SCHEDULE 8AMENDMENTS TO THE MEDICINES ACTS ETC.
PART 1Consequential amendments to the Medicines Acts 1968 and 1971
The Medicines Act 1968
I91
The Medicines Act 196841 shall be amended as follows.
I362
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).
I583
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”.
I264
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).
I305
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”.
I506
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”.
I447
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”.
I398
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””.
I669
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”.
I6410
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”.
I2011
In section 15 (provision for extending or modifying exemptions)—
a
in subsection (1), omit “appropriate”; and
b
in subsection (3), omit “appropriate”.
I3512
In section 18 (application for licence), omit subsection (3)49.
I3713
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).
I4114
In section 28 (general power to suspend, revoke or vary licences), omit subsection (3)(i)51.
I715
Sections 32 to 36 and 38 to 40 shall be omitted.
I6116
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”.
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).
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”.
I1519
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”.
I1920
In section 48 (postponement of restrictions in relation to exports), in subsection (1), for “sections 49 and 49A” substitute “section 49”.
I1821
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”.
I2722
In section 51 (general sale lists)—
a
in subsection (1), omit “appropriate”; and
b
in subsection (3), omit “appropriate”.
I4723
In section 52 (sale or supply of medicinal products not on general sale list), in subsection (2)56, omit “Health”.
I3224
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.
I1425
In section 54 (sale of medicinal products from automatic machines), in subsection (2), omit “appropriate”.
I2926
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”.
I5227
In section 56 (exemptions in respect of herbal remedies), in subsection (3), omit “appropriate”.
I2528
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”.
I6829
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”.
I4530
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”.
I6731
Section 58B (requirement to specify certain products for veterinary use as prescription-only products)61 shall be omitted.
I832
In section 59 (special provisions in relation to new medicinal products), in subsection (2)(b), omit “appropriate”.
I4233
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”.
I5534
In section 61 (special restrictions on persons to be supplied with medicinal products), omit “appropriate”.
I5735
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”.
I4936
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”.
I4037
In section 66 (further powers to regulate dealings with medicinal products), in subsection (1), omit “appropriate”.
I2338
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”.
I1039
In section 73 (power to extend or modify conditions)—
a
in subsection (1), omit “Health”; and
b
in subsection (3), omit “Health”.
I1240
In section 76 (supplementary provisions as to registration of premises), omit subsection (6).
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”.
I5642
In section 85 (labelling and marking of containers and packages), in subsection (1), omit “appropriate”.
I2443
In section 86 (leaflets)65, in subsection (1), omit “appropriate”.
I6544
In section 87 (requirements as to containers), in subsection (1)—
a
omit “appropriate”; and
b
for “those Ministers” substitute “the Ministers”.
I3445
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”.
I2146
In section 89 (display of information on automatic machines), in subsection (1), omit “appropriate”.
I5947
Section 90 (provisions as to medicated animal feeding stuffs) shall be omitted.
I1648
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”.
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”.
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
I6251
In section 101 (other publications), in subsection (2)—
a
for “the Health Ministers or the Agriculture Ministers” substitute “the Ministers”; and
b
omit “concerned”.
I7052
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”.
I353
In section 103 (construction of references to specified publications)69, in subsection (1), omit paragraph (d).
I2854
In section 104 (application of Act to certain articles and substances)70, in subsection (1), omit “, the Health Ministers or the Agriculture Ministers”.
I6955
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”.
I4356
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,”.
I2257
In section 109 (enforcement in Scotland), in subsection (2), omit paragraph (d).
I5358
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)”.
I3359
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”.
I3860
Section 117 (special enforcement and sampling provisions relating to animal feeding stuffs) shall be omitted.
I5461
In section 121 (contravention due to default of other person), in subsection (4), for “85 to 90” substitute “85 to 89”.
I1362
In section 122 (warranty as defence), in subsection (2), omit “and section 90”.
I4663
In section 125 (prosecutions), in subsection (4)—
a
omit “or subsection (8)”; and
b
for “either of those subsections” substitute “that subsection”.
I5164
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”.
I4865
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).
I6066
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.
I1167
In section 132 (general interpretation provisions)—
a
in subsection (1)—
i
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.
I3168
In Schedule 3 (sampling), in paragraph 17—
a
omit paragraph (a); and
b
in paragraph (b), omit “in any other case”.
I6369
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.
The Medicines Act 1971I1770
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.