Regulation 257C Packaging requirements: advanced therapy medicinal productsF1
The information specified in Part 4 of Schedule 24 must appear—
on the outer packaging of an advanced therapy medicinal product F2... (other than an exempt advanced therapy medicinal product); and
on the immediate packaging of that product, unless paragraph (2) or (3) applies to the packaging.
This paragraph applies to the 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 4 of Schedule 24.
This paragraph applies to immediate packaging if the packaging is too small to display the information required by Part 4 of Schedule 24.
The information specified in Part 5 of Schedule 24 must appear on immediate packaging to which paragraph (2) or (3) applies.
Nothing in this regulation applies to an advanced therapy medicinal product that is a POC medicinal product, if the entirety of the product is to be administered immediately after manufacture.
Annotations
Textual amendments
- F1
Regs. 257C-257E inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 200 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 154); 2020 c. 1, Sch. 5 para. 1(1)
- F2
Words in reg. 257C(1)(a) 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), 114
- F3
Reg. 257C(5) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 30