SCHEDULES

SCHEDULE 2 U.K.Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

PART 8 U.K.Amendment of Part 9 (amendment of Part 9 (borderline products))

100.  In regulation 133 (amendment of regulation 159 (provisional determination)) for paragraph (b) substitute— U.K.

“(b) for “Article 126a authorisation” insert “ , only in relation to a product for sale or supply in Northern Ireland, an Article 126a authorisation or an EU marketing authorisation, ”.”.

Commencement Information

I1 Sch. 2 para. 100 in force at 31.12.2020 immediately before IP completion day, see reg. 1

101.  In regulation 134 (amendment of regulation 164 (effect of determination)) for paragraph (b) substitute— U.K.

“(b) for “Article 126a authorisation” insert “ , only in relation to a product for sale or supply in Northern Ireland, an Article 126a authorisation or an EU marketing authorisation, ”.”.

Commencement Information

I2 Sch. 2 para. 101 in force at 31.12.2020 immediately before IP completion day, see reg. 1