OpenLegislation

Paragraph 8

Changes not yet applied. Later legislation changes this provision in ways not yet written into the text below:

An Off-label application is an application for extension of an approved use under regulation 10, or for modification of such an extension under regulation 13(7)(b), of the 1995 Regulations of a type which calls for examination of data or detailed examination of technical information but is not a Departmental application.