# The Medicines (Products for Human Use) (Fees) Regulations 2012, 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.

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Source: https://www.legislation.gov.uk/nisr/2012/134/schedule/2/paragraph/22 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-2/paragraph-22
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.