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Regulation 31 Amendment of Schedule 6 to the principal Regulations

Original text. Later amendments are not shown.

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.”.