SCHEDULE 8AMENDMENTS TO THE MEDICINES ACTS ETC.

Regulation 44(2)

PART 1Consequential amendments to the Medicines Acts 1968 and 1971

The Medicines Act 1968

I111

The Medicines Act 196841 shall be amended as follows.

Annotations:
Commencement Information
I11

Sch. 8 Pt. 1 para. 1 in force at 1.10.2006, see reg. 1

I432

In section 1 (Ministers responsible for administration of the Act)42

a

in subsection (1)—

i

in paragraph (a), for “the Health Ministers”, in both places those words appear, substitute “the Ministers” and omit “concerned with health in England”, and

ii

omit paragraph (b) and the words following that paragraph; and

b

omit subsection (2).

Annotations:
Commencement Information
I43

Sch. 8 Pt. 1 para. 2 in force at 1.10.2006, see reg. 1

I693

In section 3 (functions of the Commission)43, in subsection (1), for “any one or more of the Ministers specified in paragraphs (a) and (b) of section 1(1) of this Act” substitute “either or both of the Ministers”.

Annotations:
Commencement Information
I69

Sch. 8 Pt. 1 para. 3 in force at 1.10.2006, see reg. 1

I334

In section 4 (establishment of committees)44

a

in subsection (1), omit “, the Health Ministers or the Agriculture Ministers”;

b

in subsection (5), omit “by whom a committee is established under this section”; and

c

omit subsection (5A).

Annotations:
Commencement Information
I33

Sch. 8 Pt. 1 para. 4 in force at 1.10.2006, see reg. 1

I375

In section 5 (supplementary provisions as to Commission and committees)—

a

in subsection (2), omit “specified in paragraphs (a) and (b) of section 1(1) of this Act”; and

b

in subsection (3), omit “specified in paragraphs (a) and (b) of section 1(1) of this Act”.

Annotations:
Commencement Information
I37

Sch. 8 Pt. 1 para. 5 in force at 1.10.2006, see reg. 1

I576

In section 6 (the licensing authority)—

a

in subsection (1), for the words from “a body of Ministers” to the end substitute “a body consisting of the Ministers”;

b

in subsection (2), for the words from “by any one” to the end substitute “by either of the Ministers acting alone or both of them acting jointly”; and

c

in subsection (3), for “any one or more of those”, in both places those words appear, substitute “either or both of the”.

Annotations:
Commencement Information
I57

Sch. 8 Pt. 1 para. 6 in force at 1.10.2006, see reg. 1

I517

In section 7 (general provisions as to dealing with medicinal products)45

a

in subsection (1), omit paragraph (b);

b

in subsection (5)(b), omit “, a ready-made veterinary drug” and “other than a veterinary drug”;

c

in subsection (6A), omit the words from “Where the product” to “veterinary drug,”;

d

omit subsection (6B); and

e

in subsection (7)—

i

at the end of the definition of “radiopharmaceutical”, omit “and”, and

ii

omit the definition of “ready-made veterinary drug”.

Annotations:
Commencement Information
I51

Sch. 8 Pt. 1 para. 7 in force at 1.10.2006, see reg. 1

I468

In section 8 (provisions as to manufacture and wholesale dealing)46

a

in subsection (1), for “(a) to (c)” substitute “(a) and (c)”;

b

in subsection (3)(b), omit “, ready-made veterinary drug” and “other than a veterinary drug”;

c

in subsection (4), omit the words from “Where the product” to “veterinary drug,”;

d

omit subsection (5); and

e

in subsection (6), for the words from ““homoeopathic” to “veterinary drug”” substitute ““proprietary medicinal product” and “radiopharmaceutical””.

Annotations:
Commencement Information
I46

Sch. 8 Pt. 1 para. 8 in force at 1.10.2006, see reg. 1

I789

In section 9 (exemptions for doctors, dentists, veterinary surgeons and veterinary practitioners)47

a

omit subsections (2) and (3); and

b

the heading of section 9 accordingly becomes “Exemptions for doctors and dentists”.

Annotations:
Commencement Information
I78

Sch. 8 Pt. 1 para. 9 in force at 1.10.2006, see reg. 1

I7510

In section 10 (exemptions for pharmacists)48

a

in subsection (1), omit “Subject to the next following subsection,”;

b

omit subsection (2);

c

in subsection (3), omit paragraph (b) and the word “or” before it;

d

omit subsection (6A);

e

in subsection (7A), omit “Health”.

Annotations:
Commencement Information
I75

Sch. 8 Pt. 1 para. 10 in force at 1.10.2006, see reg. 1

I2611

In section 15 (provision for extending or modifying exemptions)—

a

in subsection (1), omit “appropriate”; and

b

in subsection (3), omit “appropriate”.

Annotations:
Commencement Information
I26

Sch. 8 Pt. 1 para. 11 in force at 1.10.2006, see reg. 1

I4212

In section 18 (application for licence), omit subsection (3)49.

Annotations:
Commencement Information
I42

Sch. 8 Pt. 1 para. 12 in force at 1.10.2006, see reg. 1

I4413

In section 23 (special provisions as to effect of manufacturer’s licence)50

a

in subsection (1), omit “the provisions of this Part of this Act relating to medicinal tests on animals and to”;

b

in subsection (2)—

i

omit “Subject to the next following subsection,”, and

ii

omit paragraph (b) and the word “or” before it; and

c

omit subsection (3).

Annotations:
Commencement Information
I44

Sch. 8 Pt. 1 para. 13 in force at 1.10.2006, see reg. 1

I4814

In section 28 (general power to suspend, revoke or vary licences), omit subsection (3)(i)51.

Annotations:
Commencement Information
I48

Sch. 8 Pt. 1 para. 14 in force at 1.10.2006, see reg. 1

I915

Sections 32 to 36 and 38 to 40 shall be omitted.

Annotations:
Commencement Information
I9

Sch. 8 Pt. 1 para. 15 in force at 1.10.2006, see reg. 1

I7216

In section 44 (provision of information to the licensing authority)52

a

in subsection (1), 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)”;

b

in subsection (2), omit “, or of an animal test certificate,”;

c

in subsection (3), omit “or certificate”; and

d

in subsection (4)—

i

omit “, or of a certificate issued in pursuance of section 37(4) of this Act,”,

ii

omit “or certificate”, in each place those words appear,

iii

in paragraph (a), for “sections 25 and 37(4)” substitute “section 25”, and

iv

in paragraph (b), omit “or issue”.

Annotations:
Commencement Information
I72

Sch. 8 Pt. 1 para. 16 in force at 1.10.2006, see reg. 1

I517

In section 45 (offences under Part II)53

a

in subsection (1)—

i

for “, section 8, section 32, section 34 or section 40” substitute “or section 8”,

ii

omit “or animal feeding stuff”, and

iii

for “any of those sections” substitute “either of those sections”;

b

in subsection (2)—

i

omit “or animal feeding stuff”,

ii

omit “, section 32 or section 40”, and

iii

omit “or feeding stuff”;

c

in subsection (3)—

i

omit “or of an animal test certificate”, and

ii

omit “or certificate”, in both places those words appear; and

d

omit subsections (4) and (5).

Annotations:
Commencement Information
I5

Sch. 8 Pt. 1 para. 17 in force at 1.10.2006, see reg. 1

I118

In section 46 (special defences under s45)54

a

in subsection (1)—

i

omit “or of an animal test certificate”, and

ii

omit “or certificate”; and

b

in subsection (2)—

i

omit “or of an animal test certificate” in the first place those words appear,

ii

in paragraph (a), omit “or of an animal test certificate applicable to them”,

iii

in paragraph (b), omit “or certificate”.

Annotations:
Commencement Information
I1

Sch. 8 Pt. 1 para. 18 in force at 1.10.2006, see reg. 1

I1919

In section 47 (standard provisions for licences or certificates)55

a

in subsection (2), omit “or any animal test certificate” and “or issued”;

b

in subsection (4)—

i

omit “, or any animal test certificate,”, and

ii

omit “or certificate”, in both places those words appear;

c

in subsection (5)—

i

omit “, or in any certificate issued in pursuance of section 37(4) of this Act,”, and

ii

omit “or certificate”, in both places those words appear;

d

in subsection (6), omit “or certificate”, in both places those words appear;

e

in subsection (8), omit “or certificate”; and

f

in subsection (9), omit “or certificate”, in both places those words appear.

The heading accordingly becomes “Standard provisions for licences”.

Annotations:
Commencement Information
I19

Sch. 8 Pt. 1 para. 19 in force at 1.10.2006, see reg. 1

I2320

In section 48 (postponement of restrictions in relation to exports), in subsection (1), for “sections 49 and 49A” substitute “section 49”.

Annotations:
Commencement Information
I23

Sch. 8 Pt. 1 para. 20 in force at 1.10.2006, see reg. 1

I2221

In section 49 (special provisions in respect of exporting certain products)—

a

in subsection (1), for “the Health Ministers or the Agriculture Ministers” substitute “the Ministers”; and

b

in subsection (2)—

i

for “the Health Ministers or the Agriculture Ministers” substitute “the Ministers”, and

ii

for “the Ministers making the order” substitute “them”.

Annotations:
Commencement Information
I22

Sch. 8 Pt. 1 para. 21 in force at 1.10.2006, see reg. 1

I3422

In section 51 (general sale lists)—

a

in subsection (1), omit “appropriate”; and

b

in subsection (3), omit “appropriate”.

Annotations:
Commencement Information
I34

Sch. 8 Pt. 1 para. 22 in force at 1.10.2006, see reg. 1

I5423

In section 52 (sale or supply of medicinal products not on general sale list), in subsection (2)56, omit “Health”.

Annotations:
Commencement Information
I54

Sch. 8 Pt. 1 para. 23 in force at 1.10.2006, see reg. 1

I3924

In section 53 (sale or supply of medicinal products on general sale list), in subsection (2)—

a

omit “either”; and

b

omit paragraph (b) and the word “or” before it.

Annotations:
Commencement Information
I39

Sch. 8 Pt. 1 para. 24 in force at 1.10.2006, see reg. 1

I1825

In section 54 (sale of medicinal products from automatic machines), in subsection (2), omit “appropriate”.

Annotations:
Commencement Information
I18

Sch. 8 Pt. 1 para. 25 in force at 1.10.2006, see reg. 1

I3626

In section 55 (exemptions for doctors, dentists, veterinary surgeons and veterinary practitioners)57

a

in subsection (2)—

i

in paragraph (a), omit “Health”, and

ii

in paragraph (b), for “Health Ministers” substitute “Ministers”; and

b

omit subsection (3).

The heading of section 55 accordingly becomes “Exemptions for doctors and dentists etc”.

Annotations:
Commencement Information
I36

Sch. 8 Pt. 1 para. 26 in force at 1.10.2006, see reg. 1

I6127

In section 56 (exemptions in respect of herbal remedies), in subsection (3), omit “appropriate”.

Annotations:
Commencement Information
I61

Sch. 8 Pt. 1 para. 27 in force at 1.10.2006, see reg. 1

I3228

In section 57 (power to extend or modify exemptions)58

a

in subsection (1), omit “appropriate”;

b

omit subsections (2A) to (2D); and

c

in subsection (3), omit “appropriate”.

Annotations:
Commencement Information
I32

Sch. 8 Pt. 1 para. 28 in force at 1.10.2006, see reg. 1

I8129

In section 58 (medicinal products on prescription only)59

a

in subsection (1), for “appropriate Ministers” substitute “Ministers”;

b

in subsection (1A), in paragraph (h), for “appropriate Ministers”, in both places those words appear, substitute “Ministers”;

c

omit subsection (1B);

d

in subsection (3), omit paragraph (b) and the word “or” before it;

e

in subsection (4), for “appropriate Ministers” substitute “Ministers”; and

f

in subsection (6), for “appropriate Ministers” substitute “Ministers”.

Annotations:
Commencement Information
I81

Sch. 8 Pt. 1 para. 29 in force at 1.10.2006, see reg. 1

I5230

In section 58A (requirement to specify certain products for human use as prescription-only products)60

a

in subsection (1), omit “appropriate”;

b

in subsection (3), omit “appropriate”;

c

in subsection (4), omit “appropriate”; and

d

in subsection (5), omit “and section 58B of this Act”.

The heading of section 58A accordingly becomes “Requirement to specify certain products as prescription-only products”.

Annotations:
Commencement Information
I52

Sch. 8 Pt. 1 para. 30 in force at 1.10.2006, see reg. 1

I7931

Section 58B (requirement to specify certain products for veterinary use as prescription-only products)61 shall be omitted.

Annotations:
Commencement Information
I79

Sch. 8 Pt. 1 para. 31 in force at 1.10.2006, see reg. 1

I1032

In section 59 (special provisions in relation to new medicinal products), in subsection (2)(b), omit “appropriate”.

Annotations:
Commencement Information
I10

Sch. 8 Pt. 1 para. 32 in force at 1.10.2006, see reg. 1

I4933

In section 60 (restricted sale, supply and administration of certain medicinal products)62

a

in subsection (1), omit “appropriate”, in both places that word appears;

b

in subsection (3), omit “appropriate”;

c

in subsection (4), omit “appropriate”;

d

in subsection (5)—

i

omit “appropriate”, in each place that word appears, and

ii

for “those Ministers” substitute “the Ministers”; and

e

in subsection (7), for “appropriate Ministers” substitute “Ministers”.

Annotations:
Commencement Information
I49

Sch. 8 Pt. 1 para. 33 in force at 1.10.2006, see reg. 1

I6434

In section 61 (special restrictions on persons to be supplied with medicinal products), omit “appropriate”.

Annotations:
Commencement Information
I64

Sch. 8 Pt. 1 para. 34 in force at 1.10.2006, see reg. 1

I6635

In section 62 (prohibition of sale or supply, or importation, of medicinal products of specified description, or of animal feeding stuffs incorporating such products)63

a

in the heading, omit “, or of animal feeding stuffs incorporating such products”;

b

in subsection (1)—

i

omit “appropriate”, and

ii

omit paragraph (b);

c

in subsection (3)—

i

for “appropriate Ministers” substitute “Ministers”, and

ii

omit “, whether of human beings or of animals”;

d

in subsection (5)—

i

for “appropriate Ministers”, in each place those words appear, substitute “Ministers”, and

ii

for “those Ministers”, in both places those words appear, substitute “the Ministers”; and

e

in subsection (6), omit “appropriate”.

Annotations:
Commencement Information
I66

Sch. 8 Pt. 1 para. 35 in force at 1.10.2006, see reg. 1

I5636

In section 65 (compliance with standards specified in monographs in certain publications)—

a

in subsection (4), omit “, the British Veterinary Codex”;

b

in subsection (5), in paragraph (c), omit “or the British Veterinary Codex”; and

c

in subsection (7), omit “Health”.

Annotations:
Commencement Information
I56

Sch. 8 Pt. 1 para. 36 in force at 1.10.2006, see reg. 1

I4737

In section 66 (further powers to regulate dealings with medicinal products), in subsection (1), omit “appropriate”.

Annotations:
Commencement Information
I47

Sch. 8 Pt. 1 para. 37 in force at 1.10.2006, see reg. 1

I2938

In section 72A (the responsible pharmacist)64

a

in subsection (2), omit “Health”;

b

in subsection (4)(b), omit “Health”;

c

in subsection (5)(b), omit “Health”; and

d

in subsection (6), omit “Health”.

Annotations:
Commencement Information
I29

Sch. 8 Pt. 1 para. 38 in force at 1.10.2006, see reg. 1

I1239

In section 73 (power to extend or modify conditions)—

a

in subsection (1), omit “Health”; and

b

in subsection (3), omit “Health”.

Annotations:
Commencement Information
I12

Sch. 8 Pt. 1 para. 39 in force at 1.10.2006, see reg. 1

I1640

In section 76 (supplementary provisions as to registration of premises), omit subsection (6).

Annotations:
Commencement Information
I16

Sch. 8 Pt. 1 para. 40 in force at 1.10.2006, see reg. 1

I441

In section 79 (provision for modifying or extending restrictions under section 78)—

a

in subsection (1), omit “Health”;

b

in subsection (2), omit “Health”; and

c

in subsection (3), omit “Health”.

Annotations:
Commencement Information
I4

Sch. 8 Pt. 1 para. 41 in force at 1.10.2006, see reg. 1

I6542

In section 85 (labelling and marking of containers and packages), in subsection (1), omit “appropriate”.

Annotations:
Commencement Information
I65

Sch. 8 Pt. 1 para. 42 in force at 1.10.2006, see reg. 1

I3043

In section 86 (leaflets)65, in subsection (1), omit “appropriate”.

Annotations:
Commencement Information
I30

Sch. 8 Pt. 1 para. 43 in force at 1.10.2006, see reg. 1

I7644

In section 87 (requirements as to containers), in subsection (1)—

a

omit “appropriate”; and

b

for “those Ministers” substitute “the Ministers”.

Annotations:
Commencement Information
I76

Sch. 8 Pt. 1 para. 44 in force at 1.10.2006, see reg. 1

I4145

In section 88 (distinctive colours, shapes and markings of medicinal products), in subsection (1)—

a

omit “appropriate”; and

b

for “those Ministers” substitute “the Ministers”.

Annotations:
Commencement Information
I41

Sch. 8 Pt. 1 para. 45 in force at 1.10.2006, see reg. 1

I2746

In section 89 (display of information on automatic machines), in subsection (1), omit “appropriate”.

Annotations:
Commencement Information
I27

Sch. 8 Pt. 1 para. 46 in force at 1.10.2006, see reg. 1

I7047

Section 90 (provisions as to medicated animal feeding stuffs) shall be omitted.

Annotations:
Commencement Information
I70

Sch. 8 Pt. 1 para. 47 in force at 1.10.2006, see reg. 1

I2048

In section 91 (offences under Part V, and supplementary provisions)66

a

in subsection (1), for “, section 86(3) or (4) or section 90(2)” substitute “or section 86(3) or (4)”;

b

in subsection (2), omit “or any of those provisions as applied by section 90(1) of this Act”; and

c

in subsection (3), omit “, and any power to make regulations conferred by those sections as applied by section 90(1) of this Act shall be exercisable in a corresponding way”.

Annotations:
Commencement Information
I20

Sch. 8 Pt. 1 para. 48 in force at 1.10.2006, see reg. 1

I249

In section 95 (powers to regulate advertisements and representations)67

a

in subsection (1), omit “appropriate”, in both places that word appears; and

b

in subsection (3), omit “appropriate”.

Annotations:
Commencement Information
I2

Sch. 8 Pt. 1 para. 49 in force at 1.10.2006, see reg. 1

I650

In section 99 (new editions of British Pharmacopoeia, and other compendia)68

a

in subsection (4), in paragraph (a), for “veterinary drugs” substitute “veterinary medicinal products”;

b

in subsection (6)—

i

for “subsection (3)(a)” substitute “subsection (3)”,

ii

omit “Health”, and

iii

omit the words from “; and where the appropriate body has prepared” to the end; and

c

in subsection (7)—

i

after “In this Part of this Act” insert “—”,

ii

for “, and “relevant” substitute “;

  • “relevant”; and

iii

at the end insert

  • “veterinary medicinal product” has the same meaning as in the Veterinary Medicines Regulations 2006

Annotations:
Commencement Information
I6

Sch. 8 Pt. 1 para. 50 in force at 1.10.2006, see reg. 1

I7351

In section 101 (other publications), in subsection (2)—

a

for “the Health Ministers or the Agriculture Ministers” substitute “the Ministers”; and

b

omit “concerned”.

Annotations:
Commencement Information
I73

Sch. 8 Pt. 1 para. 51 in force at 1.10.2006, see reg. 1

I8452

In section 102 (supplementary provisions)—

a

in subsection (2)—

i

omit “Health”, and

ii

for “those Ministers” substitute “the Ministers”;

b

in subsection (4), omit “appropriate”;

c

in subsection (5), omit “appropriate”;

d

in subsection (6), omit “appropriate”; and

e

in subsection (7), omit the words from ““the appropriate Ministers”” to “to be published, and”.

Annotations:
Commencement Information
I84

Sch. 8 Pt. 1 para. 52 in force at 1.10.2006, see reg. 1

I353

In section 103 (construction of references to specified publications)69, in subsection (1), omit paragraph (d).

Annotations:
Commencement Information
I3

Sch. 8 Pt. 1 para. 53 in force at 1.10.2006, see reg. 1

I3554

In section 104 (application of Act to certain articles and substances)70, in subsection (1), omit “, the Health Ministers or the Agriculture Ministers”.

Annotations:
Commencement Information
I35

Sch. 8 Pt. 1 para. 54 in force at 1.10.2006, see reg. 1

I8355

In section 105 (application of Act to certain other substances which are not medicinal products)71, in subsection (1), in paragraph (b), omit “, or of causing danger to the health of animals generally or of one or more species of animals”.

Annotations:
Commencement Information
I83

Sch. 8 Pt. 1 para. 55 in force at 1.10.2006, see reg. 1

I5056

In section 108 (enforcement in England and Wales)72

a

in subsection (6), in paragraph (a), omit “40,” and “and of any regulations made under section 40 of this Act”;

b

omit subsection (8);

c

in subsection (9), for “(2) to (8)” substitute “(2) to (7)”;

d

in subsection (10), as amended by section 31(1)(d) of the Health Act 200673, omit “and (8)”; and

e

in subsection (11)—

i

omit paragraph (a), and

ii

in paragraph (b), omit “in all other respects,”.

Annotations:
Commencement Information
I50

Sch. 8 Pt. 1 para. 56 in force at 1.10.2006, see reg. 1

I2857

In section 109 (enforcement in Scotland), in subsection (2), omit paragraph (d).

Annotations:
Commencement Information
I28

Sch. 8 Pt. 1 para. 57 in force at 1.10.2006, see reg. 1

I6258

In section 110 (enforcement in Northern Ireland)—

a

in subsection (1), as amended by section 31(3)(a) of the Health Act 2006, for “subsections (3C) and (4)” substitute “subsection (3C)”;

b

omit subsection (4); and

c

in subsection (5)—

i

in paragraph (a), for “(2) to (8)” substitute “(2) to (7)”, and

ii

in paragraph (b), as amended by section 31(3) (d) of the Health Act 2006, omit “and (8)”.

Annotations:
Commencement Information
I62

Sch. 8 Pt. 1 para. 58 in force at 1.10.2006, see reg. 1

I4059

In section 116 (liability to forfeiture under Customs and Excise Management Act 1979)74, in subsection (3), omit “or are, or normally are, animal feeding stuffs in which medicinal products have been incorporated”.

Annotations:
Commencement Information
I40

Sch. 8 Pt. 1 para. 59 in force at 1.10.2006, see reg. 1

I4560

Section 117 (special enforcement and sampling provisions relating to animal feeding stuffs) shall be omitted.

Annotations:
Commencement Information
I45

Sch. 8 Pt. 1 para. 60 in force at 1.10.2006, see reg. 1

I6361

In section 121 (contravention due to default of other person), in subsection (4), for “85 to 90” substitute “85 to 89”.

Annotations:
Commencement Information
I63

Sch. 8 Pt. 1 para. 61 in force at 1.10.2006, see reg. 1

I1762

In section 122 (warranty as defence), in subsection (2), omit “and section 90”.

Annotations:
Commencement Information
I17

Sch. 8 Pt. 1 para. 62 in force at 1.10.2006, see reg. 1

I5363

In section 125 (prosecutions), in subsection (4)—

a

omit “or subsection (8)”; and

b

for “either of those subsections” substitute “that subsection”.

Annotations:
Commencement Information
I53

Sch. 8 Pt. 1 para. 63 in force at 1.10.2006, see reg. 1

I5964

In section 126 (presumptions)75

a

in subsection (1)—

i

omit paragraph (a),

ii

omit “animal feeding stuff or”, in both places those words appear, and

iii

omit “animal feeding stuffs or”;

b

in subsection (2)—

i

omit “or animal feeding stuff”, in each place those words appear, and

ii

omit “or of animal feeding stuffs in which medicinal products have been incorporated”;

c

in subsection (3), omit the words from “, to any of those provisions” to the end; and

d

in subsection (4)—

i

omit “, or of so much of subsection (2) of section 90 of this Act as relates to leaflets”,

ii

omit “or of animal feeding stuffs in which medicinal products have been incorporated”, and

iii

for the words from “in his possession” to the end, substitute “in his possession for the purpose of supplying it with a medicinal product”.

Annotations:
Commencement Information
I59

Sch. 8 Pt. 1 para. 64 in force at 1.10.2006, see reg. 1

I5565

In section 129 (orders and regulations)76

a

in subsection (2), omit “, paragraph 5”;

b

in subsection (3), in paragraph (a), omit “, 35(2)(b)” and “, 117”; and

c

omit subsection (6A).

Annotations:
Commencement Information
I55

Sch. 8 Pt. 1 para. 65 in force at 1.10.2006, see reg. 1

I7166

In section 130 (meaning of “medicinal product” and related expressions)77

a

in subsection (1), omit “or animals”, in both places those words appear;

b

omit subsections (3A) to (3C);

c

in subsection (4)—

i

omit “or (3A)”,

ii

omit “or animals”, and

iii

in paragraph (c), omit the words from “, or beneficial to” to the end of the paragraph;

d

in subsection (5), in paragraph (c), omit “, the Health Ministers or the Agriculture Ministers”;

e

in subsection (6)—

i

omit “or (3B)”, and

ii

for “the relevant subsection”, in both places those words appear, substitute “that subsection”; and

f

in subsection (9)—

i

omit “or an animal”, and

ii

omit “or feeding”, in both places those words appear.

Annotations:
Commencement Information
I71

Sch. 8 Pt. 1 para. 66 in force at 1.10.2006, see reg. 1

I1367

In section 132 (general interpretation provisions)—

a

in subsection (1)—

i

omit the definitions of the following expressions—

  • “animal”,

  • “animal feeding stuff”78,

  • “animal test certificate”,

  • “the appropriate Ministers”,

  • “the 1981 Directive”79,

  • “herd”,

  • “medicinal test on animals”,

  • “poultry”, and

  • “veterinary drug”,

ii

in the definition of “manufacture”, omit “and does not include the incorporation of the product in any animal feeding stuff”, and

iii

after the definition of “the Marketing Authorisation Regulations” insert the following definition—

“the Ministers” shall be construed in accordance with section 1(1) of this Act;

b

in subsection (2)—

i

in paragraph (a), omit “, or of causing danger to the health of animals generally or of one or more species of animals”, and

ii

omit paragraph (b); and

c

in subsection (3), omit the words from “, and any reference” to the end.

Annotations:
Commencement Information
I13

Sch. 8 Pt. 1 para. 67 in force at 1.10.2006, see reg. 1

I3868

In Schedule 3 (sampling), in paragraph 17—

a

omit paragraph (a); and

b

in paragraph (b), omit “in any other case”.

Annotations:
Commencement Information
I38

Sch. 8 Pt. 1 para. 68 in force at 1.10.2006, see reg. 1

I7469

In Schedule 4 (provisions relating to Northern Ireland)80

a

omit paragraphs 2 to 5;

b

in paragraph 6—

i

for “The appropriate Northern Ireland Minister or Ministers” substitute “The appropriate Northern Ireland Minister”,

ii

for “appropriate Ministers” substitute “Ministers”,

iii

omit “, section 35”, and

iv

omit “or their”;

c

omit paragraph 7;

d

in paragraph 8—

i

omit “, or the Minister of Agriculture for Northern Ireland, or both those Ministers,”, and

ii

omit “, paragraph 5”;

e

in paragraph 9—

i

for ““the appropriate Northern Ireland Minister or Ministers”” substitute ““the appropriate Northern Ireland Minister””,

ii

in paragraph (a), omit the words from “for the purpose” to “of animals,”,

iii

omit paragraphs (b) and (c), and

iv

omit the words after paragraph (c); and

f

in paragraph 10—

i

omit “or to the Minister of Agriculture for Northern Ireland”,

ii

for “either or both of those Ministers” substitute “that Minister”,

iii

omit the words from “or, as the case may require” to the end.

Annotations:
Commencement Information
I74

Sch. 8 Pt. 1 para. 69 in force at 1.10.2006, see reg. 1

The Medicines Act 1971I2170

In section 1 of the Medicines Act 1971 (fees payable for the purposes of Part II of the Medicines Act 1968)81, in subsection (1A), in the definition of “medicinal product”, omit paragraph (b) and the word “and” before it.

Annotations:
Commencement Information
I21

Sch. 8 Pt. 1 para. 70 in force at 1.10.2006, see reg. 1

PART 2Consequential amendments to secondary legislation

The Medicines (Surgical Materials) Order 1971I311

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

Annotations:
Commencement Information
I31

Sch. 8 Pt. 2 para. 1 in force at 1.10.2006, see reg. 1

The Medicines (Specified Articles and Substances) Order 1976I602

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”.

Annotations:
Commencement Information
I60

Sch. 8 Pt. 2 para. 2 in force at 1.10.2006, see reg. 1

The Medicines (Radioactive Substances) Order 1978I143

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”.

Annotations:
Commencement Information
I14

Sch. 8 Pt. 2 para. 3 in force at 1.10.2006, see reg. 1

The Medicines (Administration of Radioactive Substances) Regulations 1978I74

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

Annotations:
Commencement Information
I7

Sch. 8 Pt. 2 para. 4 in force at 1.10.2006, see reg. 1

The Medicines (Cyanogenetic Substances) Order 1984I775

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

Annotations:
Commencement Information
I77

Sch. 8 Pt. 2 para. 5 in force at 1.10.2006, see reg. 1

The Medicines Act 1968 (Hearings by Persons Appointed) Rules 1986I686

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)”.

Annotations:
Commencement Information
I68

Sch. 8 Pt. 2 para. 6 in force at 1.10.2006, see reg. 1

The Medicines Act 1968 (Application to Radiopharmaceutical-associated Products) Regulations 1992I247

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”.

Annotations:
Commencement Information
I24

Sch. 8 Pt. 2 para. 7 in force at 1.10.2006, see reg. 1

The Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994I88

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”.

Annotations:
Commencement Information
I8

Sch. 8 Pt. 2 para. 8 in force at 1.10.2006, see reg. 1

The Medicines (Advertising) Regulations 1994I679

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.

Annotations:
Commencement Information
I67

Sch. 8 Pt. 2 para. 9 in force at 1.10.2006, see reg. 1

The Medicines (Monitoring of Advertising) Regulations 1994I8010

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.

Annotations:
Commencement Information
I80

Sch. 8 Pt. 2 para. 10 in force at 1.10.2006, see reg. 1

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994I1511

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”.

Annotations:
Commencement Information
I15

Sch. 8 Pt. 2 para. 11 in force at 1.10.2006, see reg. 1

The Medicines and Healthcare Products Regulatory Agency Trading Fund Order 2003I5812

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,”.

Annotations:
Commencement Information
I58

Sch. 8 Pt. 2 para. 12 in force at 1.10.2006, see reg. 1

The Herbal Medicines Advisory Committee Order 2005I8213

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

Annotations:
Commencement Information
I82

Sch. 8 Pt. 2 para. 13 in force at 1.10.2006, see reg. 1

The Medicines (Advisory Bodies) (No. 2) Regulations 2005I2514

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;