SCHEDULE 8AMENDMENTS TO THE MEDICINES ACTS ETC.

PART 2Consequential amendments to secondary legislation

The Medicines (Surgical Materials) Order 19711

In the Medicines (Surgical Materials) Order 197182, in article 3 (application of specified provisions of the Medicines Act 1968 to surgical materials), omit “Health”.

The Medicines (Specified Articles and Substances) Order 19762

In the Medicines (Specified Articles and Substances) Order 197683, in article 2 (application of specified provisions of the Medicines Act 1968 to articles and substances specified in Schedule 1), omit “Health”.

The Medicines (Radioactive Substances) Order 19783

In the Medicines (Radioactive Substances) Order 197884, in article 2 (application of specified provisions of the Medicines Act 1968 to certain substances or articles consisting of or containing radioactive substances), omit “Health”.

The Medicines (Administration of Radioactive Substances) Regulations 19784

In the Medicines (Administration of Radioactive Substances) Regulations 197885, for “the Health Ministers”, in each place those words appear, substitute “the Ministers”.

The Medicines (Cyanogenetic Substances) Order 19845

In the Medicines (Cyanogenetic Substances) Order 198486, in article 2 (application of specified provisions of the Medicines Act 1968), omit “Health”.

The Medicines Act 1968 (Hearings by Persons Appointed) Rules 19866

In the Medicines Act 1968 (Hearings by Persons Appointed) Rules 198687, in rule 2 (interpretation), in paragraph (b), in the definition of “relevant Minister”, in sub-paragraph (ii), for “the appropriate Ministers as defined in section 1(2)” substitute “the Ministers as defined in section 1(1)”.

The Medicines Act 1968 (Application to Radiopharmaceutical-associated Products) Regulations 19927

In the Medicines Act 1968 (Application to Radiopharmaceutical-associated Products) Regulations 199288, in the Schedule—

a

in the entry relating to section 44(1) to (3)—

i

for the first entry in column (2) substitute “as though in subsection (1) “(including a licence of right)” were omitted”,

ii

omit the second entry in column (2), and

iii

in the third entry in column (2), omit “and the words “or certificate” were omitted”;

b

in the entry relating to section 45(1), (2) and (6) to (9)—

i

for the first entry in column (2) substitute “as though in subsection (1) the words “, section 8” were omitted and for “any of those sections” there were substituted “that section””, and

ii

omit the second entry in column (2);

c

in the entry relating to section 46(1), omit

“or of an animal test certificate” and “or certificate” were omitted and”;

d

in the entry relating to section 47, omit the second, third and fourth entries in column (2);

e

in the entry relating to section 91—

i

for the first entry in column (2) substitute “as though in subsection (1) for “section 85(5), section 83(3) or (4) or section 90(2)” there were substituted “section 86(3) or (4)”,

ii

in the second entry in column (2) for “section 90(1)” substitute “section 87(2)”, and

iii

in the third entry in column (2), omit “and the words from “and any power to make regulations conferred by those sections” to the end of the subsection were omitted”; and

f

for the entry relating to section 126(4), substitute “as though the words “or subsection (3)” were omitted”.

The Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 19948

In the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 199489—

a

in regulation 6 (grant of a certificate), omit “appropriate”; and

b

in Schedule 4 (application of the provisions of the Medicines Act 1968)—

i

omit the entries relating to sections 23, 58A, 121, 122 and 126,

ii

in the entry relating to section 44—

aa

omit “or for an animal test certificate (including a certificate to which a person is entitled by virtue of section 37(4) of this Act”,

bb

omit “and as though “, or of an animal test certificate,” were omitted”, and

cc

for “as though “licence or” were omitted” substitute “as though for “licence” there were substituted “certificate””,

iii

in the entry relating to section 108, omit the words from “as though in subsection (8)” to the end, and

iv

in the entry relating to section 110, omit “as though subsection (4) were omitted”.

The Medicines (Advertising) Regulations 19949

In the Medicines (Advertising) Regulations 199490, in regulation 2 (interpretation), for paragraph (4) substitute the following paragraph—

4

In these Regulations, “the Health Ministers” means the Ministers specified in section 1(1) of the Act, and the functions of the Health Ministers under these Regulations may be performed by either of them acting alone or both of them acting jointly.

The Medicines (Monitoring of Advertising) Regulations 199410

In the Medicines (Monitoring of Advertising) Regulations 199491, in regulation 2 (interpretation and application), for paragraph (3) substitute the following paragraph—

3

In these Regulations, “the Health Ministers” means the Ministers specified in section 1 of the Act, and the functions of the Health Ministers under these Regulations may be performed by either of them acting alone or both of them acting jointly.

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 199411

In the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 199492, in Schedule 4 (modifications of enforcement provisions of the Medicines Act 1968)—

a

in paragraph 9, in paragraph (b), for “85 to 90” substitute “85 to 89”; and

b

in paragraph 10, in paragraph (b), for “sections 85 to 88 and section 90” substitute “and sections 85 to 88”.

The Medicines and Healthcare Products Regulatory Agency Trading Fund Order 200312

In the Medicines and Healthcare Products Regulatory Agency Trading Fund Order 200393, in Schedule 1 (funded operations), in paragraph 1, in sub-paragraph (a), omit “the Health Ministers,”.

The Herbal Medicines Advisory Committee Order 200513

In the Herbal Medicines Advisory Committee Order 200594, in article 2 (Herbal Medicines Advisory Committee), in paragraph (b), omit “Health”.

The Medicines (Advisory Bodies) (No. 2) Regulations 200514

In the Medicines (Advisory Bodies) (No. 2) Regulations 200595, in regulation 1 (citation, commencement and interpretation), in paragraph (3), for the definition of “the appropriate Ministers” substitute the following definition—

  • “the appropriate Ministers” means the Secretary of State for Health and the Department for Health, Social Services and Public Safety acting jointly;