6

• (1) This sub-paragraph applies where—

• (a) a clinical trial is conducted after 30th April 2004; and

• (b) immediately before 1st May 2004, the exemption conferred by article 2(2) of the Medicines (Exemption from Licences) (Special Cases and Miscellaneous Provisions) Order 1972 applied in respect of the sale or supply of medicinal products for the purposes of that trial.

• (2) Where sub-paragraph (1) applies—

• (a) the trial shall be treated for the purposes of these Regulations as having been authorised by the licensing authority;

• (b) regulations 17 to 21 shall not apply in relation to the trial; and

• (c) regulations 11, 24(2), 29, 31 and 45(1), and Schedule 7, shall apply in relation to the trial with the modification that references to the request for authorisation shall be read as references to the notification to the licensing authority specified in article 2(3)(c) or (4)(a) of the Medicines (Exemption from Licences) (Special Cases and Miscellaneous Provisions) Order 1972.

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

7

• (1) This sub-paragraph applies where—

• (a) an application for a clinical trial certificate has been made in accordance with section 36 of the Act and the licensing authority has not before 1st May 2004 determined whether to issue a certificate;

• (b) the licensing authority has received a notice pursuant to article 4(1)(a) of the Medicines (Exemption from Licences) (Clinical Trials) Order 1995 and on 1st May 2004—

• (i) the specified period within the meaning of article 4(2) of that Order has not expired, and

• (ii) the authority has not given or sent a notice pursuant to article 4(1)(b); or

• (c) the licensing authority has received a notice pursuant to article 4(2)(iv) of the Medicines (Exemption from Licences) (Special Cases and Miscellaneous Provisions) Order 1972 and on 1st May 2004—

• (i) the period specified in article (2)(v) of that Order has not expired, and

• (ii) the authority has not given a direction pursuant to that article.

• (2) Where sub-paragraph (1) applies the licensing authority shall treat the application or notice as a valid request for authorisation to conduct the clinical trial to which the application or notice relates under regulation 17.

Signed

Signed by authority of the Secretary of State for Health

Warner — Parliamentary Under Secretary of State, — Department of Health — 2004-03-31

Explanatory note

(This note is not part of the Regulations)

Footnotes

Membership

Deputies and co-opted members

Expenses

In this Schedule—

“Commission Directive 2003/94/EC” in relation to the holder of an authorisation means—

• (a) in the case of a holder in Great Britain—

• (i) Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice for medicinal products for human use and for investigational medicinal products for human use, as modified by Schedule 2A to the 2012 Regulations, or

• (ii) if Regulations have been made under the powers in regulation B17(1) of the 2012 Regulations, and have come into force, those Regulations;

• (b) in the case of a holder in Northern Ireland, Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice for medicinal products for human use and for investigational medicinal products for human use;

“product specification” means—

• (a) in the case of an investigational medicinal product manufactured before a request for authorisation to conduct the clinical trial involving those products has been made—

• (i) in the case of an investigational medicinal product manufactured or assembled in Great Britain, in accordance with regulation 17, or

• (ii) in the case of an investigational medicinal product manufactured or assembled in Northern Ireland, in accordance with regulation 17 or any equivalent provisions in any EEA State,

the specification for that product provided by the person who is to act as the sponsor of the proposed clinical trial,

• (b) in the case of an investigational medicinal product manufactured for the purpose of export, the specification for that product provided by the person to whose order the products are manufactured, or

• (c) in any other case, the specification for an investigational medicinal product contained in the investigational medicinal product dossier for that product.

Clinical trial exemptions or notifications prior to 1st May 2004

Editorial notes