SCHEDULES

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

PART 8Amendment of Part 9 (amendment of Part 9 (borderline products))

I1100

In regulation 133 (amendment of regulation 159 (provisional determination)) for paragraph (b) substitute—

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, ”.