Solon does not know this law's official route yet. The proposal is recorded all the same, and the route appears here once its source is added.
210 provisions
120 Amendment to paragraph 1
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.
.
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/EC.
;
(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.
;
(c) after sub-paragraph (3) insert—
(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.
.
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”.
After paragraph 6 (administration by veterinary surgeons from other countries) insert—
Administration of autogenous vaccines
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.
.
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”.
After paragraph 9 insert—
Misuse of the cascade
9A. A person must not promote or facilitate any purported use of the cascade which is not in accordance with this Schedule.
.
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;
.
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”.
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”.
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”.
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”.
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”.
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”.
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”.
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”.
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).
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”.
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”.
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”.
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”.
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%
.
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.
.
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”.
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”.
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.
.
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”.
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”.
In paragraph 2 (placing on market, import and administration) at the end insert “and the manufacturer appears on the register maintained under paragraph 3A”.
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.
.
After paragraph 3 insert—
Register of persons placing veterinary medicinal products on the market (small pet animals)
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).
Persons registered in accordance with paragraph 3A: annual return
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.
.
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”;
(c) in paragraph (b) for “adverse reaction”, in both places it occurs, substitute “adverse event”;
(d) omit sub-paragraph (2);
(e) in the heading for “Adverse reactions” substitute “Adverse events”.