The Medicines (Products for Human Use) (Fees) Regulations 2016

Type II Complex Variation Application U.K.

23.  A Type II Complex Variation Application is an application for a variation of a marketing authorisation, 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 [F1 in the case of a UKMA(NI) or UKMA(UK), paragraph 1 (changes to active substances) or paragraph 2 (changes to strength, pharmaceutical form and route of administration) of Annex I to Commission Regulation (EC) No 1234/2008 applies or, in the case of a UKMA(GB), sub-paragraph (a) (changes to active substances) or sub-paragraph (b) (changes to strength, pharmaceutical form and route of administration) of the definition of “extension of a UK marketing authorisation” in paragraph 1 of Schedule 10A to the Human Medicines Regulations 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 [F2 in the case of a UKMA(NI) or UKMA(UK), Article 2(3) of Commission Regulation (EC) No 1234/2008 or, in the case of a UKMA(GB), paragraph 1 of Schedule 10A to the Human Medicines Regulations] 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 authorisation 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 [F3 in the case of a UKMA(NI) or UKMA(UK), Commission Regulation (EC) No 1234/2008 or, in the case of a UKMA(GB), paragraph 1 of Schedule 10A to the Human Medicines Regulations] .

Textual Amendments

F1 Words in Sch. 2 para. 23(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(4)(a) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(iii)(aa)); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in Sch. 2 para. 23(b) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(4)(b) (with Sch. 1 para. 11) (as amended byThe Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(iii)(bb)); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Sch. 2 para. 23(c) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(4)(c) (with Sch. 1 para. 11) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(iii)(cc)); 2020 c. 1, Sch. 5 para. 1(1)