Regulation 111 Insertion of new regulations 257AA and 257ABI1

After regulation 257 (packaging requirements: general), insert—

“Packaging requirements: variation in accordance with regulation 68(11I)

257AA.

(1)

This regulation applies where, in accordance with regulation 68(11I), the licensing authority thinks that a variation is necessary so that a UKMA(UK)(Category 2) is treated as a UKMA(GB) and separate UKMA(NI).

(2)

Where this regulation applies, the licensing authority may require that, in relation to the UKMA(GB), the information specified in paragraph 18B of Schedule 24 is replaced with a statement that the medicinal product is for sale or supply in Great Britain only.

Transitional arrangements

257AB.

The information specified in paragraph 18B of Schedule 24 is not required to appear on the packaging of a medicinal product released for sale or distribution before 1st January 2025, unless the product has been re-packaged or relabelled after that date.”.