2005 No. 2754
The Medicines (Advisory Bodies) (No. 2) Regulations 2005
S-1
Citation, commencement and interpretationCitation, commencement and interpretation
1.—(1) These Regulations may be cited as the Medicines (Advisory Bodies) (No. 2) Regulations 2005.
(2) These Regulations shall come into force—
(a)
(a) for the purpose of Schedules 1 and 2, immediately after the coming into force of the Medicines (Advisory Bodies) Regulations 2005; and
(b)
(b) for all other purposes, 30th October 2005.
(3) In these Regulations—
“the Act” means the Medicines Act 1968;
“appropriate committee” means—
(a) in a case where—
(i) a committee has been established under section 4 of the Act for purposes which consist of or include any of those specified in subsection (3) of that section, and
(ii) the relevant authority considers it to be the appropriate committee in the circumstances,
that committee; and
(b) in any other case, the Commission.
“the appropriate Ministers” has the meaning given by section 1(2) of the Act;
“the Clinical Trials Regulations” means the Medicines for Human Use (Clinical Trials) Regulations 2004;
“the Commission” means the Commission on Human Medicines established under section 2A of the Act;
“licence” means a licence granted under Part II of the Act;
“licensing authority” has the meaning given by section 6 of the Act;
“the Marketing Authorization Regulations” means the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994;
“marketing authorization” means—
(a) a marketing authorization granted by the licensing authority under the Marketing Authorization Regulations;
(b) a product licence granted under Part II of the Act that has effect as a marketing authorization by virtue of paragraph 1 of Schedule 7 to those Regulations;
“relevant authority” means—
(a) in relation to Part 2 of Schedule 5, the appropriate Ministers, and
(b) in relation to any other provision of these Regulations, the licensing authority;
“the time allowed” means the period of 28 days beginning with the date of the relevant notification, or such longer period as the licensing authority may allow in any particular case.
Amendments to the Act
2. The amendments to the Act set out in Schedule 1 shall have effect.
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Amendments to the Marketing Authorization RegulationsAmendments to the Marketing Authorization Regulations
3. The amendments to the Marketing Authorization Regulations set out in Schedule 2 shall have effect.
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Amendments to the Clinical Trials RegulationsAmendments to the Clinical Trials Regulations
4. The amendments to the Clinical Trials Regulations set out in Schedule 3 shall have effect.
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Amendments to other enactmentsAmendments to other enactments
5. The provisions of the enactments specified in Schedule 4 shall be amended as there specified.
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Transitional ProvisionsTransitional Provisions
6. The transitional provisions set out in Schedule 5 shall have effect.
SCHEDULE 1
Regulation 2
AMENDMENTS TO THE ACT
1. Amendment of section 3 of the Act
(1) Section 3 of the Act (functions of the Commission) shall be amended as follows.
(2) In subsection (1), for paragraph (c) substitute the following paragraph—
“(c)
“(c) relating to the execution of the Marketing Authorization Regulations, the Homoeopathic Regulations, the Herbal Regulations or the Clinical Trials Regulations,”.
(3) In subsection (2)—
(a)
(a) for “the Marketing Authorization Regulations or the Clinical Trials Regulations” substitute “the Marketing Authorization Regulations, the Homoeopathic Regulations, the Herbal Regulations or the Clinical Trials Regulations”; and
(b)
(b) in paragraph (b)(i) for “the Marketing Authorization Regulations or the Clinical Trial Regulations” substitute “the Marketing Authorization Regulations, the Homoeopathic Regulations, the Herbal Regulations or the Clinical Trials Regulations”.
2. Amendment of section 4 of the Act
In section 4 of the Act (establishment of committees), in subsection (2)(a), after “the Marketing Authorization Regulations” insert “, the Homoeopathic Regulations, the Herbal Regulations”.
3. Amendment of section 132 of the Act
In section 132 of the Act (general interpretation provisions), after the definition of “health centre”, insert the following definition—
““the Herbal Regulations” means the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005;”.
4. Amendment of Schedule 1A to the Act
In Schedule 1A to the Act (provisions relating to Commission and committees)—
(a) in paragraph 4(1)(b), after “the Marketing Authorization Regulations” insert “, a certificate of registration under the Homoeopathic Regulations, a traditional herbal registration under the Herbal Regulations”; and
(b) in paragraph 5(2), after paragraph (b) insert the following paragraph—
“(bb)
“(bb) the Herbal Regulations;”.
SCHEDULE 2
Regulation 3
AMENDMENTS TO THE MARKETING AUTHORIZATION REGULATIONS
1.—(1) Schedule 2 to the Marketing Authorization Regulations (procedural provisions relating to the grant, renewal, variation, revocation and suspension of United Kingdom marketing authorizations) is amended as follows.
(2) In paragraph 2, for sub-paragraph (a), substitute the following sub-paragraph—
“(a)
“(a) any application for the grant of an authorization for a relevant medicinal product, except where—
(i) at any time during the period beginning with the date on which the application is made and ending with the date on which the licensing authority gave a decision on the application, there is a marketing authorization in force in respect of that product anywhere in the Community, or
(ii) the application has been submitted to the licensing authority in accordance with Article 28(1) and (3) of the 2001 Directive;”.
(3) In paragraph 14(8)(a), for “section” substitute “paragraph”.
SCHEDULE 3
Regulation 4
AMENDMENTS TO THE CLINICAL TRIALS REGULATIONS
1. In regulation 2 (interpretation), in paragraph (1), for the definition of “appropriate committee” substitute—
““appropriate committee”, for the purposes of any provision of these Regulations under which a function falls to be performed, means—
(a) in a case where—
(i) a committee has been established under section 4 of the Act for purposes which consist of or include any of those specified in subsection (3) of that section, and
(ii) the authority performing that function considers it to be the appropriate committee in the circumstances,
that committee; and
(b) in any other case, the Commission on Human Medicines established by section 2A of the Act;”.
2. In regulation 19 (authorization procedure for clinical trials involving medicinal products for gene therapy etc), in paragraph (10), in sub-paragraph (a), for “Committee on Safety of Medicines” substitute “Commission on Human Medicines established by section 2A of the Act”.
3. In regulation 26 (reference to appropriate committee or the Medicines Commission)—
(a) in paragraph (1)—
(i) in sub-paragraph (c)—
(bb) for “24(4)”, substitute “24(5)”,
(ii) omit “or, if for the time being there is no such committee, the Medicines Commission”.
(b) in paragraph (2), omit “, or as the case may be, the Medicines Commission”.
4.—(1) Regulation 31 (suspension or termination of clinical trial) shall be amended as follows.
(2) In paragraph (7), omit “or, if for the time being there is no such committee, the Medicines Commission”.
(3) In paragraph (8), omit “or, as the case may be, the Medicines Commission”.
(4) In paragraph (9), omit “or the Medicines Commission”.
5. For Schedule 5 (procedural provisions relating to the refusal or amendment of, or imposition of conditions relating to, clinical trial authorizations and the suspension or termination of clinical trials), substitute the following Schedule—
“SCHEDULE 5
Regulations 26(2) and 31(8)
PROCEDURAL PROVISIONS RELATING TO THE REFUSAL OR AMENDMENT OF, OR IMPOSITION OF CONDITIONS RELATING TO, CLINICAL TRIAL AUTHORISATIONS AND THE SUSPENSION OR TERMINATION OF CLINICAL TRIALS
Hearing before the appropriate committee
1.—(1) Where the licensing authority are notified of the wish of a sponsor or investigator to make representations in accordance with regulation 26(1) or 31(7), the authority shall inform the appropriate committee and the committee shall give the sponsor or investigator an opportunity to make such representations in accordance with sub-paragraphs (2) to (5).
(2) Subject to sub-paragraph (3), the sponsor or investigator shall provide the appropriate committee with—
(a)
(a) his written representations or a written summary of the oral representations he intends to make; and
(b)
(b) any documents on which he wishes to rely in support of those representations,
before the end of the period of six months beginning with the date of the notice referred to in sub-paragraph (1), or within such shorter period as the licensing authority may specify in the notification referred to in sub-paragraph (1).
(3) If the sponsor or investigator so requests, the appropriate committee may extend the time limit referred to in sub-paragraph (2), up to a maximum period of twelve months beginning with the date of the notice referred to in sub-paragraph (1).
(4) The sponsor or investigator may not submit any additional written representations or documents once the time limit referred to in sub-paragraphs (2) and (3) has expired, except with the permission of the appropriate committee.
(5) If the...
