1.—(1) These Regulations may be cited as the Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2004 and shall come into force on 1st April 2004.
(2) In these Regulations—
“the Devices Regulations” means the Medical Devices (Consultation Requirements) (Fees) Regulations 1995 M1;
“the General Fees Regulations” means the Medicines (Products for Human Use—Fees) Regulations 1995 M2; and
“the Homoeopathic Products Regulations” means the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 M3.
Marginal Citations
M1S.I. 1995/449; as amended by S.I. 1998/574, 1999/566, 2000/592, 2001/795, 2002/236 and 542, and 2003/625.
2.—(1) The Homoeopathic Products Regulations are amended as follows.
(2) In regulation 14 M4 (fees for variations of certificates)—
(a)in paragraph (2)(a), for “£216” substitute “ £218 ”;
(b)in paragraph (2)(b)(i), for “£216” substitute “ £218 ”;
(c)in paragraph (2)(b)(ii), for “£216” substitute “ £218 ”;
(d)in paragraph (2)(b)(iii), for “£108” substitute “ £110 ”; and
(e)in paragraph (2)(b)(iv), for “£54” substitute “ £55 ”.
(3) In regulation 15(1) M5 (fees payable by holders of certificates), for “£14” substitute “ £15 ”.
(4) In the Table in Schedule 2 M6 (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 “£132” substitute “ £134 ”,
(ii)for “£397” substitute “ £402 ”, and
(iii)for “£656” substitute “ £664 ”; and
(b)in column (3) (fees for other applications)—
(i)for “£326” substitute “ £330 ”,
(ii)for “£585” substitute “ £592 ”, and
(iii)for “£859” substitute “ £869 ”.
Marginal Citations
M4As amended by regulation 2(2) of S.I. 2003/625.
M5As amended by regulation 2(3) of S.I. 2003/625.
M6As amended by regulation 2(4) of S.I. 2003/625.
3. In regulation 3 of the Devices Regulations M7 (fees)—
(a)in paragraph (1)(a), for “£3,533” substitute “ £3,575 ”;
(b)in paragraph (1)(b), for “£8,234” substitute “ £8,333 ”;
(c)in paragraph (2)(a), for “£699” substitute “ £707 ”;
(d)in paragraph (2)(b), for “£1,955” substitute “ £1,978 ”;
(e)in paragraph (3)(a), for “£3,533” substitute “ £3,575 ”;
(f)in paragraph (3)(b), for “£8,234” substitute “ £8,333 ”;
(g)in paragraph (4)(a), for “£699” substitute “ £707 ”;
(h)in paragraph (4)(b), for “£1,955” substitute “ £1,978 ”;
(i)in paragraph (5)(a), for “£36,126” substitute “ £36,560 ”; and
(j)in paragraph (5)(b), for “£8,969” substitute “ £9,077 ”.
Marginal Citations
M7As amended by regulation 3 of S.I. 2003/625.
F14. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F1Regs. 4-15 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))
F15. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F1Regs. 4-15 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))
F16. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F1Regs. 4-15 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))
F17. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F1Regs. 4-15 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))
F18. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F1Regs. 4-15 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))
F19. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F1Regs. 4-15 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))
F110. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F1Regs. 4-15 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))
F111. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F1Regs. 4-15 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))
F112. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F1Regs. 4-15 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))
F113. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F1Regs. 4-15 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))
F114. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F1Regs. 4-15 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))
F115. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F1Regs. 4-15 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))
Signed by authority of the Secretary of State for Health
Warner
Parliamentary Under Secretary of State,
Department of Health
Sealed with the Official Seal of the Department of Health, Social Services and Public Safety
GowdyD. C.
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,
Derek Twigg
Nick Ainger
Two of the Lords Commissioners of Her Majesty’s Treasury