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United Kingdom Statutory Instruments |
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You are here: BAILII >> Databases >> United Kingdom Statutory Instruments >> The Medicines for Human Use (Fees Amendments) Regulations 2005 No. 1124 URL: http://www.bailii.org/uk/legis/num_reg/2005/20051124.html |
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| Made | 6th April 2005 | ||
| Laid before Parliament | 7th April 2005 | ||
| Coming into force | |||
| Except for the purposes of regulations 3 (2) and 4 | 1st May 2005 | ||
| For the purposes of regulations 3 (2) and 4 | 1st July 2005 |
(2) In these Regulations "the General Fees Regulations" means the Medicines (Products for Human Use - Fees) Regulations 1995[7].
Amendment of regulation 13 of the General Fees Regulations
2.
In regulation 13 of the General Fees Regulations (fees for inspections), at the end of paragraph (5) add ", if the time taken to make that inspection is not more than 2 hours".
Amendment of Part II of Schedule 1 to the General Fees Regulations
3.
- (1) Part II of Schedule 1 to the General Fees Regulations (capital fees for applications for authorizations, licences and certificates) is amended as follows.
(2) In column 2 of the Table in paragraph 1(1) -
(3) In paragraph 7[8] (clinical trial authorisations), head (iii) of paragraph (2)(b) is omitted.
Amendment of Part IIIA of Schedule 1 to the General Fees Regulations
4.
In paragraph 2(a) of Part IIIA of Schedule 1 to the General Fees Regulations (capital fees for assessment of labels and leaflets), for "£319" substitute "£430".
Amendment of Schedule 5 to the General Fees Regulations
5.
In Schedule 5 to the General Fees Regulations (waiver, reduction or refund of capital fees), after paragraph 2B[9], insert the following paragraph -
the fee payable under regulations 4 or 7(1)(a) in connection with that application may be waived.
(2) Where an application for the grant of, or for a variation to, a marketing authorization, other than a major application, relates to a medicinal product which is -
and no product which contains the same active ingredient and is in the same formulation as proposed for the product in question has previously been granted a marketing authorization, the fee payable under regulations 4 or 7(1)(a) in connection with that application may be waived.
(3) Where the licensing authority holds a meeting with a person for the purpose of providing scientific advice and that meeting was held with a view to that person making an application which falls within sub-paragraphs (1) or (2), the fee payable under regulation 3B may be waived.
(4) In this paragraph -
Signed by authority of the Secretary of State for Health
Warner
Parliamentary Under Secretary of State, Department of Health
4th April 2005
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
4th April 2005
Sealed with the Official Seal of the Department of Agriculture and Rural Development
Pat Toal
Permanent Secretary, Department of Agriculture and Rural Development
31st March 2005
We consent,
Jim Murphy and John Heppell
Two of the Lords Commissioners of Her Majesty's Treasury
6th April 2005
[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); 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.back
[5] 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).back
[6] 1968 c.67; section 129(6) was extended by section 1(3)(b) of the Medicines Act 1971.back
[7] 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, 2003/625 and 2321, and 2004/666 and 1157.back
[8] As amended by regulation 9(3)(b) of S.I. 2004/1157.back
[9] Paragraph 2B was inserted by regulation 5(8) of S.I. 2002/542.back
