Paragraph 22 Type IB and Type II Applications

(1)

A Type IB Application is an application by a marketing authorization holder to vary a marketing authorization (not being a parallel import licence) which is a “minor variation of type IB” within the meaning of Article 2(5) of EC Regulation No. 1234/2008.

(2)

A Type II Application is an application by a marketing authorization holder to vary a marketing authorization (not being a parallel import licence) which is not—

(a)

a reclassification variation;

(b)

a Type IA Application;

(c)

a Type IB Application;

(d)

a Type II Complex Variation Application;

(e)

an Extended Type II Complex Variation Application; or

(f)

an application for an extension of a marketing authorization within the meaning of Article 2(4) of EC Regulation No. 1234/2008.

(3)

For the purposes of sub-paragraph (2)(b), a “Type IA Application” means an application by a marketing authorization holder to vary a marketing authorization (not being a parallel import licence) which is a “minor variation of type IA” within the meaning of Article 2(2) of EC Regulation No. 1234/2008.