Paragraph 22 Type IB and Type II Applications

(1)

A Type IB Application is an application by a marketing authorisation holder to vary a marketing authorisation (not being a parallel import licence) which is a “minor variation of type IB” within the meaning of

F1(a)

in the case of a UKMA(NI) or UKMA(UK), Article 2(5) of Commission Regulation (EC) No 1234/2008;

(b)

in the case of a UKMA(GB), paragraph 1 of Schedule 10A to the Human Medicines Regulations

(2)

A Type II Application is an application by a marketing authorisation holder to vary a marketing authorisation (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 authorisation within the meaning of Article 2(4) of Commission Regulation (EC) No 1234/2008.

F2(a)

in the case of a UKMA(NI) or UKMA(UK), Article 2(4) of Commission Regulation (EC) No 1234/2008;

(b)

in the case of a UKMA(GB), paragraph 1 of Schedule 10A to the Human Medicines Regulations

(3)

For the purposes of sub-paragraph (2)(b), a “Type IA Application” means an application by a marketing authorisation holder to vary a marketing authorisation (not being a parallel import licence) which is a “minor variation of type IA” within the meaning of

F3(a)

in the case of a UKMA(NI) or UKMA(UK), Article 2(2) of Commission Regulation (EC) No 1234/2008;

(b)

in the case of a UKMA(GB), paragraph 1 of Schedule 10A to the Human Medicines Regulations

Annotations

Textual amendments

F1: Sch. 2 para. 22(1)(a)(b) substituted for words in Sch. 2 para. 22(1) (31.12.2020) by S.I. 2019/775, Sch. 1 para. 7(3)(a) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(ii)(aa))
F2: Sch. 2 para. 22(2)(a)(b)(f) substituted for words in Sch. 2 para. 22(2)(f) (31.12.2020) by S.I. 2019/775, Sch. 1 para. 7(3)(b) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(ii)(bb))
F3: Sch. 2 para. 22(3)(a)(b) substituted for words in Sch. 2 para. 22(3) (31.12.2020) by S.I. 2019/775, Sch. 1 para. 7(3)(c) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(ii)(cc))