Regulation 49 Amendment to paragraph 28

for “risk-benefit balance”, in both places it occurs, substitute “benefit-risk balance”;

after sub-paragraph (3) insert—

“(4)

A marketing authorisation holder must retain all of the original documents from every clinical trial from which data was derived in support of the application for authorisation under this Schedule, and in support of any variation of the authorisation (whether granted or otherwise), for at least five years from the date on which the authorisation ceases.”;

in the heading, at the beginning insert “Records and”.