Regulation 194A Amendment of regulation 251 (compliance with standards specified in certain publications)F1I1

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.”.