Paragraph 9
A Normal application is—
(a)
an application under regulation 8 (emergency approvals), or for modification of such an approval under regulation 13(7)(b), of the 1995 Regulations, or
(b)
an application under regulation 5 (standard approvals), a subsequent application (as detailed in Note 23) under regulation 7 (provisional approvals), or an application for modification of either such approval under regulation 13(7)(b), of the 1995 Regulations of a type which calls for significant data examination,
which is not a Departmental application.