Paragraph 56 I1

After regulation 76 (renewal of conditional marketing authorisation) insert—

“Amendment of regulation 67 (failure to place on the market etc.)

76A

(1)

Regulation 67 (failure to place on the market etc.) is amended as follows.

(2)

In paragraph (1) after “in the United Kingdom” insert “ (or, in the case of a UKMA(GB) granted after an application under the unfettered access route, in Great Britain) ”.

(3)

In paragraph (2) after “in the United Kingdom” insert “ (or, in the case of a UKMA(GB) granted after an application under the unfettered access route, in Great Britain) ”.”.