The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003

Made: 8th September 2003

Laid before Parliament: 9th September 2003

Coming into force

The Secretary of State, being a Minister designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to medicinal products , 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 , the Secretary of State, the Department of Health, Social Services and Public Safety and the Department 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 , or, as the case may be, powers conferred by those provisions and now vested in them , 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 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

1

• (1) These Regulations may be cited as the Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003.

• (2) These Regulations shall come into force—

• (a) for the purposes of—

• (i) regulation 7(2)(a)(ii) and (b), (3) and (4)(a),

• (ii) regulation 8(2)(b) & (3),

• (iii) regulation 9,

• (iv) regulation 11, except paragraphs (2)(c)(iii)(bb) and (5), and

• (v) regulation 13,

on 1st October 2003, and

• (b) for all other purposes, on 31st October 2003.

• (3) In these Regulations, “the General Fees Regulations” means the Medicines (Products for Human Use—Fees) Regulations 1995 .

Amendment of the Medicines Act 1968

2

In the Medicines Act 1968 , in section 132 (interpretation), in paragraph (1), in the definition of “the 2001 Directive”, after “human use”insert “ , as amended ”.

Amendment of the Standard Provisions Regulations 1971

3

In the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971 —

• (a) in regulation 2 (interpretation), in paragraph (1), in the definition of “the 2001 Directive”, after “human useinsert “ , as amended ”; and

• (b) in Part I of Schedule 1 (standard provisions for product licences), in paragraph 16, for “Part 4G of Annex I to the 2001 Directive” substitute “ point 6 of Part II of Annex I to the 2001 Directive ”.

Amendment of the Product Licences Regulations 1993

4

In the Medicines (Applications for Grant of Product Licences—Products for Human Use) Regulations 1993 —

• (a) in regulation 1 (citation, commencement and interpretation), in paragraph (2), in the definition of “the 2001 Directive”, after “human use” insert “ , as amended ”; and

• (b) in Schedule 1 (information, documents etc. required in respect of applications)—

• (i) in paragraph 17, for “Part 3, paragraph 1.1, second sub-paragraph of the Annex I to the 2001 Directive” substitute “ paragraph (9) of the Introduction and general principles of Annex I to the 2001 Directive ”, and

• (ii) in paragraph 18, for “Part 4, paragraph B.2 of the Annex I to the 2001 Directive” substitute “ paragraph 5.2(a) of Part I of Annex I to the 2001 Directive ”.

Amendment of the Homoeopathic Medicinal Products for Human Use Regulations 1994

5

In the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 , in regulation 1 (citation, commencement and interpretation), in paragraph (2), in the definition of “the 2001 Directive”, after “human use” insert “ , as amended ”.

Amendment of the Advertising Regulations 1994

6

In the Medicines (Advertising) Regulations 1994 , in regulation 1 (interpretation), in paragraph (1), in the definition of “the 2001 Directive”, after “human use” insert “ , as amended ”.

Amendment of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

7

• (1) The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 shall be amended as follows.

• (2) In regulation 1 (citation, commencement and interpretation)—

• (a) in paragraph (2)—

• (i) in the definition of “the 2001 Directive”, after “human use” insert “ , as amended ”, and

• (ii) in the definition of “the relevant Community provisions”—

• (aa) omit “Regulation (EC) No. 541/95, as amended” and “Regulation (EC) No. 542/95, as amended”, and

• (bb) after “Regulation (EC) No. 847/2000” insert the following entries—

Regulation (EC) No. 1084/2003 , and Regulation (EC) No. 1085/2003 ;

; and

• (b) in paragraph (4), after sub-paragraph (b) insert the following sub-paragraph—

(bb) any reference in these Regulations to an application for the variation of a marketing authorization includes a reference to a notification of such a variation, and any reference to an applicant for a variation to a marketing authorization includes a reference to a person submitting such a notification; and

• (3) After regulation 6 (revocation, suspension or variation of a United Kingdom marketing authorization or the suspension of the use or marketing of medicinal products), insert the following regulation—

(6A) (1) The licensing authority may, subject to and in accordance with the relevant Community provisions, impose an urgent safety restriction on the holder of a United Kingdom marketing authorization. (2) Where the licensing authority imposes an urgent safety restriction in accordance with paragraph (1), the holder of the marketing authorization shall— (a) implement the restriction within a period specified by the licensing authority; and (b) apply to vary the authorization so as to take account of that safety restriction immediately and in any event not later than 15 days after the restriction was imposed.

• (4) In Schedule 3 (offences, penalties etc) —

• (a) after paragraph 3 insert the following paragraph—

(3A) Any person who is the holder of a marketing authorization who fails to implement an urgent safety restriction imposed on him by the licensing authority under regulation 6A or by the European Commission under Commission Regulation (EC) No. 1085/2003 shall be guilty of an offence.

; and

• (b) in paragraph 6, in sub-paragraph (c), for “paragraph D of Part 2 of Annex I to the 2001 Directive” substitute “ paragraphs 3.2(9), 3.2.1.2(c) and 3.2.2.4(c) of Part I of Annex I to the 2001 Directive ”.

Amendment of regulation 2 of the General Fees Regulations

8

• (1) Regulation 2 of the General Fees Regulations (interpretation) is amended as follows.

• (2) In paragraph (1)—

• (a) in the definition of “the 2001 Directive”, after “human use” insert “ , as amended ”; and

• (b) in the definition of “variation” for “Article 2.1 of Commission Regulation (EC) No. 541/95” substitute “ Article 3.1 of Commission Regulation (EC) No. 1084/2003 ”.

• (3) After paragraph (2) insert the following paragraph—

(3) In these Regulations any reference to an application for the variation of a marketing authorization includes a reference to a notification of such a variation, and any reference to an applicant for a variation to a marketing authorization includes a reference to a person submitting such a notification.

Amendment of regulation 3B of the General Fees Regulations

9

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of Part II of Schedule 1 to the General Fees Regulations

10

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of Part III of Schedule 1 to the General Fees Regulations

11

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of Schedule 3 to the General Fees Regulations

12

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of Schedule 5 to the General Fees Regulations

13

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Signed

Signed by authority of the Secretary of State for Health

Warner — Parliamentary Under Secretary of State, — Department of Health — 2003-09-05

Sealed with the Official Seal of the Department of Health, Social Services and Public Safety

D.C. Gowdy — Permanent Secretary, — Department of Health, Social Services and Public Safety — 2003-09-05

Sealed with the Official Seal of the Department of Agriculture and Rural Development

Pat Toal — Permanent Secretary, — Department of Agriculture and Rural Development — 2003-09-05

We consent,

Nick Ainger — Joan Ryan — Two of the Lords Commissioners of Her Majesty’s Treasury — 2003-09-08

Explanatory note

(This note is not part of the Regulations)

Footnotes

[^f00001]: 1972 c. 68.

[^f00002]: S.I. 1972/1811.

[^f00003]: 1973 c. 51.

[^f00004]: 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); see therefore section 1(1) of the 1968 Act, as amended by article 2(2) of, and Schedule 1 to, S.I. 1969/388, by article 5 of, and the Schedule to, S.I. 1999/3142, and by article 5(1) of, and paragraph 15 of Schedule 1 to, S.I. 2002/794, which contains a definition of “the Ministers” which is relevant to the powers being exercised in the making of these Regulations. See also regulation 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 authorization under the 1994 Regulations.

[^f00005]: In the case of the Secretary of State, by virtue of article 2(1) of, and paragraph 1 of the Schedule to, S.I. 1999/3142 and article 3(1)(c) and (7) of, and paragraph 15 of Schedule 1 to, S.I. 2002/794; and in the case of the Department of Health, Social Services and Public Safety and the Department of Agriculture and Rural Development, by virtue of the powers vested in the Ministers in charge of those Departments by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c. 47) which may now be exercised by the Departments by virtue of section 1(8) of, and paragraph 4(1)(b) of the Schedule to, the Northern Ireland Act 2000 (c. 1); the Departments were renamed by virtue of Article 3(4) and (6) of S.I. 1999/283 (N.I.1).

[^f00006]: 1968 c. 67; section 129(6) was extended by section 1(3)(b) of the Medicines Act 1971.

[^f00007]: S.I. 1995/1116; as amended by S.I. 1996/683, 1998/574, 1999/566, 2000/592 and 3031, 2001/795, 2002/236 and 542 and 2003/625.

[^f00008]: 1968 c. 67; relevant amendments were made by S.I. 2002/236.

[^f00009]: Directive 2001/83/EC was amended by Commission Directive 2003/63/EC (OJ No. L 159, 27.6.2003, p. 46).

[^f00010]: S.I. 1971/972; relevant amendments were made by S.I. 2002/236.

[^f00011]: S.I. 1993/2538; relevant amendments were made by S.I. 2002/236.

[^f00012]: S.I. 1994/105; relevant amendments were made by S.I. 2002/236.

[^f00013]: S.I. 1994/1932; relevant amendments were made by S.I. 2002/236.

[^f00014]: S.I. 1994/3144; as amended by S.I. 1998/3105, 2000/292, 2001/795, 2002/236, 2002/542 and 2003/1618.

[^f00015]: The definition of “the relevant Community provisions” was substituted by regulation 8(a)(ii) of S.I. 2002/236.

[^f00016]: OJ No. L159, 27.6.2003, p.1.

[^f00017]: OJ No. L159, 27.6.2003, p.24.

[^f00018]: Expressions used in the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 have the same meaning as in the relevant Community provisions (by virtue of regulation 1(5)); for the definition of “urgent safety restriction” see article 3(5) of Regulation (EC) No. 1084/2003.

[^f00019]: Schedule 3 was amended by S.I. 1998/3105, 2000/292 and 2002/236.

[^f00020]: The definition of “reclassification variation application” was inserted by regulation 5(6)(a)(i) of S.I. 2002/542.

[^f00021]: The definition of “Type II Complex Variation Application” was amended by S.I. 1996/683, 1998/574 and 2002/236.

[^f00022]: Paragraph 14 was amended by regulation 4(4) of S.I. 1998/574.

[^f00023]: OJ No. L 22, 9.2.1965, p. 369.

[^f00024]: OJ No. L 147, 9.6.1975, p. 1.

[^f00025]: OJ No. L 147, 9.6.1975, p. 13

[^f00026]: OJ No. L 142, 25.5.1989, p. 14.

[^f00027]: OJ No. L 142, 25.5.1989, p. 16.

[^f00028]: OJ No. L 181, 28.6.1989, p. 44.

[^f00029]: OJ No. L 113, 30.4.1992, p. 5.

[^f00030]: OJ No. L 113, 30.4.1992, p. 8.

[^f00031]: OJ No. L 297, 13.10.1992, p. 8.

[^f00032]: OJ No. L 311, 28.11.2001, p. 67.

[^f00033]: OJ No. L 214, 24.8.1993, p. 1.

[^f00034]: OJ No. L 159, 27.6.2003, p. 1.

[^f00035]: OJ No. L 159, 27.6.2003, p. 24.

[^f00036]: OJ No. L 159, 27.6.2003, p. 46.

Editorial notes

[^c5080291]: 1972 c. 68.