The Medicines (Advisory Bodies) (No. 2) Regulations 2005

Regulation 5

SCHEDULE 4 CONSEQUENTIAL AMENDMENTS TO OTHER ENACTMENTS

1.  In the Medicines (Extension to Antimicrobial Substances) Order 1973(1), in regulation 2 (application of specified provisions of the Act to certain classes of substances), in paragraph (1), for “sections 20 to 22” substitute “sections 20 to 22A”.

2.  In the Medicines (Labelling) Regulations 1976(2), in regulation 17 (general provisions), in paragraph (6), for “Medicines Commission” substitute “Commission on Human Medicines”.

3.  In the Medicines (Administration of Radioactive Substances) Regulations 1978(3)—

(a) in regulation 3 (advisory committee), in paragraph (4), for “paragraph 1(a) of Schedule 1” substitute “paragraph 6(a) of Schedule 1A”(4);

(b) in regulation 7 (hearings and written representations), for paragraph (3) substitute—

“(3) The provisions of subsections (2) to (9) and (10)(b) of section 22A of the Act shall have effect in relation to a person appointed under paragraph 1 of this regulation and to proceedings before him and his report—

(a) subject to sub-paragraphs (b) to (d), as they have effect for the purposes of that section;

(b) as though in subsections (4), (5), (6), (7), (9) and (10)(b), for “licensing authority”, in each place those words appear, were substituted “Health Ministers”;

(c) as in though in subsection (5)(b)—

(i) for “licence” there were substituted “certificate”, and

(ii) for “and notify the applicant accordingly” there were substituted “or to suspend, revoke or vary the certificate, as the case may be”; and

(d) as though in subsection (9)(b)—

(i) for “licence” there were substituted “certificate”, and

(ii) for “confirm or alter their decision” there were substituted “suspend, revoke or vary the certificate”.”.

4.  In the Medicines (Exemption from Licences) (Importation) Order 1984(5), in article 2 (interpretation), in sub-paragraph (1)(a), in the definition of “British approved name” for “Medicines Commission” substitute “Commission”.

5.  In the Medicines (Fixing of Fees Relating to Medicinal Products for Human Use) Order 1989(6)—

(a) in Schedule 1—

(i) in paragraph 3, for “Medicines Commission” substitute “Commission on Human Medicines”;

(ii) in paragraph 4, for “the Committee on Safety of Medicines” substitute “the Advisory Board on the Registration of Homoeopathic Products and the Herbal Medicines Advisory Committee”;

(iii) after paragraph 9B, insert the following paragraphs—

“9C.   Functions of the licensing authority which are functions of theirs by virtue of the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 and the functions of any person appointed under Schedule 2 to those Regulations.

9D.   Functions of the licensing authority which are functions of theirs by virtue of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994(7) and the functions of any person appointed under Schedule 5 to those Regulations.”;

(b) in Schedule 2, in paragraph 1, for “Medicines Commission” substitute “Commission on Human Medicines”.

6.  In the Medicines Act 1968 (Application to Radiopharmaceutical-associated Products) Regulations 1992(8), in the Schedule—

(a) for “sections 20 to 22” substitute “sections 20 to 22A”; and

(b) for the entry relating to Schedule 2 of the Act, substitute the following entry—

• “as though in paragraph 6 sub-paragraph (a) were omitted;

• as though in paragraph 9 the words “if the licence is a product licence,” were omitted;

• as though in sub-paragraph (b) of paragraph 10 the words “in the case of a product licence,” were omitted.”.

7.—(1) The Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003(9) shall be amended as follows.

(2) In regulation 1 (citation, commencement and interpretation), in paragraph (2)—

(a) after the definition of “the 1994 Regulations”, insert the following definition—

““the 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 appropriate Minister 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 1968 Act;”; and

(b) omit the definition of “CSM”.

(3) In regulation 3 (procedure for determinations of compliance with the TSE Guideline)—

(a) in sub-paragraph (3)(b)(ii), for “CSM” (in both places where it appears), substitute “appropriate committee”;

(b) in paragraph (4), for “CSM”, substitute “appropriate committee”;

(c) in paragraph (5), for “CSM” (in both places where it appears), substitute “appropriate committee”;

(d) in paragraph (7), for “CSM”, substitute “appropriate committee”.

(e) in paragraph (8), for “CSM” (in each place where it appears), substitute “appropriate committee”.

(1)

S.I. 1973/367.

(2)

S.I. 1976/1726, amended by S.I. 1996/2194; there are other amending instruments but none is relevant.

(3)

S.I. 1978/1006, amended by S.I. 1995/2147.

(4)

Schedule 1A to the Act was inserted by regulation 7 of S.I. 2005/1094, which came into force on 31st May 2005 for the purposes of making regulations under paragraph 6 of Schedule 1A.

(5)

S.I. 1984/673.

(6)

S.I. 1989/684, amended by S.I. 1995/871, 2004/1031.

(7)

S.I. 1994/105; as amended by S.I. 1994/899, 1995/541, 1996/482, 1998/574, 1999/566, 2001/795, 2002/236 and 542, 2003/625 and 2321, 2004/666 and 2005/2753.

(8)

S.I. 1992/605, to which there are amendments not relevant to these regulations.

(9)

S.I. 2003/1680, to which there are amendments not relevant to these regulations.