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Regulation 2

SCHEDULE 1AMENDMENTS TO THE ACT

Amendment of section 3 of the Act

1.—(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)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)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)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”.

Amendment of section 4 of the Act

2.  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”.

Amendment of section 132 of the Act

3.  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(1);.

Amendment of Schedule 1A to the Act

4.  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)the Herbal Regulations;.

(1)

S.I. 2005/2750.