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The Medicines (Products for Human Use) (Fees) Regulations 2012

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Type IB and Type II Applications

22.—(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.

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