PART 5U.K.Capital Fees for Applications for Variations of Authorisations, Registrations and Licences and for Associated Compliance Activities

Applications for multiple variationsU.K.

23.—(1) Unless paragraph (3) or (5) applies, a separate fee is payable in respect of each application to vary each term of a marketing authorisation.

(2) Unless paragraph (5) applies, a separate fee is payable in respect of each variation of each provision of a traditional herbal registration, manufacturing authorisation or licence applied for in any one application.

(3) A separate fee is not payable for each application to vary a term of a marketing authorisation which—

(a)falls within the same type of group application; or

(b)the licensing authority—

[F1(i)have agreed—

(aa)in the case of a UKMA(NI) or UKMA(UK), in consultation with member States concerned and in accordance with Article 7(2)(c) of Commission Regulation (EC) No 1234/2008, should be subject to the procedure for grouping of variations within the meaning of that Article;

(bb)in the case of a UKMA(GB), should be subject to the procedure for grouping of variations within the meaning of paragraph 5(2)(c) of Schedule 10A to the Human Medicines Regulations; and]

(ii)have agreed fall, or should be treated as falling, within the same type of group application.

(4) For the purposes of paragraph (3) the reference to a group application means an application which is a—

(a)Minor Variation (Type IB) Group Application;

(b)Major Variation (Type II) Group Application;

(c)Major Variation (Type II) Complex Group Application; or

(d)Major Variation (Type II) Extended Complex Group Application.

(5) A separate fee is not payable for a variation which is wholly consequential upon another variation of a provision of a marketing authorisation, traditional herbal registration, manufacturing authorisation or licence which is applied for in the same application.

[F2(6)  In a case where a recommendation on the classification of a variation is made in accordance with—

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

(b)in the case of a UKMA(GB), paragraph 3 of Schedule 10A to the Human Medicines Regulations,

the fee payable for the application made in respect of that variation is the appropriate fee for the classification given to the variation or, as the case may be, the appropriate fee which arises as a consequence of the classification given to the variation.]

(7) In this regulation and Part 4 of Schedule 2—

“Major Variation (Type II) Group Application” means an application for several variations to one marketing authorisation and—

(a)

at least one of the variations is a major variation of type II;

(b)

[F3subject to sub-paragraph (c), the variations fall—

(i)

in the case of a UKMA(NI) or UKMA(UK), within the scope of paragraphs (2)(b) and (c) of Article 7 or paragraphs 2(b) and (c) of Article 13d of Commission Regulation (EC) No 1234/2008;

(ii)

in the case of a UKMA(GB), within the scope of paragraph 5(2)(b) or (c) of Schedule 10A to the Human Medicines Regulations;]

(c)

the variations do not include a variation—

(i)

[F4of a kind referred to—

(aa)

in the case of a UKMA(NI) or UKMA(UK), in paragraph 1 (extension of the marketing authorisation) or paragraph 3 (minor variation of type IB and consequential variations) of Annex III to Commission Regulation (EC) No 1234/2008;

(bb)

in the case of UKMA(GB), in paragraph 5(3)(a) or (c) of Schedule 10A to the Human Medicines Regulations;]

(ii)

which relates to a change which is referred to in paragraph 23 of Schedule 2 (Type II Complex Variation Application); or

(iii)

of a marketing authorisation so that the medicinal product is indicated for a use referred to in paragraph 9(a) or (b) of Schedule 2 (Extended Type II Complex Variation Application); and

(d)

the variations may include one or more minor variations of type IA or one or more minor variations of type IB;

“Major Variation (Type II) Complex Group Application” means an application for several variations to one marketing authorisation and—

(a)

at least one of the variations relates to one or more of the changes referred to in paragraph 23 of Schedule 2;

(b)

[F5subject to sub-paragraph (c), the variations fall—

(i)

in the case of a UKMA(NI) or UKMA(UK), within the scope of paragraphs (2)(b) and (c) of Article 7 or paragraphs 2(b) and (c) of Article 13d of Commission Regulation (EC) No 1234/2008;

(ii)

in the case of a UKMA(GB), within the scope of paragraph 5(2)(b) or (c) of Schedule 10A to the Human Medicines Regulations;]

(c)

the variations do not include a variation of—

(i)

[F6of a kind referred to—

(aa)

in the case of a UKMA(NI) or UKMA(UK), in paragraph 1 (extension of the marketing authorisation) or paragraph 3 (minor variation of type IB and consequential variations) of Annex III to Commission Regulation (EC) No 1234/2008;

(bb)

in the case of a UKMA(GB), in paragraph 5(3)(a) or (c) of Schedule 10A to the Human Medicines Regulations;]

(ii)

a marketing authorisation so that the medicinal product is indicated for a use referred to in paragraph 9(a) or (b) of Schedule 2; and

(d)

the variations may include one or more minor variations of type IA or one or more minor variations of type IB or one or more major variations of type II;

“Major Variation (Type II) Extended Complex Group Application” means an application for several variations to one marketing authorisation and—

(a)

at least one of the variations is a variation to a marketing authorisation so that the medicinal product is indicated for a use referred to in paragraph 9(a) or (b) of Schedule 2;

(b)

[F7subject to sub-paragraph (c), the variations fall—

(i)

in the case of a UKMA(NI) or UKMA(UK), within the scope of paragraphs (2)(b) and (c) of Article 7 or paragraphs 2(b) and (c) of Article 13d of Commission Regulation (EC) No 1234/2008;

(ii)

in the case of a UKMA(GB), within the scope of paragraph 5(2)(b) or (c) of Schedule 10A to the Human Medicines Regulations;]

(c)

[F8the variations do not include a variation of a kind referred to—

(i)

in the case of a UKMA(NI) or UKMA(UK), in paragraph 1 of Annex III to Commission Regulation (EC) No 1234/2008;

(ii)

in the case of a UKMA(GB), in paragraph 5(3)(a) of Schedule 10A to the Human Medicines Regulations; and]

(d)

the variations may include minor variations of type IA, minor variations of type IB or other major variations of type II or a variation relating to a change referred to in paragraph 23(a), (b) or (c) of Schedule 2;

[F9“major variation of type II”—

(a)

in the case of a UKMA(NI) or UKMA(UK), has the meaning given in Article 2(3) of Commission Regulation (EC) No 1234/2008; and

(b)

in the case of a UKMA(GB), has the meaning given in paragraph 1 of Schedule 10A to the Human Medicines Regulations;]

“Minor Variation (Type IB) Group Application” means an application for several variations to one marketing authorisation and—

(a)

at least one of the variations is a minor variation of type IB;

(b)

[F10subject to sub-paragraph (c), the variations fall—

(i)

in the case of a UKMA(NI) or UKMA(UK), within the scope of paragraphs (2)(b) and (c) of Article 7 or paragraphs 2(b) and (c) of Article 13d of Commission Regulation (EC) No 1234/2008;

(ii)

in the case of a UKMA(GB), within the scope of paragraph 5(2)(b) or (c) of Schedule 10A to the Human Medicines Regulations;]

(c)

the variations do not include—

(i)

[F11a variation of a kind referred to—

(aa)

in the case of a UKMA(NI) or UKMA(UK), in paragraph 1 or paragraph 2 of Annex III of Commission Regulation (EC) No 1234/2008;

(bb)

in the case of a UKMA(GB), in paragraph 5(3)(a) or (b) of Schedule 10A to the Human Medicines Regulations; or]

(ii)

a major variation of type II; and

(d)

the variations may include one or more minor variations of type IA;

[F12“minor variation of type IA”—

(a)

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

(b)

in the case of a UKMA(GB), has the meaning given in paragraph 1 of Schedule 10A to the Human Medicines Regulations;]

[F13“minor variation of type IB”—

(a)

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

(b)

in the case of a UKMA(GB), has the meaning given in paragraph 1 of Schedule 10A to the Human Medicines Regulations; and]

“work sharing” means [F14, in the case of a UKMA(NI) or UKMA(UK),] the work sharing procedure within the meaning of Article 20 of Commission Regulation (EC) No 1234/2008.

Textual Amendments

F1Reg. 23(3)(b)(i) substituted (31.12.2020) by S.I. 2019/775, Sch. 1 para. 3(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(d))

F6Words in reg. 23(7) substituted (31.12.2020) by S.I. 2019/775, Sch. 1 para. 3(4)(b)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(d))

F7Words in reg. 23(7) substituted (31.12.2020) by S.I. 2019/775, Sch. 1 para. 3(4)(c)(i) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(d))

F8Words in reg. 23(7) substituted (31.12.2020) by S.I. 2019/775, Sch. 1 para. 3(4)(c)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(d))

F9Words in reg. 23(7) substituted (31.12.2020) by S.I. 2019/775, Sch. 1 para. 3(4)(d) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(d))

F11Words in reg. 23(7) substituted (31.12.2020) by S.I. 2019/775, Sch. 1 para. 3(4)(e)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(d))

F12Words in reg. 23(7) substituted (31.12.2020) by S.I. 2019/775, Sch. 1 para. 3(4)(f) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(d))

F13Words in reg. 23(7) substituted (31.12.2020) by S.I. 2019/775, Sch. 1 para. 3(4)(g) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(d))

F14Words in reg. 23(7) inserted (31.12.2020) by S.I. 2019/775, Sch. 1 para. 3(4)(h) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(d))