Regulation 257 Packaging requirements: general
The information specified in Part 1 of Schedule 24 must appear—
on the outer packaging of a medicinal product; and
on the immediate packaging of the product, unless paragraph (2) or (3) applies to the packaging.
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.
This paragraph applies to immediate packaging if the packaging is too small to display the information required by Part 1 of Schedule 24.
The information specified in Part 2 of Schedule 24 must appear on immediate packaging to which paragraph (2) applies.
The information specified in Part 3 of Schedule 24 must appear on immediate packaging to which paragraph (3) applies.
Nothing in this regulation or Schedule 24 applies to a registrable homoeopathic medicinal product.
Nothing in this regulation applies to the outer or immediate packaging of an advanced therapy medicinal product F4....
This regulation is subject to regulation 257AA.
Nothing in this regulation applies to a POC medicinal product that is the subject of a UKMA(UK)(Category 1).
Annotations
Textual amendments
- F1
Words 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)
- F2
Words in reg. 257(6) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 110(a) (with reg. 1(2))
- F3
Reg. 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)
- F4
Words in reg. 257(8) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 110(b) (with reg. 1(2))
- F5
Reg. 257(9) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 110(c) (with reg. 1(2))
- F6
Reg. 257(10) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 29