Regulation 203 Amendment of regulation 260 (package leaflets)I1

Regulation 260 is amended as follows.

After paragraph (1) insert—

“(1A)

If the medicinal product is an advanced therapy medicinal product F1for sale or supply in Great Britain only (other than an exempt advanced therapy medicinal product), the package leaflet must contain the information specified in Part 3 of Schedule 27 in the order specified in that Part.”.

In paragraph (2), after “Part 2 of that Schedule)” insert “ , or where the product is an advanced therapy medicinal product F2for sale or supply in Great Britain only, the information specified in Part 3 of that Schedule, ”.

In paragraph (3), for “marketing authorisationF3...” substitute “ UK marketing authorisation F4, EU marketing authorisation, ”.