The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001

Statutory Instruments

2001 No. 795

MEDICINES

FEES AND CHARGES

The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001

Made

8th March 2001

Laid before Parliament

9th March 2001

Coming into force

1st April 2001

The Secretary of State, being a Minister designated for the purposes of section 2(2) of the European Communities Act 1972(1) in relation to medicinal products(2), in exercise of the powers conferred upon him by the said section 2(2), the Secretary of State, with the consent of the Treasury, in exercise of the powers conferred upon him by section 56(1) and (2) of the Finance Act 1973(3), the Secretary of State concerned with health in England, the Minister of Agriculture, Fisheries and Food, the Minister of Health, Social Services and Public Safety and the Minister of Agriculture and Rural Development, acting jointly and with the consent of the Treasury, in exercise of powers conferred upon them by section 1(1) and (2) of the Medicines Act 1971(4), or, as the case may be, powers conferred by those provisions and now vested in them(5), and in each case in exercise of all other powers respectively enabling them in that behalf, after consultation in accordance with section 129(6) of the Medicines Act 1968(6), as extended by section 1(3)(b) of the Medicines Act 1971, with such organisations as appear to them to be representative of interests likely to be substantially affected, hereby make the following Regulations:—

Citation, commencement and interpretation U.K.

1.—(1) These Regulations may be cited as the Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001 and shall come into force on 1st April 2001.

(2) In these Regulations—

“the Devices Regulations” means the Medical Devices (Consultation Requirements) (Fees) Regulations 1995(7);

“the General Fees Regulations” means the Medicines (Products for Human Use—Fees) Regulations 1995(8);

“the Homoeopathic Products Regulations” means the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994(9);

“the Marketing Authorisations Regulations” means the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994(10).

Amendment of the Marketing Authorisations Regulations U.K.

2.—(1) In regulation 1(2) of the Marketing Authorisations Regulations (interpretation)—

(a) after the definition of “Community marketing authorisation” there shall be inserted the following definition—

““EEA State” means a contracting party to the Agreement on the European Economic Area signed at Oporto on 2nd May 1992(11) as adjusted by the Protocol signed at Brussels on 17th March 1993(12);”;

(b) after the definition of “the EMEA” there shall be inserted the following definition—

““parallel import licence” means a United Kingdom marketing authorisation granted by the licensing authority under these Regulations in respect of a relevant medicinal product which is imported into the United Kingdom from another EEA state in accordance with the rules of Community law relating to parallel imports”;

(c) the definition of “parallel import” shall be omitted; and

(d) for the definition of “United Kingdom marketing authorisation” there shall be substituted the following definition—

““United Kingdom marketing authorisation” means a marketing authorisation granted by the licensing authority under these Regulations and includes a parallel import licence.”.

(2) In regulation 4(1) of the Marketing Authorisations Regulations (applications for the grant, renewal or variation of a United Kingdom marketing authorisation), for the words “any provision of Community law affecting” there shall be substituted the words “the rules of Community law relating to”.

(3) In regulation 5 of the Marketing Authorisations Regulations (consideration, and grant or refusal, of an application for, or for renewal or variation of, a United Kingdom marketing authorisation)—

(a) in paragraph (1), after the word “provisions” at each place where it occurs, there shall be inserted the words “and (where applicable) the rules of Community law relating to parallel imports”;

(b) in paragraph (2), after the words “every authorisation” there shall be inserted the words “, other than a parallel import licence,”; and

(c) in paragraph (4), after the words “the 1965 Directive” there shall be inserted the words “or in relation to a parallel import licence”.

Amendment of the Homoeopathic Products Regulations U.K.

3.—(1) In regulation 1(2) of the Homoeopathic Products Regulations(13) (interpretation), in the definition of “standard variation”—

(a) at the end of paragraph (n) the word “or” shall be omitted;

(b) at the end of paragraph (o) there shall be inserted the word “or”; and

(c) after paragraph (o) there shall be inserted the following paragraph—

“(p) a change following modification to the manufacturing authorisation.”.

(2) In regulation 14(14) of the Homoeopathic Products Regulations (fees for variations of certificates)—

(a) in paragraph (1)(a), for “£90” there shall be substituted “£95”;

(b) in paragraph (1)(b)(i), for “£90” there shall be substituted “£95”;

(c) in paragraph (2)(a), for “£176” there shall be substituted “£185”;

(d) in paragraph (2)(b)(i), for “£176” there shall be substituted “£185”; and

(e) in paragraph (2)(b)(ii), for “£176” there shall be substituted “£185”.

(3) In regulation 15(1)(15) of the Homoeopathic Products Regulations (fees payable by holders of certificates), for “£11” there shall be substituted “£12”.

(4) In the Table in Schedule 2 to the Homoeopathic Products Regulations(16) (fees for applications for the grant of certificates of registration)—

(a) in column (2) (fees for applications in respect of products prepared from not more than 5 homoeopathic stocks)—

(i) for “£108” there shall be substituted “£113”,

(ii) for “£325” there shall be substituted “£341”, and

(iii) for “£535” there shall be substituted “£562”; and

(b) in column (3) (fees for other applications)—

(i) for “£267” there shall be substituted “£280”,

(ii) for “£478” there shall be substituted “£502”, and

(iii) for “£701” there shall be substituted “£736”.

Amendment of regulation 3 of the Devices Regulations U.K.

4.  In regulation 3 of the Devices Regulations(17) (fees)—

(a) in paragraph (1)(a), for “£2,885” there shall be substituted “£3,029”;

(b) in paragraph (1)(b), for “£6,406” there shall be substituted “£6,726”;

(c) in paragraph (2)(a), for “£570” there shall be substituted “£599”;

(d) in paragraph (2)(b), for “£1,596” there shall be substituted “£1,676”;

(e) in paragraph (5)(a), for “£29,326” there shall be substituted “£30,972”; and

(f) in paragraph (5)(b), for “£7,324” there shall be substituted “£7,690”.

Amendment of the General Fees Regulations U.K.

5.—(1) In regulation 2(1) of the General Fees Regulations(18) (interpretation)—

(a) in the definition of “authorised medicinal product”, the words “or marketing authorisation (parallel import)” shall be omitted;

(b) the definition of “marketing authorisation (parallel import)” shall be omitted;

(c) after the definition of “orphan medicinal product” there shall be inserted the following definition—

““parallel import licence” means a United Kingdom marketing authorisation granted by the licensing authority under the 1994 Regulations in respect of a relevant medicinal product which is imported into the United Kingdom from another EEA State in accordance with the rules of Community law relating to parallel imports;” and

(d) after the definition of “periodic fee” there shall be inserted the following definition—

““Periodic Safety Update Report” means a report prepared to meet the requirements of Council Directive 65/65/EEC(19) on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products, as amended(20), and Council Directive 75/318/EEC(21) on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products, as amended(22), and in accordance with the International Conference on Harmonisation and Committee on Proprietary Medicinal Products Guidance on clinical safety data management—Periodic Safety Update Reports for marketing drugs;”.

(2) Regulations 4A, 4B, and 4C of the General Fees Regulations(23) shall be renumbered regulations 6A, 6B and 6C respectively.

(3) In regulation 6(2) of the General Fees Regulations (applications for certificates by exporters of medicinal products)—

(a) in sub-paragraph (a) for the words “up to four” there shall be substituted the word “two”; and

(b) in sub-paragraph (b) for the word “five” there shall be substituted the word “three”.

(4) In regulation 16(1) of the General Fees Regulations(24) (time for payment in connection with applications or inspections) for “4C” there shall be substituted “6C”.

(5) In paragraph 1 of Part I of Schedule 1 to the General Fees Regulations (interpretation), in the definition of “standard application”, for the words “marketing authorisation (parallel import)”, there shall be substituted the words “parallel import licence”.

(6) In entry 5 in column 1 in the table in paragraph 1 of Part II of Schedule 1 to the General Fees Regulations (capital fees for applications for authorisations, licences and certificates), for the words “marketing authorisation (parallel import)” there shall be substituted the words “parallel import licence”.

(7) In paragraph 2 of Part IIA of Schedule 1 to the General Fees Regulations(25) (outgoing mutual recognition applications), for “4B” there shall be substituted “6B”.

(8) In paragraph 1 of Part III of Schedule 1 to the General Fees Regulations (capital fees for variations of authorisations, licences and certificates), in the definitions of “Type I Application” and “Type II Application”, for the words “marketing authorisation (parallel import)”, at each place where they occur, there shall be substituted the words “parallel import licence”.

(9) In paragraph 6 of Part III of Schedule 1 to the General Fees Regulations—

(a) for the words “marketing authorisation (parallel import)”, there shall be substituted the words “parallel import licence”;

(b) in sub-paragraph (a)(i) to (vi) for the word “authorisation”, at each place where it occurs, there shall be substituted the word “licence”; and

(c) in sub-paragraph (a)(vii)(aa) to (dd) for the words “marketing authorisation (parallel import)”, at each place where they occur, there shall be substituted the words “parallel import licence”.

(10) In paragraph 1 of Part IV of Schedule 3 to the General Fees Regulations (types of marketing authorisation for which only one periodic fee is payable), for the words “Marketing authorisations (parallel import)” there shall be substituted the words “Parallel import licences”

(11) In paragraph 4A of Schedule 4 to the General Fees Regulations (26) (time for payment of capital fees - applications by small companies), for “4B” there shall be substituted “6B”.

(12) After paragraph 2 of Schedule 5 to the General Fees Regulations (waiver, reduction or refund of capital fees) there shall be inserted the following paragraph—

“2A.   Where an application is made for the variation of a marketing authorisation so as to demonstrate compliance with the “Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products” published by the European Commission in Volume 3 of its publication “The Rules Governing Medicinal Products in the European Union”, the fee payable under regulation 7(1) in connection with that application may be waived.”.

(13) In paragraph 6 of Schedule 5 to the General Fees Regulations—

(a) for the words “marketing authorisation (parallel import)”, at each place where they occur, there shall be substituted the words “parallel import licence”;

(b) for the words “where the authorisation” there shall be substituted the words “where the licence”;

(c) for the words “of that authorisation” there shall be substituted the words “of that licence”; and

(d) for the words “authorisation applies for a variation to the authorisation” there shall be substituted the words “licence applies for a variation to the licence”.

(14) In each provision of the General Fees Regulations specified in the entries in column (1) of the Schedule to these Regulations (the content of which is described in column (2) of that Schedule), for the amount specified opposite that provision in column (3) of that Schedule there shall be substituted the amount specified opposite that provision in column (4) of that Schedule.

Signed by authority of the Secretary of State for Health

Hunt

Parliamentary Under Secretary of State,

Department of Health

5th March 2001

Hayman

Minister of State, Ministry of Agriculture, Fisheries and Food

6th March 2001

Bairbre de Brún

Minister of Health, Social Services and Public Safety

7th March 2001

Bríd Rodgers

Minister of Agriculture and Rural Development

7th March 2001

We consent,

Greg Pope

Jim Dowd

Two of the Lords Commissioners of Her Majesty’s Treasury

8th March 2001

Regulation 5(14)

SCHEDULE U.K.

Column (1)	Column (2)	Column (3)	Column (4)
Provision in the General Regulations	Subject matter	Old amount	New amount
Regulation 6	Applications for certificates by exporters of medicinal products
Paragraph (1)(a)		£96	£100
Paragraph (1)(b)		£34	£44
Paragraph (1)(c)(i)		£34	£44
Paragraph (1)(c)(ii)		£17	£22
Regulation 10	Renewals of clinical trial certificates	£1,795	£1,885
Regulation 11(1)	Renewals of certain manufacturer’s licences	£102	£107
Part II of Schedule 1	Capital fees for applications for authorisations, licences and certificates
In column 2 of the Table in paragraph 1(1)
Entry 1(a)		£21,545	£22,622
Entry 1(b)		£46,085	£48,389
Entry 1(c)		£65,835	£69,127
Entry 2(a)		£12,568	£13,196
Entry 2(b)		£17,955	£18,853
Entry 3(a)		£4,605	£4,835
Entry 3(b)		£6,584	£6,913
Entry 4		£1,795	£1,885
Entry 5		£1,196	£1,256
Entry 6		£296	£310
Paragraph 5(1)(a)		£114	£120
Paragraph 5(1)(b)		£216	£227
Paragraph 5(1)(c)		£1,972	£2,070
Paragraph 6(1)		£775	£814
Paragraph 6(2)		£570	£598
Paragraph 6(4)		£250	£262
Paragraph 7		£13,885	£14,579
Part III of Schedule 1	Capital fees for applications for variations of authorisations, licences and certificates
Paragraph 2(a)		£176	£184
Paragraph 2(b)		£404	£424
Paragraph 2(c)		£5,984	£6,282
Paragraph 3(a)		£274	£288
Paragraph 3(b)		£490	£514
Paragraph 3(c)		£9,336	£9,802
Paragraph 6(a)		£114	£120
Paragraph 6(b)		£239	£251
Paragraph 7(a)		£108	£113
Paragraph 7(b)		£216	£227
Paragraph 8		£108	£113
Paragraph 9		£250	£262
Paragraph 10		£108	£113
Paragraph 11		£176	£185
Paragraph 12		£90	£95
Schedule 2	Fees for inspections
Paragraph 2(a)(i)		£1,870	£1,964
Paragraph 2(a)(ii)		£3,470	£3,643
Paragraph 2(a)(iii)		£4,190	£4,400
Paragraph 2(a)(iv)		£7,182	£7,541
Paragraph 2(b)(i)		£2,034	£2,136
Paragraph 2(b)(ii)		£4,190	£4,400
Paragraph 2(b)(iii)		£6,582	£6,911
Paragraph 2(b)(iv)		£11,970	£12,568
Paragraph 2(c)(i)		£718	£754
Paragraph 2(c)(ii)		£2,010	£2,110
Paragraph 2(c)(iii)		£3,003	£3,153
Paragraph 2(c)(iv)		£5,625	£5,906
Paragraph 2(d)		£136	£143
Paragraph 5(1)		£376	£395
Paragraph 5(1)		£826	£867
Part III of Schedule 3	Periodic fees for marketing authorisations and licences
In column 2 of the Table in paragraph 1
Entry 2(a)		£4,788	£5,027
Entry 2(b)(i)		£1,197	£1,257
Entry 2(b)(ii)		£598	£628
Entry 2(b)(iii)		£194	£204
Entry 2(c)(i)		£524	£550
Entry 2(c)(ii)		£262	£275
Entry 2(c)(iii)		£97	£102
Entry 2(d)(i)		£216	£227
Entry 2(d)(ii)		£108	£113
Entry 2(d)(iii)		£48	£50
Entry 2(e)		£59	£62
Paragraph 2(a)		£268	£280
Paragraph 2(b)		£131	£138
Paragraph 2(c)		£55	£58
Paragraph 3(a)		£4,788	£5,027
Paragraph 3(b)		£3,232	£3,394
Paragraph 7		£239	£251
Paragraph 8(1)		£148	£155
Paragraph 8(2)		£89	£93

Explanatory Note

(This note is not part of the Regulations)

These Regulations make further amendments to the Medical Devices (Consultation Requirements) (Fees) Regulations 1995 (“the Devices Regulations”), the Medicines (Products for Human Use—Fees) Regulations 1995 (“the General Fees Regulations”), the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 (“the Homoeopathic Products Regulations”) and the Medicines for Human Use (Marketing Authorisations etc.) Regulations 1994 (“the Marketing Authorisations Regulations”).

The Marketing Authorisations Regulations implemented in part the following provisions of the European Community: Council Directives 65/65/EEC(27), 75/318/EEC(28), 75/319/EEC(29) and any Regulation adopted by the Commission under Article 15 of that Directive, 89/342/EEC(30), 89/343/EEC(31), 89/381/EEC(32), 92/26/EEC(33), 92/27/EEC(34), 92/73/EEC(35), Regulation (EEC) No. 2309/93(36) and any Regulations adopted by the Commission under Article 15.4 or 22.1 of that Regulation. They provide for the manner of making applications for the grant, renewal or variation of a United Kingdom marketing authorisation and for procedures for consideration, revocation, suspension and related matters. Regulation 2 of these Regulations amends the Marketing Authorisations Regulations by inserting into regulation 1(2) of those Regulations a definition of “EEA State”, omitting the definition of “parallel import”, inserting a definition of “parallel import licence” and substituting a new definition of “United Kingdom marketing authorisation”. Regulations 2(2) and (3) make amendments consequential on those new definitions. These amendments together with the amendments to the Fees Regulations referred to below clarify the status of the parallel import scheme.

The Homoeopathic Products Regulations implemented in part Council Directive 92/73/EEC(37) by introducing a new registration procedure for the marketing of certain homoeopathic medicinal products for human use. These Regulations amend the Homoeopathic Products Regulations in the following way. Regulation 3(1) of these Regulations adds to the definition of “standard variation”, regulation 3(2) increases the amounts of the fees payable for variations of certificates of registration, regulation 3(3) increases the fee payable by holders of certificates of registration and regulation 3(4) increases the amounts of the capital fees payable for applications for certificates of registration. These increases average overall 5%.

The Devices Regulations prescribe the fees which are payable where a notified body consults the competent body in accordance with Council Directive 93/42/EEC(38) concerning medical devices. Regulation 4 of these Regulations amends the Devices Regulations by increasing the amounts of certain of the fees specified in regulation 3 of those Regulations by an average overall of 5%.

The General Fees Regulations make provision for the fees payable under the Medicines Act 1971 relating to marketing authorisations, licences and certificates in respect of medicinal products for human use. These Regualtions amend those Regulations as follows: regulation 5(1) of these Regulations amends regulation 2(1) of those Regulations by inserting a definition of “parallel import licence” and amends the definition of “authorised medicinal product” to take account of this; regulation 5(6), (8), (9), (10) and (13) make amendments consequential on this; these amendments together with those made to the Marketing Authorisations Regulations referred to above clarify the status of the parallel import scheme. Regulation 5(2) renumbers regulations 4A–4C of the General Fees Regulations and regulations 5(4), (7) and (11) make amendments consequential upon this. Regulation 5(3) of these Regulations reduces the number of export certificates comprising a “set”. Regulation 5(12) allows for the waiver of any fee payable in connection with a variation application for the purpose of demonstrating compliance with the “Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products”, published by the European Commission.

There is also a package of changes to the General Fees Regulations relating to the levels of capital fees payable for applications for marketing authorisations, manufacturer’s licences, wholesale dealer’s licences, clinical trial certificates and export certificates; capital fees payable for variations and renewals of such authorisations, licences and certificates; periodic fees payable in connection with the holding of certain authorisations and licences; and the fees payable in connection with site inspections. Fees have been increased by approximately 5% except in the case of the fee for export certificates, which is increased by 30%.

A Regulatory Impact Assessment in relation to these Regulations has been placed in the libraries of both Houses of Parliament, and copies can be obtained from the Medicines Control Agency, Room 16107, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.

(1)

1972 c. 68.

(2)

S.I. 1972/1811.

(3)

1973 c. 51.

(4)

1971 c. 69; as amended by section 21 of the Health and Medicines Act 1988 (c. 49). By virtue of section 1(3) of the 1971 Act, expressions used in that section have the same meaning as in the Medicines Act 1968 (c. 67), as amended by article 2(2) of, and Schedule 1 to, S.I. 1969/388 and by article 5 of, and the Schedule to, S.I. 1999/3142; see therefore section 1(1) of the 1968 Act, which contains a definition of “the Ministers” which is relevant to the powers being exercised in the making of these Regulations. See also regultion 9(12) of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (S.I. 1994/3144), by virtue of which the references in section 1(1) and (2)(b) of the 1971 Act to a licence under Part II of the 1968 Act include reference to a marketing authorisation under the 1994 Regulations.

(5)

In the case of the Secretary of State concerned with health in England, by virtue of articles 2(1) and 5 of, and the Schedule to, S.I. 1999/3142; in the case of the Minister of Agriculture, Fisheries and Food, by virtue of articles 2(2) and 5 of, and the Schedule to, S.I. 1999/3142; in the case of the Minister of Health, Social Services and Public Safety and the Minister of Agriculture and Rural Development, by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c. 47).

(6)

1968 c. 67.

(7)

S.I. 1995/449; amended by S.I. 1998/574, 1999/566 and 2000/592.

(8)

S.I. 1995/1116; amended by S.I. 1996/683, 1998/574, 1999/566, 2000/592 and 2000/3031.

(9)

S.I. 1994/105; amended by S.I. 1995/541, 1996/482, 1998/574, 1999/566 and 2000/592.

(10)

S.I. 1994/3144; amended by S.I. 1998/3105 and 2000/292.

(11)

OJ No. L1, 3.1.1994, p.3.

(12)

OJ No. L1, 3.1.1994, p.572.

(13)

As amended by S.I. 1998/574.

(14)

As amended by regulation 2(1) of S.I. 2000/592.

(15)

As amended by regulation 2(2) of S.I. 2000/592.

(16)

As amended by regulation 2(3) of S.I. 2000/592.

(17)

As amended by regulation 3 of S.I. 2000/592.

(18)

As amended by S.I. 1996/683, 2000/592 and 2000/3031.

(19)

OJ No. L22 of 9.2.1965, p.369.

(20)

Council Directive 65/65/EEC has been amended by Directive 66/454/EEC (OJ No. L144, 5.8.1966, p.2658), Council Directive 75/319/EEC (OJ No. L147, 9.6.1975, p.13), Council Directive 83/570/EEC (OJ No. L332, 28.11.1983, p.1), Council Directive 87/21/EEC (OJ No. L15, 17.1.1987, p.36), Council Directive 89/341/EEC (OJ No. L142, 25.5.1989, p.11), Council Directive 89/342/EEC (OJ No. L142, 25.5.1989, p.14), Council Directive 92/27/EEC (OJ No. L113, 30.4.1992, p.8), Council Directive 92/73/EEC (OJ No. L297, 13.10.1992, p.8) and Council Directive 93/39/EEC (OJ No. L215, 24.8.1993, p.22).

(21)

OJ No. L147, 9.6.1975, p.1.

(22)

Council Directive 75/318/EEC has been amended by Council Directive 75/319/EEC (OJ No. L147, 9.6.1975, p.13), Council Directive 83/570/EEC (OJ No. L332, 28.11.1983, p.1), Council Directive 87/19/EEC (OJ No. L15, 17.1.1987, p.31), Council Directive 89/341/EEC (OJ No. L142, 25.5.1989, p.11), Commission Directive 91/507/EEC (OJ No. L270, 26.9.1991, p.32), Council Directive 93/39/EEC (OJ No. L214, 24.8.93, p.22), Commission Directive 1999/82/EC (OJ No. L243, 15.9.1999, p.7) and Commission Directive 1999/83/EC (OJ No. L243, 15.9.1999, p.7).

(23)

Inserted by regulation 3 of S.I. 2000/3031.

(24)

As amended by S.I. 2000/3031.

(25)

Inserted by regulation 6 of S.I. 2000/3031.

(26)

Inserted by regulation 6 of S.I. 2000/3031.

(27)

OJ No. L22, 9.2.1965, p.369.

(28)

OJ No. L147, 9.6.1975, p.1.

(29)

OJ No. L147, 9.6.1975, p.13.

(30)

OJ No. L142, 25.5.1989, p.14.

(31)

OJ No. L142, 25.5.1989, p.16.

(32)

OJ No. L181, 28.6.1989, p.44.

(33)

OJ No. L113, 30.4.1992, p.5.

(34)

OJ No. L113, 30.4.1992, p.8.

(35)

OJ No. L297, 13.10.1992, p.8.

(36)

OJ No. L214, 24.8.1993, p.1.

(37)

OJ No. L297, 13.10.1993, p.8.

(38)

OJ No. L169, 12.7.1993, p.1.