The Veterinary Medicines (Amendment etc.) Regulations 2024

PART 7 Amendments to Schedule 5 to the 2013 Regulations

Introduction

127.  Schedule 5 to the 2013 Regulations (medicated feedingstuffs and specified feed additives) is amended in accordance with this Part.

Amendment to paragraph 1

128.  In paragraph 1(3) (interpretation)—

(a) omit the definition of “premixture”;

(b) at the appropriate place insert—

““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;”.

Amendment to paragraph 3

129.  In paragraph 3(3) (enforcement of Regulation (EC) No 1831/2003) for “a premixture” substitute “an intermediate feedingstuff”.

Amendment to paragraph 7

130.  In paragraph 7 (approval of manufacturers and distributors of feedingstuffs containing veterinary medicinal products)—

(a) in sub-paragraph (2)—

(i) for “veterinary medicinal product”, in each place it occurs, substitute “medicinal premix”;

(ii) for “a premixture” substitute “an intermediate feedingstuff”;

(iii) for “premixtures” substitute “intermediate feedingstuffs”;

(iv) for “approved” substitute “authorised”;

(b) in sub-paragraph (3)—

(i) for “approval”, in both places it occurs, substitute “authorisation”;

(ii) for “establishments” substitute “premises”;

(c) in sub-paragraph (4) for “approved” substitute “authorised”;

(d) for sub-paragraph (5) substitute—

“(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.”;

(e) in sub-paragraph (6) for “veterinary medicinal product” substitute “medicinal premix”;

(f) in sub-paragraph (7) for “approval” substitute “authorisation”;

(g) in the heading—

(i) for “Approval” substitute “Authorisation”;

(ii) for “veterinary medicinal products” substitute “medicinal premixes”.

Amendment to paragraph 8

131.  In paragraph 8 (incorporation of veterinary medicinal product into premixture)—

(a) for “veterinary medicinal product”, in both places it occurs, substitute “medicinal premix”;

(b) for “a premixture” substitute “an intermediate feedingstuff”;

(c) in the heading for “veterinary medicinal product into a premixture” substitute “medicinal premix into an intermediate feedingstuff”.

Amendment to paragraph 10

132.  In paragraph 10 (incorporation of veterinary medicinal product into feedingstuffs)—

(a) for “veterinary medicinal product”, in each place it occurs other than the occurrence dealt with in sub-paragraph (b), substitute “medicinal premix”;

(b) for “a premixture containing a veterinary medicinal product” substitute “an intermediate feedingstuff”;

(c) in sub-paragraph (c) for “prescription” substitute “medicated feedingstuff prescription”;

(d) in the heading for “veterinary medicinal product” substitute “medicinal premix”.

Amendment to paragraph 11

133.  In paragraph 11 (additional record keeping requirements)—

(a) in sub-paragraph (1)—

(i) in paragraph (a)—

(aa) for “veterinary medicinal product” substitute “medicinal premix”;

(bb) for “a premixture” substitute “an intermediate feedingstuff”;

(ii) in paragraph (b)—

(aa) for “a premixture” substitute “an intermediate feedingstuff”;

(bb) for “veterinary medicinal product” substitute “medicinal premix”;

(iii) in paragraph (c) for “veterinary medicinal product” substitute “medicinal premix”;

(iv) in paragraph (d)—

(aa) for “veterinary medicinal products” substitute “medicinal premixes”;

(bb) for “premixture” substitute “intermediate feedingstuffs”;

(v) in paragraph (e)—

(aa) for “premixture” substitute “intermediate feedingstuffs”;

(bb) for “veterinary medicinal product” substitute “medicinal premix”;

(b) in sub-paragraph (2)—

(i) for “approved” substitute “authorised”;

(ii) for “premixtures” substitute “intermediate feedingstuffs”;

(iii) for “veterinary medicinal products” substitute “medicinal premixes”;

(c) in sub-paragraph (3)—

(i) in paragraph (c) for “premixture” substitute “intermediate feedingstuffs”;

(ii) in paragraph (e) for “veterinary medicinal product” substitute “medicinal premix”;

(iii) after paragraph (e) omit “and”;

(iv) after paragraph (f) insert—

“; and

(g) the batch number.”;

(d) in the heading for “veterinary medicinal products” substitute “medicinal premixes”.

Amendment to paragraph 12

134.  In paragraph 12 (labelling a premixture containing veterinary medicinal product)—

(a) in sub-paragraph (1)—

(i) in the words before paragraph (a)—

(aa) for “A premixture” substitute “An intermediate feedingstuff”;

(bb) for “veterinary medicinal product” substitute “medicinal premix”;

(ii) in paragraph (a) for “MEDICATED PREMIXTURE” substitute “INTERMEDIATE FEEDINGSTUFF”;

(iii) in paragraph (b) for “veterinary medicinal product” substitute “medicinal premix”;

(iv) in paragraph (c) for “premixture” substitute “intermediate feedingstuff”;

(v) in paragraph (d)—

(aa) for “premixture” substitute “intermediate feedingstuff”;

(bb) for “prescription” substitute “medicated feedingstuffs prescription”;

(vi) after paragraph (e) insert—

“(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”;”;

(vii) in paragraph (f) for “prescription” substitute “medicated feedingstuffs prescription”;

(viii) in paragraph (h) at the end insert “required by the marketing authorisation”;

(ix) in paragraph (i) for “prescription” substitute “medicated feedingstuffs prescription”;

(b) in sub-paragraph (2) for “veterinary medicinal product” substitute “medicinal premix”;

(c) in sub-paragraph (3) for “premixture” substitute “intermediate feedingstuff”;

(d) in sub-paragraph (4) for “a premixture” substitute “an intermediate feedingstuff”;

(e) in the heading—

(i) for “a premixture” substitute “an intermediate feedingstuff”;

(ii) for “veterinary medicinal product” substitute “medicinal premix”.

Amendment to paragraph 14

135.  In paragraph 14 (labelling of feedingstuffs containing veterinary medicinal product)—

(a) in sub-paragraph (1)—

(i) for “veterinary medicinal product”, in each place it occurs, substitute “medicinal premix”;

(ii) after paragraph (e) insert—

“(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”;”;

(iii) in paragraph (f) for “prescription” substitute “medicated feedingstuffs prescription”;

(iv) after paragraph (f) insert—

“(fa) the batch number;”;

(v) in paragraph (i) for “prescription” substitute “medicated feedingstuffs prescription”;

(vi) in paragraph (j) for “approval” substitute “authorisation”;

(b) in sub-paragraph (2) for “veterinary medicinal product” substitute “medicinal premix”;

(c) in sub-paragraph (4) after “feedingstuffs” insert “containing a medicinal premix”;

(d) in the heading for “veterinary medicinal product” substitute “medicinal premix”.

Amendment to paragraph 15

136.  In paragraph 15 (supply of specified feed additives)—

(a) for “approved”, in each place it occurs, substitute “authorised”;

(b) in sub-paragraph (2)(b) for “premixture” substitute “intermediate feedingstuff”;

(c) in sub-paragraph (3)(b) for “premixture” substitute “intermediate feedingstuff”.

Amendment to paragraph 16

137.  In paragraph 16 (supply of premixture)—

(a) for “approved”, in each place it occurs, substitute “authorised”;

(b) in sub-paragraph (1) for “a premixture”, in both places it occurs, substitute “an intermediate feedingstuff or specified feed additive”;

(c) in sub-paragraph (2) for “premixture”, in both places it occurs, substitute “intermediate feedingstuff or specified feed additive”;

(d) in sub-paragraph (3) for “premixture” substitute “intermediate feedingstuff or specified feed additive”;

(e) in the heading for “premixture” substitute “intermediate feedingstuff or specified feed additive”.

Amendment to paragraph 17

138.  In paragraph 17 (supply of complementary feedingstuff)—

(a) for “approved”, in each place it occurs, substitute “authorised”;

(b) in sub-paragraph (2)(b) for “a premixture” substitute “an intermediate feedingstuff”;

(c) in sub-paragraph (3)(b) for “a premixture” substitute “an intermediate feedingstuff”;

(d) omit sub-paragraph (4).

Amendment to paragraph 18

139.  In paragraph 18 (supply of feedingstuffs containing veterinary medicinal product)—

(a) for “approved”, in each place it occurs, substitute “authorised”;

(b) in sub-paragraph (1) for “veterinary medicinal product” substitute “medicinal premix”;

(c) in sub-paragraph (2)(b) for “a person who keeps animals” substitute “an animal keeper”;

(d) in sub-paragraph (3)(b) for “a person who keeps animals” substitute “an animal keeper”;

(e) in sub-paragraph (4)—

(i) for “a person who keeps animals” substitute “an animal keeper”;

(ii) for “prescription” substitute “medicated feedingstuff prescription”;

(f) in sub-paragraph (5) for “prescription” substitute “medicated feedingstuff prescription”;

(g) in sub-paragraph (7) for “prescription” substitute “medicated feedingstuff prescription”;

(h) after sub-paragraph (7) insert—

“(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.”;

(i) in the heading for “veterinary medicinal product” substitute “medicinal premix”.

Amendment to paragraph 19

140.  In paragraph 19 (prescriptions for feedingstuffs containing veterinary medicinal product)—

(a) in sub-paragraph (1)—

(i) for “prescription” substitute “medicated feedingstuff prescription”;

(ii) for “veterinary medicinal product”, in both places it occurs, substitute “medicinal premix”;

(iii) after paragraph (e) insert—

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

(iv) for paragraph (h) substitute—

“(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;”;

(v) after paragraph (j) insert—

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

(vi) in paragraph (l)—

(aa) for “approved” substitute “authorised”;

(bb) at the end insert “, whichever is the supplier to the end user”;

(vii) after paragraph (n) insert—

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

(viii) omit paragraph (o);

(b) in sub-paragraph (2) for “prescription” substitute “medicated feedingstuff prescription”;

(c) after sub-paragraph (2) insert—

“(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.”.

(d) for sub-paragraph (3) substitute—

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

(e) in the heading—

(i) for “Prescriptions” substitute “Medicated feedingstuff prescriptions”;

(ii) for “veterinary medicinal product” substitute “medicinal premix”.

Amendment to paragraph 20

141.  In paragraph 20 (writing the prescription)—

(a) in sub-paragraph (1)—

(i) in the words before paragraph (a) for “prescription” substitute “medicated feedingstuff prescription”;

(ii) in paragraph (a)—

(aa) for “veterinary medicinal product” substitute “medicinal premix”;

(bb) at the end insert “, whichever is the supplier to the end user”;

(b) in sub-paragraph (2) for “veterinary medicinal product”, in both places it occurs, substitute “medicinal premix”;

(c) in paragraph (3)—

(i) for “veterinary medicinal product”, in each place it occurs, substitute “medicinal premix”;

(ii) for “veterinary medicinal products” substitute “medicinal premixes”;

(d) in the heading for “prescription” substitute “medicated feedingstuff prescription”.

Amendment to paragraph 21

142.  In paragraph 21 (possession)—

(a) in sub-paragraph (1)—

(i) in the words before paragraph (a) for “approval” substitute “authorisation”;

(ii) in paragraph (a) for “veterinary medicinal product” substitute “medicinal premix”;

(iii) in paragraph (b)—

(aa) for “premixtures” substitute “intermediate feedingstuffs”;

(bb) for “veterinary medicinal product” substitute “medicinal premix”;

(iv) in paragraph (c) for “such an additive or a veterinary medicinal product” substitute “a medicinal premix”;

(b) in sub-paragraph (2)—

(i) for “veterinary medicinal product” substitute “medicinal premix”;

(ii) for “prescription” substitute “medicated feedingstuffs prescription”.

Amendment to paragraph 22

143.  In paragraph 22 (sampling and analysis), in sub-paragraph (2) for the table substitute—

“Tolerance table for medicated feedingstuff

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

New paragraph 22A

144.  After paragraph 22 insert—

“Sampling for cross-contamination

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.”.

Amendment to paragraph 23

145.  In paragraph 23 (storage)—

(a) for “veterinary medicinal product”, in both places it occurs, substitute “medicinal premix”;

(b) for “a premixture” substitute “an intermediate feedingstuff”.

Amendment to paragraph 24

146.  In paragraph 24 (packages and other containers) for “veterinary medicinal product” substitute “medicinal premix”.

Amendment to paragraph 25

147.  In paragraph 25 (transport)—

(a) in sub-paragraph (2) for “veterinary medicinal products” substitute “medicinal premixes”;

(b) in sub-paragraph (3) for “veterinary medicinal product” substitute “medicinal premix or specified feed additive”;

(c) in sub-paragraph (4) for “veterinary medicinal products” substitute “medicinal premixes”.

Amendment to paragraph 26

148.  In paragraph 26 (possession, placing on market and use of feedingstuffs)—

(a) in sub-paragraph (1) for “veterinary medicinal products” substitute “medicinal premixes”;

(b) in sub-paragraph (2), for “veterinary medicinal product”, in each place it occurs, substitute “medicinal premix”;

(c) after sub-paragraph (2) insert—

“(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.”;

(d) in sub-paragraph (3) for “veterinary medicinal product” substitute “medicinal premix”.

New paragraph 26A

149.  After paragraph 26 insert—

“Unused and expired medicated feedingstuffs

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

Amendment to paragraph 28

150.  In paragraph 28(b) (trade) for “veterinary medicinal product”, in the second place it occurs, substitute “medicinal premix”.

Amendment to paragraph 29

151.  In paragraph 29 (import for incorporation into premixture or feedingstuffs for export)—

(a) in sub-paragraph (1) for “premixture”, in both places it occurs, substitute “intermediate feedingstuffs”;

(b) in sub-paragraph (2) for “premixture” substitute “intermediate feedingstuff”;

(c) in the heading for “premixture” substitute “intermediate feedingstuffs”.

Amendment to paragraph 30

152.  In paragraph 30 (animals on domestic premises)—

(a) in sub-paragraph (1)—

(i) for “approval” substitute “authorisation”;

(ii) for “veterinary medicinal product”, in both places it occurs, substitute “medicinal premix”;

(b) in sub-paragraph (2)—

(i) for “a premixture” substitute “an intermediate feedingstuff”;

(ii) for “veterinary medicinal product”, in both places it occurs, substitute “medicinal premix”;

(c) in sub-paragraph (3) for “premixture” substitute “intermediate feedingstuffs”.

Amendment to paragraph 31

153.  In paragraph 31 (offences)—

(a) after sub-paragraph (p) insert—

“(pa) paragraph 19;”;

(b) after sub-paragraph (r) insert—

“(ra) paragraph 22A;”;

(c) in sub-paragraph (v) for “or (2)” substitute “, (2), (2A), (2B) or (2C)”;

(d) after sub-paragraph (v) insert—

“(va) paragraph 26A;”.