Packaging requirements: generalU.K.
257.—(1) The information specified in Part 1 of Schedule 24 must appear—
(a)on the outer packaging of a medicinal product; and
(b)on the immediate packaging of the product, unless paragraph (2) or (3) applies to the packaging.
(2) This paragraph applies to immediate packaging if the packaging is in the form of a blister pack and is placed in outer packaging which complies with the requirements of Part 1 of Schedule 24.
(3) This paragraph applies to immediate packaging if the packaging is too small to display the information required by Part 1 of Schedule 24.
(4) The information specified in Part 2 of Schedule 24 must appear on immediate packaging to which paragraph (2) applies.
(5) The information specified in Part 3 of Schedule 24 must appear on immediate packaging to which paragraph (3) applies.
(6) Information included on the packaging of a product in accordance with this regulation, [F1regulation 257C where the product is for sale or supply in Great Britain only,] regulation 261 and Schedule 24 must be easily legible, comprehensible and indelible.
(7) Nothing in this regulation or Schedule 24 applies to a registrable homoeopathic medicinal product.
[F2(8) Nothing in this regulation applies to the outer or immediate packaging of an advanced therapy medicinal product for sale or supply in Great Britain only.]
Textual Amendments
F1Words in reg. 257(6) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 198(2) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 152(a)); 2020 c. 1, Sch. 5 para. 1(1)
F2Reg. 257(8) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 198(3) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 152(b)); 2020 c. 1, Sch. 5 para. 1(1)