Regulation 257CA Packaging requirements: POC medicinal productsF1
This regulation applies to a POC medicinal product that is the subject of a UKMA(UK)(Category 1) and not—
an advanced therapy medicinal product; and
to be administered in its entirety immediately after manufacture.
The information specified in Part 6 of Schedule 24 must appear—
on the outer packaging of a POC medicinal product to which this regulation applies; and
on the immediate packaging of that product, unless paragraph (3) or (4) 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 6 of Schedule 24.
This paragraph applies to the immediate packaging if the packaging is too small to display the information required by Part 6 of Schedule 24.
The information specified in Part 7 of Schedule 24 must appear on the immediate packaging to which paragraph (3) or (4) applies.
Annotations
Textual amendments
- F1
Reg. 257CA inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 31