# The Medicines (Products for Human Use — Fees) Regulations 1995, Paragraph 1: Marketing authorizations


In this Part of this Schedule—
“Type I Application” means an application by a marketing authorisation holder to vary a marketing authorization (not being a marketing authorization (parallel import)) which is a “minor variation” within the meaning of Article 3.1(a) of Regulation (EC) No. 541/95;
“Type II Application” means any application to vary a marketing authorization (not being a marketing authorization (parallel import) or a product licence of right) which is neither a Type I Application nor an application for a Type II complex variation nor a change to which Annex II to Commission Regulation (EC) 541/95 applies;
“Type II complex variation” means a variation of a marketing authorization which relates to a change—
(a) in the formulation of a medicinal product comprising one or more of the following
(i) a change which necessitates in-vivo bioavailability studies to be performed on that product:
(ii) a change in that product’s preservative system; or
(iii) a change in that product’s excipients which significantly affects the pharmaceutical or the therapeutic properties of that product; or
(b) in the therapeutic indications of a medicinal product, such as a change in respect of use in a new category of patients or as a treatment for a new category of disease, other than a change to which paragraph 2 (changes to therapeutic indications) of Annex II to Commission Regulation (EC) No. 541/95 applies;
(c) in the composition, manufacture or use of a medicinal product to which any one or more of paragraphs (c), (e), (g) to (j) or (n) of the definition of complex application would apply where an application for a marketing authorisation is made in respect of a medicinal product.

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Source: https://www.legislation.gov.uk/uksi/1995/1116/schedule/1/part/III/paragraph/1 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/schedule-1/part-III/paragraph-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.