The Medicines for Human Use (Clinical Trials) Regulations 2004 No. 1031

SCHEDULE 8 U.K. PROCEDURAL PROVISIONS RELATING TO PROPOSALS TO GRANT, REFUSE TO GRANT, VARY, SUSPEND OR REVOKE MANUFACTURING AUTHORISATIONS

3.  Any notification given under paragraph 2 shall include a statement of the proposals of the licensing authority and of the reasons for them. U.K.