Regulation 7 Amendment of Schedule 1 to the Medicines Fees Regulations

(1)

Schedule 1 to the Medicines Fees Regulations (capital fees for applications for, and variations to, marketing authorizations, licences and certificates) is amended as follows.

(2)

In Part I (interpretation), in paragraph 1—

(a)

in the definition of “complex application”^f1—

(i)

for “sub-paragraphs (a) to (o)” substitute “sub-paragraphs (a) to (r)”, and

(ii)

after paragraph (o) insert—

“(p)
an application where the sole or primary evidence for the safety and efficacy of the medicinal product consists of published scientific literature;

(q)
the application is—

(i)
for an extension of an existing marketing authorization which fulfils the conditions set out in Annex II to Commission Regulation (EC) No. 1084/2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State^f2, and

(ii)
includes the results of pre-clinical tests or clinical trials as specified in Article 8(3)(i) of the 2001 Directive;

(r)
the application—

(i)
is not an application in accordance with Article 10, 10a or 10c of the 2001 Directive, and

(ii)
includes the results of pre-clinical tests or clinical trials as specified in Article 8(3)(i) of the 2001 Directive;”;

(b)

after the definition of “EC marketing authorization”, insert the following definition—

““eCTD format” means the electronic format of the Common Technical Document referred to in the guidance published by the European Commission in Volume 2B of “The Rules Governing Medicinal Products in the European Union”, referred to in paragraph (1) of the Introduction to Annex I to the 2001 Directive^f3;”; and

(c)

after the definition of “major application”, insert the following definition—

““the MHRA portal” means the internet-based hosted platform which enables persons to carry out business with the Medicines and Healthcare products Regulatory Agency of the Department of Health electronically, known as the “the MHRA Portal”^f4;”.

(3)

In Part II (capital fees for applications for authorizations, licences and certificates), in paragraph 1, for sub-paragraph (1) substitute—

“(1)
Subject to paragraphs 1A, 2, 3, 4 and 4A, the fee payable under regulation 4(a) in connection with an application for a marketing authorization of a kind described in column 1 of the following table shall be—

(a)
if—

(i)
the application is made using the MHRA portal, and

(ii)
the particulars and documents accompanying the application are presented in eCTD format,

the fee specified in the corresponding entry in column 2 of that table; or

(b)
in any other case, the fee specified in the corresponding entry in column 3 of that table.

Fees for marketing authorization applications

Column 1

Kind of application

Column 2

Fee payable if application is in eCTD format

Column 3

Fee payable in other cases

1 Major application
(a) in respect of an application relating to an orphan medicinal product to which point 6 of Part II of Annex 1 to the 2001 Directive applies £28,494 £29,890
(b) which is a mutual recognition procedure incoming application £61,959 £64,995
(c) which is a European reference product application £61,959 £64,995
(d) which is a decentralised procedure application where the United Kingdom is a concerned Member State £88,993 £93,249
(e) which is a decentralised procedure application where the United Kingdom is a reference Member State £126,982 £133,204
(f) in any other case £88,893 £93,249
2 Complex application
(a) which is a mutual recognition procedure incoming application £17,202 £18,045
(b) which is a European reference product application £17,202 £18,045
(c) which is a decentralised procedure application where the United Kingdom is a concerned Member State £24,576 £25,780
(d) which is a decentralised procedure application where the United Kingdom is a reference Member State £34,353 £36,036
(e) in any other case £24,576 £25,780
3 Standard application
(a) which is a mutual recognition procedure incoming application £6,304 £6,613
(b) which is a European reference product application £6,304 £6,613
(c) which is a decentralised procedure application where the United Kingdom is a concerned Member State £9,011 £9,453
(d) which is a decentralised procedure application where the United Kingdom is a reference Member State £12,921 £13,554
(e) in any other case £9,011 £9,453
4 Simple application
(a) which is a decentralised procedure application where the United Kingdom is a concerned Member State £2,457 £2,577
(b) in any other case £2,457 £2,577
5 Application for a parallel import licence Not applicable £1,718
6 Change of ownership application Not applicable £424

”

Column 1 Kind of application	Column 2 Fee payable if application is in eCTD format	Column 3 Fee payable in other cases
1 Major application
(a) in respect of an application relating to an orphan medicinal product to which point 6 of Part II of Annex 1 to the 2001 Directive applies	£28,494	£29,890
(b) which is a mutual recognition procedure incoming application	£61,959	£64,995
(c) which is a European reference product application	£61,959	£64,995
(d) which is a decentralised procedure application where the United Kingdom is a concerned Member State	£88,993	£93,249
(e) which is a decentralised procedure application where the United Kingdom is a reference Member State	£126,982	£133,204
(f) in any other case	£88,893	£93,249
2 Complex application
(a) which is a mutual recognition procedure incoming application	£17,202	£18,045
(b) which is a European reference product application	£17,202	£18,045
(c) which is a decentralised procedure application where the United Kingdom is a concerned Member State	£24,576	£25,780
(d) which is a decentralised procedure application where the United Kingdom is a reference Member State	£34,353	£36,036
(e) in any other case	£24,576	£25,780
3 Standard application
(a) which is a mutual recognition procedure incoming application	£6,304	£6,613
(b) which is a European reference product application	£6,304	£6,613
(c) which is a decentralised procedure application where the United Kingdom is a concerned Member State	£9,011	£9,453
(d) which is a decentralised procedure application where the United Kingdom is a reference Member State	£12,921	£13,554
(e) in any other case	£9,011	£9,453
4 Simple application
(a) which is a decentralised procedure application where the United Kingdom is a concerned Member State	£2,457	£2,577
(b) in any other case	£2,457	£2,577
5 Application for a parallel import licence	Not applicable	£1,718
6 Change of ownership application	Not applicable	£424

(4)

In Part III (capital fees for applications for variations of authorizations, licences and certificates)—

(a)

for paragraph 2 substitute the following paragraph—

“2.

Subject to paragraphs 4 to 6 and 13 to 15, the fee payable under regulation 7(1) in connection with an application for a variation of a marketing authorization of a kind described in column 1 of the following table shall be—

(a)
if—

(i)
the application is made using the MHRA portal, and

(ii)
the particulars and documents accompanying the application are presented in eCTD format,

the fee specified in the corresponding entry in column 2 of that table; or

(b)
in any other case, the fee specified in the corresponding entry in column 3 of that table.

Fees for applications for variations of marketing authorizations

Column 1

Kind of application

Column 2

Fee payable if application is in eCTD format

Column 3

Fee payable in other cases

1 Application where, for the purposes of Commission Regulation (EC) No. 1084/2003, the United Kingdom is the reference Member State as defined in Article 3.4 of that Regulation
(a) Type IA Application £264 £276
(b) Type IB Application £526 £552
(c) Type II Application £852 £894
(d) Type II Complex Variation Application £13,808 £14,484
(e) Extended Type II Complex Variation Application £34,353 £36,036
2 Other variation applications
(a) Type IA Application £170 £178
(b) Type IB Application £266 £280
(c) Type II Application £704 £738
(d) Type II Complex Variation Application £7,964 £8,354
(e) Extended Type II Complex Variation Application £24,576 £25,780
(f) reclassification variation application £8,206 £8,206

”

Column 1 Kind of application	Column 2 Fee payable if application is in eCTD format	Column 3 Fee payable in other cases
1 Application where, for the purposes of Commission Regulation (EC) No. 1084/2003, the United Kingdom is the reference Member State as defined in Article 3.4 of that Regulation
(a) Type IA Application	£264	£276
(b) Type IB Application	£526	£552
(c) Type II Application	£852	£894
(d) Type II Complex Variation Application	£13,808	£14,484
(e) Extended Type II Complex Variation Application	£34,353	£36,036
2 Other variation applications
(a) Type IA Application	£170	£178
(b) Type IB Application	£266	£280
(c) Type II Application	£704	£738
(d) Type II Complex Variation Application	£7,964	£8,354
(e) Extended Type II Complex Variation Application	£24,576	£25,780
(f) reclassification variation application	£8,206	£8,206

; and

(b)

omit paragraph 3.

Annotations

Footnotes

f1: The definition was amended by S.I. 2002/542, 2004/666 and 2005/2979.
f2: OJ No. L159, 27.6.2003, p.1.
f3: Volume 2B of “The Rules Governing Medicinal Products in the European Union” is available at http://ec.europa.eu/enterprise/pharmaceuticals/index_en.htm.
f4: The MHRA Portal may be accessed at http://portal.mhra.gov.uk.