Paragraph 23 Type II Complex Variation Application

A Type II Complex Variation Application is an application for a variation of a marketing authorization, other than an Extended Type II Complex Variation Application, which relates to a change—

(a)

in the formulation of a medicinal product comprising one or more of the following changes, other than a change to which paragraph 1 (changes to active substances) or paragraph 2 (changes to strength, pharmaceutical form and route of administration) of Annex I to EC Regulation No. 1234/2008 applies—

(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)

which is considered a “major variation of type II” within the meaning of Article 2(3) of EC Regulation No. 1234/2008 and which is—

(i)

supported by data which comprises or includes the results of clinical trials or physicochemical, biological, microbiological or pharmacological and toxicological tests; or

(ii)

accompanied by evidence relating to post-marketing experience which is information of any type described in paragraph 5.2.6 of Part I of Annex I to the 2001 Directive (clinical documentation); or

(c)

in the composition, manufacture or use of a medicinal product to which—

(i)

sub-paragraph (c), (e), (g), (h), (j) or (n) of the definition of complex application in paragraph 5 of this Schedule would apply where an application for a marketing authorization is made in respect of a medicinal product; or

(ii)

sub-paragraph (i) of that definition would so apply and the change is not a minor variation of type IA or a minor variation of type IB within the meaning of EC Regulation No. 1234/2008.