The Veterinary Medicines (Amendment etc.) Regulations 2024

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/EC(1).”;

(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.”.

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—

“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.”.

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—

“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.”.

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”;

(c) after sub-paragraph (b) insert—

“(ba) paragraph 6A;”;

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

(e) after sub-paragraph (c) insert—

“(d) paragraph 9A.”.

(1)

EUR 2018/470.