Legalize / United Kingdom / Statutory-Instrument

The Veterinary Medicines (Amendment etc.) Regulations 2024

Type Statutory-Instrument

Publication 2024-04-25

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

PDF Download

articles Not indexed

Reform history JSON API

After paragraph 21 (and immediately before the heading for Part 3) insert—

(21A) The Secretary of State must establish, maintain and publish on a website a register of authorised wholesale dealers and their sites. (21B) (1) This paragraph applies in relation to wholesale supply of veterinary medicinal products. (2) The holder of a wholesale dealer’s authorisation must ensure that a document accompanies each consignment of veterinary medicinal products specifying— (a) the name of the veterinary medicinal product; (b) the strength and pharmaceutical form; (c) the date on which the veterinary medicinal product was supplied; (d) the quantity of product supplied; (e) the batch number; (f) the expiry date; (g) the name and address of the wholesale dealer supplying the product; (h) the means by which the product was transported and the required conditions of storage; (i) the name of the person to whom the product was supplied and the address to which it is to be delivered. (3) The holder of a wholesale dealer’s authorisation must make a record of the information mentioned in sub-paragraph (2) and must keep it for at least five years. (21C) (1) The holder of a wholesale dealer’s authorisation must comply with any requirement by the Secretary of State to recall a veterinary medicinal product and must record the details of the recall operation. (2) The holder of a wholesale dealer’s authorisation must record any veterinary medicinal product which is— (a) recalled (whether or not the holder physically receives the recalled product); (b) discovered to be counterfeit; or (c) returned. (3) Where any veterinary medicinal product is recalled or returned and physically received, the wholesale qualified person must assess the product received in order to determine whether the product has been stored (including during transport) in accordance with the summary of product characteristics. (4) Where a recalled or returned veterinary medicinal product has not been stored (including during transport) in accordance with the summary of product characteristics or where it is not possible for the wholesale qualified person to determine whether the product has been stored in accordance with the summary of product characteristics, the product may not be re-sold. (5) Any veterinary medicinal products which may not be re-sold must be identified, held separately and destroyed and the holder of a wholesale dealer’s authorisation must develop a suitable procedure to set out the steps to be taken in accordance with this sub-paragraph. (6) The holder of a wholesale dealer’s authorisation must keep any information recorded under this paragraph for five years. (21D) (1) At least once a year, the holder of a wholesale dealer’s authorisation must carry out a detailed audit of stock and compare the incoming and outgoing veterinary medicinal products recorded with products currently held and record the results of the audit in written form. (2) Where, as a result of the audit mentioned in sub-paragraph (1), the holder identifies a discrepancy the holder must— (a) make a record of that fact, (b) conduct an investigation for the purpose of discovering the cause of the discrepancy, and (c) maintain records of that investigation. (3) The holder must keep the records mentioned in sub-paragraphs (1) and (2) for a period of five years from the date of the audit and the Secretary of State may require the holder to provide a copy of them at any time within that period. (21E) Where the holder of a wholesale dealer’s authorisation contracts out any wholesale dealing activities to another such holder, the arrangement must record in writing the responsibilities of each party in relation to their respective roles in the supply process and, in particular, in connection with the recall of a veterinary medicinal product under paragraph 21C. (21F) (1) The holder of a wholesale dealer’s authorisation must have in place a self-inspection programme which ensures that every aspect of its business is inspected at least once a year in order to ensure that it is complying with good distribution practice. (2) Where, as a result of the self-inspection mentioned in sub-paragraph (1), the holder identifies any non-compliance the holder must— (a) make a record of that fact, (b) conduct an investigation for the purpose of discovering the cause of the non-compliance, and (c) maintain records of that investigation. (3) The holder must keep the records mentioned in sub-paragraph (2) for a period of five years from the date of the audit and the Secretary of State may require the holder to provide a copy of them at any time within that period.

Amendment to paragraph 23

117

In paragraph 23(1) (use of sheep dip) for the words from the beginning to “holds either” substitute “No person may use sheep dip which contains a veterinary medicinal product unless they hold, or they are acting under the supervision and in the presence of a person who holds, either”.

Amendment to paragraph 24

118

In paragraph 24 (offences)—

(a) after sub-paragraph (b) insert—

(ba) paragraph 3A; (bb) paragraph 3B; (bc) paragraph 3C; (bd) paragraph 3D; (be) paragraph 3E;

(b) after sub-paragraph (d) insert—

(da) paragraph 6;

(ea) paragraph 7A;

(d) after sub-paragraph (m) insert—

(ma) paragraph 16;

(e) omit sub-paragraph (n);

(f) after sub-paragraph (o) insert—

(oa) paragraph 21B; (ob) paragraph 21C; (oc) paragraph 21D; (od) paragraph 21E; (oe) paragraph 21F;

PART 6 — Amendments to Schedule 4 to the 2013 Regulations

Introduction

119

Schedule 4 to the 2013 Regulations (administration outside terms of marketing authorisation) is amended in accordance with this Part.

Amendment to paragraph 1

120

In paragraph 1 (administration under the cascade)—

(a) in sub-paragraph (4)—

(i) for the words “Any pharmacologically active substances” substitute “All substances”;

(ii) at the end insert “or substances which do not fall within the scope of Regulation (EC) No 470/2009 of the European Parliament and of the Council”;

(b) after sub-paragraph (4) insert—

(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.

Amendment to paragraph 2

121

In paragraph 2 (withdrawal periods)—

(a) for sub-paragraph (2) substitute—

(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/EC¹¹.

(b) in sub-paragraph (3)—

(i) for paragraph (a) substitute—

(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;

(ii) for paragraph (b) substitute—

(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;

(iii) for paragraph (c) substitute—

(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;

(iv) for paragraph (d) substitute—

(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.

(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.

Amendment to paragraph 4

122

In paragraph 4 (immunological products for serious epizootic disease)—

(a) after “epizootic diseases” insert “or emerging diseases”;

(b) in the heading at the end insert “or emerging disease”.

New paragraph 6A

123

After paragraph 6 (administration by veterinary surgeons from other countries) insert—

(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.

Amendment to paragraph 9

124

In paragraph 9 (administration under animal test certificate)—

(a) in sub-paragraph (1) for “research purposes” substitute “clinical trials”;

(b) in sub-paragraph (4)—

(i) for “serious adverse reaction” substitute “adverse event”;

(ii) for “15 days” substitute “30 days”.

New paragraph 9A

125

After paragraph 9 insert—

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

Amendment to paragraph 10

126

In paragraph 10 (offences)—

(a) before sub-paragraph (a) insert—

(za) paragraph 2;

(b) in sub-paragraph (b) omit “or”;

(ba) paragraph 6A;

(d) in sub-paragraph (c) for “(4).” substitute “(4); or”;

(e) after sub-paragraph (c) insert—

(d) paragraph 9A.

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”;

(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”;

(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”;

(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”;

(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”;

(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”;

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”;

(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”;

(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”;

(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”;

(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—

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—

(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”;

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”;

(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—

(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”;

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”;

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;

(d) after sub-paragraph (v) insert—

(va) paragraph 26A;

PART 8 — Amendments to Schedule 6 to the 2013 Regulations

Introduction

154

Schedule 6 to the 2013 Regulations (exemptions for small pet animals) is amended in accordance with this Part.

Amendment to paragraph 2

155

In paragraph 2 (placing on market, import and administration) at the end insert “and the manufacturer appears on the register maintained under paragraph 3A”.

Amendment to paragraph 3

156

In paragraph 3 (manufacture) for sub-paragraph (2) substitute—

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

New paragraphs 3A and 3B

157

After paragraph 3 insert—

(3A) (1) A person placing the product on the market must be registered in accordance with this paragraph. (2) An application for registration in respect of that person must be submitted under sub-paragraph (4)— (a) at least two months before that person places the product on the market, or (b) where that person has already placed the product on the market, within six months of the date on which this provision comes into force. (3) Information may be submitted to the Secretary of State pursuant to sub-paragraph (2) prior to the date on which this provision comes into force, and in such a case— (a) as regards an applicant for registration who has not already placed the product on the market, the period of two months is to be treated as having started on the date of submission; (b) as regards an applicant for registration who has already placed the product on the market, the information is to be treated as having been submitted within the period of six months. (4) An application for registration must be made to the Secretary of State electronically and must include— (a) the name and address of the person placing the product on the market; (b) the individual making the application in respect of that person; (c) the telephone number and email address of the individual mentioned in sub-paragraph (b); (d) the name and address of the manufacturer of the product; (e) the brand name of the product; (f) the names and quantities of the active substances; (g) the method and (where applicable) route of administration; (h) the dosage instructions; (i) the category of animal mentioned in paragraph 1 for which the product is intended. (5) For the purposes of sub-paragraph (1) the Secretary of State must establish and maintain a register of persons placing on the market products to which this Schedule applies. (6) The particulars entered on the register must include the name and the address of the person mentioned in sub-paragraph (1). (3B) At least once each calendar year a person registered under paragraph 3A must notify the Secretary of State in writing of the following in respect of each product placed on the market— (a) the name and registered address of the person (if different from that listed on the register); (b) the individual designated for the purpose of making the annual return under this paragraph; (c) the telephone number and email address of the individual mentioned in sub-paragraph (b); (d) the name and address of the manufacturer of the product; (e) the brand name of the product; (f) the names and quantities of the active substances; (g) the method and (where applicable) route of administration; (h) the dosage instructions; (i) the category of animal mentioned in paragraph 1 for which the product is intended.

Amendment to paragraph 4

158

In paragraph 4(4)(b) (approval of active substance) for “serious adverse reactions” substitute “adverse events”.

Amendment to paragraph 9

159

In paragraph 9 (adverse reactions)—

(a) for “manufacturer, importer or retailer” substitute “manufacturer or importer”;

(b) in paragraph (a) for “adverse reactions (as defined in paragraph 57 of Schedule 1)” substitute “adverse events”;

(d) omit sub-paragraph (2);

(e) in the heading for “Adverse reactions” substitute “Adverse events”.

New paragraph 10

160

After paragraph 9 insert—

(10) It is an offence to fail to comply with— (a) paragraph 3A(1); (b) paragraph 3B; or (c) paragraph 9(1).

PART 9 — Amendments to Schedule 7 to the 2013 Regulations

Introduction

161

Schedule 7 to the 2013 Regulations (fees) is amended in accordance with this Part.

Amendment to paragraph 1

162

In paragraph 1 (interpretation)—

(a) the existing text is renumbered as sub-paragraph (1);

(b) in sub-paragraph (1), in the definition of “pharmaceutical product”, at the end insert “or a biological veterinary medicinal product that is not immunological”;

(2) For the purposes of this Schedule “manufacturing authorisation” means the following activities— (a) manufacture or import of an authorised veterinary medicinal product; (b) manufacture of a product to which paragraph 2 of Schedule 6 relates; (c) manufacture of a product for administration under the cascade; (d) manufacture of— (i) an autogenous vaccine; (ii) a stem cell product; or (iii) a blood product for administration to non-food animals.

Amendment to paragraph 4

163

In paragraph 4 (multiple inspections)—

(a) omit “, approval”;

(b) after “time,” insert “and in relation to the same legal entity,”.

Amendment to paragraph 7

164

In paragraph 7 (specified pharmaceutical applications)—

(a) after “a pharmaceutical” insert “, immunological or biological that is not immunological”;

(b) in sub-paragraph (a)—

(i) at the end of paragraph (i) insert “, or”;

(ii) in paragraph (ii)—

(aa) after “application” insert “for a pharmaceutical veterinary medicinal product”;

(bb) omit “or”;

(iii) omit paragraph (iii);

Application	Fee (£) per authorisation
Base fee	27,995
Fee for 1st additional strength	4,590
Fee for each subsequent additional strength	1,465

(d) in the heading, after “pharmaceutical” insert “, immunological or biological that is not immunological”.

New paragraph 7A

165

After paragraph 7 insert—

(7A) The fee for an application for a marketing authorisation which involves one or more of the following is £45,000— (a) any biotechnical process involving recombinant DNA or the controlled expression of genes; (b) a veterinary medicinal product containing a new active substance; (c) a biopharmaceutical product.

Amendment to paragraph 9

166

Omit paragraph 9 (application for marketing authorisation for immunological or biosimilar product).

Amendment to paragraph 11

167

For paragraph 11 (application for marketing authorisation based on informed consent) substitute—

(11) The fee for applications for marketing authorisations using identical data submitted simultaneously or on the basis of information provided under paragraph 9 of Schedule 1 is as follows—

Application	Fee (£) per authorisation
Application	1,465

Amendment to paragraph 13

168

In paragraph 13 (application for exceptional marketing authorisation – immunological)—

(a) after “immunological product”, in both places it occurs, insert “or a biological veterinary medicinal product that is not immunological”;

(b) in the heading, for “(immunological)” substitute “(immunological or biological non-immunological)”.

Amendment to paragraph 15

169

Omit paragraph 15 (application for marketing authorisation for parallel import).

New paragraph 15A

170

After paragraph 15 insert—

(15A) (1) The fee for a marketing authorisation in respect of a generic veterinary medicinal product is to be calculated in accordance with the following table.

Application	Fee (£) per authorisation	Fee (£) per authorisation
	Hybrid	Standard
Base Fee	13,950	12,390
Fee for 1st additional strength	4,590
Fee for each subsequent additional strength	1,465.

(2) In this paragraph “hybrid” means an application to which paragraph 10A of Schedule 1 applies.

Amendment to paragraph 17

171

In paragraph 17 (application for variation to marketing authorisation under national or mutual recognition procedure)—

(a) in sub-paragraph (1) omit “18, 19 or”;

(b) for the table substitute—

Type of variations	Type of variations	Type of variations	Fee (£)
Single variations; one change for each product	Single variations; one change for each product	Single variations; one change for each product	Single variations; one change for each product
Variation – standard	Variation – standard	Variation – standard	2,895
	Unless the variation is—	Unless the variation is—
	(a) a change of route of administration, or the addition of a new one, of—	(a) a change of route of administration, or the addition of a new one, of—
	(i)	an immunological product, or a pharmaceutical product for a non-food-producing animal	5,390
	(ii)	a pharmaceutical product for a food-producing animal	7,135
	(b) a change of bioavailability	(b) a change of bioavailability	8,415
	(c) a change of active substance, where the change is to—	(c) a change of active substance, where the change is to—
	(i)	use a different biologically active substance with a slightly different molecular structure	8,415
	(ii)	modify the vector used to produce the antigen or the source material, including a new master cell bank from a different source	8,415
	(d) a change of pharmacokinetics	(d) a change of pharmacokinetics	8,415
	Simultaneous application falling within (a) to (d): fee for each additional product in the application	Simultaneous application falling within (a) to (d): fee for each additional product in the application	1,465
Variation – reduced	Variation – reduced	Variation – reduced	885
Variation - no assessment	Variation - no assessment	Variation - no assessment	455
Grouped variations	Grouped variations	Grouped variations
Variation – standard led	Variation – standard led	Variation – standard led
	For the first nine changes	For the first nine changes	6,280
	For each subsequent group of five or fewer changes	For each subsequent group of five or fewer changes	2,250
Variation – reduced led:	Variation – reduced led:	Variation – reduced led:
	For the first nine changes	For the first nine changes	1,770
	For each subsequent group of five or fewer changes	For each subsequent group of five or fewer changes	2,250

Amendment to paragraph 18

172

Omit paragraph 18 (application for variation to marketing authorisation under worksharing procedure).

Amendment to paragraph 22

173

In paragraph 22 (application for renewal of marketing authorisation)—

(a) omit sub-paragraph (1);

(b) for the heading substitute—

Amendment to paragraph 25

174

Omit paragraph 25 (renewal of homeopathic remedy).

Amendment to paragraph 28

175

In paragraph 28 (application for manufacturing authorisation)—

(a) the existing text is renumbered as sub-paragraph (1);

(b) for the words from “is—” to the end substitute “is £762”;

(2) Fees relating to an application for a manufacturing authorisation are payable with the application.

Amendment to paragraph 29

176

In paragraph 29 (application for variation to manufacturing authorisation)—

(a) in sub-paragraph (a) for “£636” substitute “£684”;

(b) for sub-paragraph (b) substitute—

(b) £105 if the variation only involves an administrative variation such as a change of ownership.”;

Amendment to paragraph 30

177

In paragraph 30 (application for manufacturing authorisation for autogenous vaccine or product for administration under the cascade)—

(a) omit sub-paragraph (1);

(b) for sub-paragraph (2) substitute—

(2) The fees for the inspection of sites in connection with an authorisation (or an application for authorisation) for the manufacture of unauthorised veterinary medicinal products for administration under the cascade are set out in the following table—

Type of site	Fee (£)	Fee (£)
	United Kingdom site	Site outside the United Kingdom
Super site	21,416	22,710
Major site	12,850	14,144
Standard site	6,425	7,719
Minor site	4,283	5,577

(d) for the heading substitute—

New paragraphs 30A and 30B

178

After paragraph 30 insert—

(30A) (1) The fee for the scientific assessment of an authorisation (or an application for authorisation) to manufacture an autogenous vaccine is £6,962. (2) The fees for the inspection of sites in connection with an authorisation (or an application for authorisation) to manufacture autogenous vaccines are set out in the following table—

Type of site	Fee (£)	Fee (£)
	United Kingdom site	Site outside the United Kingdom
Super site	21,416	22,710
Major site	12,850	14,144
Standard site	6,425	7,719
Minor site	4,283	5,577

(30B) The fee for the scientific assessment of an application for the variation of an authorisation to manufacture an autogenous vaccine is— (a) £2,895 if the variation requires complex scientific or pharmaceutical assessment; (b) £885 if the variation requires simple scientific or pharmaceutical assessment; (c) £455 in relation to an administrative variation.

Amendment to paragraph 31

179

For paragraph 31 (annual fees) substitute—

(31) An annual fee of £575 is payable in respect of each manufacturing authorisation held.

Amendment to paragraph 33

180

In paragraph 33 (inspection of manufacturing site for immunological veterinary medicinal products) for the table substitute—

Type of site	Fee (£)	Fee (£)
	United Kingdom site	Site outside the United Kingdom
Super site	32,124	33,418
Major site	21,416	22,710
Standard site	10,708	12,002
Minor site	6,425	7,719

Amendment to paragraph 34

181

In paragraph 34 (inspection of manufacturing site for sterile veterinary medicinal products) for the table substitute—

Type of site	Fee (£)	Fee (£)
	United Kingdom site	Site outside the United Kingdom
Super site	27,841	29,135
Major site	19,274	20,569
Standard site	10,708	12,002
Minor site	6,425	7,719

Amendment to paragraph 35

182

In paragraph 35 (inspection of manufacturing site for other veterinary medicinal products) for the table substitute—

Type of site	Type of site	Fee (£)	Fee (£)
		United Kingdom site	Site outside the United Kingdom
Super site	Super site	21,416	22,710
Major site	Major site	12,850	14,144
Standard site	Standard site	8,566	9,861
Minor site	Minor site	4,283	5,577
If the site is only involved in the manufacture of veterinary medicinal products authorised under Schedule 6 (exemptions for small pet animals)—	If the site is only involved in the manufacture of veterinary medicinal products authorised under Schedule 6 (exemptions for small pet animals)—
	Standard site	3,212	4,507
	Minor site	2,142	3,436

Amendment to paragraph 36

183

In paragraph 36 (inspection of site where veterinary medicinal products are assembled) for the table substitute—

Type of site	Fee (£)	Fee (£)
	United Kingdom site	Site outside the United Kingdom
Super site	17,133	18,427
Major site	10,708	12,002
Standard site	6,425	7,719
Minor site	4,283	5,577

Amendment to paragraph 37

184

In paragraph 37 (test sites)—

(a) for “£3,344” substitute “£3,212”;

(b) for “£3,177” substitute “£4,507”.

Amendment to paragraph 38

185

For paragraph 38 (animal blood bank or equine stem cell centre authorisations) substitute—

(38) (1) The fee for the inspection of a blood bank is— (a) £3,212 for a site in the United Kingdom; and (b) £4,507 for a site outside the United Kingdom. (2) The fee for the inspection of a non-food animal stem cell centre is— (a) £2,142 for a site in the United Kingdom; and (b) £3,436 for a site outside the United Kingdom

Amendment to paragraph 39

186

For paragraph 39 (application for wholesale dealer’s authorisation) substitute—

(39) (1) The fee for an application for a wholesale dealer’s authorisation is £344. (2) Fees relating to an application for a wholesale dealer’s authorisation are payable with the application.

Amendment to paragraph 40

187

For paragraph 40 (variation of wholesale dealer’s authorisation) substitute—

(40) The fee for an application to vary a wholesale dealer’s authorisation is— (a) £265 if the variation requires scientific or pharmaceutical assessment; (b) £105 for a change of ownership or other administrative variation.

Amendment to paragraph 41

188

For paragraph 41 (annual fee for wholesale dealer’s authorisation) substitute—

(41) The annual fee for a wholesale dealer’s authorisation is £427.

Amendment to paragraph 42

189

For paragraph 42 (inspection of wholesale dealer’s premises) substitute—

(42) The fee for inspection of a wholesale dealer’s site is— (a) £1,177; or (b) £877 if— (i) the authorisation only relates to products classified as AVM-GSL or homeopathic remedies; or (ii) the authorisation only relates to products marketed under Schedule 6 (exemptions for small pet animals).

Amendment to paragraph 43

190

In paragraph 43 (approval fees and annual fees for feedingstuffs in Great Britain)—

(a) in sub-paragraph (1)—

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

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

(iii) for “£70” substitute “£105”;

(b) in sub-paragraph (2)—

(i) for “£70” substitute “£122”;

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

(i) for “an establishment” substitute “premises”;

(ii) for “veterinary medicinal product intended to be incorporated into feedingstuffs” substitute “medicinal premix”;

(iii) for “that establishment” substitute “those premises”;

(d) in sub-paragraph (4) omit “or on invoice for the subsequent annual fee”;

(e) in sub-paragraph (5) for “establishment” substitute “premises by the same legal entity”;

(f) in the heading for “approvals” substitute “applications for authorisation”.

Amendment to paragraph 44

191

In paragraph 44 (inspection fees for feedingstuffs in Great Britain)—

(a) in the words before the table for “establishments” substitute “premises”;

(b) for the table substitute—

Type of premises inspected	Fee payable (£)
Manufacturer of a specified feed additive (SFA)	1,610
Manufacturer of an intermediate feedingstuff (including balancers) containing a medicinal premix or an SFA	976
Manufacturer of a feedingstuff for sale containing— a medicinal premix and/or an SFA, and/or an intermediate feedingstuff containing a medicinal premix or an SFA	841
Manufacturer of a feedingstuff for feeding to their own animals only, containing— a medicinal premix and/or an SFA incorporated at a rate of at least 2kg/t, and/or an intermediate feedingstuff containing a medicinal premix and/or an SFA incorporated at a rate of at least 2kg/t	476
Distributor or trader of Schedule 5 products (A distributor of specified feed additives, or intermediate feedingstuffs containing specified feed additives or medicinal premixes; or feedingstuffs containing a medicinal premix)	350

Amendment to paragraph 46

192

In paragraph 46 (premises for supply by suitably qualified persons)—

(a) in sub-paragraph (1)—

(i) for “to approve” substitute “for an application for the authorisation”;

(ii) for “£265” substitute “£105”;

(iii) omit paragraph (b) and the preceding “or”;

(b) after sub-paragraph (1) insert—

(1A) The fees for the inspection of sites authorised for the retail supply of veterinary medicinal products by suitably qualified persons are set out in the following table—

Type of sites inspected	Fee payable (£)
Sites authorised to supply companion animal medicines	285
Sites authorised to supply equine medicines	285
Sites authorised to supply livestock medicines	338
Sites authorised to supply avian medicines	285.

(1B) Where a site is inspected in relation to a single authorisation, and falls within more than one of the categories in the table, only one fee (the highest) is payable.

(i) for “£185” substitute “£57”;

(ii) omit paragraph (b) and the preceding “or”;

(d) after sub-paragraph (2) insert—

(3) The application fee for authorisation of sites for supply is payable with the application.

Amendment to paragraph 48

193

In paragraph 48 (animal test certificates)—

(a) in sub-paragraph (1) for “£815” substitute “£1,170”;

(b) in sub-paragraph (2) for “£30” substitute “£40”;

(4) The fee for an application for the variation of the certificate is— (a) in the case of a small scale trial, £40; and (b) in the case of any other trial, £390.

(d) for sub-paragraph (5) substitute—

(5) The fee for an application to renew a certificate is— (a) in the case of a small scale trial, £40; and (b) in the case of any other trial, £190.

Amendment to paragraph 53

194

In paragraph 53 (export certificates)—

(a) for “£30” substitute “£54”;

(b) omit the words from “, and £15” to the end.

New paragraph 54A

195

After paragraph 54 (provision of advice) insert—

(54A) The fee for an application for written advice from the Secretary of State in relation to scientific matters is £4,487.

Amendment to paragraph 57

196

In paragraph 57 (veterinary surgeon’s practice premises)—

(a) for sub-paragraph (1) substitute—

(1) The fees for the inspection of a veterinary practice premises are set out in the following table—

Type of premises inspected	Fee payable (£)
Sites registered to supply companion animal medicines	536
Sites registered to supply equine medicines	536
Sites registered to supply livestock medicines	536
Mixed practice premises	698
Any other type of practice	451

(b) in sub-paragraph (2), for “£34” substitute “£38”;

(4) For the purposes of sub-paragraph (1) “mixed practice” means premises supplying veterinary medicinal products to livestock in addition to any other category mentioned in that provision.

(d) in the heading omit “surgeon’s”.

New paragraphs 57A and 57B

197

After paragraph 57 insert—

(57A) The fee for verifying the destruction of a controlled drug listed in Schedule 2, 3 or 4 to the Misuse of Drugs Regulations 2001¹² is— (a) £142; or (b) £31 (where the verification takes place during the course of an inspection for other purposes). (57B) (1) In relation to a pharmacovigilance inspection the fee is— (a) £3,600 in the case of a large marketing authorisation holder; and (b) £1,650 in the case of a small marketing authorisation holder. (2) In sub-paragraph (1)— - “large marketing authorisation holder” means a marketing authorisation holder who holds 30 or more marketing authorisations; - “small marketing authorisation holder” means a marketing authorisation holder who holds fewer than 30 marketing authorisations.

Amendment to paragraph 60

198

In paragraph 60 (non-payment of fees)—

(a) omit “(other than any fee relating to a manufacturing authorisation or wholesale dealer’s authorisation)”;

(b) after “from the person” insert “or any authorisation held by the person”.

Amendment to paragraph 61

199

After paragraph 61(1) (waiver or reduction of fees) insert—

(1A) If the Secretary of State is satisfied that exceptional circumstances exist the Secretary of State may waive or reduce an inspection fee payable under these Regulations.

PART 10 — Transitional provisions

Labelling

200

(1) Notwithstanding the amendments made to the following paragraphs of Schedule 1 to the 2013 Regulations by this instrument—

(a) paragraph 48 (labelling of immediate packaging of veterinary medicinal products);

(b) paragraph 49 (labelling of the outer packaging of veterinary medicinal products);

(d) paragraph 51 (package leaflet of veterinary medicinal products);

(e) paragraph 52 (small containers other than ampoules);

(f) paragraph 53 (homeopathic remedies),

it is not an offence under regulation 6 of the 2013 Regulations (marketing of products not in accordance with a marketing authorisation) for the holder of a marketing authorisation in respect of a veterinary medicinal product immediately before the coming into force of this instrument or the manufacturer to supply that veterinary medicinal product before 1st April 2029 in circumstances which would have been in accordance with those paragraphs as they had effect immediately before the coming into force of this instrument if, and for so long as, the conditions in paragraph (2) are met.

(2) The conditions are—

(a) there have been no amendments to the marketing authorisation which involve changes to the labelling approved by the Secretary of State under paragraph 45 of Schedule 1 to the 2013 Regulations since the coming into force of these Regulations;

(b) the information on the labelling remains accurate.

(3) As regards a veterinary medicinal product to which paragraph (1) applies immediately before 1st April 2029—

(a) the provisions referred to in paragraph (1)(a) to (f), as amended by this instrument, apply in respect of that product on and after that date,

(b) any further supply of that veterinary medicinal product which does not comply with those provisions is deemed not to be in accordance with the marketing authorisation for the purposes of regulation 6 of the 2013 Regulations, notwithstanding any previous approvals given under paragraph 45 of Schedule 1 to the 2013 Regulations.

Advertising

201

Notwithstanding the amendments made to regulations 10 (advertising the product) and 11 (advertising of prescription products, etc.) of the 2013 Regulations by this instrument, it is not an offence under regulation 43(f) or (g) of the 2013 Regulations for a person to advertise a veterinary medicinal product before the end of the period which expires three months after the date on which this instrument comes into force if that advertisement would not have caused that person to fail to comply with regulations 10 or 11 of the 2013 Regulations as they had effect immediately before the coming into force of this instrument.

Wholesale supply of veterinary medicinal products by marketing authorisation holders

202

Notwithstanding the amendments made to paragraph 2(1) of Schedule 3 to the 2013 Regulations (wholesale supply of veterinary medicinal products) by this instrument, until the end of the period which expires six months after the date on which this instrument comes into force—

(a) that paragraph is to be read as if it continued to include reference to a holder of a marketing authorisation being able to supply a veterinary medicinal product wholesale, or to be in possession of it for that purpose, and

(b) it is not an offence under paragraph 24(a) of that Schedule for the holder of a marketing authorisation to make such a supply (or to be in such possession) in accordance with that paragraph.

Recording of reasons for prescriptions

203

Notwithstanding the amendments made to paragraph 5 of Schedule 3 to the 2013 Regulations (prescriptions) by this instrument, it is not an offence under paragraph 24(d) of that Schedule to fail to comply with paragraph 5(1A), (1B) or (4) of that Schedule before the end of the period which expires six months after the date on which this instrument comes into force.

Prescription requirements

204

(1) Notwithstanding the amendments made to paragraph 6 of Schedule 3 to the 2013 Regulations (written prescriptions) by this instrument—

(a) it is not an offence under paragraph 24(da) of that Schedule to fail to comply with paragraph 6(1) before the end of the period which expires six months after the date on which this instrument comes into force;

(b) a written prescription issued before the end of the period which expires six months after the date on which this instrument comes into force in accordance with paragraph 6 of Schedule 3 to the 2013 Regulations as it had effect immediately before the coming into force of this instrument is to be treated as validly issued for the purposes of the 2013 Regulations.

(2) A written prescription issued before the end of the period which expires six months after the date on which this instrument comes into force in accordance with paragraph 6 of Schedule 3 to the 2013 Regulations as it had effect immediately before the coming into force of this instrument (including a written prescription to which paragraph (1)(b) applies) continues to be valid until it expires in accordance with paragraph 6(2) or (3) of that Schedule.

Feedingstuffs labelling requirements

205

Notwithstanding the amendments made to paragraphs 12 and 14 of Schedule 5 to the 2013 Regulations (labelling of premixtures and feedingstuffs containing veterinary medicinal product) by this instrument, it is not an offence under paragraph 31(j) or (l) of that Schedule to make a supply before the end of the period which expires six months after the date on which this instrument comes into force which is labelled in accordance with paragraph 12 or 14 (as the case may be) as it had effect immediately before the coming into force of this instrument.

Medicated feedingstuffs prescription requirements

206

Notwithstanding the amendments made to paragraph 19 of Schedule 5 to the 2013 Regulations (prescriptions for feedingstuffs containing a veterinary medicinal product) by this instrument, a prescription issued before the end of the period which expires six months after the date on which this instrument comes into force in accordance with that paragraph as it had effect immediately before the coming into force of this instrument continues to be valid until it expires in accordance with paragraph 19(2).

Sampling for tolerances

207

Notwithstanding the amendments made to paragraph 22 of Schedule 5 to the 2013 Regulations (sampling and analysis) by this instrument, the defence referred to in paragraph 22(2) of that Schedule continues to be available in respect of a sample taken before the end of the period which expires six months after the date on which this instrument comes into force if the active ingredient in the medicated feedingstuff sample is within the tolerances set out in the table in that paragraph as it had effect immediately before the coming into force of this instrument.

Sampling for cross-contamination

208

Notwithstanding the insertion of paragraph 22A of Schedule 5 to the 2013 Regulations (sampling for cross-contamination) by this instrument, it is not an offence under paragraph 31(ra) of that Schedule to fail to comply with paragraph 22A before the end of the period which expires six months after the date on which this instrument comes into force.

PART 11 — Consequential amendment to assimilated direct legislation

Commission Regulation (EC) No 1234/2008

209

Commission Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products¹³ is revoked.

Signed

Douglas-Miller — Parliamentary Under Secretary of State — Department for Environment, Food and Rural Affairs — 25th April 2024

Explanatory note

(This note is not part of the Regulations)

EXPLANATORY NOTE

These Regulations amend the Veterinary Medicines Regulations 2013 (S.I. 2013/2033, “the 2013 Regulations”) in respect of Great Britain only.

Part 2 amends Parts 1 to 5 of the 2013 Regulations. New and amended provision is made in respect of—

the manufacture of veterinary medicinal products (regulation 5);

the prohibition of supply of veterinary medicinal products after their expiry date (regulation 6);

advertising and promotion of veterinary medicinal products (regulations 7 to 9);

exemptions from the scope of the 2013 Regulations (regulation 10);

record-keeping requirements (regulations 11 to 15);

imports of unauthorised veterinary medicinal products (regulation 16);

appeals (regulation 17);

exports (regulation 18);

time limits (regulation 19);

enforcement (regulations 20 to 25).

Regulation 4 amends the interpretation provision in the 2013 Regulations, and regulation 26 amends the statutory review clause so as to provide that the report in respect of the next review must be published by 31st December 2028.

Part 3 amends Schedule 1 to the 2013 Regulations, which governs applications for marketing authorisations in respect of veterinary medicinal products.

Part 4 amends Schedule 2 to the 2013 Regulations, which governs the manufacture of veterinary medicinal products. Regulation 92 inserts new Part 2 to that Schedule, concerning the authorisation of autogenous vaccines, blood-banks, stem cell centres and products manufactured under the cascade. Regulation 93 inserts new Part 2A (regulating active substances) and Part 2B (offences) to that Schedule.

Part 5 amends Schedule 3 to the 2013 Regulations, which governs classification and supply of veterinary medicines, wholesale dealers and sheep dip.

Part 6 amends Schedule 4 to the 2013 Regulations, which governs administration of veterinary medicines outside the terms of a marketing authorisation.

Part 7 amends Schedule 5 to the 2013 Regulations, which governs medicated feedingstuffs and specified feed additives.

Part 8 amends Schedule 6 to the 2013 Regulations, which governs exemptions from the 2013 Regulations in respect of small pet animals.

Part 9 amends Schedule 7 to the 2013 Regulations, which sets out fees in respect of the 2013 Regulations.

Part 10 sets out transitional provisions in respect of certain amendments in earlier Parts of the instrument concerning—

labelling of veterinary medicinal products (regulation 200);

advertising (regulation 201);

wholesale supply of veterinary medicinal products by marketing authorisation holders (regulation 202);

prescriptions (regulations 203 and 204);

feedingstuffs labelling requirements (regulation 205);

medicated feedingstuffs prescription requirements (regulation 206);

sampling (regulations 207 and 208).

Part 11 contains a consequential amendment to assimilated direct legislation, revoking Commission Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (EUR 2008/1234).

A full impact assessment has not been produced for this instrument as no, or no significant, impact on the private, voluntary or public sector is foreseen.

Footnotes

2021 c. 3.

S.I. 2013/2033 (as amended by S.I. 2014/599, 2018/761, 2019/676 (itself amended by S.I. 2020/461), 865, 1488, 2020/1461 and 1631).

The ATC index can be searched at www.whocc.no/atcvet/atcvet_index/.

S.I. 2002/2443, amended by S.I. 2019/88, 1252; there are other amending instruments but none is relevant.

S.S.I. 2002/541, amended by S.S.I. 2019/57, 86; there are other amending instruments but none is relevant.

S.I. 2002/3188 (W. 304), amended by S.I. 2019/1316, 1492; there are other amending instruments but none is relevant.

S.I. 1999/3106, amended by S.I. 2004/994; there are other amending instruments but none is relevant.

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

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