SCHEDULES
SCHEDULE 2Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019
PART 11Amendment of Part 12 (amendment of Part 12 (dealings with medicinal products))
I1149
After regulation 194 (amendment of regulation 249 (restrictions on persons to be supplied with medicinal products) insert—
Amendment of regulation 251 (compliance with standards specified in certain publications)194A
In regulation 251 (compliance with standards specified in certain publications), after paragraph (5) insert—
6
In paragraph (1), (2) or (3) a product is to be treated as complying with the standard specified in the relevant monograph where—
a
the product complies with the standard specified in a relevant marketing authorisation for the product concerned, and
b
the standard specified in that marketing authorisation does not comply with the standard specified in the relevant monograph.
7
In paragraph (6), “relevant marketing authorisation” means—
a
an EU marketing authorisation;
b
an authorisation granted by the licencing authority under Chapter 4 of Title III to the 2001 Directive; or
c
a UKMA(GB) granted under the unfettered access route.