The Medicines (Products for Human Use) (Fees) Regulations 2013

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

Fees for variations of authorisations, registrations and licences

18.—(1) Unless Part 16 of these Regulations (revocations and savings) applies, the fee mentioned in paragraph (2) applies for an application—

(a) under the Human Medicines Regulations, under regulation—

(i) 29 (variation of licence on application of holder);

(ii) 68 (revocation, variation and suspension of UK marketing authorisation);

(iii) 135 (revocation, variation and suspension of a traditional herbal registration) but only in relation to a variation of such a registration;

(b) to vary a parallel import licence;

(c) to vary a broker’s registration or an active substance registration;

(d) under regulation 44 (variation of manufacturing authorisation) of the Clinical Trials Regulations(1) for the variation of a manufacturing authorisation.

(2) The fee referred to in paragraph (1) is—

(a) the fee prescribed in Part 4 of Schedule 2 in connection with the application; and

(b) in respect of an inspection of a site made in connection with the application, the fee payable in accordance with regulations 29, 31, 32, 34 and 36.

(3) Unless regulation 31 applies, the fee referred to in paragraph (1) is payable by the applicant.

Fees for amendments to clinical trial authorisations

19.—(1) A person who sends a valid notice of amendment under regulation 24 (amendments by the sponsor) of the Clinical Trial Regulations(2) relating to amendment of the protocol or the dossier related to a request for authorisation in accordance with paragraphs 10 or 11 of Part 2 of Schedule 3 (request for authorisation) to those Regulations must pay the fees mentioned in paragraph (2).

(2) The fees referred to in paragraph (1) are—

(a) the fee prescribed in paragraph 48 of Schedule 2 in connection with that amendment; and

(b) in respect of an inspection of a site made in connection with the application, the fee payable in accordance with regulations 29, 31, 32, 34 and 36.

Fees for notification of changes and reports for broker’s registrations

20.—(1) A fee of £257 is payable by the holder of a broker’s registration who provides, in accordance with any Regulations in connection with that registration—

(a) any report that must be submitted relating to that registration, or

(b) any notification that must be submitted about changes relating to that registration.

(2) The fee in paragraph (1) is payable for each report or notification of change made in connection with that broker’s registration.

Fees for notification of changes and compliance Reports for active substance registrations

21.—(1) A fee of £257 is payable by the holder of an active substance registration who provides, in accordance with any Regulations in connection with that registration—

(a) any report that must be submitted relating to that registration, or

(b) any notification that must be submitted about changes relating to that registration.

(2) The fee in paragraph (1) is payable for each report or notification of change made in connection with that active substance registration.

Applications for multiple variations

22.—(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—

(i) in consultation with other member States concerned, have agreed, 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; 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.

(6) In a case where a recommendation on the classification of a variation is made in accordance with Article 5 of Commission Regulation (EC) No 1234/2008, the fee payable for the application made in respect of that variation shall be 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) Unless paragraph (8) applies, 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)

subject to sub-paragraph (c), the variations fall within the scope of Article 7(2)(b) and (c) of Commission Regulation (EC) No 1234/2008;

(c)

the variations do not include a variation—

(i)

of a kind referred to 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;

(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)

subject to sub-paragraph (c), the variations fall within the scope of Article 7(2)(b) and (c) of Commission Regulation (EC) No 1234/2008;

(c)

the variations do not include a variation of—

(i)

a kind referred to in paragraph 1 or paragraph 3 of Annex III to Commission Regulation (EC) No 1234/2008; or

(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)

subject to sub-paragraph (c), the variations fall within the scope of Article 7(2)(b) and (c) of Commission Regulation (EC) No 1234/2008;

(c)

the variations do not include a variation of a kind referred to in paragraph 1 of Annex III to Commission Regulation (EC) No 1234/2008; 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;

“major variation of type II” has the meaning given in Article 2(3) of Commission Regulation (EC) No 1234/2008;

“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)

subject to sub-paragraph (c), the variations fall within the scope of Article 7(2)(b) and (c) of Commission Regulation (EC) No 1234/2008;

(c)

the variations do not include—

(i)

a variation of a kind referred to in paragraph 1 or paragraph 2 of Annex III of Commission Regulation (EC) No 1234/2008; or

(ii)

a major variation of type II; and

(d)

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

“minor variation of type IA” has the meaning given in Article 2(2) of Commission Regulation (EC) No 1234/2008;

“minor variation of type IB” has the meaning given in Article 2(5) of Commission Regulation (EC) No 1234/2008; and

“work sharing” means the work sharing procedure within the meaning of Article 20 of Commission Regulation (EC) No 1234/2008.

(8) From 4th August 2013, 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)

subject to sub-paragraph (c), the variations fall 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 (as amended);

(c)

the variations do not include a variation—

(i)

of a kind referred to 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;

(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)

subject to sub-paragraph (c), the variations fall 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 (as amended);

(c)

the variations do not include a variation of—

(i)

a kind referred to in paragraph 1 or paragraph 3 of Annex III to Commission Regulation (EC) No 1234/2008; or

(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)

subject to sub-paragraph (c), the variations fall 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 (as amended);

(c)

the variations do not include a variation of a kind referred to in paragraph 1 of Annex III to Commission Regulation (EC) No 1234/2008; 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;

“major variation of type II” has the meaning given in Article 2(3) of Commission Regulation (EC) No 1234/2008;

“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)

subject to sub-paragraph (c), the variations fall 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 (as amended);

(c)

the variations do not include—

(i)

a variation of a kind referred to in paragraph 1 or paragraph 2 of Annex III of Commission Regulation (EC) No 1234/2008; or

(ii)

a major variation of type II; and

(d)

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

“minor variation of type IA” has the meaning given in Article 2(2) of Commission Regulation (EC) No 1234/2008;

“minor variation of type IB” has the meaning given in Article 2(5) of Commission Regulation (EC) No 1234/2008; and

“work sharing” means the work sharing procedure within the meaning of Article 20 of Commission Regulation (EC) No 1234/2008.

(9) In this regulation—

“Commission Regulation (EC) No 1234/2008” means Commission Regulation (EC) No 1234/2008 as in force on the 1st April 2013;

“Commission Regulation (EC) No 1234/2008 (as amended)” means Commission Regulation (EC) No 1234/2008 as amended by Commission Regulation (EU) No 712/2012(3) from 4th August 2013.

(1)

Regulation 44 has been amended by S.I. 2006/1928.

(2)

Regulation 24 has been amended by S.I. 2006/1928.

(3)

OJ No L 209, 4.8.2012, p4.