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.”.