Regulation 44 New paragraph 22A

After paragraph 22 insert—

“Withdrawal of application for marketing authorisation

22A.

(1)

Where an applicant for a marketing authorisation withdraws the application before the Secretary of State has produced an assessment of the dossier under paragraph 21 the applicant must give written reasons for so doing.

(2)

Where an applicant withdraws an application for a marketing authorisation in the circumstances mentioned in sub-paragraph (1) the Secretary of State must publish—

(a)

the fact that the application has been withdrawn; and

(b)

a summary of the reasons for withdrawal.”.