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Regulation 46 Amendment to paragraph 25

Original text. Later amendments are not shown.

In paragraph 25 (publication following the grant of a marketing authorisation)—

(a)

after sub-paragraph (3) insert—

“(4)

Where the Secretary of State refuses to grant a marketing authorisation or suspends or revokes an authorisation the Secretary of State must publish that fact.

(5)

Where the Secretary of State varies a marketing authorisation in relation to the summary of product characteristics the Secretary of State must publish the terms of the variation.”;

(b)

in the heading after “grant” insert “, refusal, suspension, variation or revocation”.