Legalize / United Kingdom / Statutory-Instrument

The Veterinary Medicines Regulations 2006

Type Statutory-Instrument

Publication 2006-09-05

Last updated 2022-04-01

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

PDF Download

articles Not indexed

Reform history JSON API

(5) The notice shall be at least A4 size with a laminated transparent cover, coloured and printed to scale on front and back substantially in accordance with the following two diagrams, except that in Wales it may be in Welsh as well as in English—

Use of sheep dip

23

(1) It is an offence to use sheep dip unless this is done by, or under the supervision and in the presence of, a person who holds a Certificate of Competence in the Safe Use of Sheep Dips showing that Parts 1 and 2 or units 1 and 2 of the assessment referred to in the Certificate have been satisfactorily completed and issued by—

(a) in England, Wales and Northern Ireland by the National Proficiency Tests Council, or by NPTC Part of the City & Guilds Group; or

(b) in Scotland, by one of those organisations or the Scottish Skills Testing Service.

(2) In the case of a person who has had practical experience of sheep dipping before 1st October 2006, this paragraph does not apply until 31st December 2008, and in any other case does not apply until 1st April 2007.

SCHEDULE 4 — ADMINISTRATION OF A VETERINARY MEDICINAL PRODUCT OUTSIDE THE TERMS OF A MARKETING AUTHORISATION

Administration under the cascade

1

(1) A veterinary surgeon acting under this paragraph may either administer a veterinary medicinal product prescribed by him personally or may direct another person to do so under his responsibility.

(2) If there is no authorised veterinary medicinal product in the United Kingdom for a condition the veterinary surgeon responsible for the animal may, in particular to avoid unacceptable suffering, treat the animal concerned with the following (“the cascade”), cascaded in the following order—

(a) a veterinary medicinal product authorised in the United Kingdom for use with another animal species, or for another condition in the same species; or

(b) if and only if there is no such product that is suitable, either—

(i) a medicinal product authorised in the United Kingdom for human use; or

(ii) a veterinary medicinal product not authorised in the United Kingdom but authorised in another member State for use with any animal species (in the case of a food-producing animal, it must be a food-producing species); or

(c) if and only if there is no such product that is suitable, a veterinary medicinal product prepared extemporaneously by a pharmacist, a veterinary surgeon or a person holding a manufacturing authorisation authorising the manufacture of that type of product.

(3) In the case of a veterinary medicinal product imported from another member State, if the veterinary surgeon has not obtained a certificate from the Secretary of State under regulation 25(5) permitting him to import it, he must obtain a certificate from the Secretary of State before he administers it.

(4) For the purposes of this paragraph a food-producing animal includes an animal belonging to the equidae family unless it has been declared, as not being intended for slaughter for human consumption in accordance with—

(a) the Horse Passports (England) Regulations 2004²⁸;

(b) the Horse Passports Regulations (Northern Ireland) 2004²⁹;

(d) the Horse Passports (Wales) Regulations 2005³¹.

(5) Any pharmacologically active substances included in a medicinal product administered to a food-producing animal under the cascade must be listed in Annex I, II or III to Council Regulation (EEC) No. 2377/90.

Withdrawal periods

2

(1) A veterinary surgeon administering a veterinary medicinal product to a food-producing animal under the cascade must specify an appropriate withdrawal period.

(2) The withdrawal period must ensure that, if there is a maximum residue limit specified for the active substance in Council Regulation (EEC) No. 2377/90, the level of residue of the active substance does not exceed that limit.

(3) In any event, unless the Secretary of State has specified in writing a different withdrawal period for a particular veterinary medicinal product, the withdrawal period (irrespective of whether or not a maximum residue limit is specified in Council Regulation (EEC) No. 2377/90) must not be less than—

(a) 7 days for eggs;

(b) 7 days for milk;

(d) 500 degree days³² for fish meat.

(4) In the case of a homeopathic remedy in which active principles figure in Annex II to Council Regulation (EEC) No. 2377/90, the withdrawal period is zero.

Immunological products for serious epizootic disease

3

(1) In the event of serious epizootic diseases, the Secretary of State may permit in writing the administration of immunological veterinary medicinal products without a marketing authorisation, in the absence of a suitable medicinal product and after informing the Commission of the detailed conditions of use.

(2) He shall publicise any permit as he sees fit.

Immunological products for an imported or exported animal

4

If an animal is imported from, or exported to, a third country, the Secretary of State may permit the administration to that animal of an immunological veterinary medicinal product that is not covered by a marketing authorisation in the United Kingdom but is authorised under the legislation of the third country.

Administration by veterinary surgeons from other member States

5

(1) Veterinary surgeons practising in another member State may bring into the United Kingdom and administer to animals small quantities of veterinary medicinal products that are not authorised for use in the United Kingdom if—

(a) the quantity does not exceed the requirements for the treatment of specific animals;

(b) the product is authorised in the member State in which the veterinary surgeon is established;

(d) in the case of administration to food-producing animals, there is a veterinary medicinal product authorised in the United Kingdom that has the same qualitative and quantitative composition in terms of active substances;

(e) the veterinary surgeon has acquainted himself with the Guide to Professional Conduct issued by the Royal College of Veterinary Surgeons³³.

(2) The veterinary surgeon must only supply to the owner or keeper enough veterinary medicinal product to complete the treatment of animals concerned.

(3) He must—

(a) ensure that the withdrawal period specified on the label of the product is complied with, or the United Kingdom withdrawal period for the equivalent product authorised in the United Kingdom if this is longer than the one on the label; and

(b) keep detailed records of the animals treated, the diagnosis, the products administered, the dosage administered, the duration of treatment and the withdrawal period applied, and shall keep them in the United Kingdom for at least three years, and failure to comply with this sub-paragraph is an offence.

(4) The overall range and quantity of veterinary medicinal products carried by the veterinary surgeon must not exceed that generally required for the daily needs of good veterinary practice.

(5) This paragraph does not apply in relation to immunological veterinary medicinal products.

Treatment in exceptional circumstances

6

(1) the health situation so requires, and where there is no suitable veterinary medicinal product available either as an authorised product or under the cascade, a veterinary surgeon may treat an animal with a medicinal product authorised in a third country; but if the veterinary surgeon has not obtained a certificate from the Secretary of State under regulation 25(5) permitting him to import it, he must obtain a certificate from the Secretary of State before he treats the animal.

(2) The certificate may be granted subject to any condition the Secretary of State thinks fit.

Administration of a homeopathic remedy

7

(1) A registered homeopathic remedy or a homeopathic remedy prepared and supplied by a pharmacist under paragraph 8 of Schedule 3 may be administered to an animal by anyone, subject to any restrictions specified in its registration.

(2) A homeopathic remedy that was on the market before 1st January 1994 may be administered by anyone.

(3) A veterinary surgeon may administer, either himself or under his responsibility—

(a) a homeopathic remedy authorised for human use, or

(b) a homeopathic remedy prepared extemporaneously by a veterinary surgeon or a person holding a manufacturing authorisation authorising the manufacture of that type of product.

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—

“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 (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 safety³⁴) the competent authority is the Secretary of State.

(2) Any person who contravenes any of the following provisions of that Regulation is guilty of an offence—

(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 (of the European Parliament and the Council on additives for use in animal nutrition³⁵) the competent authority is the Secretary of State.

(2) When he grants an authorisation under Article 3(2) of that Regulation, the authorisation shall be in writing.

(3) It is an offence to be in possession of a specified feed additive, or a premixture 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 a third country.

(4) Any person who contravenes any of the following provisions of that Regulation is guilty of an offence—

(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

4

For the purposes of Regulation (EC) No. 882/2004 (of the European Parliament and the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules³⁶) 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 (of the European Parliament and of the Council laying down requirements for feed hygiene³⁷) the competent authority is the Secretary of State.

(2) Any person who contravenes any of the following provisions of that Regulation is guilty of an offence—

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

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

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

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

(i) 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 and failure to do so is an offence.

(4) In the case of the refusal, suspension or revocation of an approval under the Regulation the representations procedure relating to a manufacturing authorisation in paragraph 6 of Schedule 2 applies.

Approval of manufacturers and distributors of feedingstuffs containing veterinary medicinal products

6

(1) It is an offence to incorporate a veterinary medicinal product into a premixture or feedingstuffs, or to act as a distributor of premixtures or feedingstuffs containing a veterinary medicinal product, without being approved to do so by the Secretary of State.

(2) The requirements of this paragraph do not apply in relation to a person who incorporates a veterinary medicinal product into feedingstuffs in domestic premises for feeding, on those premises—

(a) non-food-producing animals, or

(b) food-producing animals kept purely for domestic consumption.

(3) The provisions of Regulation (EC) No. 183/2005 apply to those producers and distributors in the same way as to persons approved under Article 9 of that Regulation.

(4) A manufacturer must ensure that, so far as is reasonably practicable, the veterinary medicinal product is evenly incorporated throughout the feedingstuffs and failure to do so is an offence.

(5) In the case of the refusal, suspension or revocation of an approval under this paragraph the representations procedure relating to a manufacturing authorisation in paragraph 6 of Schedule 2 applies.

Incorporation of a veterinary medicinal product into a premixture

7

(1) Any person who incorporates a veterinary medicinal product into a premixture—

(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 veterinary medicinal product does not contain the same active substance as any other additive.

(2) It is an offence to fail to comply with this paragraph.

Incorporation of a veterinary medicinal product into feedingstuffs

8

(1) Any person who incorporates a veterinary medicinal product (or a premixture containing a veterinary medicinal product) 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 veterinary medicinal product does not contain the same active substance as any other additive;

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

(d) must ensure that the daily dose of the veterinary medicinal product 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 supplementary feedingstuffs.

(2) It is an offence to fail to comply with this paragraph.

Additional record keeping requirements relating to veterinary medicinal products

9

(1) Any person who—

(a) incorporates a veterinary medicinal product into a premixture;

(b) incorporates a premixture containing a veterinary medicinal product into feedingstuffs; or

must make a daily record of— the types and quantities of all veterinary medicinal products (and specified feed additives, if any) and premixture used in the manufacturing process; and the quantity of feedingstuffs and premixture containing veterinary medicinal product manufactured that day.

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

(a) the types and quantities of all premixtures and feedingstuffs containing veterinary medicinal products bought and sold that day;

(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 veterinary medicinal product incorporated into the feedingstuffs; and

(f) the expiry date.

(4) Records must be kept for five years.

(5) It is an offence to fail to comply with this paragraph.

Labelling a premixture containing a veterinary medicinal product

10

(1) A premixture containing a veterinary medicinal product must be clearly and legibly labelled with the following—

(a) the words “MEDICATED PREMIXTURE” in upper case letters;

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

(d) the inclusion rate into the feedingstuffs (or, where liquid is to be incorporated into the final feedingstuffs, the words “typical inclusion rate but refer to the prescription for the exact inclusion rate” or equivalent wording);

(e) the level of the active ingredient in the final feedingstuffs;

(f) warnings and contra-indications;

(g) withdrawal period;

(h) the expiry date;

(i) any special storage instructions;

(j) where a prescription is required, a statement to this effect.

(2) If the premixture 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. 1831/2003.

(3) It is an offence to supply such a premixture not labelled in accordance with this paragraph.

Labelling of feedingstuffs containing a specified feed additive

11

(1) Feedingstuffs containing a specified feed additive must be clearly and legibly labelled with the following—

(a) the name of the specified feed additive;

(b) the name and amount of the active substance (mg/kg) in the feedingstuffs;

(d) the expiry date;

(e) the name and approval number of the manufacturer or the distributor;

(f) any particulars concerning the proper use of the feedingstuffs specified in the authorisation of the specified feed additive.

(2) It is an offence to supply such feedingstuffs not labelled in accordance with this paragraph.

Labelling of feedingstuffs containing a veterinary medicinal product

12

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

(a) the words “MEDICATED FEEDINGSTUFFS” in upper case letters;

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

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

(e) warnings and contra-indications;

(f) the withdrawal period;

(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 prescription;

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

(2) It is an offence to supply feedingstuffs not labelled in accordance with this paragraph.

Supply of specified feed additives

13

(1) A manufacturer or distributor of specified feed additives may only supply them to a person approved to hold them in accordance with this Schedule.

(2) It is an offence to fail to comply with this paragraph.

Supply of premixture

14

(1) A manufacturer or distributor of a premixture may only supply it to a person approved to hold it in accordance with this Schedule.

(2) It is an offence to fail to comply with this paragraph.

Supply of feedingstuffs containing a veterinary medicinal product

15

(1) A manufacturer (if his approval so permits) or distributor of feedingstuffs containing a veterinary medicinal product may only supply those feedingstuffs to—

(a) a person approved to hold them in accordance with this Schedule, or

(b) in accordance with a prescription as specified in paragraph 22, a person who keeps animals.

(2) He must keep the prescription for five years.

(3) It is an offence to fail to comply with this paragraph.

Possession

16

(1) It is an offence for any person other than a person holding the appropriate approval under this Schedule to be in possession of any—

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

(b) premixtures containing such an additive or a veterinary medicinal product; or

(2) It is an offence for any person other than a manufacturer or distributor to be in possession of feedingstuffs incorporating a veterinary medicinal product unless it has been supplied under a prescription.

Sampling and analysis

17

(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 Council Directive 76/371/EEC (establishing Community methods of sampling for the official control of feedingstuffs³⁸).

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

(a) not exceeding 50 mg/kg of active ingredient: ±50%;

(b) exceeding 50 mg/kg but not exceeding 500 mg/kg: ±40%;

(d) exceeding 5g/kg but not exceeding 50g/kg: ±20%;

(e) exceeding 50g/kg: ±10%.

Storage

18

(1) Any person who stores veterinary medicinal products intended for incorporation into feedingstuffs, or a premixture or feedingstuffs containing such veterinary medicinal products, shall do so in a suitable storage area that is locked when not in use or in hermetic containers designed to store those products.

(2) It is an offence to fail to comply with this paragraph.

Packages and other containers

19

(1) Any person placing feedingstuffs containing a veterinary medicinal product on the market in packages or containers must ensure that they are sealed in such a way that, when the package or container is opened, the seal is damaged.

(2) It is an offence to fail to comply with this paragraph.

Transport

20

(1) In the case of feedingstuffs distributed by road tankers or in bulk the labelling requirements must be given in a document accompanying the feedingstuffs, and the transporter must hand over details when he delivers the feedingstuffs unless these have already been provided to the purchaser.

(2) Any person transporting feedingstuffs containing veterinary medicinal products 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 veterinary medicinal product he must ensure that the vehicle is accompanied by documentation stating this.

(4) Any person operating an undertaking transporting feedingstuffs containing veterinary medicinal products 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.

(5) It is an offence to fail to comply with this paragraph.

Possession, placing on the market and use of feedingstuffs

21

(1) It is an offence for any person to possess, place on the market or feed to animals any feedingstuffs incorporating veterinary medicinal products or specified feed additives unless they have been incorporated in accordance with this Schedule.

(2) It is an offence to feed to any animal, or buy or possess for the purpose of feeding to any animal, any feedingstuff containing a veterinary medicinal product or specified feed additive unless that veterinary medicinal product or specified feed additive is authorised for that species of animal and for the purpose for which it is used (unless prescribed under the cascade).

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

Prescriptions for feedingstuffs containing a veterinary medicinal product

22

(1) A prescription for feedingstuffs containing a veterinary medicinal product must be in writing (notwithstanding the provisions of paragraph 5 of Schedule 3) and 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 owner or keeper;

(f) the date of the prescription;

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

(h) the name and amount of the product prescribed;

(i) the dosage and administration instructions;

(j) any necessary warnings;

(k) the withdrawal period;

(l) the manufacturer or the distributor of the feedingstuffs (who must be approved for the purpose);

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

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

(o) the inclusion rate of the veterinary medicinal product and the resulting inclusion rate of the active substance;

(p) any special instructions for the stockfarmer; and

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

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

(3) The prescription must be sufficient for only one course of treatment.

(4) If the 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.

(5) The person who writes the prescription must—

(a) give a copy to the person incorporating the veterinary medicinal product into the feedingstuffs or to the distributor of the feedingstuffs;

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

(6) The person who writes the prescription must be satisfied that—

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

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

(7) For the avoidance of doubt, a veterinary surgeon may prescribe either a veterinary medicinal product authorised for that species and condition, or under the cascade.

(8) It is an offence to fail to comply with this paragraph.

Imports from third countries

23

No person shall import feedingstuffs containing a veterinary medicinal product from a third country, and it is an offence to fail to comply with this paragraph.

Trade between member States

24

(1) No person shall bring in feedingstuffs containing a veterinary medicinal product from another member State unless—

(a) they have been manufactured in accordance with the provisions of Council Directive 90/167/EEC (laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community³⁹) and Regulation (EC) No. 183/2005; and

(b) they only contain a veterinary medicinal product that has the same quantitative and qualitative composition as a veterinary medicinal product authorised in the United Kingdom.

(2) It is an offence to fail to comply with this paragraph.

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 fish;

(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

(1) A veterinary medicinal product intended solely for an animal to which this Schedule applies may be placed on the market or imported without a marketing authorisation if it complies with this Schedule.

(2) There are no restrictions on its administration to the target species.

Manufacture

3

(1) The product must have been manufactured by—

(a) the holder of a manufacturing authorisation if manufactured in the United Kingdom;

(b) the holder of a manufacturing authorisation issued under Directive (EC) No. 2001/82 if manufactured in another member State;

(c) in the case of Australia, Canada, New Zealand, or Switzerland, the holder of an authorisation from the competent authority permitting him to manufacture medicinal products;

(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) This paragraph does not apply until 1st November 2007.

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 must grant an approval if he is satisfied that the substance does not require veterinary control.

(3) The approval must specify the animals for which it is approved, and may specify how it 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) serious adverse reactions are reported making suspension or revocation necessary; or

(i) is carcinogenic;

(ii) is genotoxic; or

(iii) shows developmental toxicity (including teratogenicity).

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) If it contains an active substance contained in a veterinary medicinal product authorised in the United Kingdom as a product that can only be prescribed by a veterinary surgeon, a product containing that active substance must have been so authorised for at least five years.

(5) 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.

(6) The requirement that a veterinary medicinal product may only contain an active substance approved under paragraph 4 does not apply until 1st November 2007 in relation to a veterinary medicinal product on the market on 30th October 2005.

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 name and strength of each active substance;

(d) the batch number;

(e) the expiry date;

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

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

(h) the name and address of the manufacturer;

(i) the target species;

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

(k) storage instructions;

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

(m) disposal advice;

(n) full indications, including—

(i) therapeutic indications;

(ii) contra-indications;

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

(o) 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”.

(4) This paragraph does not apply until 1st November 2007 in relation to a veterinary medicinal product on the market on 30th October 2005.

Administration

7

The method of administration must be oral or topical or (in the case of a product for fish) 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 treatment of an aquarium of 25,000 litres.

Adverse reactions

9

(1) The manufacturer or importer of a product must notify the Secretary of State of any serious adverse reactions (as defined in paragraph 56 of Schedule 1) of which he becomes aware within 15 days of learning of the reaction.

(2) It is an offence to fail to comply with this paragraph.

SCHEDULE 7 — FEES

PART 1 — Introduction

Interpretation of Schedule 7

1

In this Schedule—

“national application” means an application for a marketing authorisation that does not involve another member State;

“pharmaceutical product” means any veterinary medicinal product other than an immunological product;

“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; and in the case of a pharmaceutical product, they have different strengths of the active substance, and, in the case of an application involving more than one member State, the additional applications do not include a member State that was not included in the first application.

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 is inspected for more than one type of authorisation at the same time, only one fee (the highest) is payable.

Translation

5

All translation costs are charged additionally.

PART 2 — Fees relating to marketing authorisations

Fees for specified pharmaceutical applications

6

The following table sets out the fees relating to a pharmaceutical veterinary medicinal product for—

(a) a national application for a marketing authorisation that is—

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

(ii) a bibliographic application; or

(iii) an application based on pharmacological equivalence;

(b) an application for a marketing authorisation using the decentralised procedure where the United Kingdom is a concerned member State;

			Pharmacologically equivalent national application	Pharmacologically equivalent national application
Menu	Full national application under Part 1 of Schedule 1 (£)	Bibliographic national application (£)	Reference product authorised in UK (£)	Reference product not authorised in UK (£)	Decentralised application where the UK is a concerned member State or recognition of a product authorised in another member State (£)
Base Fee: The following fees are in addition to the base fee—	910	1,800	1,800	2,320	460
Quality assessment (if quality data are assessed):	3,810	3,230	2,710	3,470	1,810
Safety assessment (if safety data are assessed):	3,810	3,030	1,030	1,330	1,810
Efficacy assessment (if efficacy data are assessed):	3,810	3,030	1,030	1,330	1,810
Ecotoxicology assessment (if ecotoxicology data are assessed):	640	520	320	410	390
Additional fee if any of the target species is a food-producing animal (not payable if neither safety data nor ecotoxicology data are assessed):	3,740	3,420	2,070	2,650	1,350
Reduced by—
if no safety data are assessed:	2,100	2,100	1,290	1,650	640
if no ecotoxicology data are assessed:	990	760	290	370	290
Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom—
food-producing animal:	7,170	6,330	5,610	7,200	2,520
non-food-producing animal:	6,260	5,620	5,360	6,870	2,200
Additional fee for each additional pack type:	720	720	590	740	330
Reduced by—
if no quality data are assessed:	350	350	350	450	120
if no safety data are assessed:	180	180	120	150	60
if no efficacy data are assessed:	60	60	60	70	60
if no ecotoxicity data are assessed:	60	60	—	—	60
Additional fee for each additional active ingredient (food-producing animal):	6,210	5,870	3,880	4,960	2,000
Reduced by—
if no quality data are assessed:	1,400	1,400	1,400	1,790	470
if no safety data are assessed:	2,630	2,630	1,580	2,020	820
if no efficacy data are assessed:	880	700	530	670	290
if no ecotoxicity data are assessed:	700	580	—	—	230
Additional fee for each additional active ingredient (non-food-producing animal):	4,140	3,940	3,110	3,960	1,430
Reduced by—
if no quality data are assessed:	1,400	1,400	1,400	1,790	470
if no safety data are assessed:	1,400	1,400	880	1,120	470
if no efficacy data are assessed:	880	700	530	670	290
if no ecotoxicity data are assessed:	60	60	—	—	60
Additional fee if there is more than one target species, for each additional species (food-producing animal):	3,820	3,430	2,330	2,980	1,240
Reduced by—
if no quality data are assessed:	180	180	180	220	60
if no safety data are assessed:	1,400	1,400	880	1,120	470
if no efficacy data are assessed:	1,750	1,400	1,050	1,350	530
if no ecotoxicity data are assessed:	120	120	—	—	60
Additional fee if there is more than one target species, for each additional species (non-food-producing animal):	2,400	2,010	1,490	1,900	780
Reduced by—
if no quality data are assessed:	180	180	180	220	60
if no safety data are assessed:	180	180	120	150	60
if no efficacy data are assessed:	1,750	1,400	1,050	1,350	530
if no ecotoxicity data are assessed:	60	60	—	—	60
Additional fee for each additional recommended route of administration (food-producing animal):	2,590	2,390	1,560	1,980	910
Reduced by—
if no safety data are assessed:	1,400	1,400	880	1,120	470
if no efficacy data are assessed:	880	700	530	670	290
if no ecotoxicity data are assessed:	60	60	—	—	60
Additional fee for each additional recommended route of administration (non- food-producing animal):	1,170	970	720	910	390
Reduced by—
if no safety data are assessed:	180	180	120	150	60
if no efficacy data are assessed:	880	700	530	670	290
Simultaneous applications: fee for each additional product in the application:	2,780	2,780	2,780	3,560	1,610

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

7

(1) The fee for a decentralised application for a pharmaceutical product where the United Kingdom is the reference member State is the same as for a national application as set out in the table in paragraph 6, with the addition of the fees in the following table.

Application	Additional fee (£)
Food-producing animal: one concerned member State:	3,560
Non-food-producing animal: one concerned member State:	3,100
Each additional concerned member State:	510

(2) In the case of a simultaneous application, the fee for each additional product in the application is £6,400 for one concerned member State and £110 for each additional concerned member State.

Application for a marketing authorisation for an immunological product

8

(1) The fee for a national application for a marketing authorisation relating to an immunological product, a decentralised application where the United Kingdom is the concerned member State or the mutual recognition of a product authorised in another member State is in accordance with the following table.

Menu	National application for a marketing authorisation (£)	Decentralised application where the UK is a concerned member State or recognition of a product authorised in another member State (£)
Base fee:	11,310	5,560
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:	7,100	2,390
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:	1,300	640
More than one antigenic component—fee for each additional component:	1,290	390
More than one species—fee for each additional species:	5,170	1,550
More than one route of administration—fee for each additional route of administration:	5,170	1,550
Simultaneous application—fee for each additional product in the application:	2,780	1,610

(2) The fee for an application for a marketing authorisation for an immunological product that is identical to a product already authorised in the United Kingdom but with a lesser number of antigens and which only contains antigens contained in the product already authorised is £10,020 (United Kingdom only) or £5,170 (decentralised application where the United Kingdom is a concerned member State).

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

9

(1) The fee for a decentralised application for a marketing authorisation for an immunological product where the United Kingdom is the reference member State is the same as for a national application as set out in the table in paragraph 8(1), with the additions of £3,330 for one concerned member State and £510 for each additional concerned member State.

(2) In the case of a simultaneous application the fee for each additional product in the application is £6,400 for one concerned member State and £110 for each additional concerned member State.

Application for a marketing authorisation using identical data

10

The fee for an application for a marketing authorisation using identical data is in accordance with the following table.

Application	Fee (£)
Any application other than decentralised where the United Kingdom is the reference member State:	910
Decentralised application where the United Kingdom is the reference member State—
one concerned member State:	4,000
each additional concerned member State:	510

Application for a provisional marketing authorisation

11

The fee for an application for a provisional marketing authorisation is the same as that for a full national marketing authorisation in paragraph 6 (in the case of a pharmaceutical product) or the fee for a national application in paragraph 8 (in the case of an immunological product), and the fee for its conversion into a full marketing authorisation is—

(a) if the application for the full marketing authorisation is received within two years of the grant of the provisional marketing authorisation—

(i) £8,130, or

(ii) if the application for the provisional marketing authorisation was made before 1st October 2006, £10,705; and

(b) in any other case the same fee as for the provisional marketing authorisation.

Application for a marketing authorisation relating to a parallel import

12

The fee for a marketing authorisation for a parallel import is in accordance with the following table.

Application	Fee (£)
Application where the imported product has been authorised in accordance with the mutual recognition procedure or decentralised procedure, and the United Kingdom is included in these procedures—
import from one member State:	1,690
each additional member State:	340
Any other application—fee for each member State from which the product is imported:	2,050

Application for a variation

13

(1) An applicant must make a separate application for a variation for each change in the marketing authorisation (unless a change is a direct consequence of the first change) and the appropriate fee is payable for each application.

(2) As an exception from sub-paragraph (1), if an applicant applies for more than one variation to the quality data in a marketing authorisation on the same application form, he may elect to pay a total fee of £4,440; but this sub-paragraph does not apply—

(a) if one or more of the variations relates to a new source of an active substance and the applicant does not submit a Certificate of Suitability issued by the European Pharmacopeia relating to the new source, or

(b) if a significant formulation change is applied for that requires a new assessment of the safety or efficacy of the veterinary medicinal product.

(3) If the variation is one specified in Annex I to Commission Regulation (EC) No. 1084/2003, the fee is £440 for a variation specified as Type 1A in that Annex.

(4) If the variation is specified as Type 1B in that Annex, the fee is £835 except in accordance with the following table.

Variation	Conditions	Fee (£)
Identical changes to a number of products—	All the products are from the same marketing authorisation holder Supporting data are identical All applications are submitted at the same time	First product 835 Each subsequent product 440

(5) The fee for a variation classified as Type II in Article 3 of Commission Regulation (EC) No.1084/2003 is £2,220 except in the following cases, where the fee is as specified.

Change	Conditions	Fee (£)
a Identical changes to a number of products—	All the products are from the same marketing authorisation holder Supporting data are identical All applications are submitted at the same time	First product2,220 Each subsequent product440
b Change of distributor—	No other aspect of the dossier is changed and the marketing authorisation holder remains the same	835
c Change of legal entity of marketing authorisation holder—	No other aspect of the dossier is changed	835
d Simple dosage instruction changes intended to remove ambiguity—	The change is not as a result of safety concerns No new studies are required to support the change The dosage regime remains the same	835
e Addition or change to safety warnings—	No other aspects of the dossier are changed No safety warnings are removed No new studies are required to support the change and the proposed warnings serve to increase the protection of the user/environment/target species as appropriate	835
f Corrections or simple text layout changes to summary of product characteristics and/or product literature. Included in this is the introduction of multilingual labelling—	The changes are not a result of safety concerns No new studies are required to support the change and no other aspect of the dossier is changed The legibility of the current English labelling is not compromised The indications and warnings are the same in all languages	835
g Abbreviated resubmission of a previously refused Type II variation—	At the time of refusal of a Type II variation, the Secretary of State has given written permission for resubmission under this category The application has been resubmitted within 3 months of the date the refusal advice was issued	835
h Submission made following the formal advice of the Secretary of State—	The Secretary of State has already assessed the relevant data and formed an opinion on these The change is not required as a result of the holder failing to keep the Part II (quality) data in accordance with current practice or in line with current guidelines issued by the Committee for Medicinal Products for Veterinary Use⁴⁰	835
i Approval of a mock-up for an authorised pack size—	The pack size is already authorised No new studies are required to support the change and no other aspect of the dossier is changed	835
j Changes to the summary of product characteristics and product literature of a Marketing Authorisation for Parallel Import as a direct consequence of the approval of a variation to the summary of product characteristics and product literature for the United Kingdom authorised product—	The only changes to the summary of product characteristics and product literature are those required to bring the marketing authorisation for parallel import back in direct line with those of the United Kingdom authorised product	835

Application for a variation to a marketing authorisation that has been issued in other member States

14

(1) In this paragraph the types of variation are those specified in Commission Regulation (EC) 1084/2003.

(2) An applicant must make a separate application for a variation for each change in the marketing authorisation (unless a change is a direct consequence of the first change).

(3) The fee is in accordance with the following table.

Type of variation	UK is the reference member State (£)	UK is a concerned member State (£)
Type II variation:	8,990	2,220
If a marketing authorisation holder applies for a Type II variation for a number of marketing authorisations, and— all the applications have identical supporting data all the changes are identical all the applications are submitted at the same time the fee payable is—
for the first variation:	8,990	2,220
for each subsequent variation:	1,555	440
If a marketing authorisation holder— applies for a Type II variation to correct the Summary of Product Characteristics or product literature or where variations are required for simple text layout changes the change is not a result of safety concerns no new studies are required to support the change no other aspects of the dossier are changed the fee payable is:	2,455	475
Type 1A variation:	1,555	440
Type 1B variation:	2,455	475
If a marketing authorisation holder applies for a Type 1B variation for a number of marketing authorisations, and— all the applications have identical supporting data all the changes are identical all the applications are submitted at the same time the fee payable is—
for the first variation:	2,455	475
for each subsequent variation:	1,555	440

Application for an extension to a marketing authorisation

15

The fee for an application for an extension to a marketing authorisation is in accordance with the following table.

Extension	Fee if the marketing authorisation is UK only (£)	Fee for a decentralised application where the United Kingdom is a concerned member State or the mutual recognition of an extension authorised in another member State (£)
Change of strength or potency or the addition of a new strength or potency:	6,400	3,180
Change of pharmaceutical form or the addition of a new pharmaceutical form:	8,080	3,690
Change of route of administration, or the addition of a new one, of— an immunological product, or a pharmaceutical product for a non-food-producing animal:	5,170	2,790
a pharmaceutical product for a food-producing animal:	6,850	3,300
Change or addition of target species:	9,240	4,080
Change of active substance:	8,080	3,690
Other:	8,080	3,690
Simultaneous application —fee for each additional product in the application:	2,780	1,610

Decentralised application for an extension where the United Kingdom is the reference member State

16

(1) The fee for a decentralised application for an extension where the United Kingdom is the reference member State is the same as for a national application as set out in the table in paragraph 15, with the additions of the fees in the following table.

Application	Additional fee (£)
Pharmaceutical product for a food-producing animal—one concerned member State:	3,560
Pharmaceutical product for a non-food-producing animal—one concerned member State:	3,100
Immunological product—one concerned member State:	3,300
Each additional concerned member State:	510

(2) In the case of a simultaneous application, the fee for each additional product in the application is £6,400 for one concerned member State and £110 for each additional concerned member State.

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

17

(1) Where an application is made for the Secretary of State to provide information to other member States to enable them to recognise a marketing authorisation already granted by the United Kingdom the following fees are payable.

(2) Where a valid application to provide information to another member State is received within six months of the original grant of the marketing authorisation, or where the Secretary of State has already provided the information to a member State, and a further valid application is made for him to provide the information to an additional member State within six months of the date he last provided the information the fees are—

Type of application	Fee (£)
Pharmaceutical product for a food-producing animal—one member State:	2,345
Pharmaceutical product for a non-food-producing animal—one member State:	1,820
Immunological product—one member State:	2,050
Each additional member State:	510

(3) In any other case the fees are—

Type of application	Fee (£)
Pharmaceutical product for a food-producing animal—one member State:	10,105
Pharmaceutical product for a non-food-producing animal—one member State:	7,080
Immunological product—one member State:	8,595
Each additional member State:	510

(4) In the case of simultaneous applications, the above fees are payable for each additional product in the application for one member State, with a fee of £110 for each additional product for each additional member State.

Application for the renewal of a national marketing authorisation

18

(1) The fee for the renewal of a national marketing authorisation originally granted on or after 30th October 2005 is £1,305.

(2) In the case of a marketing authorisation originally granted before 30th October 2005—

(a) if it is the first time the marketing authorisation has been renewed, or if the renewal entails assessment of post authorisation commitments the fee is £1,305, and

(b) otherwise £295.

(3) The fee for the first reassessment of a provisional marketing authorisation is £295, and the fee for each subsequent reassessment is £1,305.

Application for the renewal of a marketing authorisation granted in more than one member State

19

The fee for the renewal of a marketing authorisation granted in more than one member State is—

(a) £1,765 if the United Kingdom is the reference member State, and

(b) £1,175 where the United Kingdom is a concerned member State.

Registration of a homeopathic remedy

20

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

Type of application	Fee (£)
If all stocks and the formulation have already been assessed by the Secretary of State— not more than five stocks:	155
more than five stocks:	360
If either all the stocks have already been assessed by the Secretary of State but there is a new formulation, or 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:	440
more than five stocks:	640
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:	730
more than five stocks:	945
If the product is already authorised for human use in the United Kingdom, or for human or veterinary use in the United Kingdom or in another member State— not more than five stocks:	155
more than five stocks:	360

Annual fees for marketing authorisations

21

(1) Within 30 days of receiving a written demand from the Secretary of State, a holder of a marketing authorisation shall provide him with a statement of his turnover for the previous calendar year; and, if specified in the demand, an audit certificate relating to the turnover.

(2) When he provides the statement of his turnover he shall pay an annual fee, rounded up to the next £10, of—

$$£0.67T100+£220n$ where T is 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 £220,000, the amount, rounded up to the next £10, is—

$$£0.67T100+£110n$ where T and n mean the same as in the preceding sub-paragraph.$

(4) In this paragraph—

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

“manufacturers' prices” means the prices charged 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 which he has neither manufactured nor obtained from the manufacturer, in which case it means the prices paid by him for those products.

Auditor’s certificate

22

(1) If the Secretary of State required an audit certificate when he sent out the demand for the statement of turnover, and the holder of the marketing authorisation has not provided it within 30 days, an additional fee is payable for that year of £10,765 plus an additional £2,155 in respect of each marketing authorisation held.

(2) 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, he shall require the marketing authorisation holder to produce within 30 days a further certificate and specify what further assurances he needs; and if these are not provided within those 30 days the additional fee specified in sub-paragraph (1) is payable.

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

Late payment of annual fees

23

(1) Where a person fails to pay the annual fee for a marketing authorisation within 30 days from and including the date of the demand, he must pay an additional fee, rounded up to the nearest £10, of—

(a) where payment is received after 30 but before 60 days have expired from and including the due date, 1% of the annual fee;

(b) where payment is received after 60 but before 90 days have expired from and including the due date, 2% of the annual fee; and

(2) Where a marketing authorisation holder has not provided the Secretary of State with a statement of his annual turnover so that the annual fee cannot be determined before the due date, he may make a payment of an amount on account of the annual fee, in which case the additional fee is calculated on the difference between the amount paid on account and the actual amount due.

PART 3 — Fees payable by manufacturers

Application for a manufacturing authorisation

24

The fee for an application for a manufacturing authorisation for a veterinary medicinal product is £2,660.

Application for a variation of a manufacturing authorisation

25

The fee for an application to vary a manufacturing authorisation is £475 where the variation requires scientific or pharmaceutical assessment, and £165 where it does not.

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

26

(1) The fee for an application for a standard authorisation to manufacture an autogenous vaccine or a veterinary medicinal product for administration under the cascade is £3,035 for each manufacturing site, with the same fee for each subsequent inspection.

(2) In the case of an application for an individual authorisation to manufacture a single batch of autogenous vaccine, or a single batch of veterinary medicinal product for administration under the cascade the fee is £1,515.

(3) The fee to vary an authorisation is £285 if no further inspection is required, and otherwise is the full application fee.

Annual fees

27

(1) An annual fee of £245 is payable in respect of each manufacturing authorisation held (other than a manufacturing authorisation in relation to an autogenous vaccine or a veterinary medicinal product for administration under the cascade).

(2) The annual fee for a manufacturing authorisation for an autogenous vaccine or a veterinary medicinal product for administration under the cascade is 0.67% of the turnover in the previous calendar year rounded up to the next £1, with a minimum fee of £10, and in this paragraph “turnover” has the meaning given in paragraph 21(4).

Site inspections—type of site

28

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

29

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 (£)
Super site:	24,615
Major site:	17,325
Standard site:	5,570
Minor site:	4,865

Inspection of a site where sterile veterinary medicinal products are manufactured

30

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 (£)
Super site:	18,125
Major site:	10,020
Standard site:	4,925
Minor site:	3,295

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

31

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	Fee (£)
Super site:	10,925
Major site:	5,750
Standard site:	4,125
Minor site:	2,225

Inspection of a site where veterinary medicinal products are assembled

32

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 (£)
Super site:	7,945
Major site:	5,365
Standard site:	2,635
Minor site:	1,360

Test sites

33

The fee for the inspection of a test site is £2,730.

Animal blood bank authorisations

34

(1) The fee for an authorisation to operate a blood bank is £3,035, with the same fee for each subsequent inspection.

(2) The fee for a variation is £285.

Expenses

35

In addition the travel and subsistence costs of the inspectors, and any additional costs reasonably incurred by them (including, in the case of an inspection outside the United Kingdom, interpreters' fees) are payable.

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

Application for a wholesale dealer’s authorisation

36

(1) The fee for an application for a wholesale dealer’s authorisation is—

(a) £1,550; or

(b) £635 if the application is accompanied by an estimate that the first year’s turnover will be less than £40,000.

(2) If the applicant paid a fee of £635, he shall send a declaration of his turnover for the first year of trading on the anniversary of the grant of the authorisation, and if the figure is more than £40,000 he shall pay the balance of £915 within 30 days.

(3) If the applicant paid £1,550 but his turnover for the first year of trading was lower than £40,000, if he sends a declaration certifying the turnover, the Secretary of State shall refund the excess.

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

(5) For the purposes of this paragraph, “turnover” has the same meaning as in paragraph 38.

Variation of a wholesale dealer’s authorisation

37

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

(a) £475 if the variation requires scientific or pharmaceutical assessment;

(b) otherwise £165.

Annual fee for a wholesale dealer’s authorisation

38

(1) The annual fee for a wholesale dealer’s authorisation, payable on the anniversary of the grant of the authorisation, is—

(a) £495, or

Reading this document does not replace reading the official text published on legislation.gov.uk. Contains public sector information licensed under the Open Government Licence v3.0. We assume no responsibility for any inaccuracies arising from the conversion of the original CLML XML to this format.

This text is published under legislation.gov.uk's own terms of reuse, not a Legalize or public-domain licence. legislation.gov.uk
Open Government Licence v3.0 (attribution required)
© Crown and database right. Derived from content available under the Open Government Licence v3.0 from legislation.gov.uk.