Legalize / United Kingdom / Statutory-Instrument

The Veterinary Medicines Regulations 2013

Type Statutory-Instrument

Publication 2013-08-06

Last updated 2024-05-17

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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Reform history JSON API

(ba) paragraph 6A;

(d) paragraph 9A.

SCHEDULE 5 — Medicated feedingstuffs and specified feed additives

Scope and interpretation

1

(1) This Schedule applies in relation to the following (referred to in this Schedule as “specified feed additives”) when used as feed additives—

(a) coccidiostats;

(b) histomonostats; and

(i) digestibility enhancers;

(ii) gut flora stabilisers; and

(iii) substances incorporated with the intention of favourably affecting the environment.

(2) It also applies in relation to the manufacture and placing on the market of feedingstuffs containing a veterinary medicinal product.

(3) In this Schedule—

“animal keeper” means any natural or legal person responsible for animals, whether on a permanent or a temporary basis;

“batch” means an identifiable quantity of feed determined to have common characteristics whether in relation to origin, variety, type of packaging, packer, consignor or labelling and, in the case of a production process, a unit of production from a single plant using uniform production parameters or a number of such units when produced in continuous order and stored together;

“cross-contamination” means contamination of a non-target feed with an active substance originating from the previous use of the relevant facilities or equipment;

“distributor” means a feed business operator distributing specified feed additives, intermediate feedingstuff or complete feed containing specified feed additives, or intermediate feedingstuff or complete feed containing medicinal premixes;

“feed business” means any undertaking whether for profit or not and whether public or private, carrying out any operation of production, manufacture, processing, storage, transport or distribution of feed including any producer producing, processing or storing feed for feeding to animals on their own holding;

“feed business operator” means any person responsible for ensuring that the requirements of this Schedule are met within the feed business under that person’s control;

“non-target feed” means feed, whether medicated or not which is not intended to contain a specific active substance;

“premises” means any unit of a feed business;

“premixture” means a mixture of a veterinary medicinal product or a specified feed additive with feedingstuffs materials, intended for further mixing with feedingstuffs before being fed to animals;

“zootechnical additive” means any additive used to maintain animals in good health or favourably affect their performance.

Enforcement of Regulation (EC) No 178/2002

2

(1) For the purposes of Regulation (EC) No 178/2002 the competent authority is the Secretary of State.

(2) No person may fail to comply with any of the following provisions of that Regulation—

(a) Article 11 (requirements relating to imports);

(b) Article 12 (requirements relating to exports);

(d) Article 16 so far as it prohibits misleading labelling, advertising or presentation of feedingstuffs;

(e) Article 18(2) and (3) (requirements of traceability) in so far as it relates to feed business operators; and

(f) Article 20 (responsibilities of feed business operators).

Enforcement of Regulation (EC) No 1831/2003

3

(1) For the purposes of Regulation (EC) No 1831/2003 the competent authority is the Secretary of State.

(2) An authorisation under Article 3(2) of that Regulation must be in writing.

(3) No person may possess a specified feed additive, or an intermediate feedingstuff or feedingstuffs containing a specified feed additive, unless the specified feed additive has been authorised under Regulation (EC) No 1831/2003 or is for export to another country.

(4) No person may fail to comply with any of the following provisions of that Regulation—

(a) Article 3(1) or Article 3(3) (the authorisation, conditions of use and labelling of specified feed additives);

(b) Article 12(1) or (2) (conditions relating to specified feed additives);

(d) Article 16(3) (additional labelling requirement);

(e) Article 16(4) (premixtures containing specified feed additives);

(f) Article 16(5) (packaging).

Enforcement of Regulation (EC) No 882/2004 Regulation (EU) 2017/625

4

For the purposes of Regulation (EU) 2017/625 the competent authority is the Secretary of State.

Enforcement of Regulation (EC) No 183/2005

5

(1) For the purposes of Regulation (EC) No 183/2005 the competent authority is the Secretary of State.

(2) No person may fail to comply with any of the following provisions of that Regulation—

(a) Article 5(2), (5) or (6) (specific obligations);

(b) Article 6(1) as read with (2) and (3) (HACCP system);

(d) Article 9(2) (official controls, notification and registration);

(e) Article 10(1) (approval of feed business establishments);

(f) Article 11 (prohibition on operating without approval or registration);

(g) Article 17(2) (exemption from on-site visits);

(h) Article 18(3) (declaration of compliance);

(i) Article 23(1) (conditions relating to imports from third countries);

(j) Article 25 (feedingstuffs produced for export to third countries).

(3) A manufacturer must ensure that, so far as is reasonably practicable, the active ingredient is evenly incorporated throughout the feedingstuffs.

(4) In the case of the refusal, suspension or revocation of an approval under the Regulation the appeals procedure relating to a manufacturing authorisation in regulation 30 applies.

Enforcement of Regulation (EC) No 767/2009

6

No person may contravene Article 8 of Regulation (EC) No 767/2009 of the European Parliament and of the Council in relation to feedingstuffs containing specified feed additives.

Approval of manufacturers and distributors of feedingstuffs containing veterinary medicinal products

7

(1) For the purposes of Directive 90/167/EEC laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community³⁸ the competent authority is the Secretary of State.

(2) No person may incorporate a medicinal premix into an intermediate feedingstuff or feedingstuff, or act as a distributor of intermediate feedingstuffs or feedingstuffs containing a medicinal premix, without being authorised to do so by the Secretary of State.

(3) The conditions which govern authorisation of feed business premises under Regulation (EC) No 183/2005 laying down requirements for feed hygiene³⁹ also govern authorisation of manufacturers and distributors under sub-paragraph (2).

(4) The Secretary of State shall conduct inspections of manufacturers and distributors authorised under sub-paragraph (2) basing the frequency of inspection on the risks associated with each premises’ history and the nature of the products handled at the premises.

(5) A manufacturer must ensure that, so far as is reasonably practical the medicinal premix is evenly incorporated and homogeneously dispersed throughout the feedingstuffs, taking into account the specific properties of the medicinal premix and the mixing technology employed.

(6) The provisions of this paragraph do not apply in relation to any person breeding or selling ornamental fish not intended for human consumption provided that the person does not use more than a total of 1kg of medicinal premix annually for that purpose.

(7) In the case of the refusal, suspension or revocation of an authorisation under this paragraph the appeals procedure relating to a manufacturing authorisation in regulation 30 applies.

Incorporation of a veterinary medicinal product into a premixture

8

Any person who incorporates a medicinal premix into an intermediate feedingstuff—

(a) must do so in accordance with the summary of product characteristics, and must take account of any interactions listed there; and

(b) must ensure that the medicinal premix does not contain the same active substance as any other additive.

Top dressing

9

No person may promote or label any veterinary medicinal product, or anything containing a veterinary medicinal product, as being suitable for top dressing (that is, sprinkling it on to feedingstuffs without thoroughly incorporating it) unless the summary of product characteristics specifically permits this use.

Incorporation of a veterinary medicinal product into feedingstuffs

10

Any person who incorporates a medicinal premix (or an intermediate feedingstuff) into feedingstuffs—

(a) must do so in accordance with the summary of product characteristics, and must take account of any interactions listed there;

(b) must ensure that the medicinal premix does not contain the same active substance as any other additive;

(c) must ensure that the medicinal premix is incorporated in accordance with its marketing authorisation (unless it has been prescribed under the cascade) and the medicated feedingstuff prescription;

(d) must ensure that the daily dose of the medicinal premix is contained in a quantity of medicated feedingstuffs corresponding to at least half the daily feedingstuffs ration of the animals treated or, in the case of ruminants, corresponding to at least half the daily requirements of non-mineral complementary feedingstuffs.

Additional record keeping requirements relating to medicinal premixes

11

(1) Any person who—

(a) incorporates a medicinal premix into an intermediate feedingstuff;

(b) incorporates an intermediate feedingstuff containing a medicinal premix into feedingstuffs; or

must make a daily record of—

(d) the types and quantities of all medicinal premixes (and specified feed additives, if any) and intermediate feedingstuffs used in the manufacturing process; and

(e) the quantity of feedingstuffs and intermediate feedingstuffs containing medicinal premix manufactured that day.

(2) An authorised distributor must make a daily record of—

(a) the types and quantities of all intermediate feedingstuffs and feedingstuffs containing medicinal premixes bought and sold that day; and

(b) the quantity held.

(3) A manufacturer and distributor must also record, as soon as reasonably practicable, for each consignment supplied—

(a) the date of delivery;

(b) the name and address of each consignee (or, in the case of a manufacturer supplying to a distributor, the name and address of the distributor);

(d) the quantity;

(e) the type of medicinal premix incorporated into the feedingstuffs; ...

(f) the expiry date ; and

(g) the batch number.

(4) Records must be kept for five years.

Labelling a premixture containing a veterinary medicinal product

12

(1) An intermediate feedingstuff containing a medicinal premix must be clearly and legibly labelled with the following—

(a) the words “INTERMEDIATE FEEDINGSTUFF” (or, if it is to be labelled as “complementary feedingstuffs” under legislation implementing Council Directive 79/373/EEC on the marketing of compound feedingstuffs⁴⁰, “MEDICATED COMPLEMENTARY FEEDINGSTUFFS” ) in upper case letters;

(b) the proprietary name of the medicinal premix and the authorisation number;

(d) the range of acceptable inclusion rates of the intermediate feedingstuff into the final feedingstuffs, the range of acceptable levels of the active ingredients in the final feedingstuffs and the words “refer to the medicated feedingstuffs prescription for the exact inclusion rate” or equivalent wording;

(e) warnings and contra-indications;

(ea) a statement that the product must be used in accordance with its summary of product characteristics;

(eb) the contact details (including a free helpline number) for the supplier of the product;

(ec) the words “inappropriate disposal of this product poses a serious threat to the environment”;

(ed) in the case of a product containing an antibiotic, the words “inappropriate disposal of this product may contribute to antimicrobial resistance”;

(f) the withdrawal period, and a statement that, if the medicated feedingstuffs prescription requires a longer withdrawal period, that is the one that applies;

(g) the expiry date;

(h) any special storage instructions required by the marketing authorisation;

(i) where a medicated feedingstuffs prescription is required, a statement to this effect.

(2) If there is more than one medicinal premix used, the longest withdrawal period must be shown on the label.

(3) If the intermediate feedingstuff also contains a specified feed additive to which this Schedule applies it must also contain the information required under Article 16 of Regulation (EC) No 1831/2003⁴¹.

(4) No person may supply such an intermediate feedingstuff unless it is labelled in accordance with this paragraph.

Labelling of feedingstuffs containing a specified feed additive

13

No person may contravene the labelling requirements of Article 15 and Article 17 of Regulation (EC) No 767/2009 of the European Parliament and of the Council.

Labelling of feedingstuffs containing a medicinal premix

14

(1) Feedingstuffs containing a medicinal premix must be clearly and legibly labelled with the following—

(a) the words “MEDICATED COMPLETE FEED” in upper case letters, or where feedingstuffs are to be labelled as a complementary feedingstuff and intended to be fed to animals without further mixing with feed materials, the words “MEDICATED COMPLEMENTARY FEEDINGSTUFF”;

(b) the proprietary name, authorisation number and inclusion rate (kg/tonne or mg/kg) of the medicinal premix incorporated into the feedingstuffs;

(d) the species of animal for which the feedingstuffs are intended;

(e) warnings and contra-indications;

(ea) the contact details (including a free helpline number) for the supplier of the product;

(eb) the words “inappropriate disposal of this product poses a serious threat to the environment”;

(ec) in the case of a product containing an antibiotic, the words “inappropriate disposal of this product may contribute to antimicrobial resistance”;

(f) the withdrawal period, and a statement that, if the medicated feedingstuffs prescription requires a longer withdrawal period, that is the one that applies;

(fa) the batch number;

(g) the expiry date;

(h) any special storage instructions required by the marketing authorisation;

(i) a statement to the effect that the feedingstuffs must only be fed in accordance with its medicated feedingstuffs prescription;

(j) the name and authorisation number of the manufacturer or the distributor.

(2) If there is more than one medicinal premix used, the longest withdrawal period must be shown on the label.

(3) If the feedingstuff also contains a specified feed additive to which this Schedule applies it must also contain the information required by Articles 15 and 17 of Regulation (EC) No 767/2009 of the European Parliament and of the Council.

(4) No person may supply feedingstuffs containing a medicinal premix unless they are labelled in accordance with this paragraph.

Supply of specified feed additives

15

(1) No person other than the person who manufactured a specified feed additive or an authorised distributor may supply a specified feed additive.

(2) The person who manufactured the specified feed additive may only supply it to—

(a) an authorised distributor;

(b) an authorised intermediate feedingstuff manufacturer or an authorised complementary feedingstuffs manufacturer; or

(3) An authorised distributor may only supply it to—

(a) another authorised distributor;

(b) an authorised intermediate feedingstuff manufacturer or an authorised complementary feedingstuffs manufacturer; or

Supply of premixture

16

(1) No person other than the person who manufactured an intermediate feedingstuff or specified feed additive or an authorised distributor may supply an intermediate feedingstuff or specified feed additive.

(2) The person who manufactured the intermediate feedingstuff or specified feed additive may only supply it to—

(a) an authorised distributor; or

(b) a feedingstuff manufacturer authorised to incorporate that intermediate feedingstuff or specified feed additive.

(3) An authorised distributor may only supply it to—

(a) another authorised distributor; or

(b) a feedingstuff manufacturer authorised to incorporate that intermediate feedingstuff or specified feed additive.

Supply of a complementary feedingstuff

17

(1) No person other than—

(a) the person who manufactured a complementary feedingstuff containing a specified feed additive; or

(b) an authorised distributor

may supply a complementary feedingstuff containing a specified feed additive.

(2) The person who manufactured such complementary feedingstuff may only supply it to—

(a) an authorised distributor; or

(b) a feedingstuff manufacturer registered to incorporate that complementary feedingstuff or authorised to incorporate an intermediate feedingstuff.

(3) An authorised distributor may only supply it to—

(a) another authorised distributor, or

(b) a feedingstuff manufacturer registered to incorporate that complementary feedingstuff or authorised to incorporate an intermediate feedingstuff.

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

Supply of feedingstuffs containing a veterinary medicinal product

18

(1) No person other than the person who manufactured the feedingstuffs or an authorised distributor may supply feedingstuffs containing a medicinal premix.

(2) The person who manufactured the feedingstuff may only supply it to—

(a) an authorised distributor; or

(b) an animal keeper for feeding to those animals.

(3) A distributor may only supply it to—

(a) another authorised distributor; or

(b) an animal keeper for feeding to those animals.

(4) Supply to an animal keeper must be in accordance with a written medicated feedingstuff prescription as specified in the following paragraph.

(5) If a medicated feedingstuff prescription is for a period of longer than one month, the supplier may not provide more than one month’s supply at any one time.

(6) No manufacturer or distributor may supply a feedingstuff to anyone not specified in this paragraph, or otherwise than in accordance with this paragraph.

(7) The person supplying the feedingstuff must keep the medicated feedingstuff prescription for five years.

(8) Nothing in this paragraph prevents a commercial feed manufacturer from incorporating a medicinal premix with a feedingstuff in advance of receiving a written prescription for that feedingstuff.

Prescriptions for feedingstuffs containing a veterinary medicinal product

19

(1) A medicated feedingstuff prescription for feedingstuffs containing a medicinal premix must contain the following—

(a) the name and address of the person prescribing the product;

(b) the qualifications enabling the person to prescribe the product;

(d) the species of animal, identification and number of the animals;

(e) the premises at which the animals are kept if this is different from the address of the keeper;

(ea) the diagnosed disease to be treated or prevented (in the case of immunological veterinary medicinal products or antiparasitics without antimicrobial effects);

(f) the date of the prescription;

(g) the signature or other authentication of the person prescribing the product;

(h) the name, active substance, amount of the product prescribed and inclusion rate of the medicinal premix and resulting inclusion rate of the active substance;

(i) the dosage and administration instructions;

(j) any necessary warnings;

(ja) a statement that the prescription may not be re-used;

(k) the withdrawal period;

(l) the manufacturer or the distributor of the feedingstuffs (who must be authorised for the purpose) , whichever is the supplier to the end user;

(m) if the validity exceeds one month, a statement that not more than 31 days’ supply may be provided at any time;

(n) the name, type and quantity of feedingstuffs to be used;

(na) the overall amount of feedingstuff to be supplied under the prescription;

(o) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(p) any special instructions;

(q) the percentage of the prescribed feedingstuffs to be added to the daily ration; and

(r) if it is prescribed under the cascade, a statement to that effect.

(2) It is valid for three months or such shorter period as may be specified in the medicated feedingstuff prescription.

(2A) In the case of a prescription to which sub-paragraph (1) applies which relates to an antibiotic, the time between a prescription being issued and the course of treatment starting must be no more than five working days.

(2B) Subject to paragraph 7A in Schedule 3, a prescription for a medicated feedingstuff containing a medicinal premix which includes an antibiotic may not be issued for prophylactic purposes.

(3) In relation to food-producing animals a medicated feedingstuffs prescription may not confer authority for more than one course of treatment.

Writing the prescription

20

(1) The person who writes the medicated feedingstuff prescription must—

(a) give a copy to the person incorporating the medicinal premix into the feedingstuffs or to the distributor of the feedingstuffs , whichever is the supplier to the end user;

(b) give one copy to the keeper of the animals to be treated;

(2) The person must be satisfied that—

(a) there is no undesirable interaction between the medicinal premix and any feed additive used in the feedingstuffs; and

(b) the active substance of the medicinal premix is not the same as an active substance in any feed additive used in the feedingstuffs.

(3) The person must prescribe a medicinal premix authorised for incorporation in feedingstuffs but may, if there is no medicinal premix authorised for a condition in a particular species—

(a) prescribe a medicinal premix authorised for another species or for another condition in the same species, and

(b) prescribe more than one medicinal premix,

provided all medicinal premixes prescribed are authorised for incorporation in feedingstuffs.

Possession

21

(1) No person other than a person holding the appropriate authorisation under this Schedule may be in possession of any—

(a) specified feed additive or medicinal premix to which this Schedule applies;

(b) intermediate feedingstuffs containing such an additive or a medicinal premix; or

(2) No person other than a manufacturer or distributor may be in possession of feedingstuffs incorporating a medicinal premix unless it has been supplied under a medicated feedingstuffs prescription.

Sampling and analysis

22

(1) If any enforcement action is taken under this Schedule based on a sample, that sample must have been taken and analysed in accordance with Regulation (EC) No 152/2009 laying down methods of sampling and analysis for the official control of feedingstuffs.

(2) Unless otherwise specified in the marketing authorisation, it is a defence if the active ingredient in the medicated feedingstuff sample is within the following tolerances—

Level of active ingredient specified on the label	Tolerance
≤500mg/kg	±30%
˃500mg/kg ≤5g/kg	±20%
˃5g/kg	±10%

(3) Unless otherwise specified in the Commission Regulation authorising the specified feed additive in question, it is a defence if the active ingredient of a specified feed additive in a feedingstuff sample is within the tolerances set out in Articles 11(5) and paragraph 2(e) of Annex IV to Regulation (EC) No 767/2009 of the European Parliament and of the Council.

Storage

23

No person may store a medicinal premix intended for incorporation into feedingstuffs, or an intermediate feedingstuff or feedingstuffs containing a medicinal premix, except in—

(a) a suitable storage area that is locked when not in use; or

(b) a hermetic container designed to store those products.

Packages and other containers

24

No person may place on the market feedingstuffs containing a medicinal premix except in packages or containers that are sealed in such a way that, when the package or container is opened, the seal is damaged.

Transport

25

(1) No person may transport feedingstuffs by road tankers or in bulk unless the labelling requirements are set out in a document accompanying the feedingstuffs, and the transporter must hand over details when delivering the feedingstuffs unless these have already been provided to the purchaser.

(2) Any person transporting feedingstuffs containing medicinal premixes or specified feed additives in road tankers or similar containers must ensure that the vehicle or container is cleaned before any re-use if this is necessary to prevent undesirable interaction or contamination.

(3) In the case of feedingstuffs containing a medicinal premix or specified feed additive the transporter must ensure that the vehicle is accompanied by documentation stating this.

(4) Any person operating an undertaking transporting feedingstuffs containing medicinal premixes or specified feed additives must give written instructions to drivers on how to load and unload vehicles so as to avoid cross-contamination, and take reasonable steps to ensure that the driver complies with those instructions.

Possession, placing on the market and use of feedingstuffs

26

(1) No person may possess, place on the market or feed to animals any feedingstuffs incorporating medicinal premixes or specified feed additives unless they have been incorporated in accordance with this Schedule.

(2) No person may feed to any animal, or buy, possess or supply for the purpose of feeding to any animal, any feedingstuff containing a medicinal premix or specified feed additive unless—

(a) that medicinal premix or specified feed additive is authorised for that species of animal and for the purpose for which it is used; or

(b) in the case of a medicinal premix, it was prescribed for that animal.

(2A) An animal keeper must ensure that any product to which this Schedule applies is appropriately stored in accordance with its authorisation.

(2B) An animal keeper must ensure in respect of any such product that—

(a) no cross-contamination occurs between products held by the keeper;

(b) no product contaminates any feedingstuff or feed material;

(d) a product is administered only to correctly identified animals mentioned on the medicated feedingstuffs prescription.

(2C) An animal keeper must comply with the withdrawal period in relation to any such product.

(3) This paragraph does not apply in relation to feedingstuffs if the medicinal premix has been incorporated in accordance with an animal test certificate or the feedingstuff has been imported in accordance with this Schedule.

Imports from third countries

27

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

Trade between member States

28

No person may bring in from another country a feedingstuff containing a veterinary medicinal product unless—

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

(b) it only contains a veterinary medicinal product that has the same quantitative and qualitative composition as a medicinal premix authorised in Great Britain.

Import for incorporation into premixture or feedingstuffs for export

29

(1) A manufacturer of intermediate feedingstuffs or feedingstuffs who imports a veterinary medicinal product authorised in another ... country for the purposes of incorporating it into intermediate feedingstuffs or feedingstuffs for export does not commit an offence under regulation 43(q) (importation of an unauthorised veterinary medicinal product) or regulation 43(r) (possession of an unauthorised veterinary medicinal product)

(2) No person may place that intermediate feedingstuff or feedingstuff on the market in the United Kingdom once the veterinary medicinal product has been incorporated into it.

Animals on domestic premises

30

(1) The requirements of paragraph 7 (authorisation of manufacturers and distributors of feedingstuffs containing medicinal premix) do not apply in relation to a person who incorporates a medicinal premix into feedingstuffs in domestic premises for feeding, on those premises—

(a) non-food-producing animals; or

(b) food-producing animals provided that the animals or products from those animals are not sold or supplied commercially.

(2) Notwithstanding paragraphs 16 and 18 of this Schedule, a veterinary surgeon, a pharmacist or a suitably qualified person who is registered in accordance with paragraph 14 of Schedule 3 may be supplied with and may supply an intermediate feedingstuff containing a medicinal premix, or feedingstuffs containing a medicinal premix, to such a producer.

(3) The requirement for a written prescription does not apply in relation to such supply, but the provisions of Schedule 3 relating to supply of a veterinary medicinal product apply in relation to the supply of intermediate feedingstuffs and feedingstuffs in the same way as they apply to a veterinary medicinal product.

Offences

31

It is an offence to fail to comply with—

(a) paragraph 2(2);

(b) paragraph 3(3) or (4);

(d) paragraph 6;

(e) paragraph 7(2) or (5);

(f) paragraph 8;

(g) paragraph 9;

(h) paragraph 10;

(i) paragraph 11;

(j) paragraph 12(4);

(k) paragraph 13;

(l) paragraph 14(4);

(m) paragraph 15;

(n) paragraph 16;

(o) paragraph 17;

(p) paragraph 18;

(pa) paragraph 19;

(q) paragraph 20;

(r) paragraph 21;

(ra) paragraph 22A;

(s) paragraph 23;

(t) paragraph 24;

(u) paragraph 25;

(v) paragraph 26(1) , (2), (2A), (2B) or (2C);

(va) paragraph 26A;

(w) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(x) paragraph 28; or

(y) paragraph 29(2).

SCHEDULE 6 — Exemptions for small pet animals

Animals to which this Schedule applies

1

This Schedule applies in relation to veterinary medicinal products intended solely for the following animals kept exclusively as a pet—

(a) aquarium animals;

(b) cage birds;

(d) homing pigeons;

(e) rabbits;

(f) small rodents; and

(g) terrarium animals.

Placing on the market, importing and administering the product

2

A veterinary medicinal product intended solely for an animal to which this Schedule applies may be placed on the market, imported or administered without a marketing authorisation if it complies with this Schedule and the manufacturer appears on the register maintained under paragraph 3A.

Manufacture

3

(1) The product must have been manufactured by—

(a) the holder of a manufacturing authorisation if manufactured in Great Britain;

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

(d) in the case of any other country, a manufacturer whose premises have been inspected and approved by an officer of the Secretary of State.

(2) Sub-paragraph (1)(d) does not apply where the United Kingdom has a formal agreement with the exporting country that includes mutual recognition of good manufacturing practice or where the Secretary of State is satisfied that the exporting country requires manufacturers of veterinary medicinal products to apply standards of good manufacturing practice which are at least equivalent to those in Great Britain.

Approval of the active substance

4

(1) The Secretary of State may approve an active substance for use in a veterinary medicinal product manufactured under this Schedule.

(2) The Secretary of State may not grant an approval if the active substance requires veterinary control.

(3) The approval must specify the species of animals for which it is approved, and may specify how the active substance or a product containing it is to be administered.

(4) The Secretary of State may suspend or revoke the approval (or limit it to a smaller number of species) if—

(a) it is demonstrated that the substance requires veterinary control;

(b) adverse events are reported making suspension or revocation necessary; or

(i) is carcinogenic;

(ii) is genotoxic; or

(iii) shows developmental toxicity (including teratogenicity).

(5) The procedure for the refusal, suspension or revocation of an approval under this paragraph is the same as the procedure for a marketing authorisation.

The product

5

(1) The active substance in the veterinary medicinal product must be approved under paragraph 4.

(2) The veterinary medicinal product must not be an antibiotic.

(3) It must not contain any narcotic or psychotropic substance.

(4) It must not be intended for treatments or pathological processes that require a precise prior diagnosis or the use of which may cause effects that impede or interfere with subsequent diagnostic or therapeutic measures.

Labelling

6

(1) The product must be clearly labelled as being exempt from the requirements of these Regulations in relation to a marketing authorisation.

(2) The labelling must show the following—

(a) the name of the veterinary product, including, if it is part of the name, its strength and pharmaceutical form;

(b) the authorisation number of the manufacturer;

(d) the route of administration;

(e) the batch number;

(f) the expiry date;

(g) the words “For animal treatment only”;

(h) the contents by weight, volume or number of dose units;

(i) the name and address of the manufacturer or distributor;

(j) the target species;

(k) the words “Keep out of reach of children”;

(l) storage instructions;

(m) the shelf-life after the immediate packaging has been opened for the first time;

(n) disposal advice;

(o) full indications, including—

(i) therapeutic indications;

(ii) contra-indications;

(iii) interaction with other medicines and other forms of interaction; and

(p) dosage instructions.

(3) If there is insufficient room on the label, the information may instead be in a package leaflet, but the leaflet must contain all the information in the preceding sub-paragraph other than the batch number and the expiry date, but the label on the product must contain at least the following—

(a) the name of the veterinary medicinal product;

(b) its active substance and its strength;

(d) the batch number;

(e) the expiry date; and

(f) the words “For animal treatment only”.

Administration

7

The method of administration must be oral or topical or (in the case of a product for fish) by addition to the water.

Pack size

8

The pack size must only be sufficient for a single course of treatment or, in the case of a veterinary medicinal product for aquarium fish, sufficient for a single course of treatment of no more than 7 administrations to an aquarium of25,000 litres.

Adverse reactions

9

(1) The manufacturer or importer of a veterinary medicinal product must—

(a) notify the Secretary of State within 15 days of learning of any serious adverse events; and

(b) make a record of each adverse event and serious adverse event on becoming aware of it and keep it for three years.

(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SCHEDULE 7 — Fees

PART 1 — Introduction

Interpretation

1

(1) In this Schedule—

“pharmaceutical product” means any veterinary medicinal product other than an immunological product or a biological veterinary medicinal product that is not immunological;

“simultaneous application” is an application in which, at the time an authorisation for a product is applied for, one or more additional applications are submitted for products that are identical to the first product except that—in the case of an immunological product, they have a lesser number of antigens than the first product, but only contain antigens contained in the first product; andin the case of a pharmaceutical product, they have different strengths of the active substance,...

(2) For the purposes of this Schedule “manufacturing authorisation” means the following activities—

(a) manufacture or import of an authorised veterinary medicinal product;

(b) manufacture of a product to which paragraph 2 of Schedule 6 relates;

(d) manufacture of—

(i) an autogenous vaccine;

(ii) a stem cell product; or

(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) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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.”;

(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.

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