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The Veterinary Medicines Regulations 2013

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Regulation 14

SCHEDULE 5U.K.Medicated feedingstuffs and specified feed additives

This Atodlen has no associated Memorandwm Esboniadol

Scope and interpretationU.K.

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

(c)all other zootechnical additives except—

(i)digestibility enhancers;

(ii)gut flora stabilisers; and

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

(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—

[F1“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;]

[F2“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.

Textual Amendments

Enforcement of Regulation (EC) No 178/2002U.K.

2.—(1) For the purposes of [F3Regulation (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);

(c)Article 15(1) (prohibition on the placing on the market or feeding unsafe feedingstuffs);

(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).

Textual Amendments

Enforcement of Regulation (EC) No 1831/2003E+W+S

3.—(1) For the purposes of [F4Regulation (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 [F5an 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 [F6another] 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);

(c)Article 16(1) (labelling);

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

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

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

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

Enforcement of Regulation (EC) No 1831/2003N.I.

3.—(1) For the purposes of [F158Regulation (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 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) 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);

(c)Article 16(1) (labelling);

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

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

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

Extent Information

E25This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Enforcement of [F7Regulation (EU) 2017/625] E+W+S

4.  For the purposes of [F8 Regulation (EU) 2017/625] the competent authority is the Secretary of State.

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

[F159Enforcement of Regulation (EU) 2017/625N.I.

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

Extent Information

E26This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Enforcement of Regulation (EC) No 183/2005U.K.

5.—(1) For the purposes of [F9Regulation (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);

(c)Article 7(1) (documents concerning the 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.

Textual Amendments

Enforcement of Regulation (EC) No 767/2009U.K.

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.

[F10Authorisation] of manufacturers and distributors of feedingstuffs containing [F11medicinal premixes]E+W+S

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 Community(1) the competent authority is the Secretary of State.

(2) No person may incorporate a [F12medicinal premix] into [F13an intermediate feedingstuff] or feedingstuff, or act as a distributor of [F14intermediate feedingstuffs] or feedingstuffs containing a [F12medicinal premix], without being [F15authorised] to do so by the Secretary of State.

(3) The conditions which govern [F16authorisation] of feed business [F17premises] under Regulation (EC) No 183/2005 laying down requirements for feed hygiene(2) also govern [F16authorisation] of manufacturers and distributors under sub-paragraph (2).

(4) The Secretary of State shall conduct inspections of manufacturers and distributors [F18authorised] 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.

[F19(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 [F20medicinal premix] annually for that purpose.

(7) In the case of the refusal, suspension or revocation of an [F21authorisation] under this paragraph the appeals procedure relating to a manufacturing authorisation in regulation 30 applies.

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

Approval of manufacturers and distributors of feedingstuffs containing veterinary medicinal productsN.I.

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 Community(1) the competent authority is the Secretary of State.

(2) No person may incorporate a veterinary medicinal product into a premixture or feedingstuff, or act as a distributor of premixtures or feedingstuffs containing a veterinary medicinal product, without being approved to do so by the Secretary of State.

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

(4) The Secretary of State shall conduct inspections of manufacturers and distributors approved 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 veterinary medicinal product is evenly incorporated throughout the feedingstuffs.

(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 veterinary medicinal product annually for that purpose.

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

Extent Information

E27This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Incorporation of a [F22medicinal premix into an intermediate feedingstuff]E+W+S

8.  Any person who incorporates a [F23medicinal premix] into [F24an 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 [F23medicinal premix] does not contain the same active substance as any other additive.

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

Incorporation of a veterinary medicinal product into a premixtureN.I.

8.  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.

Extent Information

E28This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Top dressingU.K.

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 [F25medicinal premix] into feedingstuffsE+W+S

10.  Any person who incorporates a [F26medicinal premix] (or [F27an 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 [F26medicinal premix] does not contain the same active substance as any other additive;

(c)must ensure that the [F26medicinal premix] is incorporated in accordance with its marketing authorisation (unless it has been prescribed under the cascade) and the [F28medicated feedingstuff prescription];

(d)must ensure that the daily dose of the [F26medicinal 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.

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

Incorporation of a veterinary medicinal product into feedingstuffsN.I.

10.  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 complementary feedingstuffs.

Extent Information

E29This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Additional record keeping requirements relating to [F29medicinal premixes] E+W+S

11.—(1) Any person who—

(a)incorporates a [F30medicinal premix] into [F31an intermediate feedingstuff];

(b)incorporates [F32an intermediate feedingstuff] containing a [F33medicinal premix] into feedingstuffs; or

(c)incorporates a [F34medicinal premix] into feedingstuffs,

must make a daily record of—

(d)the types and quantities of all [F35medicinal premixes] (and specified feed additives, if any) and [F36intermediate feedingstuffs] used in the manufacturing process; and

(e)the quantity of feedingstuffs and [F37intermediate feedingstuffs] containing [F38medicinal premix] manufactured that day.

(2) An [F39authorised] distributor must make a daily record of—

(a)the types and quantities of all [F40intermediate feedingstuffs] and feedingstuffs containing [F41medicinal 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);

(c)the type of feedingstuffs or [F42intermediate feedingstuffs] supplied;

(d)the quantity;

(e)the type of [F43medicinal premix] incorporated into the feedingstuffs; F44...

(f)the expiry date [F45; and

(g)the batch number.]

(4) Records must be kept for five years.

Textual Amendments

F37Words in Sch. 5 para. 11(1)(e) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 133(a)(v)(aa)

Additional record keeping requirements relating to veterinary medicinal productsN.I.

11.—(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

(c)incorporates a veterinary medicinal product into feedingstuffs,

must make a daily record of—

(d)the types and quantities of all veterinary medicinal products (and specified feed additives, if any) and premixture used in the manufacturing process; and

(e)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; 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);

(c)the type of feedingstuffs or premixture supplied;

(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.

Labelling [F46an intermediate feedingstuff] containing a [F47medicinal premix]E+W+S

12.—(1) [F48An intermediate feedingstuff] containing a [F49medicinal premix] must be clearly and legibly labelled with the following—

(a)the words “[F50INTERMEDIATE FEEDINGSTUFF]” (or, if it is to be labelled as “complementary feedingstuffs” under legislation implementing Council Directive 79/373/EEC on the marketing of compound feedingstuffs(3), “MEDICATED COMPLEMENTARY FEEDINGSTUFFS” ) in upper case letters;

(b)the proprietary name of the [F51medicinal premix] and the authorisation number;

(c)the name and amount of the active substance (mg/kg) in the [F52intermediate feedingstuff];

(d)the range of acceptable inclusion rates of the [F53intermediate feedingstuff] into the final feedingstuffs, the range of acceptable levels of the active ingredients in the final feedingstuffs and the words “refer to the [F54medicated feedingstuffs prescription] for the exact inclusion rate” or equivalent wording;

(e)warnings and contra-indications;

[F55(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 [F56medicated feedingstuffs prescription] requires a longer withdrawal period, that is the one that applies;

(g)the expiry date;

(h)any special storage instructions [F57required by the marketing authorisation];

(i)where a [F58medicated feedingstuffs prescription] is required, a statement to this effect.

(2) If there is more than one [F59medicinal premix] used, the longest withdrawal period must be shown on the label.

(3) If the [F60intermediate 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 1831/2003(4).

(4) No person may supply such [F61an intermediate feedingstuff] unless it is labelled in accordance with this paragraph.

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

Labelling a premixture containing a veterinary medicinal productN.I.

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

(a)the words “MEDICATED PREMIXTURE” (or, if it is to be labelled as “complementary feedingstuffs” under legislation implementing Council Directive 79/373/EEC on the marketing of compound feedingstuffs(3), “MEDICATED COMPLEMENTARY FEEDINGSTUFFS” ) in upper case letters;

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

(c)the name and amount of the active substance (mg/kg) in the premixture;

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

(e)warnings and contra-indications;

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

(g)the expiry date;

(h)any special storage instructions;

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

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

(3) 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(4).

(4) No person may supply such a premixture unless it is labelled in accordance with this paragraph.

Extent Information

E30This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Labelling of feedingstuffs containing a specified feed additiveU.K.

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 [F62medicinal premix]E+W+S

14.—(1) Feedingstuffs containing a [F63medicinal 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 [F63medicinal premix] incorporated into the feedingstuffs;

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

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

(e)warnings and contra-indications;

[F64(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 [F65medicated feedingstuffs prescription] requires a longer withdrawal period, that is the one that applies;

[F66(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 [F67medicated feedingstuffs prescription];

(j)the name and [F68authorisation] number of the manufacturer or the distributor.

(2) If there is more than one [F69medicinal 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 [F70containing a medicinal premix] unless they are labelled in accordance with this paragraph.

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

Labelling of feedingstuffs containing a veterinary medicinal productN.I.

14.—(1) Feedingstuffs containing a veterinary medicinal product 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 veterinary medicinal product incorporated into the feedingstuffs;

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

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

(e)warnings and contra-indications;

(f)the withdrawal period, and a statement that, if the 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)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) If there is more than one veterinary medicinal product 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 unless they are labelled in accordance with this paragraph.

Extent Information

E31This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Supply of specified feed additivesE+W+S

15.—(1) No person other than the person who manufactured a specified feed additive or an [F71authorised] distributor may supply a specified feed additive.

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

(a)an [F71authorised] distributor;

(b)an [F71authorised] [F72intermediate feedingstuff] manufacturer or an [F71authorised] complementary feedingstuffs manufacturer; or

(c)a feedingstuff manufacturer [F71authorised] to mix a specified feed additive directly into feedingstuff.

(3) An [F71authorised] distributor may only supply it to—

(a)another [F71authorised] distributor;

(b)an [F71authorised] [F73intermediate feedingstuff] manufacturer or an [F71authorised] complementary feedingstuffs manufacturer; or

(c)a feedingstuff manufacturer [F71authorised] to mix a specified feed additive directly into feedingstuff.

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

Supply of specified feed additivesN.I.

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

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

(a)an approved distributor;

(b)an approved premixture manufacturer or an approved complementary feedingstuffs manufacturer; or

(c)a feedingstuff manufacturer approved to mix a specified feed additive directly into feedingstuff.

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

(a)another approved distributor;

(b)an approved premixture manufacturer or an approved complementary feedingstuffs manufacturer; or

(c)a feedingstuff manufacturer approved to mix a specified feed additive directly into feedingstuff.

Extent Information

E32This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Supply of [F74intermediate feedingstuff or specified feed additive]E+W+S

16.—(1) No person other than the person who manufactured [F75an intermediate feedingstuff or specified feed additive] or an [F76authorised] distributor may supply [F75an intermediate feedingstuff or specified feed additive].

(2) The person who manufactured the [F77intermediate feedingstuff or specified feed additive] may only supply it to—

(a)an [F76authorised] distributor; or

(b)a feedingstuff manufacturer [F76authorised] to incorporate that [F77intermediate feedingstuff or specified feed additive].

(3) An [F76authorised] distributor may only supply it to—

(a)another [F76authorised] distributor; or

(b)a feedingstuff manufacturer [F76authorised] to incorporate that [F78intermediate feedingstuff or specified feed additive].

Extent Information

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

Textual Amendments

Supply of premixtureN.I.

16.—(1) No person other than the person who manufactured a premixture or an approved distributor may supply a premixture.

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

(a)an approved distributor; or

(b)a feedingstuff manufacturer approved to incorporate that premixture.

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

(a)another approved distributor; or

(b)a feedingstuff manufacturer approved to incorporate that premixture.

Extent Information

E33This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Supply of a complementary feedingstuffE+W+S

17.—(1) No person other than—

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

(b)an [F79authorised] 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 [F79authorised] distributor; or

(b)a feedingstuff manufacturer registered to incorporate that complementary feedingstuff or [F79authorised] to incorporate [F80an intermediate feedingstuff].

(3) An [F79authorised] distributor may only supply it to—

(a)another [F79authorised] distributor, or

(b)a feedingstuff manufacturer registered to incorporate that complementary feedingstuff or [F79authorised] to incorporate [F81an intermediate feedingstuff].

F82(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

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

Textual Amendments

Supply of a complementary feedingstuffN.I.

17.—(1) No person other than—

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

(b)an approved 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 approved distributor; or

(b)a feedingstuff manufacturer registered to incorporate that complementary feedingstuff or approved to incorporate a premixture.

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

(a)another approved distributor, or

(b)a feedingstuff manufacturer registered to incorporate that complementary feedingstuff or approved to incorporate a premixture.

(4) In this paragraph “complementary feedingstuff” has the meaning given in Article 3 of Regulation EC No 767/2009.

Extent Information

E34This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Supply of feedingstuffs containing a [F83medicinal premix]E+W+S

18.—(1) No person other than the person who manufactured the feedingstuffs or an [F84authorised] distributor may supply feedingstuffs containing a [F85medicinal premix].

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

(a)an [F84authorised] distributor; or

(b)[F86an animal keeper] for feeding to those animals.

(3) A distributor may only supply it to—

(a)another [F84authorised] distributor; or

(b)[F87an animal keeper] for feeding to those animals.

(4) Supply to [F88an animal keeper] must be in accordance with a written [F89medicated feedingstuff prescription] as specified in the following paragraph.

(5) If a [F90medicated 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 [F91medicated feedingstuff prescription] for five years.

[F92(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.]

Extent Information

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

Textual Amendments

Supply of feedingstuffs containing a veterinary medicinal productN.I.

18.—(1) No person other than the person who manufactured the feedingstuffs or an approved distributor may supply feedingstuffs containing a veterinary medicinal product.

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

(a)an approved distributor; or

(b)a person who keeps animals for feeding to those animals.

(3) A distributor may only supply it to—

(a)another approved distributor; or

(b)a person who keeps animals for feeding to those animals.

(4) Supply to a person who keeps animals must be in accordance with a written prescription as specified in the following paragraph.

(5) If a 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 prescription for five years.

Extent Information

E35This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F93Medicated feedingstuff prescriptions] for feedingstuffs containing a [F94medicinal premix]E+W+S

19.—(1) A [F95medicated feedingstuff prescription] for feedingstuffs containing a [F96medicinal 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;

(c)the name and address of the keeper of the animals to be treated;

(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;

[F97(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;

[F98(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;

[F99(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 [F100authorised] for the purpose) [F101, 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;

[F102(na)the overall amount of feedingstuff to be supplied under the prescription;]

F103(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 [F104medicated feedingstuff prescription].

[F105(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.]

[F106(3) In relation to food-producing animals a medicated feedingstuffs prescription may not confer authority for more than one course of treatment.]

Extent Information

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

Textual Amendments

Prescriptions for feedingstuffs containing a veterinary medicinal productN.I.

19.—(1) A prescription for feedingstuffs containing a veterinary medicinal product 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;

(c)the name and address of the keeper of the animals to be treated;

(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;

(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)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;

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

(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 prescription.

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

Extent Information

E36This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Writing the [F107medicated feedingstuff prescription]E+W+S

20.—(1) The person who writes the [F108medicated feedingstuff prescription] must—

(a)give a copy to the person incorporating the [F109medicinal premix] into the feedingstuffs or to the distributor of the feedingstuffs [F110, whichever is the supplier to the end user];

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

(c)keep a copy.

(2) The person must be satisfied that—

(a)there is no undesirable interaction between the [F111medicinal premix] and any feed additive used in the feedingstuffs; and

(b)the active substance of the [F111medicinal premix] is not the same as an active substance in any feed additive used in the feedingstuffs.

[F112(3) The person must prescribe a [F113medicinal premix] authorised for incorporation in feedingstuffs but may, if there is no [F113medicinal premix] authorised for a condition in a particular species—

(a)prescribe a [F113medicinal premix] authorised for another species or for another condition in the same species, and

(b)prescribe more than one [F113medicinal premix],

provided all [F114medicinal premixes] prescribed are authorised for incorporation in feedingstuffs.]

Extent Information

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

Textual Amendments

Writing the prescriptionN.I.

20.—(1) 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;

(c)keep a copy.

(2) The person 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.

[F160(3) The person must prescribe a veterinary medicinal product authorised for incorporation in feedingstuffs but may, if there is no veterinary medicinal product authorised for a condition in a particular species—

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

(b)prescribe more than one veterinary medicinal product,

provided all veterinary medicinal products prescribed are authorised for incorporation in feedingstuffs.]

Extent Information

E37This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

PossessionE+W+S

21.—(1) No person other than a person holding the appropriate [F115authorisation] under this Schedule may be in possession of any—

(a)specified feed additive or [F116medicinal premix] to which this Schedule applies;

(b)[F117intermediate feedingstuffs] containing such an additive or a [F118medicinal premix]; or

(c)feedingstuffs or complementary feedingstuffs containing [F119a medicinal premix] unless supplied under these Regulations.

(2) No person other than a manufacturer or distributor may be in possession of feedingstuffs incorporating a [F120medicinal premix] unless it has been supplied under a [F121medicated feedingstuffs prescription].

Extent Information

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

Textual Amendments

PossessionN.I.

21.—(1) No person other than a person holding the appropriate approval under this Schedule may 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

(c)feedingstuffs or complementary feedingstuffs containing such an additive or a veterinary medicinal product unless supplied under these Regulations.

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

Extent Information

E38This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Sampling and analysisE+W+S

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 [F122Regulation (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—

[F123Tolerance table for medicated feedingstuff

Level of active ingredient specified on the labelTolerance
≤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.

Extent Information

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

Textual Amendments

Sampling and analysisN.I.

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 [F161Regulation (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—

Tolerance table for medicated feedingstuff

Level of active ingredient specified on the labelTolerance
≤50 mg/kg ±  50%
>50 mg/kg ≤ 500 mg/kg ±  40%
>500 mg/kg ≤ 5g/kg ±  30%
>5g/kg ≤50g/kg ±  20%
>50g/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.

Extent Information

E39This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

[F124Sampling for cross-contaminationE+W+S

22A.—(1) A feed business operator must ensure that cross-contamination of non-target feeds is as low as is reasonably achievable.

(2) A feed business operator must analyse samples of non-target feeds in order to determine whether cross-contamination into non-target feed has occurred.

(3) Where as a result of the process mentioned in sub-paragraph (2) it is determined that a cross-contamination rate has occurred which is 1% or more but less than 3% compared to the authorised maximum content, the feed business operator must make a record of this cross-contamination.

(4) Where as a result of the process mentioned in sub-paragraph (2) it is determined that a cross-contamination rate has occurred of 3% or more compared to the authorised maximum content, the feed business operator must conduct an investigation in order to discover the cause of the occurrence and make a record of the fact and any conclusions.

(5) The feed business operator must keep the records under sub-paragraphs (3) and (4) for at least five years.

(6) Upon request of the Secretary of State, the feed business operator must provide any information in the feed business operator’s possession relating to the matters mentioned in this paragraph.]

Textual Amendments

StorageE+W+S

23.  No person may store a [F125medicinal premix] intended for incorporation into feedingstuffs, or [F126an intermediate feedingstuff] or feedingstuffs containing a [F125medicinal 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.

Extent Information

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

Textual Amendments

StorageN.I.

23.  No person may store a veterinary medicinal product intended for incorporation into feedingstuffs, or a premixture or feedingstuffs containing a veterinary medicinal product, except in—

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

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

Extent Information

E40This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Packages and other containersE+W+S

24.  No person may place on the market feedingstuffs containing a [F127medicinal 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.

Extent Information

E17This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Packages and other containersN.I.

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

Extent Information

E41This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

TransportE+W+S

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 [F128medicinal 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 [F129medicinal 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 [F130medicinal 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.

Extent Information

E18This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

TransportN.I.

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 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 the transporter 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.

Extent Information

E42This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Possession, placing on the market and use of feedingstuffsE+W+S

26.—(1) No person may possess, place on the market or feed to animals any feedingstuffs incorporating [F131medicinal 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 [F132medicinal premix] or specified feed additive unless—

(a)that [F132medicinal 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 [F132medicinal premix], it was prescribed for that animal.

[F133(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;

(c)no product escapes into the environment; and

(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 [F134medicinal premix] has been incorporated in accordance with an animal test certificate or the feedingstuff has been imported in accordance with this Schedule.

Extent Information

E19This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Possession, placing on the market and use of feedingstuffsN.I.

26.—(1) No person may 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) No person may feed to any animal, or buy, possess or supply for the purpose of feeding to any animal, any feedingstuff containing a veterinary medicinal product or specified feed additive unless—

(a)that veterinary medicinal product 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 veterinary medicinal product, it was prescribed for that animal.

(3) This paragraph does 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.

Extent Information

E43This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F135Unused and expired medicated feedingstuffsE+W+S

26A.  No person may feed medicated feedingstuffs which have passed their expiry date to an animal.]

Textual Amendments

Imports from third countriesE+W+S

F13627.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E20This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Imports from third countriesN.I.

27.  No person may import a feedingstuff containing a veterinary medicinal product from a third country.

Extent Information

E44This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Trade between [F137countries]E+W+S

28.  No person may bring in from another [F138country] a feedingstuff containing a veterinary medicinal product unless—

F139(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b)it only contains a veterinary medicinal product that has the same quantitative and qualitative composition as a [F140medicinal premix] authorised in [F141Great Britain].

Extent Information

E21This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Trade [F162with] member StatesN.I.

28.  No person may bring in from [F163a] member State a feedingstuff containing a veterinary medicinal product unless—

(a)the feedingstuff has 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 Community(5)) and Regulation (EC) No 183/2005 of the European Parliament and of the Council laying down requirements for food hygiene; and

(b)it only contains a veterinary medicinal product that has the same quantitative and qualitative composition as a veterinary medicinal product authorised in [F164Northern Ireland].

Extent Information

E45This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Import for incorporation into [F142intermediate feedingstuffs] or feedingstuffs for exportE+W+S

29.—[F143(1) A manufacturer of [F144intermediate feedingstuffs] or feedingstuffs who imports a veterinary medicinal product authorised in another F145... country for the purposes of incorporating it into [F144intermediate 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 [F146intermediate feedingstuff] or feedingstuff on the market in the United Kingdom once the veterinary medicinal product has been incorporated into it.

Extent Information

E22This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Import for incorporation into premixture or feedingstuffs for exportN.I.

29.—[F165(1) A manufacturer of premixture or feedingstuffs who imports a veterinary medicinal product authorised in [F166a] Member State or third country for the purposes of incorporating it into premixture 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 premixture or feedingstuff on the market in [F167Northern Ireland] once the veterinary medicinal product has been incorporated into it.

Extent Information

E46This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Animals on domestic premisesE+W+S

30.—(1) The requirements of paragraph 7 ([F147authorisation] of manufacturers and distributors of feedingstuffs containing [F148medicinal premix]) do not apply in relation to a person who incorporates a [F148medicinal 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 [F149an intermediate feedingstuff] containing a [F150medicinal premix], or feedingstuffs containing a [F150medicinal 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 [F151intermediate feedingstuffs] and feedingstuffs in the same way as they apply to a veterinary medicinal product.

Extent Information

E23This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Animals on domestic premisesN.I.

30.—(1) The requirements of paragraph 7 (approval of manufacturers and distributors of feedingstuffs containing veterinary medicinal product) 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 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 a premixture containing a veterinary medicinal product, or feedingstuffs containing a veterinary medicinal product, 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 premixture and feedingstuffs in the same way as they apply to a veterinary medicinal product.

Extent Information

E47This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

OffencesE+W+S

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

(a)paragraph 2(2);

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

(c)paragraph 5(2) or (3);

(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;

[F152(pa)paragraph 19;]

(q)paragraph [F15320];

(r)paragraph 21;

[F154(ra)paragraph 22A;]

(s)paragraph 23;

(t)paragraph 24;

(u)paragraph 25;

(v)paragraph 26(1) [F155, (2), (2A), (2B) or (2C)];

[F156(va)paragraph 26A;]

F157(w). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(x)paragraph 28; or

(y)paragraph 29(2).

Extent Information

E24This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F153Word in Sch. 5 para. 31(q) substituted (14.4.2014) by The Veterinary Medicines (Amendment) Regulations 2014 (S.I. 2014/599), regs. 1, 3(4)

OffencesN.I.

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

(a)paragraph 2(2);

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

(c)paragraph 5(2) or (3);

(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;

(q)paragraph [F16820] ;

(r)paragraph 21;

(s)paragraph 23;

(t)paragraph 24;

(u)paragraph 25;

(v)paragraph 26(1) or (2);

(w)paragraph 27;

(x)paragraph 28; or

(y)paragraph 29(2).

Extent Information

E48This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F168Word in Sch. 5 para. 31(q) substituted (14.4.2014) by The Veterinary Medicines (Amendment) Regulations 2014 (S.I. 2014/599), regs. 1, 3(4)

(1)

OJ No L 92, 7.4.1990, p. 42.

(2)

OJ No L 35, 8.2.2005, p. 1.

(3)

OJ No L86, 6.4.1979, p. 30.

(4)

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

(5)

OJ No L 92, 7.4.90, p. 42.

Yn ôl i’r brig

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Mae deddfwriaeth ar gael mewn fersiynau gwahanol:

Y Diweddaraf sydd Ar Gael (diwygiedig):Y fersiwn ddiweddaraf sydd ar gael o’r ddeddfwriaeth yn cynnwys newidiadau a wnaed gan ddeddfwriaeth ddilynol ac wedi eu gweithredu gan ein tîm golygyddol. Gellir gweld y newidiadau nad ydym wedi eu gweithredu i’r testun eto yn yr ardal ‘Newidiadau i Ddeddfwriaeth’.

Gwreiddiol (Fel y’i Deddfwyd neu y’i Gwnaed): Mae'r wreiddiol fersiwn y ddeddfwriaeth fel ag yr oedd pan gafodd ei deddfu neu eu gwneud. Ni wnaed unrhyw newidiadau i’r testun.

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Gweler y wybodaeth ychwanegol ochr yn ochr â’r cynnwys

Rhychwant ddaearyddol: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.

Dangos Llinell Amser Newidiadau: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.

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Dewisiadau Agor

Dewisiadau gwahanol i agor deddfwriaeth er mwyn gweld rhagor o gynnwys ar y sgrin ar yr un pryd

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Memorandwm Esboniadol

Mae Memoranda Esboniadol yn nodi datganiad byr o ddiben Offeryn Statudol ac yn rhoi gwybodaeth am ei amcan polisi a goblygiadau polisi. Maent yn ceisio gwneud yr Offeryn Statudol yn hygyrch i ddarllenwyr nad oes ganddynt gymhwyster cyfreithiol, ac maent yn cyd-fynd ag unrhyw Offeryn Statudol neu Offeryn Statudol Drafft a gyflwynwyd ger bron y Senedd o Fehefin 2004 ymlaen.

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Rhagor o Adnoddau

Gallwch wneud defnydd o ddogfennau atodol hanfodol a gwybodaeth ar gyfer yr eitem ddeddfwriaeth o’r tab hwn. Yn ddibynnol ar yr eitem ddeddfwriaeth sydd i’w gweld, gallai hyn gynnwys:

  • y PDF print gwreiddiol y fel deddfwyd fersiwn a ddefnyddiwyd am y copi print
  • rhestr o newidiadau a wnaed gan a/neu yn effeithio ar yr eitem hon o ddeddfwriaeth
  • manylion rhoi grym a newid cyffredinol
  • pob fformat o’r holl ddogfennau cysylltiedig
  • slipiau cywiro
  • dolenni i ddeddfwriaeth gysylltiedig ac adnoddau gwybodaeth eraill
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Asesiadau Effaith

Impact Assessments generally accompany all UK Government interventions of a regulatory nature that affect the private sector, civil society organisations and public services. They apply regardless of whether the regulation originates from a domestic or international source and can accompany primary (Acts etc) and secondary legislation (SIs). An Impact Assessment allows those with an interest in the policy area to understand:

  • Why the government is proposing to intervene;
  • The main options the government is considering, and which one is preferred;
  • How and to what extent new policies may impact on them; and,
  • The estimated costs and benefits of proposed measures.
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Llinell Amser Newidiadau

This timeline shows the different points in time where a change occurred. The dates will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. The first date in the timeline will usually be the earliest date when the provision came into force. In some cases the first date is 01/02/1991 (or for Northern Ireland legislation 01/01/2006). This date is our basedate. No versions before this date are available. For further information see the Editorial Practice Guide and Glossary under Help.

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Rhagor o Adnoddau

Defnyddiwch y ddewislen hon i agor dogfennau hanfodol sy’n cyd-fynd â’r ddeddfwriaeth a gwybodaeth am yr eitem hon o ddeddfwriaeth. Gan ddibynnu ar yr eitem o ddeddfwriaeth sy’n cael ei gweld gall hyn gynnwys:

  • y PDF print gwreiddiol y fel gwnaed fersiwn a ddefnyddiwyd am y copi print
  • slipiau cywiro

liciwch ‘Gweld Mwy’ neu ddewis ‘Rhagor o Adnoddau’ am wybodaeth ychwanegol gan gynnwys

  • rhestr o newidiadau a wnaed gan a/neu yn effeithio ar yr eitem hon o ddeddfwriaeth
  • manylion rhoi grym a newid cyffredinol
  • pob fformat o’r holl ddogfennau cysylltiedig
  • dolenni i ddeddfwriaeth gysylltiedig ac adnoddau gwybodaeth eraill