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The Veterinary Medicines Regulations 2013

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Regulation 8

SCHEDULE 4U.K.Administration of a veterinary medicinal product outside the terms of a marketing authorisation

This schedule has no associated Explanatory Memorandum

Administration under the cascadeE+W+S

1.—(1) A veterinary surgeon acting under this paragraph who prescribes a veterinary medicinal product may either administer it personally or may direct another person to do so under the responsibility of the veterinary surgeon.

(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 there is no such product that is suitable, either—

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

(ii)a veterinary medicinal product not authorised in the United Kingdom but authorised in another [F1country] for use with any animal species (in the case of a food-producing animal, it must be a food-producing species); or

(c)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 [F2country], if the veterinary surgeon has not obtained a certificate from the Secretary of State under regulation 25(5) permitting importation, the veterinary surgeon must obtain a certificate from the Secretary of State before administration.

(4) [F3All substances] included in a medicinal product administered to a food-producing animal under the cascade must [F4be substances for which a maximum residue limit has been established under Regulation (EC) No 470/2009 of the European Parliament and of the Council] [F5or substances which do not fall within the scope of Regulation (EC) No 470/2009 of the European Parliament and of the Council].

[F6(5) Where a substance mentioned in sub-paragraph (4) is administered, the maximum residue limits established in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council must be complied with.]

Extent Information

E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F3Words in Sch. 4 para. 1(4) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 120(a)(i)

F5Words in Sch. 4 para. 1(4) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 120(a)(ii)

Administration under the cascadeN.I.

1.—(1) A veterinary surgeon acting under this paragraph who prescribes a veterinary medicinal product may either administer it personally or may direct another person to do so under the responsibility of the veterinary surgeon.

(2) If there is no authorised veterinary medicinal product in [F33Northern Ireland] 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 [F33Northern Ireland] for use with another animal species, or for another condition in the same species; or

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

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

(ii)a veterinary medicinal product not authorised in [F33Northern Ireland] 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 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 importation, the veterinary surgeon must obtain a certificate from the Secretary of State before administration.

(4) Any pharmacologically active substances included in a medicinal product administered to a food-producing animal under the cascade must be listed in Table 1 in the Annex to Commission Regulation (EU) No 37/2010.

Extent Information

E9This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Withdrawal periodsE+W+S

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

[F7(2) The withdrawal period must ensure that—

(a)where there is a maximum residue limit established for the active substance for the treated species under Regulation (EC) No 470/2009 of the European Parliament and of the Council, the level of residue of the active substance does not exceed that limit; and

(b)where there is no maximum residue limit for the treated species established under Regulation (EC) No 470/2009 of the European Parliament and of the Council but one is established for the substance itself, the level of residue of the active substance does not exceed the level determined by reference to Commission Implementing Regulation (EU) 2018/470 on detailed rules on the maximum residue limit to be considered for control purposes for foodstuffs derived from animals which have been treated in the EU under Article 11 of Directive 2001/82/EC.]

(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 [F8has been established]) must not be less than—

[F9(a)for eggs—

(i)the longest withdrawal period in the summary of product characteristics for any species multiplied by a factor of 1.5; or

(ii)14 days, if the product is not authorised for animals producing eggs for human consumption;]

[F10(b)for milk—

(i)the longest withdrawal period in the summary of product characteristics for any species multiplied by a factor of 1.5;

(ii)7 days, if the veterinary medicinal product is not authorised for animals producing milk for human consumption; or

(iii)1 day, if the medicinal product has a zero-hour withdrawal period;]

[F11(c)for meat and offal from food-producing mammals, poultry and farmed game-birds—

(i)the longest withdrawal period provided in its summary of product characteristics for meat and offal, multiplied by a factor of 1.5;

(ii)28 days if the veterinary medicinal product is not authorised for food-producing animals; or

(iii)1 day, if the veterinary medicinal product has a zero-day withdrawal period;]

[F12(d)for aquatic species producing meat for human consumption—

(i)the longest withdrawal period for any of the aquatic species in the summary of product characteristics multiplied by a factor of 1.5 and expressed as degree-days;

(ii)if the medicinal product is authorised for food-producing terrestrial animal species, the longest withdrawal period for any of the food-producing animal species in the summary of product characteristics multiplied by a factor of 50 and expressed as degree-days; or

(iii)25 degree-days if the highest withdrawal period for any animal species is zero.]

[F13(4) For the purposes of sub-paragraph (3)—

(a)if the calculation of a withdrawal period results in a fraction of days, the withdrawal period must be rounded to the nearest number of days, with any half of a day being rounded upwards;

(b)in relation to the calculation of the withdrawal period for milk, if the calculation of the period results in a milk withdrawal period not divisible by 12, the withdrawal period must be rounded up to the nearest multiple of 12 hours.]

Extent Information

E2This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Withdrawal periodsN.I.

2.—(1) A veterinary surgeon prescribing or 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 Table 1 in the Annex to Commission Regulation (EU) No 37/2010, 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 Table 1 in the Annex to Commission Regulation (EU) No 37/2010) must not be less than—

(a)7 days for eggs;

(b)7 days for milk;

(c)28 days for meat from poultry and mammals including fat and offal;

(d)500 degree days(1) for fish meat.

Extent Information

E10This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Administration to food-producing horsesU.K.

3.—(1) If there is no authorised veterinary medicinal product for a food-producing horse (as shown on its horse passport) and treatment under the cascade is unsuitable, substances may be administered in accordance with Commission Regulation (EC) No 122/2013 (establishing, in accordance with Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products, a list of substances essential for the treatment of equidae (2)).

(2) The person administering the substance must comply with Article 3(2) of Commission Regulation (EC) No 122/2013 (recording the details of the treatment in the animal’s passport).

Immunological products for serious epizootic disease [F14or emerging disease]E+W+S

4.  In the event of serious epizootic diseases [F15or emerging 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 F16... and may publicise any permit as the Secretary of State sees fit.

Extent Information

E3This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Immunological products for serious epizootic diseaseN.I.

4.  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 and may publicise any permit as the Secretary of State sees fit.

Extent Information

E11This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Immunological products for an imported or exported animalE+W+S

5.  If an animal is imported from, or exported to, [F17another] 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 [F18that other] country.

Extent Information

E4This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Immunological products for an imported or exported animalN.I.

5.  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 [F34Northern Ireland] but is authorised under the legislation of the third country.

Extent Information

E12This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Administration by veterinary surgeons from other [F19countries] E+W+S

6.—(1) Veterinary surgeons practising in another [F20country with equivalent medicines regulation standards to those of the United Kingdom] 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 [F21country] in which the veterinary surgeon is established;

(c)the product is transported by the veterinary surgeon in the original manufacturer’s packaging;

(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 is acquainted with the Code of Professional Conduct for veterinary surgeons issued by the Royal College of Veterinary Surgeons(3).

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

(3) The veterinary surgeon 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 or clinical assessment, the products administered, the dosage administered, the duration of treatment and the withdrawal period applied, and must keep them in the United Kingdom for at least three years.

(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.

Extent Information

E5This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Administration by veterinary surgeons from F35... member StatesN.I.

6.—(1) Veterinary surgeons practising in [F36a] member State may bring into [F37Northern Ireland] and administer to animals small quantities of veterinary medicinal products that are not authorised for use in [F37Northern Ireland] 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;

(c)the product is transported by the veterinary surgeon in the original manufacturer’s packaging;

(d)in the case of administration to food-producing animals, there is a veterinary medicinal product authorised in [F38Northern Ireland] that has the same qualitative and quantitative composition in terms of active substances;

(e)the veterinary surgeon is acquainted with the Code of Professional Conduct for veterinary surgeons issued by the Royal College of Veterinary Surgeons(3).

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

(3) The veterinary surgeon must—

[F39(a)ensure that the withdrawal period specified on the label of the product is complied with, or the Northern Ireland withdrawal period for the equivalent product authorised in Northern Ireland if this is longer than the one on the label; and]

(b)keep detailed records of the animals treated, the diagnosis or clinical assessment, the products administered, the dosage administered, the duration of treatment and the withdrawal period applied, and must keep them in [F40Northern Ireland] for at least three years.

(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.

Extent Information

E13This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

[F22Administration of autogenous vaccinesE+W+S

6A.—(1) An autogenous vaccine may only be administered to animals in exceptional circumstances where no suitable immunological veterinary medicinal product has been authorised in relation to the target species and indication.

(2) Where a vaccine is used in accordance with sub-paragraph (1) it must be administered in accordance with a prescription under the cascade.]

Textual Amendments

Treatment in exceptional circumstancesE+W+S

7.—(1) Where 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 [F23another] country; but a veterinary surgeon who has not obtained a certificate from the Secretary of State under regulation 25(5) permitting importation must obtain a certificate from the Secretary of State before treating the animal.

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

Extent Information

E6This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Treatment in exceptional circumstancesN.I.

7.—(1) Where 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 a veterinary surgeon who has not obtained a certificate from the Secretary of State under regulation 25(5) permitting importation must obtain a certificate from the Secretary of State before treating the animal.

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

Extent Information

E14This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Administration of a homeopathic remedyU.K.

8.—(1) A registered homeopathic remedy or a homeopathic remedy prepared and supplied by a pharmacist under paragraph 10 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 personally or under the veterinary surgeon’s responsibility—

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

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

Administration under an animal test certificateE+W+S

9.—(1) A medicinal product may be administered in accordance with an animal test certificate granted for [F24clinical trials] by the Secretary of State.

(2) An application for an animal test certificate may be refused if this is necessary for the protection of animal or public health or the environment, and the animal test certificate may be varied, suspended or revoked in the same way as a marketing authorisation.

(3) The holder of an animal test certificate may not supply a product for administration that is not within the terms of the animal test certificate.

(4) The holder of an animal test certificate test who becomes aware of any [F25adverse event] following the administration of a product under an animal test certificate must report the reaction to the Secretary of State within [F2630 days] of learning of it.

Extent Information

E7This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Administration under an animal test certificateN.I.

9.—(1) A medicinal product may be administered in accordance with an animal test certificate granted for research purposes by the Secretary of State.

(2) An application for an animal test certificate may be refused if this is necessary for the protection of animal or public health or the environment, and the animal test certificate may be varied, suspended or revoked in the same way as a marketing authorisation.

(3) The holder of an animal test certificate may not supply a product for administration that is not within the terms of the animal test certificate.

(4) The holder of an animal test certificate test who becomes aware of any serious adverse reaction following the administration of a product under an animal test certificate must report the reaction to the Secretary of State within 15 days of learning of it.

Extent Information

E15This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F27Misuse of the cascadeE+W+S

9A.  A person must not promote or facilitate any purported use of the cascade which is not in accordance with this Schedule.]

Textual Amendments

OffencesE+W+S

10.  It is an offence to fail to comply with—

[F28(za)paragraph 2;]

(a)paragraph 3(2);

(b)paragraph 6; F29...

[F30(ba)paragraph 6A;]

(c)paragraph 9(3) or [F31(4); or]

[F32(d)paragraph 9A.]

Extent Information

E8This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

OffencesN.I.

10.  It is an offence to fail to comply with—

(a)paragraph 3(2);

(b)paragraph 6; or

(c)paragraph 9(3) or (4).

Extent Information

E16This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

(1)

The number of days of the withdrawal period is calculated by dividing 500 by the mean temperature of the water in degrees Celsius.

(2)

OJ No L42, 13.2.2013, p. 1.

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