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PART 10Transitional 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.