The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020

This section has no associated Explanatory Memorandum

157.  In regulation 203 (amendment of regulation 260 (package leaflets))—

(a)in paragraph (2), in the inserted paragraph (1A), after the first reference to “advanced therapy medicinal product” insert “for sale or supply in Great Britain only”;

(b)in paragraph (3), in the inserted text, after “advanced therapy medicinal product,” insert “for sale or supply in Great Britain only”;

(c)in paragraph (4)—

(i)omit “, Article 126a authorisation”;

(ii)after “UK marketing authorisation” insert “, EU marketing authorisation,”.