The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 No. 1488

SCHEDULES

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

PART 11 U.K. Amendment of Part 12 (amendment of Part 12 (dealings with medicinal products))

149.  After regulation 194 (amendment of regulation 249 (restrictions on persons to be supplied with medicinal products) insert— U.K.

“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.”.”.

Commencement Information

I1 Sch. 2 para. 149 in force at 31.12.2020 immediately before IP completion day, see reg. 1