Statutory Instruments

2006 No. 494

FEES AND CHARGES

MEDICINES

The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2006

Made

27th February 2006

Laid before Parliament

3rd March 2006

Coming into force

1st April 2006

^M1^,^M2 The Secretary of State for Health, the Department of Health, Social Services and Public Safety and the Department of Agriculture and Rural Development, acting jointly, make the following Regulations in exercise of the powers conferred on them by section 1(1) and (2) of the Medicines Act 1971 or, as the case may be, the powers conferred by those provisions and now vested in them .

^M3^,^M4^,^M5 In so far as these Regulations are not made under section 1(1) and (2) of the Medicines Act 1971, the Secretary of State makes these Regulations in exercise of the powers conferred on her by section 2(2) of the European Communities Act 1972 and section 56(1) and (2) of the Finance Act 1973 . The Secretary of State has been designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to medicinal products .

The Treasury has consented to the making of these Regulations as required by section 1(1) of the Medicines Act 1971 and section 56(1) of the Finance Act 1973.

^M6 In accordance with section 129(6) of the Medicines Act 1968 , the Secretary of State for Health, the Department of Health, Social Services and Public Safety and the Department of Agriculture and Rural Development have consulted with such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations.

Citation, commencement and interpretation

1. —(1) These Regulations may be cited as the Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2006 and shall come into force on 1st April 2006.

(2) In these Regulations—

^M7 “ the Devices Regulations ” means the Medical Devices (Consultation Requirements)(Fees) Regulations1995 ;

^M8 “ the General Fees Regulations ” means the Medicines (Products for Human Use—Fees) Regulations 1995 ; and

^M9 “ the Homoeopathic Products Regulations ” means the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 .

Amendment of the General Fees Regulations

^F1 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of the Homoeopathic Products Regulations

3. —(1) The Homoeopathic Products Regulations are amended as follows.

(2) In regulation 14 (fees for variations of certificates)—

(a) in paragraph (2)(a), for “£218” substitute “ £226 ” ;

(b) in paragraph (2)(b)(i), for “£218” substitute “ £226 ” ;

(d) in paragraph (2)(b)(iii), for “£110” substitute “ £114 ” ; and

(e) in paragraph (2)(b)(iv), for “£55” substitute “ £57 ” .

^M10 (3) In the table in Schedule 2 (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 “£134” substitute “ £148 ” ;

(ii) for “£402” substitute “ £444 ” ; and

(iii) for “£664” substitute “ £734 ” ; and

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

(i) for “£330” substitute “ £365 ” ;

(ii) for “£592” substitute “ £654 ” ;

(iii) for “£869” substitute “ £960 ” .

Amendment of regulation 3 of the Devices Regulations

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

(a) in paragraph (1)(a), for “£3,575” substitute “ £3,948 ” ;

(b) in paragraph (1)(b), for “£8,333” substitute “ £9,202 ” ;

(d) in paragraph (2)(b), for “£1,978” substitute “ £2,184 ” ;

(e) in paragraph (3)(a), for “£3,575” substitute “ £3,948 ” ;

(f) in paragraph (3)(b), for “£8,333” substitute “ £9,262 ” ;

(g) in paragraph (4)(a), for “£707” substitute “ £781 ” ;

(h) in paragraph 4(b), for “£1,978” substitute “ £2,184 ” ;

(i) in paragraph (5)(a), for “£36,560” substitute “ £40,374 ” and

(j) in paragraph (5)(b), for “£9,077” substitute “ £10,024 ” .

Signed by authority of the Secretary of State for Health

Jane Kennedy

Minister of State,

Department of Health

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

Andrew McCormick

Permanent Secretary,

Department of Health, Social Services and Public Safety

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

Pat Toal

Permanent Secretary,

Department of Agriculture and Rural Development

We consent,

Gillian Merron and Tom Watson

Two of the Lords Commissioners of Her Majesty's Treasury

Regulation 2(1)

^F2 SCHEDULE

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

in force	Provision is in force
in force*	In force only for specified purposes (for detail about the purposes see/hover footnote)
not in force	Not in force in England (may be in force in other geographies, see footnotes)
italics	Defined term
_dfn	Defined term (alternative style)
gry bckgrd	the in-force status of the provision is complex, check the footnotes

in force

Provision is in force

in force*

In force only for specified purposes (for detail about the purposes see/hover footnote)

not in force

Not in force in England (may be in force in other geographies, see footnotes)

italics

Defined term

_dfn

Defined term (alternative style)

gry bckgrd

the in-force status of the provision is complex, check the footnotes

footnote	commentary	related provisions
F1	Reg. 2 revoked (1.4.2008) by The Medicines (Products for Human Use-Fees) Regulations 2008 (S.I. 2008/552) , regs. 1 , 48(1) , Sch. 7 (with reg. 48(2) )	this amendment (text ) should be read in conjunction with other related provisions, see the commentary.
F2	Sch. revoked (1.4.2008) by The Medicines (Products for Human Use-Fees) Regulations 2008 (S.I. 2008/552) , regs. 1 , 48(1) , Sch. 7 (with reg. 48(2) )	this amendment (text ) should be read in conjunction with other related provisions, see the commentary.
M1	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.
M2	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) .
M3	1972 c. 68 .
M4	1973 c. 51 .
M5	S.I. 1972/181 .
M6	1968 c. 67 ; section 129(6) was extended by section 1(3)(b) of the Medicines Act 1971.
M7	S.I. 1995/449 relevant amending instrument is S.I. 2004/666 .
M8	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, 2004/666 and 1157, and 2005/1124 and 2797.
M9	S.I. 1994/105 as amended by S.I. 1994/899 , 1995/541, 1996/482, 1998/574, 1999/566, 2000/592, 2001/795, 2003/236 and 2321, 2004/666 and 2005/2753.
M10	As amended by S.I.1996/482 and S.I. 2005/2753 .

Defined Term	Section/Article	ID
the Devices Regulations	reg. 1.	def_4ef5996360
the General Fees Regulations	reg. 1.	def_5d38624dc3
the Homoeopathic Products Regulations	reg. 1.	def_50b37fb14b