The Veterinary Medicines Regulations 2013

• (iii) a blood product for administration to non-food animals.

Payment of fees

2

All fees under this Schedule are payable to the Secretary of State.

Time of payment

3

All fees are payable on invoice unless otherwise specified.

Multiple inspections

4

If a site, premises or establishment is inspected for more than one type of authorisation , approval or registration at the same time, and in relation to the same legal entity, the fee is the sum of—

• (a) the highest fee payable; and

• (b) 50% of each of the other fees.

Expenses for inspections outside the United Kingdom

5

Whenever premises outside the United Kingdom are inspected, the travel and subsistence costs of the inspectors and interpreters’ fees are payable in addition to the inspection fee specified.

Translation

6

All translation costs are charged additionally.

PART 2 — Fees relating to marketing authorisations

Specified pharmaceutical applications

7

The following table sets out the fees relating to a pharmaceutical , immunological or biological that is not immunological veterinary medicinal product for—

• (a) an application for a marketing authorisation that is—

• (i) a full application under Part 1 of Schedule 1; or

• (ii) a bibliographic application for a pharmaceutical veterinary medicinal product; ...

• (iii) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Application	Fee (£) per authorisation
Base fee	27,995
Fee for 1st additional strength	4,590
Fee for each subsequent additional strength	1,465

Decentralised pharmaceutical application where the United Kingdom is the reference member State

8

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

Application for a marketing authorisation for an immunological or biosimilar product

9

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

Decentralised immunological application where the United Kingdom is the reference member State

10

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

Applications for a marketing authorisation using data already assessed

11

The fee for applications for marketing authorisations using identical data submitted simultaneously or on the basis of information provided under paragraph 9 of Schedule 1 is as follows—

Application	Fee (£) per authorisation
Application	1,465

Application for an exceptional marketing authorisation (pharmaceutical)

12

The fee for an application for an exceptional marketing authorisation for a pharmaceutical product is in accordance with the following table.

Application	Application	Provisional (£)	Limited (£)
Base Fee:	Base Fee:	12,015	6,765
The following fees are in addition to the base fee—	The following fees are in addition to the base fee—
Additional fee if any of the target species is a food-producing animal:	Additional fee if any of the target species is a food-producing animal:	3,905	1,952
Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom—	Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom—
	food-producing animal:	5,850	3,732
	non-food-producing animal:	4,910	3,262
Additional fee for each additional pack type:	Additional fee for each additional pack type:	710	370
Additional fee for each additional active ingredient (food-producing animal):	Additional fee for each additional active ingredient (food-producing animal):	5,955	3,232
Additional fee for each additional active ingredient (non-food-producing animal):	Additional fee for each additional active ingredient (non-food-producing animal):	3,800	2,155
Additional fee if there is more than one target species, for each additional species (food-producing animal):	Additional fee if there is more than one target species, for each additional species (food-producing animal):	2,965	1,985
Additional fee if there is more than one target species, for each additional species (non-food-producing animal):	Additional fee if there is more than one target species, for each additional species (non-food-producing animal):	1,485	1,247
Additional fee for each additional recommended route of administration (food-producing animal):	Additional fee for each additional recommended route of administration (food-producing animal):	2,185	1,347
Additional fee for each additional recommended route of administration (non-food-producing animal):	Additional fee for each additional recommended route of administration (non-food-producing animal):	710	608
Simultaneous applications— fee for each additional product in the application:	Simultaneous applications— fee for each additional product in the application:	2,895	1,447

Fees for an application for an exceptional marketing authorisation (immunological)

13

The fee for an application for an exceptional marketing authorisation for an immunological product or a biological veterinary medicinal product that is not immunological is in accordance with the following table.

Application	Provisional (£)	Limited (£)
Base fee:	10,810	5,887
The following fees are in addition to the base fee—
Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom, and for each new combination of active ingredients:	5,650	3,702
Additional fee for each adjuvant or preservative not previously included in a veterinary medicinal product authorised in the United Kingdom and for each new combination of adjuvants or preservatives:	1,350	672
More than one antigenic component – fee for each additional component:	1,190	675
More than one species – fee for each additional species:	4,060	2,690
More than one route of administration – fee for each additional route of administration:	4,060	2,690
Simultaneous application - fee for each additional product in the application:	2,895	1,447

Fee for the conversion from an exceptional to a full marketing authorisation

14

The fee for the conversion of an exceptional marketing authorisation to a full marketing authorisation is £3,000.

Application for a marketing authorisation relating to a parallel import

15

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

Application to change the distribution category of a product authorised through the centralised procedure

16

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

Application for a variation to a marketing authorisation ....

17

• (1) This paragraph applies in relation to an application for a variation to one or more marketing authorisations except where paragraph ... 21 applies.

• (2) The fees for the variations to which this paragraph applies are set out in the following table.

• (3) Where applications are made at the same time seeking an identical change to the terms of more than one marketing authorisation, and those applications are based on identical data, fees are payable as for a grouped variation.

• (4) References in this paragraph to a grouped variation being “led” by a particular type of variation indicate that the principal variation in that group is a variation of that type.

Type of variations	Type of variations	Type of variations	Fee (£)
Single variations; one change for each product	Single variations; one change for each product	Single variations; one change for each product	Single variations; one change for each product
Variation – standard	Variation – standard	Variation – standard	2,895
	Unless the variation is—	Unless the variation is—
	(a) a change of route of administration, or the addition of a new one, of—	(a) a change of route of administration, or the addition of a new one, of—
	(i)	an immunological product, or a pharmaceutical product for a non-food-producing animal	5,390
	(ii)	a pharmaceutical product for a food-producing animal	7,135
	(b) a change of bioavailability	(b) a change of bioavailability	8,415
	(c) a change of active substance, where the change is to—	(c) a change of active substance, where the change is to—
	(i)	use a different biologically active substance with a slightly different molecular structure	8,415
	(ii)	modify the vector used to produce the antigen or the source material, including a new master cell bank from a different source	8,415
	(d) a change of pharmacokinetics	(d) a change of pharmacokinetics	8,415
	Simultaneous application falling within (a) to (d): fee for each additional product in the application	Simultaneous application falling within (a) to (d): fee for each additional product in the application	1,465
Variation – reduced	Variation – reduced	Variation – reduced	885
Variation - no assessment	Variation - no assessment	Variation - no assessment	455
Grouped variations	Grouped variations	Grouped variations
Variation – standard led	Variation – standard led	Variation – standard led
	For the first nine changes	For the first nine changes	6,280
	For each subsequent group of five or fewer changes	For each subsequent group of five or fewer changes	2,250
Variation – reduced led:	Variation – reduced led:	Variation – reduced led:
	For the first nine changes	For the first nine changes	1,770
	For each subsequent group of five or fewer changes	For each subsequent group of five or fewer changes	2,250

Application for a variation to a marketing authorisation dealt with under worksharing procedures

18

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

Application for an extension dealt with under the decentralised procedure where the United Kingdom is the reference member State

19

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

Provision of information relating to the recognition of a United Kingdom marketing authorisation or an extension

20

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

Exception for a variation relating to animal testing

21

If the only purpose of a variation is to remove animal testing or to reduce the numbers of animals used in testing, no fee is payable for the variation ....

Application for the renewal of a national marketing authorisation

22

• (1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (2) The fee for the first reassessment of an exceptional marketing authorisation is £305, and the fee for each subsequent reassessment is £1,360.

Application for the renewal of a marketing authorisation obtained through mutual recognition or the decentralised procedure

23

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

Registration of a homeopathic remedy

24

The fee for an application for the registration of a homeopathic remedy is in accordance with the following table.

Type of application	Type of application	Fees(£)
If all stocks and the formulation have already been assessed by the Secretary of State—	If all stocks and the formulation have already been assessed by the Secretary of State—
	not more than five stocks:	160
	more than five stocks:	375
If either all the stocks have already been assessed by the Secretary of State but there is a new formulation, or if the formulation has already been assessed by the Secretary of State but one or more of the stocks have not been already assessed—	If either all the stocks have already been assessed by the Secretary of State but there is a new formulation, or if the formulation has already been assessed by the Secretary of State but one or more of the stocks have not been already assessed—
	not more than five stocks:	455
	more than five stocks:	665
If the formulation and at least one of the stocks has not already been assessed by the Secretary of State—	If the formulation and at least one of the stocks has not already been assessed by the Secretary of State—
	not more than five stocks:	760
	more than five stocks:	985
If the product is already authorised for human use in the United Kingdom, or for human or veterinary use in the United Kingdom ...—	If the product is already authorised for human use in the United Kingdom, or for human or veterinary use in the United Kingdom ...—
	not more than five stocks:	160
	more than five stocks:	375

Renewal of a homeopathic remedy

25

The fee for the renewal of a homeopathic remedy is £320.

Annual fees for marketing authorisations

26

• (1) Within 30 days of receiving a written demand from the Secretary of State, a holder of a marketing authorisation must provide the Secretary of State with a statement of turnover for the previous calendar year.

• (2) The annual fee, rounded to the next £1, is—

$$£0.67T100+£230n$where—Tis the annual turnover in the previous calendar year;and n is the number of active marketing authorisations held at any time during the previous calendar year.$

• (3) In the case of an authorisation holder with a turnover relating to all marketing authorisations held of less than £230,000, the annual fee, rounded to the next £1 is—

$$£0.67T100+£200n$where—Tis the annual turnover in the previous calendar year;and n is the number of active marketing authorisations held at any time during the previous calendar year.$

• (4) In this paragraph—

• “turnover” means the sales value at manufacturers’ prices of all authorised veterinary medicinal products sold or supplied in the United Kingdom;

• “manufacturers’ prices” means the prices charged (excluding value added tax) for authorised products by manufacturers to wholesalers, except to the extent that—the products are supplied by manufacturers direct to retailers, in which case it means the prices charged for the products by the manufacturers to the retailers reduced by such sum as, in the opinion of the Secretary of State, represents the difference between the prices paid by the retailers and those which could be expected to be charged by the manufacturers to wholesalers according to the practice prevailing during the period in question with regard to such products;a marketing authorisation holder sells or supplies products that the marketing authorisation holder has neither manufactured nor obtained from the manufacturer, in which case it means the prices paid by the marketing authorisation holder for those products.

Auditor’s certificate

27

• (1) The Secretary of State may at any time require an audit certificate in support of a statement of turnover.

• (2) If the holder of the marketing authorisation does not provide an audit certificate before the date stipulated in the demand, an additional fee is payable for that year of £11,300 plus an additional £2,245 in respect of each marketing authorisation held.

• (3) If the Secretary of State is not satisfied that the audit certificate provides sufficient assurance that the figures fairly present the financial records of the company, the Secretary of State may require the marketing authorisation holder to produce a further certificate and specify what further assurances are needed; and if these are not provided by the required date, the additional fee specified in sub-paragraph (2) is payable.

• (4) Nothing in this paragraph limits the powers of an inspector to examine financial records.

PART 3 — Fees payable by manufacturers

Application for a manufacturing authorisation

28

• (1) The fee for an application for a manufacturing authorisation for a veterinary medicinal product is £762

• (2) Fees relating to an application for a manufacturing authorisation are payable with the application.

Application for a variation of a manufacturing authorisation

29

The fee for an application for the variation of a manufacturing authorisation is—

• (a) £684 if the variation requires scientific or pharmaceutical assessment;

• (b) £105 if the variation only involves an administrative variation such as a change of ownership.”;

• (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Application for an authorisation to manufacture an autogenous vaccine or a product for administration under the cascade

30

• (1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (2) The fees for the inspection of sites in connection with an authorisation (or an application for authorisation) for the manufacture of unauthorised veterinary medicinal products for administration under the cascade are set out in the following table—

Type of site	Fee (£)	Fee (£)
	United Kingdom site	Site outside the United Kingdom
Super site	21,416	22,710
Major site	12,850	14,144
Standard site	6,425	7,719
Minor site	4,283	5,577

• (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annual fees

31

An annual fee of £575 is payable in respect of each manufacturing authorisation held.

Site inspections – type of site

32

For the purposes of deciding the fee for a site inspection—

• “super site” is a site at which 250 or more relevant persons are employed;

• “major site” is a site at which 60 or more, but fewer than 250, relevant persons are employed;

• “standard site” is a site at which 10 or more, but fewer than 60 relevant persons are employed;

• “minor site” is a site at which fewer than 10 relevant persons are employed;

• “relevant person” means a person employed on the premises and systems inspected.

Inspection of a site where immunological veterinary medicinal products are manufactured

33

The fees for the inspection of a site where immunological veterinary medicinal products are manufactured are in accordance with the following table.

Type of site	Fee (£)	Fee (£)
	United Kingdom site	Site outside the United Kingdom
Super site	32,124	33,418
Major site	21,416	22,710
Standard site	10,708	12,002
Minor site	6,425	7,719

Inspection of a site where sterile veterinary medicinal products are manufactured

34

The following fees are payable for the inspection of a site where no immunological veterinary medicinal products are manufactured, but where sterile products are manufactured.

Type of site	Fee (£)	Fee (£)
	United Kingdom site	Site outside the United Kingdom
Super site	27,841	29,135
Major site	19,274	20,569
Standard site	10,708	12,002
Minor site	6,425	7,719

Inspection of a site where no immunological or sterile veterinary medicinal products are manufactured

35

The following fees are payable for the inspection of a site where only non-immunological and non-sterile veterinary medicinal products are manufactured—

Type of site	Type of site	Fee (£)	Fee (£)
		United Kingdom site	Site outside the United Kingdom
Super site	Super site	21,416	22,710
Major site	Major site	12,850	14,144
Standard site	Standard site	8,566	9,861
Minor site	Minor site	4,283	5,577
If the site is only involved in the manufacture of veterinary medicinal products authorised under Schedule 6 (exemptions for small pet animals)—	If the site is only involved in the manufacture of veterinary medicinal products authorised under Schedule 6 (exemptions for small pet animals)—
	Standard site	3,212	4,507
	Minor site	2,142	3,436

Inspection of a site where veterinary medicinal products are assembled

36

The following fees are payable for the inspection of a site where the only manufacturing process in relation to veterinary medicinal products is their assembly after the product has been put into its immediate container.

Type of site	Fee (£)	Fee (£)
	United Kingdom site	Site outside the United Kingdom
Super site	17,133	18,427
Major site	10,708	12,002
Standard site	6,425	7,719
Minor site	4,283	5,577

Test sites

37

The fee for the inspection of a test site is £3,212, or £4,507 for a site outside the United Kingdom.

Animal blood bank or equine stem cell centre authorisations

38

• (1) The fee for the inspection of a blood bank is—

• (a) £3,212 for a site in the United Kingdom; and

• (b) £4,507 for a site outside the United Kingdom.

• (2) The fee for the inspection of a non-food animal stem cell centre is—

• (a) £2,142 for a site in the United Kingdom; and

• (b) £3,436 for a site outside the United Kingdom

PART 4 — Fees relating to a wholesale dealer’s authorisation

Application for a wholesale dealer’s authorisation

39

• (1) The fee for an application for a wholesale dealer’s authorisation is £344.

• (2) Fees relating to an application for a wholesale dealer’s authorisation are payable with the application.

Variation of a wholesale dealer’s authorisation

40

The fee for an application to vary a wholesale dealer’s authorisation is—

• (a) £265 if the variation requires scientific or pharmaceutical assessment;

• (b) £105 for a change of ownership or other administrative variation.

Annual fee for a wholesale dealer’s authorisation

41

The annual fee for a wholesale dealer’s authorisation is £427.

Inspection of a wholesale dealer’s premises

42

The fee for inspection of a wholesale dealer’s site is—

• (a) £1,177; or

• (b) £877 if—

• (i) the authorisation only relates to products classified as AVM-GSL or homeopathic remedies; or

• (ii) the authorisation only relates to products marketed under Schedule 6 (exemptions for small pet animals).

PART 5 — Fees relating to feedingstuffs

Fees for approvals and annual fees relating to feedingstuffs in Great Britain

43

• (1) Subject to sub-paragraph (3) the fee for the application for authorisation of premises manufacturing feedingstuffs and authorisation of distributors of feedingstuffs in Great Britain is £105.

• (2) An annual fee of £122 is payable in respect of any such authorisation.

• (3) No fee is payable under sub-paragraph (1) in respect of premises where specified feed additives are manufactured if a medicinal premix is manufactured at those premises in accordance with a manufacturing authorisation.

• (4) Fees relating to feedingstuffs are payable with the application ....

• (5) Where more than one manufacturing activity is carried out at one premises by the same legal entity only one fee (the highest) is payable.

Inspection fees relating to feedingstuffs in Great Britain

44

Fees for the inspection of premises manufacturing or distributing feedingstuffs in Great Britain are in accordance with the following table.

Type of premises inspected	Fee payable (£)
Manufacturer of a specified feed additive (SFA)	1,610
Manufacturer of an intermediate feedingstuff (including balancers) containing a medicinal premix or an SFA	976
Manufacturer of a feedingstuff for sale containing—a medicinal premix and/or an SFA, and/oran intermediate feedingstuff containing a medicinal premix or an SFA	841
Manufacturer of a feedingstuff for feeding to their own animals only, containing—a medicinal premix and/or an SFA incorporated at a rate of at least 2kg/t, and/oran intermediate feedingstuff containing a medicinal premix and/or an SFA incorporated at a rate of at least 2kg/t	476
Distributor or trader of Schedule 5 products(A distributor of specified feed additives, or intermediate feedingstuffs containing specified feed additives or medicinal premixes; or feedingstuffs containing a medicinal premix)	350

Fees payable in relation to feedingstuffs in Northern Ireland

45

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

Fees relating to premises for supply by suitably qualified persons

46

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

• (a) £105; ...

• (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (1A) The fees for the inspection of sites authorised for the retail supply of veterinary medicinal products by suitably qualified persons are set out in the following table—

Type of sites inspected	Fee payable (£)
Sites authorised to supply companion animal medicines	285
Sites authorised to supply equine medicines	285
Sites authorised to supply livestock medicines	338
Sites authorised to supply avian medicines	285.

• (1B) Where a site is inspected in relation to a single authorisation, and falls within more than one of the categories in the table, only one fee (the highest) is payable.

• (2) The subsequent annual fee is—

• (a) £57; ...

• (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (3) The application fee for authorisation of sites for supply is payable with the application.

PART 6 — General

Testing samples

47

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

48

• (1) The fee for an animal test certificate is £1,170.

• (2) The fee for an animal test certificate to administer medicinal products in a small scale trial to test them for clinical safety or efficacy is £40.

• (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (4) The fee for an application for the variation of the certificate is—

• (a) in the case of a small scale trial, £40; and

• (b) in the case of any other trial, £390.

• (5) The fee for an application to renew a certificate is—

• (a) in the case of a small scale trial, £40; and

• (b) in the case of any other trial, £190.

• (6) The Secretary of State may waive the fee if satisfied that the application is in relation to developing a veterinary medicinal product for a limited market (for example, for a minor species, a minor use, or for a disease with restricted regional distribution).

Importation of a veterinary medicinal product for treatment under the cascade

49

• (1) The fee for a certificate to import (if necessary) and be in possession of and administer a veterinary medicinal product under the cascade is—

• (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (b) £30 if the veterinary medicinal product is authorised in another country.

• (2) The fee is payable in respect of each animal treated, but 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.

• (3) There is no fee if the application is made using the website of the Veterinary Medicines Directorate.

Wholesale dealer’s import certificate

50

• (1) The fee payable by the holder of a wholesale dealer’s authorisation for a certificate to import and store a veterinary medicinal product not authorised in the United Kingdom to enable it to be supplied for administration under Schedule 4 is £760 .

• (2) The fee is only payable if, in the twelve month period immediately before the application, the applicant has supplied the veterinary medicinal product to which the certificate relates in accordance with at least 100 certificates.

Specific batch control

51

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

• (a) £560; and

• (b) £100 for each additional batch affected by the same issue where the specific batch control application is made at the same time.

Submission of control tests of an immunological product

52

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

Export certificates

53

The fee for an application for an export certificate is £54 ....

Provision of advice

54

The fee for an application for written advice from the Secretary of State as to whether or not a product requires a marketing authorisation is £885.

Appeals to the Veterinary Products Committee

55

The fee for an appeal to the Veterinary Products Committee is £1,500.

Fee relating to an appointed person

56

The appellant is liable for the full economic cost of a referral to an appointed person subject to a maximum of £5,000.

Fees relating to a veterinary surgeon’s practice premises

57

• (1) The fees for the inspection of a veterinary practice premises are set out in the following table—

Type of premises inspected	Fee payable (£)
Sites registered to supply companion animal medicines	536
Sites registered to supply equine medicines	536
Sites registered to supply livestock medicines	536
Mixed practice premises	698
Any other type of practice	451

• (2) The initial registration and annual fee for the registration of veterinary practice premises with the Royal College of Veterinary Surgeons to supply veterinary medicinal products is £38.

• (3) Notwithstanding paragraph 2 of this Schedule, this is payable to the Royal College of Veterinary Surgeons.

• (4) For the purposes of sub-paragraph (1) “mixed practice” means premises supplying veterinary medicinal products to livestock in addition to any other category mentioned in that provision.

Refund of fees relating to the Veterinary Products Committee or appointed persons

58

The Secretary of State must refund the fee payable in relation to an appeal to the Veterinary Products Committee or to an appointed person if, as a result of the appeal, the Secretary of State changes the decision that was the subject of the appeal.

Fees relating to an improvement notice

59

If an improvement notice is served under these Regulations, the fee for any subsequent inspection necessary as a result of the notice is the full economic cost of the inspection, payable by the person on whom the notice was served.

Non-payment of fees

60

Where any fee (other than any fee relating to a manufacturing authorisation or wholesale dealer’s authorisation) is not paid, the Secretary of State may, after giving one month’s written warning, suspend the processing of any application from the person or any authorisation held by the person who has not paid the fee.

Waiver or reduction of fees

61

• (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 the Secretary of State may waive or reduce any fees payable under these Regulations.

• (1A) If the Secretary of State is satisfied that exceptional circumstances exist the Secretary of State may waive or reduce an inspection fee 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 fees when an application is withdrawn

62

• (1) Where an application for a marketing authorisation, or any variation referred to in paragraph 17 or 18 as a Type II variation, an extension, an extension-led grouped variation or a Type II led grouped variation is withdrawn before determination, the fee is reduced in accordance with this paragraph.

• (2) If no assessment (veterinary, scientific or pharmaceutical) has begun, the reduction is 90%.

• (3) If assessment has begun but the Secretary of State has not yet requested further data, the reduction is 50%.

• (4) If the Secretary of State has requested further information but it has not yet been provided, the reduction is 25%.

• (5) If the further information requested has been supplied but has not yet been fully assessed or the application has not been referred to the Veterinary Products Committee, the reduction is 10%

• (6) Once the further information has been fully assessed, or the application has been referred to the Veterinary Products Committee, there is no reduction.

Signed

David Heath — Minister of State for Agriculture and Food — Department for Environment, Food and Rural Affairs — 2013-07-17

We consent

Anne Milton — Mark Lancaster — Two of the Lords Commissioners of Her Majesty’s Treasury — 2013-08-06

Explanatory note

(This note is not part of the Regulations)

EXPLANATORY NOTE

These Regulations revoke and remake with amendments the Veterinary Medicines Regulations 2011 (S.I. 2011/2159).

Principal changes to the 2011 RegulationsThe major change to the Regulations is the adjustment of the fees with a view to achieving full cost recovery while avoiding cross-subsidy of one activity by another.In Great Britain food businesses will pay a much lower fee on application for approval but will pay a larger fee for any inspection. Premises will be selected for inspection on the basis of risk analysis.The fees for appeals to the Veterinary Products Committee are simplified.Criminal offences have also been amended. Instead of creating an individual offence in relation to every obligation there is now a single offence governing all relevant obligations in the body of the Regulations and a single offence in each of Schedules 1 to 5.

Other changesRegulation 35 extends inspectors’ power of seizure to cover anything they reasonably believe to be, or which purports to be, a veterinary medicine.Veterinary practice premises must be registered with the Royal College of Veterinary Surgeons and paragraph 8 of Schedule 3 gives the Secretary of State a power to require the removal of premises from this register where they fail to meet the necessary standard.

The RegulationsThe Regulations make provision for the authorisation, manufacture, classification, distribution and administration of veterinary medicinal products.They implement the following EU instruments that are Directives: a Council Directive 90/167/EEC laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community, so far it is not superseded by Regulation (EC) No 183/2005; b Commission Directive 91/412/EEC laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products; and c Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products. They provide for the enforcement of the following EU instruments that are Regulations besides that mentioned above: d Regulation (EC) No 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ No L 31, 1.2.2002 p. 1), in so far as it applies to veterinary medicinal products used in feedingstuffs e Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition (OJ No L 268, 18.10.2003 p. 29), in so far as it applies to veterinary medicinal products used in feedingstuffs; f Regulation (EC) No 882/2004 of the European Parliament and of the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ NO L 191, 28.5.2004, p.1), in so far as it applies to veterinary medicinal products used in feedingstuffs; g Regulation (EC) No 183/2005 of the European Parliament and of the Council laying down requirements for feed hygiene (OJ No L 35, 8.2.2005, p. 1), in so far as it applies to veterinary medicinal products used in feedingstuffs; and h Regulation (EC) No 470/2009 of the European Parliament and of the Council, laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin (OJ No L152, 16.6.2009, p. 11). 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 they 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 the 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 rules of 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 and Schedule 3).They control medicated feedingstuffs and feedingstuffs containing additives specified in the Regulations (regulation 14 and Schedule 5).They provide for exemptions (regulation 15 and Schedule6).They provide for fees (regulation 16 and Schedule 7).They require records to be kept (regulations 17 to 24).They create an offence of importation, possession or supply of unauthorised veterinary medicinal products (regulation 43(q) to (s)).They make provision for the existence of the Veterinary Products Committee (regulation 28). They make provision for an appeals procedure in the case of a refusal, etc., of a marketing authorisation (regulation 30).They create administrative arrangements for the enforcement of the Regulations (regulations 32 to 36 and 38 to 42) and create offences of obstructing a person acting in the execution of these Regulations (regulation 43(u)) and of failing to comply with an improvement notice (regulation 43(v)).Under regulation 44 breach of the Regulations is an offence punishable— i on summary conviction, by a fine not exceeding the statutory maximum or by imprisonment for a term not exceeding three months or both, or j on conviction on indictment, by a fine or to imprisonment for a term not exceeding two years or both. Regulation 46 requires the Secretary of State to review the operation and effect of these Regulations, other than regulation 16 and Schedule 7 (which relate to fees), and lay a report before Parliament within five years after they come into force and within every five years after that. Following a review it will fall to the Secretary of State to consider whether the Regulations should remain as they are, or be revoked or be amended. A further instrument would be needed to revoke the Regulations or to amend them.Regulation 47 revokes the Veterinary Medicines Regulations 2011.A full 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.defra.gov.uk at “Publications, Veterinary Medicines Regulations and Guidance”. It is also published with the Explanatory Memorandum alongside the instrument on www.legislation.gov.uk.

Footnotes

[^f00001]: S.I. 1999/2027.

[^f00002]: 1972 c. 68.

[^f00003]: OJ No L31, 1.2.2002, p. 1.

[^f00004]: 1973 c. 51.

[^f00005]: OJ No L136, 30.4.2004, p. 1.

[^f00006]: OJ No L334, 12.12.2008, p.7.

[^f00007]: OJ No L 15, 20.1.2010, p. 1.

[^f00008]: OJ No L 149, 7.6.2008, p. 3.

[^f00009]: OJ No L152, 16.6.2009, p. 11.

[^f00010]: OJ No L229, 1.9.2009, p. 1. Regulation (EC) No 767 2009 was last amended by Regulation (EC) 939/2010 (OJ No L277, 20.10. 2010, p. 4).

[^f00011]: 1986 c. 14.

[^f00012]: If the manufacture is carried out in the United Kingdom the manufacturer must hold a manufacturing authorisation for that type of product granted by the Secretary of State.

[^f00013]: For provisions on breaking open packages see regulation 7(3).

[^f00014]: Published by the World Health Organization at: www.who.int/medicines/en.

[^f00015]: 1981 c. 22.

[^f00016]: 1980 c. 43; sections 51 and 52 have been substituted by the Courts Act 2003 (c.39), section 47.

[^f00017]: Other offences are set out at the end of Schedules 1, 2, 3, 4 and 5.

[^f00022]: S.I. 1981/1675 (N.I. 26).

[^f00023]: OJ No L 92, 7.4.1990, p. 42.

[^f00024]: OJ No L 228, 17.8.1991, p. 70.

[^f00025]: OJ No L311, 28.11.2001, p. 1; last amended by Regulation (EC) No 596/2009 of the European Parliament and of the Council (OJ No L188, 18.7.2009, p. 14).

[^f00026]: OJ No L334, 12.12.2008, p. 7.

[^f00027]: OJ No L152, 16.6.2009, p. 11.

[^f00028]: OJ No L229, 1.9.2009, p. 1, last amended by Commission Regulation (EU) No 939/2010 (OJ L277, 21.10.2010, p. 14).

[^f00029]: OJ No L293, 11.11.2010, p.72; corrected at OJ L293, 11.11.2010, p. 72.

[^f00030]: S.I. 2011/2159.

[^f00031]: S.I. 2012/2711.

[^f00032]: OJ No L 211, 28.11.2001, p. 1 as last amended by Regulation (EC) No 470/2009 of the European Parliament and of the Council (OJ No L152, 16.6.2009, p. 11). Annex I was inserted by Commission Directive 2009/9/EC (OJ No L 44, 14.2.2009, p. 10).

[^f00033]: OJ No L334, 12.12.2008, p. 7.

[^f00034]: ISBN 9287145873.

[^f00035]: OJ No L 228, 17.8.91, p. 70.

[^f00036]: S. I. 2001/3998; relevant amending instruments are S. I. 2003/1432 and 2005/1653.

[^f00037]: Published at: http://www.vmd.defra.gov.uk/registers/sqpregister.aspx.

[^f00038]: OJ No C 63, 1.3.94, p. 4.

[^f00039]: The number of days of the withdrawal period is calculated by dividing 500 by the mean temperature of the water in degrees Celsius.

[^f00040]: OJ No L42, 13.2.2013, p. 1.

[^f00041]: Published at http://www.rcvs.org.uk/advice-and-guidance/code-of-professional-conduct-for-veterinary-surgeons/.

[^f00046]: OJ No L 92, 7.4.1990, p. 42.

[^f00047]: OJ No L 35, 8.2.2005, p. 1.

[^f00048]: OJ No L86, 6.4.1979, p. 30.

[^f00049]: OJ No L268, 18.10.2003, p. 29. Regulation (EC) no 1831/2003 was last amended by Article 29 of Regulation (EC) No 767/2009 (OJ No L229, 1.9.2009, p. 1.)

[^f00051]: OJ No L 92, 7.4.90, p. 42.

Editorial notes

[^key-006004e63878cf37320da58fc0a4eaac]: Words in Sch. 5 para. 3(1) substituted (26.3.2019) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(a), 2(4)(b)

[^key-00c898998258f304ef9a4e195e8aa975]: Words in Sch. 5 para. 21(1)(b) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 142(a)(iii)(bb)

[^key-019ed5e3cea368ce2d80da2a75aa2393]: Sch. 2 para. 13(2A) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 91(c)

[^key-025e45744118f913b5d3dc4414cc2444]: Sch. 1 para. 12(2)-(2B) substituted for Sch. 1 para. 12(2) (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 36(b)

[^key-029bb63609d994e19f5af1595402e038]: Sch. 3 para. 20(b) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 114

[^key-02be4331b2d0a69ae8fc440a566a27e7]: Words in reg. 2(2) inserted (26.3.2019) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(a), 2(2)(f)

[^key-036e5446ad7ad8a2eeeb433d6fad9abb]: Sch. 7 para. 9 omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 166

[^key-03ad9b1d300024a9099bf821e5f2f6fa]: Reg. 23(1)(1A) substituted for reg. 23(1) (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 14

[^key-03f2f1bfdd198927b7fc7a0c77f03f1f]: Word in Sch. 4 para. 6(1)(b) substituted (E.W.S.) (31.12.2020) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 3(34)(e)(ii)(bb) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-045bbc39dbd47c830e06b32fb504b0b9]: Words in Sch. 5 para. 26(3) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 148(d)

[^key-0515536ff826bc6fef261b6f02acec05]: Words in Sch. 7 para. 43(3) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 190(c)(iii)

[^key-051b69cfcc699ac7f29d88b27c41c6dc]: Word in Sch. 7 para. 7(a)(ii) omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 164(b)(ii)(bb)

[^key-05330a83de42764dc87643c017ae2042]: Sum in Sch. 7 para. 43(2) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 190(b)(i)

[^key-0613e60b1be027527b56495bbef9c653]: Words in Sch. 3 para. 4(1) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 99

[^key-06367f1e376cbcb374806bb03648f09b]: Sch. 3 para. 21(e) and word inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 115(c)

[^key-064509559f4641f38c3ac3d89ac175c9]: Words in Sch. 3 para. 11(2) omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 105(c)(ii)

[^key-068a5794b90ffdf0be58d12c6952556d]: Words in Sch. 2 para. 9(1) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 89(a)

[^key-06b612896cc55d5adcadf771335f0b95]: Words in reg. 9(1) substituted (N.I.) (31.12.2020) by The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(4)

[^key-06e688206a9b5d5954e376b987afc0af]: Words in Sch. 4 para. 9(4) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 124(b)(i)

[^key-06fd0ce398a069551c589461d6274fd1]: Sch. 1 para. 10A inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 34

[^key-075a9bdcfb8060ccd35666b7bdd3a0c7]: Sch. 5 para. 31(w) omitted (E.W.S.) (31.12.2020) by virtue of The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 3(35)(e) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-076137bb887ac94892f52180c3c3c07d]: Words in reg. 25(6)(b)(iii) substituted (E.W.S.) (31.12.2020) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 4(4)(a)

[^key-0798d93eb53bff0231ccc92025a2776c]: Sch. 5 para. 31(pa) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 153(a)

[^key-07d43ac8fc3d2d893feaa744085bee8a]: Words in reg. 30(1) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 17(a)

[^key-080c46ddb56e7e89519968be73dec902]: Words in Sch. 7 para. 43(4) omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 190(d)

[^key-08c1ba4f52dc01954b0d8ec68d476b10]: Words in Sch. 3 para. 2(1) omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 96(a) (with reg. 202)

[^key-08c5175e28a76a703423512b15cbbb75]: Sch. 7 para. 35 Table substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 182

[^key-08cacd51f91c25dbf01dd1af5df3afa6]: Words in Sch. 5 para. 11(2) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 133(b)(iii)

[^key-08e589451a48527062aacf0821790c3b]: Sum in Sch. 7 para. 53 substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 194(a)

[^key-09ffb4bcb19bfb85a2a877953a3b1125]: Sch. 1 para. 25(4)(5) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 46(a)

[^key-0a0c493481b1b46282548ab683a14054]: Sch. 1 para. 14(4) omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 39

[^key-0a4e9f4ed2ede1ce11180ade8c70bc8a]: Word in Sch. 1 para. 43(1) substituted (N.I.) (31.12.2020) by The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(13)(h)(ii)(bb)

[^key-0aa252205e00f01151f81365f55b31c3]: Words in Sch. 1 para. 59(3) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 71(c)(iii)

[^key-0b54a2b84ecf979d18bd30bc1e64eff3]: Words in Sch. 5 para. 28(b) substituted (N.I.) (31.12.2020) by The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(15)(c)(iii)

[^key-0b73414b756409afce15fcb8212547bb]: Word in Sch. 4 para. 6 heading omitted (N.I.) (31.12.2020) by virtue of The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(14)(c)(i)

[^key-0c514cd3cacf258a248bafad257beaac]: Word in Sch. 1 para. 29(2) substituted (E.W.S.) (31.12.2020) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 3(22)(b) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-0c644780a70b04179877385671d9e740]: Word in Sch. 1 para. 16 substituted (N.I.) (31.12.2020) by The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(13)(e)

[^key-0d569e24513fd164e62fc036891822f1]: Words in Sch. 5 para. 18(3)(b) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 139(d)

[^key-0d8405957e91c2c4c77ff0c5fa1d77bc]: Sch. 1 para. 8(2) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 32(b)

[^key-0dfbc0ee4db9dba1a63a519f48fc02b1]: Words in Sch. 5 para. 19(1)(l) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 140(a)(vi)(bb) (with reg. 206)

[^key-0e13fe70b6bc8c4412faa80b12bec1cc]: Sch. 3 paras. 24(ba)-(be) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 118(a)

[^key-0f36a3bfcc47bf373c0f8bb5ecad5436]: Word in Sch. 1 para. 29(1)(b) substituted (N.I.) (31.12.2020) by The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(13)(f)(iii)

[^key-0fa83893f114bc73336c29a80197cf69]: Reg. 22(f) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 13(d)

[^key-100e7b25148470f79ed2587de5efe2ed]: Reg. 24A inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 15

[^key-112e76d345192c0f96b40b4f28d546cb]: Word in Sch. 4 para. 7(1) substituted (E.W.S.) (31.12.2020) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 3(34)(f) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-11f3e82a69daf31ca1153d335d8e75c4]: Words in Sch. 5 para. 21(2) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 142(b)(ii)

[^key-124ec87e061be00fcbf0216ccbbd6dc0]: Words in Sch. 5 para. 12(1) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 134(a)(i)(aa) (with reg. 205)

[^key-12cfb994341f3edaaa14ecc557e09927]: Words in Sch. 5 para. 21(2) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 142(b)(i)

[^key-13092d3e6898724c21e175f7527889ad]: Sch. 7 para. 30(2) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 177(b)

[^key-13335e3b557179161a8d3752a1d1f4d0]: Words in Sch. 5 para. 21(1)(a) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 142(a)(ii)

[^key-14752318db81425c308fd0d6ca79aff9]: Words in Sch. 5 para. 12(1)(f) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 134(a)(vii) (with reg. 205)

[^key-14c56c1181f6d32e1256a80db43d303a]: Word in Sch. 7 para. 43(3) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 190(c)(i)

[^key-154f896e91ea7608796c61e064a144de]: Sch. 3 para. 17 substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 110

[^key-1567bd559798584dea2a07ae5703344c]: Word in reg. 34(2)(a) substituted (E.W.S.) (31.12.2020) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 3(7)(a) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-15836ff0f4e203bb7c93e4eb5d31d335]: Words in Sch. 4 para. 9(1) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 124(a)

[^key-1597a9e13ceb28f08519118b4fdd2df9]: Sch. 1 para. 50 substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 63 (with reg. 200)

[^key-15ba93d2b1499cf4808bba587bcdcd5d]: Words in Sch. 1 para. 61(1) omitted (E.W.S.) (31.12.2020) by virtue of The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 3(29)(a) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-1601228fd3f1a3da4eb643aa92e52de0]: Sch. 2 para. 8(3)(3A) substituted for Sch. 2 para. 8(3) (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 87(b)

[^key-16022a9ddb7fd21cb967647d1ab83d04]: Sch. 5 para. 19(2A)(2B) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 140(c) (with reg. 206)

[^key-164bc08f35b005015635e0d2bc3898f2]: Sch. 1 para. 28(4) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 49(b)