The Medicines (Products for Human Use-Fees) Regulations 2008

Interpretation

This section has no associated Explanatory Memorandum

12.  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.