PART 14Amendment of Part 13 (packaging and leaflets)
Amendment of regulation 260 (package leaflets)203.
(1)
Regulation 260 is amended as follows.
(2)
After paragraph (1) insert—
“(1A)
If the medicinal product is an advanced therapy medicinal product (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.”.
(3)
In paragraph (2), after “Part 2 of that Schedule)” insert “, or where the product is an advanced therapy medicinal product, the information specified in Part 3 of that Schedule,”.
(4)
In paragraph (3), for “marketing authorisation, Article 126a authorisation” substitute “UK marketing authorisation”.