Paragraph 12 Interpretation
In this Part, a reference to—
(a)
an application to the licensing authority for regulatory assistance means a reference to—
(i)
a single application of that type, or
(ii)
a set of applications of that type,
relating to a single United Kingdom marketing authorization; and
(b)
an application for a marketing authorization in a concerned member State means a reference to—
(i)
a single application of that type, or
(ii)
a set of applications of that type in a number of concerned member States,
relating to a single United Kingdom marketing authorization.