The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 No. 1928

Amendment of Schedule 6 to the principal Regulations

31.  In Schedule 6 to the principal Regulations (particulars that must accompany an application for a manufacturing authorisation)—

(a) for paragraph 2 substitute—

“2.   A statement describing the types of investigational medicinal product in respect of which the authorisation is required, including their pharmaceutical forms.”; and

(b) after paragraph 3, insert the following paragraph—

“3A.   Where the application relates to the inactivation of viral or non-conventional agents, a statement of the manufacturing process to which the authorisation is to relate.”.