The Veterinary Medicines (Amendment etc.) Regulations 2024

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);

(c) paragraph 50 (labelling of small immediate packaging units 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.