The Veterinary Medicines Regulations 2006

• (b) £245 if the holder certifies when making the payment that his turnover for that year was less than £40,000.

• (2) For the purposes of this paragraph, “turnover” means the gross value of all veterinary medicinal products (whether or not authorised for use in the United Kingdom) sold by way of wholesale dealing by the holder in the United Kingdom during the previous year.

PART 5 — Fees relating to feedingstuffs

Fees relating to feedingstuffs

39

• (1) Fees relating to feedingstuffs are payable with the application, or on invoice for the subsequent annual fee.

• (2) Where more than one activity is carried out at one premises, only one fee (the highest) is payable.

• (3) Fees are in accordance with the following table.

Application and annual fee	Fee payable in Great Britain (£)	Fee payable in Great Britain (£)	Fee payable in Northern Ireland (£)	Fee payable in Northern Ireland (£)
	Standard	Late[^f01000]	Standard	Late[^f01000]
(a) This column is the annual fee if it is not paid within 60 days of the invoice.	(a) This column is the annual fee if it is not paid within 60 days of the invoice.	(a) This column is the annual fee if it is not paid within 60 days of the invoice.	(a) This column is the annual fee if it is not paid within 60 days of the invoice.	(a) This column is the annual fee if it is not paid within 60 days of the invoice.
(b) No fee is payable for premises that already have a manufacturing authorisation relating to veterinary medicinal products for incorporating into feedingstuffs.	(b) No fee is payable for premises that already have a manufacturing authorisation relating to veterinary medicinal products for incorporating into feedingstuffs.	(b) No fee is payable for premises that already have a manufacturing authorisation relating to veterinary medicinal products for incorporating into feedingstuffs.	(b) No fee is payable for premises that already have a manufacturing authorisation relating to veterinary medicinal products for incorporating into feedingstuffs.	(b) No fee is payable for premises that already have a manufacturing authorisation relating to veterinary medicinal products for incorporating into feedingstuffs.
Application for the approval of an establishment to manufacture a specified feed additive, and the subsequent annual fee[^f01001]:	910	1,090	489	587
Application for the approval of an establishment to manufacture a premixture, and the subsequent annual fee:	575	690	386	463
Application for the approval of an establishment to manufacture feedingstuffs using specified feed additives and veterinary medicinal products directly at any concentration, or using premixtures, and the subsequent annual fee:	575	690	386	463
Application for the approval of an establishment to manufacture feedingstuffs using a veterinary medicinal product only at a rate of 2 kg per tonne or more when the feedingstuffs are to be placed on the market, and the subsequent annual fee:	385	460	285	342
Application for the approval of an establishment to manufacture feedingstuffs using premixtures containing specified feed additives when the feedingstuffs are to be placed on the market, and the subsequent annual fee:	195	235	152	182
Application for the approval of an establishment to manufacture feedingstuffs using a veterinary medicinal product only at a rate of 2 kg per tonne or more when the feedingstuffs are to be used by the person manufacturing the feedingstuffs, and the subsequent annual fee:	140	170	117	140
Application for the approval of an establishment to manufacture feedingstuffs using premixtures containing specified feed additives when the feedingstuffs are to be used by the person manufacturing the feedingstuffs, and the subsequent annual fee:	120	145	98	118

Fees relating to distributors

40

The fee for an application or subsequent annual fee to be a distributor of specified feed additives, premixtures or feedingstuffs containing specified feed additives, or premixtures or feedingstuffs containing veterinary medicinal products is £135 in Great Britain (or £160 if the annual fee is not paid within 60 days of the invoice) and £62 in Northern Ireland (or £74 if the annual fee is not paid within 60 days of the invoice).

PART 6 — General

Testing samples

41

The fee for testing a sample required to be submitted by the Secretary of State is the full economic cost of the test.

Animal test certificates

42

• (1) The fee for an animal test certificate is £330 in the case of—

• (a) an immunological veterinary medicinal product that has been authorised in another member State for the species on which the proposed test will be conducted;

• (b) a pharmaceutical veterinary medicinal product which has been authorised in another member State for use with a food-producing species on which the proposed test will be conducted where the same or similar dosage regime and method of administration is to be used in the medicinal test as is authorised; or

• (c) a pharmaceutical veterinary medicinal product authorised in another member State for human or animal use where the test is to be conducted on non-food-producing animals only.

• (2) In any other case the fee is £785.

• (3) The fee for an application for a variation of the certificate is £255 for each change.

• (4) The fee for an application to renew a certificate is £125.

Treatment under the cascade

43

The fee for a certificate to import (if necessary) and be in possession of and administer a veterinary medicinal product authorised in another member State for treatment under the cascade is £15.

Treatment in exceptional circumstances

44

• (1) The fee for a certificate to import (if necessary), be in possession of and administer a veterinary medicinal product authorised in a third country is £30 for the initial certificate and £30 for its renewal (£15 for a renewal if the certificate is renewed on-line using the website of the Veterinary Medicines Directorate) payable in respect of each animal treated.

• (2) In the case of administration to and treatment of a discrete group of animals, the Secretary of State may notify the applicant in writing that a fee for only one animal is payable.

Specific batch control

45

The fee for an authorisation to release a veterinary medicinal product under specific batch control is £535.

Submission of control tests of an immunological product

46

The fee for the submission of the results of tests carried out on a batch of immunological products prior to release is £80.

Export certificates

47

The fee for an application for an export certificate is £30, and £15 for each certified copy.

Fees relating to premises for supply by suitably qualified persons

48

• (1) The fee to approve premises for the retail supply of veterinary medicinal products by suitably qualified persons is—

• (a) £245, or

• (b) if the premises are only authorised to supply veterinary medicinal products for the treatment of horses and companion animals, £135.

• (2) The subsequent annual fee is—

• (a) £175, or £205 if the fee is not paid within 60 days of the invoice, or

• (b) if the premises are only authorised to supply veterinary medicinal products for the treatment of horses and companion animals, £90, or £110 if the fee is not paid within 60 days of the invoice.

Application to the Veterinary Products Committee

49

• (1) If the Secretary of State refuses to grant a marketing authorisation or an animal test certificate, or grants one that is different from what was applied for, the fee for making representations to the Veterinary Products Committee is in accordance with the following table.

Type of application	Fee (£)
Application involving a new active substance:	1,865
Standard application:	495
Application for a pharmacologically equivalent product:	495
Application using identical data:	195
Application for an animal test certificate:	650

• (2) If the holder of a marketing authorisation applies for a variation and the Secretary of State refuses it, the fee for making representations to the Veterinary Products Committee is in accordance with the following table—

Type of application	Fee (£)
Type 1A variation:	195
Type 1B variation:	195
Type II variation:	260

Non-payment of fees

50

Where fees (other than fees relating to a manufacturing authorisation or wholesale dealer’s authorisation) are not paid, the Secretary of State may, after giving one month’s written warning, suspend the authorisation to which the fee relates.

Waiver or reduction of fees

51

• (1) If the Secretary of State is satisfied that for reasons of human or animal health or the protection of the environment it is desirable that a product should be authorised for veterinary use or that an authorised product should remain on the market he may waive or reduce any fees payable under these Regulations.

• (2) An applicant or the holder of a marketing authorisation must provide full written justification for any waiver or reduction.

Reduction of application fee

52

• (1) Where an application for a marketing authorisation is withdrawn before determination, or refused on the grounds that data requested by the Secretary of State have not been supplied within the time limit specified in the request, the applicant may request a refund of a proportion of the fee (or, if the fee has not yet been paid, a reduction of the fee) in accordance with this paragraph.

• (2) The request for a reduced fee must be made in writing within two months of the withdrawal of the application, or of the date of notification of a refusal.

• (3) No reduction is payable if the application is withdrawn after all the data have been fully assessed, or if the application has been referred to the Veterinary Products Committee.

Stage at which application is withdrawn	Percentage reduction or refund
The assessment (veterinary, scientific or pharmaceutical) has not yet begun:	90%
The assessment has begun but the Secretary of State has not yet requested further data:	50%
The Secretary of State has requested further information but it has not yet been provided:	25%
The Secretary of State has been supplied with further information requested but has not yet fully assessed it, or the application has not been referred to the Veterinary Products Committee:	10%

SCHEDULE 8 — AMENDMENTS TO THE MEDICINES ACTS ETC.

PART 1 — Consequential amendments to the Medicines Acts 1968 and 1971

The Medicines Act 1968

1

The Medicines Act 1968⁴¹ shall be amended as follows.

2

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).

3

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”.

4

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).

5

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”.

6

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”.

7

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”.

8

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””.

9

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”.

10

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”.

11

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

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

• (b) in subsection (3), omit “appropriate”.

12

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

13

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).

14

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

15

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

16

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”.

17

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).

18

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”.

19

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”.

20

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

21

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”.

22

In section 51 (general sale lists)—

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

• (b) in subsection (3), omit “appropriate”.

23

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

24

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.

25

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

26

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”.

27

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

28

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”.

29

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”.

30

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”.

31

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

32

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

33

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”.

34

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

35

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”.

36

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”.

37

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

38

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”.

39

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

• (a) in subsection (1), omit “Health”; and

• (b) in subsection (3), omit “Health”.

40

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

41

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”.

42

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

43

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

44

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

• (a) omit “appropriate”; and

• (b) for “those Ministers” substitute “the Ministers”.

45

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”.

46

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

47

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

48

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”.

49

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”.

50

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

51

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

• (a) for “the Health Ministers or the Agriculture Ministers” substitute “the Ministers”; and

• (b) omit “concerned”.

52

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”.

53

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

54

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

55

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”.

56

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,”.

57

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

58

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)”.

59

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”.

60

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

61

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

62

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

63

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

• (a) omit “or subsection (8)”; and

• (b) for “either of those subsections” substitute “that subsection”.

64

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”.

65

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).

66

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.

67

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.

68

In Schedule 3 (sampling), in paragraph 17—

• (a) omit paragraph (a); and

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

69

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 1971

70

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.

PART 2 — Consequential amendments to secondary legislation

The Medicines (Surgical Materials) Order 1971

1

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 1976

2

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 1978

3

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 1978

4

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 1984

5

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 1986

6

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 1992

7

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 1994

8

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 1994

9

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 1994

10

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 1994

11

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 2003

12

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The Herbal Medicines Advisory Committee Order 2005

13

In the Herbal Medicines Advisory Committee Order 2005⁹³, in article 2 (Herbal Medicines Advisory Committee), in paragraph (b), omit “Health”.

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

14

In the Medicines (Advisory Bodies) (No. 2) Regulations 2005⁹⁴, 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;

SCHEDULE 9 — OTHER CONSEQUENTIAL AMENDMENTS

PART 1 — Consequential amendments to primary legislation

The Pharmacy Act 1954

1

In subsection (1) of section 13I of the Pharmacy Act 1954⁹⁵ (effect of suspension of registration)—

• (a) in paragraph (b) omit “31, 33”;

• (b) at the end of paragraph (e) omit the word “and”; and

• (c) add at the end the following—

and (g) the Veterinary Medicines Regulations 2006.

The Trade Descriptions Act 1968

2

In subsection (5) of section 2 of the Trade Descriptions Act 1968⁹⁶ (trade description) add at the end the following—

(c) where any description of a veterinary medicinal product is required to be applied to the product by an authorisation for the product granted under the Veterinary Medicines Regulations 2006, that description, when applied to the product, shall be deemed not to be a trade description.

The Poisons Act 1972

3

After subsection (1)(a) of section 11 of the Poisons Act 1972⁹⁷ (interpretation) add—

(aa) a veterinary medicinal product as defined by regulation 2 of the Veterinary Medicines Regulations 2006, nor

The City of London (Various Powers) Act 1977

4

Section 23 of the City of London (Various Powers) Act 1977⁹⁸ (animal feeding stuffs) shall cease to have effect.

The Sporting Events (Control of Alcohol etc.) Act 1985

5

In subsection (3) of section 2 of the Sporting Events (Control of Alcohol etc.) Act 1985⁹⁹ (offences in connection with alcohol, containers, etc. at sports grounds) after “(within the meaning of the Medicines Act 1968)” add “or any veterinary medicinal product (within the meaning of the Veterinary Medicines Regulations 2006)”.

The Animals (Scientific Procedures) Act 1986

6

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The Consumer Protection Act 1987

7

In subsection (1) of section 19 of the Consumer Protection Act 1987¹⁰⁰(interpretation of Part II) in the definition of “licensed medicinal product”—

• (a) at the end of paragraph (a) omit the word “or”; and

• (b) at the end of paragraph (b) add—

or (c) a veterinary medicinal product that has a marketing authorisation under the Veterinary Medicines Regulations 2006.

The Environmental Protection Act 1990

8

In subsection (7) of section 142 of the Environmental Protection Act 1990¹⁰¹ (powers to obtain information about potentially hazardous substances)—

• (a) omit the word “and” where it appears after the words “Part III of the Food and Environment Protection Act 1985;”; and

• (b) after the words “the Food Safety Act 1990;” add—

the Veterinary Medicines Regulations 2006;

The Sunday Trading Act 1994

9

In Schedule 1 to the Sunday Trading Act 1994¹⁰² (restrictions on Sunday opening of large shops)—

• (a) in paragraph 1 after the definition of “stand” add—

• “veterinary medicinal product” has the same meaning as in regulation 2 of the Veterinary Medicines Regulations 2006.

; and

• (b) in paragraph 3(1)(d)(ii) after the words “medicinal products” add the words “, veterinary medicinal products”.

The Value Added Tax Act 1994

10

In Group 15 in Part II of Schedule 8 to the Value Added Tax Act 1994¹⁰³ (zero rating)—

• (a) in item 9 insert the words “or veterinary medicinal product” after the words “medicinal product”; and

• (b) in Note (11)—

• (i) omit the words “or animals” (in both places) from the definition of “medicinal product”; and

• (ii) after paragraph (c) add—

(d) “veterinary medicinal product” has the meaning assigned to it by regulation 2 of the Veterinary Medicines Regulations 2006.

The Criminal Law (Consolidation) (Scotland) Act 1995

11

In subsection (8) of section 20 of the Criminal Law (Consolidation) (Scotland) Act 1995¹⁰⁴ (sporting events: controls)—

• (a) in the definition of “controlled container”, after “medicinal product” insert “or veterinary medicinal product”; and

• (b) after the definitions of “medicinal product” and “medicinal purpose” insert—

“veterinary medicinal product” has the meaning assigned to that term by regulation 2 of the Veterinary Medicines Regulations 2006.

The Food Standards Act 1999

12

For subsection (2) of section 29 of the Food Standards Act 1999¹⁰⁵ (consultation on veterinary products) substitute—

(2) In this section “veterinary products” means— (a) veterinary medicinal products as defined in regulation 2 of the Veterinary Medicines Regulations 2006; or (b) specified feed additives as defined in paragraph 1 of Schedule 5 to those Regulations.

The Licensing Act 2003

13

In section 191 of the Licensing Act 2003¹⁰⁶ (meaning of “alcohol”)—

• (a) at the end of subsection (1)(e) add “or a veterinary medicinal product”; and

• (b) at the end of subsection (2) add—

“veterinary medicinal product” has the same meaning as in regulation 2 of the Veterinary Medicines Regulations 2006

PART 2 — Consequential revocations of and amendments to secondary legislation

Revocations

1

The following are revoked—

• (a) the Medicines (Veterinary Drugs) (Renewal Applications for Licences and Animal Test Certificates) Regulations 1994¹⁰⁷;

• (b) the Medicines (Animal Feeding Stuffs) (Enforcement) Regulations 1985¹⁰⁸;

• (c) the Medicines (Feeding Stuffs Limits on Variation) Order 1976¹⁰⁹.

Importation of Animal Pathogens Order 1980

2

In article 5 of the Importation of Animal Pathogens Order 1980¹¹⁰ after the words “section 7 of the Medicines Act 1968 or section 32 of that Act” add “or in accordance with the Veterinary Medicines Regulations 2006”.

The Warble Fly (England and Wales) Order 1982

3

In article 2 of the Warble Fly (England and Wales) Order 1982¹¹¹ for the definition of “dressing” substitute—

• “dressing” means a product that has a marketing authorisation under the Veterinary Medicines Regulations 2006 permitting its sale and supply for systemic use to kill the warble fly;

The Environmental Protection (Prescribed Processes and Substances) Regulations 1991

4

In Section 4.8 of Schedule 1 to the Environmental Protection (Prescribed Processes and Substances) Regulations 1991¹¹² after the words “one of the ways specified in section 130(1) of the Medicines Act 1968” add “any veterinary medicinal product to which the Veterinary Medicines Regulations 2006 apply”.

The Products of Animal Origin (Import and Export) Regulations 1996

5

• (1) The Products of Animal Origin (Import and Export) Regulations 1996¹¹³ are amended in accordance with this paragraph.

• (2) In regulation 11(1) for the words “a licence issued under section 8 of the Medicines Act 1968” substitute “a manufacturer’s authorisation granted under the Veterinary Medicines Regulations 2006”.

• (3) In regulation 12(1) for the words “licence issued under section 8 of the Medicines Act 1968” substitute “manufacturer’s authorisation granted under the Veterinary Medicines Regulations 2006”.

Signed

Ben Bradshaw — Parliamentary Under-Secretary of State, — Department for Environment, Food and Rural Affairs — 8th August 2006

Kevin Brennan — Claire Ward — Two of the Lords Commissioners of Her Majesty’s Treasury — 5th September 2006

Explanatory note

(This note is not part of the Regulations)

These Regulations revoke and remake with amendments the Veterinary Medicines Regulations 2005. They also amend the Medicines Act 1968, the Medicines Act 1971 and associated legislation so that they no longer apply to veterinary medicinal products.

Principal changes to the 2005 Regulations The principal changes to the 2005 Regulations are as follows. The Regulations re-introduce requirements for recording specific batches of veterinary medicinal products administered to food-producing animals (regulations 18 and 19). They introduce provisions for the approval of a manufacturer of a veterinary medicine for administration under the cascade (Part 4 of Schedule 2). They clarify the existing regulations in respect of retail supply by veterinary surgeons, pharmacists and suitably qualified persons (Part 1 of Schedule 3). They re-introduce requirements in respect of labelling veterinary medicinal products at the time of retail supply to avoid essential safety warnings and other information being obscured (Schedule 3 paragraph 11). They extend the requirement to hold a Certificate of Competence from those purchasing a product to those who are engaged in dipping sheep (Part 3 of Schedule 3). They introduce a provision that the incorporation of veterinary medicinal products into feed for animals for domestic consumption or non-food animals no longer requires approval (Schedule 5 paragraph 6). They change the way that fees are charged for a marketing authorisation to reflect more accurately the work involved in any individual application (Schedule 7).

The Regulations The Regulations make provision for the authorisation, manufacture, classification, distribution and administration of veterinary medicinal products. They implement Directive 2001/82/EC of the European Parliament and of the Council on the Community Code relating to veterinary medicinal products (OJ No. L311, 28.11.2001, p. 1), as amended by Directive 2004/28/EC (OJ No. L136, 30.4.2004, p. 58). They also identify the competent authority for, and provide for enforcement of, Regulations (EC) No. 178/2002 (OJ No. L31, 1.2.2002, p. 1), (EC) No. 1831/2003 (OJ No. L268, 18.10.2003, p. 29), (EC) No. 882/2004 (corrected version at OJ No. L191, 28.5.2004, p. 1) and (EC) No. 183/2005 (OJ No. L35, 8.2.2005, p. 1), in so far as they apply to veterinary medicinal products used in feedingstuffs, and to the following additives used in feedingstuffs: a coccidiostats; b histomonostats; c all other zootechnical additives except— i digestibility enhancers; ii gut flora stabilisers; and iii substances incorporated with the intention of favourably affecting the environment. In addition they implement Council Directive 90/167 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community (OJ No. L92, 7.4.90, p. 42) so far as they are not rendered spent by Regulation (EC) No. 183/2005. They provide that a veterinary medicinal product must have a marketing authorisation granted by the Secretary of State before being placed on the market, and make provision for the grant of a marketing authorisation (regulation 4 and Schedule 1). They specify that a veterinary medicinal product must be manufactured by a person holding a manufacturing authorisation, and make provision for granting an authorisation (regulation 5 and Schedule 2). They regulate supply and possession of veterinary medicinal products, and introduce new classifications of those products (regulation 7 and Schedule 3). They provide that a veterinary medicinal product may only be administered as specified in its marketing authorisation or, in the case of administration by a veterinary surgeon, administration under the “cascade” (regulation 8 and Schedule 4). They control bringing a veterinary medicinal product into the United Kingdom (regulation 9) and advertising (regulation 10 to 12). They control wholesale dealing (regulation 13). They control medicated feedingstuffs and feedingstuffs containing additives specified in the Regulations (regulation 14 and Schedule 5). They provide for exemptions (regulation 15 and Schedule 6). They provide for fees (regulation 16 and Schedule 7). They require records to be kept (regulations 17 to 24). They create offences of importation, possession and supply of unauthorised veterinary medicinal products (regulations 25 to 27). They make provision for the existence of the Veterinary Products Committee (regulation 28). They make provision for a representations procedure in the case of a refusal, etc., of a marketing authorisation (regulation 29). They create administrative arrangements for the enforcement of the Regulations (regulations 32 to 41). Under regulation 42 breach of the Regulations is an offence punishable— a on summary conviction, to a fine not exceeding the statutory maximum or to imprisonment for a term not exceeding three months or both, or b on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or both. A Regulatory Impact Assessment has been prepared and placed in the libraries of both Houses of Parliament. It is available, together with a transposition note and a table showing fee changes, on www.vmd.gov.uk at “Publications, Veterinary Medicines Regulations and Guidance, new legislative developments”.

Footnotes

Editorial notes