The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2006
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.
Citation, commencement and interpretation1.
(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—
Amendment of the General Fees Regulations2.
(1)
The General Fees Regulations are amended as follows.
(2)
In each provision 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 substitute the amount specified opposite that provision in column (4) of that Schedule.
(3)
(4)
(a)
in sub-paragraph (a), at the end, insert “and”; and
(b)
omit sub-paragraph (aa).
(5)
(a)
in sub-paragraph (d), at the end, insert “and”; and
(b)
omit sub-paragraph (e).
(6)
“(1)
The fee payable under regulation 14(3) in connection with the holding of a manufacturer’s licence shall be £356.”.
Amendment of the Homoeopathic Products Regulations3.
(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”;
(c)
in paragraph (2)(b)(ii), 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”.
(3)
(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 Regulations4.
(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”;
(c)
in paragraph (2)(a), for “£707” substitute “£781”;
(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
Sealed with the Official Seal of the Department of Health, Social Services and Public Safety
Sealed with the Official Seal of the Department of Agriculture and Rural Development
We consent,
SCHEDULE
Column (1) | Column (2) | Column (3) | Column (4) |
|---|---|---|---|
Provision in the General Fees Regulations | Subject Matter | Old Amount | New Amount |
Regulation 3B15 | Capital fees for pre-application meetings | ||
Paragraph (a) | £1,012 | £1,118 | |
Paragraph (b) | £1,346 | £1,486 | |
Paragraph (c) | £1,690 | £1,866 | |
Paragraph (d) | £2,024 | £2,235 | |
Regulation 3BA16 | Capital fees for advertising advice meetings | £1,346 | £1,486 |
Regulation 3BB17 | Capital fees for pharmacovigilance advice meeting | ||
Paragraph (a) | £1,690 | £1,866 | |
Paragraph (b) | £1,346 | £1,486 | |
Regulation 3BC18 | Capital fees for advice meetings concerning labelling and leaflets | £1,012 | £1,118 |
Regulation 3BD19 | Capital fees for post authorisation regulatory advice meetings | £1,346 | £1,486 |
Regulation 6 | Applications for certificates by exporters of medicinal products | ||
Paragraph (1)(a) | £118 | £130 | |
Paragraph (1)(b) | £53 | £58 | |
Paragraph (1)(c)(i) | £53 | £58 | |
Paragraph (1)(c)(ii) | £26 | £29 | |
Regulation 11 | Renewal of certain manufacturer’s licences | £127 | £152 |
Part II of Schedule 1 | Capital fees for applications for authorizations, licences and certificates | ||
In Column 2 of the Table in paragraph 120 | |||
Entry 1(a) | £25,802 | £28,494 | |
Entry 1(b) | £56,218 | £61,959 | |
Entry 1(c) | £56,218 | £61,959 | |
Entry 1(d) | £80,698 | £88,993 | |
Entry 1(e) | £115,098 | £126,982 | |
Entry 1(f) | £80,698 | £88,993 | |
Entry 2(a) | £15,689 | £17,202 | |
Entry 2(b) | £15,689 | £17,202 | |
Entry 2(c) | £22,366 | £24,576 | |
Entry 2(d) | £31,219 | £34,353 | |
Entry 2(e) | £22,366 | £24,576 | |
Entry 3(a) | £5,820 | £6,304 | |
Entry 3(b) | £5,820 | £6,304 | |
Entry 3(c) | £8,272 | £9,011 | |
Entry 3(d) | £11,813 | £12,921 | |
Entry 3(e) | £8,272 | £9,011 | |
Entry 4(a) | £2,337 | £2,457 | |
Entry 4(b) | £2,337 | £2,457 | |
Entry 5 | £1,493 | £1,638 | |
Entry 6 | £366 | £404 | |
Paragraph 1A(1) | £6,558 | £7,824 | |
Paragraph 4(4)(b) | £500 | £594 | |
Paragraph 5(1)(a) | £142 | £156 | |
Paragraph 5(1)(b) | £268 | £295 | |
Paragraph 5(1)(c) | £2,444 | £2,688 | |
Paragraph 6(1) | £1,402 | £1,542 | |
Paragraph 6(2) | £600 | £660 | |
Paragraph 6(4) | £310 | £341 | |
In Column 2 of the Table in paragraph 721 | |||
Entry 1 | £610 | £674 | |
Entry 2 | £2,700 | £2,982 | |
Entry 3 | £2,250 | £2,485 | |
Entry 4 | £140 | £155 | |
Part IIA of Schedule 122 | Capital fees for assistance in obtaining marketing authorizations in other EEA States | ||
Paragraph 2(a)(i) | £34,400 | £37,989 | |
Paragraph 2(a)(ii) | £22,596 | £24,953 | |
Paragraph 2(b)(i) | £8,853 | £9,777 | |
Paragraph 2(b)(ii) | £5,902 | £6,518 | |
Paragraph 2(c)(i) | £3,541 | £3,910 | |
Paragraph 2(c)(ii) | £2,951 | £3,259 | |
Paragraph 2(d) | £2,119 | £2,340 | |
Part III of Schedule 1 | Capital fees for applications for variations of authorizations, licences and certificates | ||
Paragraph 2(a) | £142 | £170 | |
Paragraph 2(aa) | £224 | £266 | |
Paragraph 2(b) | £590 | £704 | |
Paragraph 2(c) | £6,672 | £7,964 | |
Paragraph 2(cc) | £22,254 | £24,576 | |
Paragraph 2(d) | £6,558 | £7,824 | |
Paragraph 3(a) | £222 | £264 | |
Paragraph 3(aa) | £442 | £526 | |
Paragraph 3(b) | £714 | £852 | |
Paragraph 3(c) | £11,568 | £13,808 | |
Paragraph 3(d) | £31,106 | £34,353 | |
Paragraph 5A(1) | £500 | £594 | |
Paragraph 6(a) | £142 | £158 | |
Paragraph 6(b) | £6,558 | £7,824 | |
Paragraph 6(c) | £296 | £326 | |
Paragraph 7(a) | £200 | £220 | |
Paragraph 7(b) | £400 | £440 | |
Paragraph 8 | £200 | £220 | |
Paragraph 9 | £378 | £416 | |
Paragraph 10 | £200 | £220 | |
Paragraph 11(1)(a) | £100 | £110 | |
Paragraph 11(1)(b) | £200 | £220 | |
Paragraph 11(1)(c) | £300 | £330 | |
Paragraph 15(a)(ii) | £500 | £594 | |
Paragraph 15(a)(iii) | £250 | £297 | |
Paragraph 15(b)(ii) | £250 | £297 | |
Part IIIA of Schedule 123 | Capital fees for assessment of labels and leaflets | ||
Paragraph 2(a) | £430 | £472 | |
Paragraph 2(b) | £273 | £300 | |
Part IV of Schedule 124 | Capital fees for regulatory assistance given by the United Kingdom acting as reference Member State relating to the assessment of applications for the renewal of specified marketing authorizations | ||
Paragraph 1(a) | £7,415 | £8,847 | |
Paragraph 1(b) | £605 | £722 | |
Paragraph 2(a)(ii) | £605 | £722 | |
Paragraph 2(b)(ii) | £303 | £361 | |
Schedule 2 | Fees for inspections | ||
Paragraph 2(a)(i) | £2,534 | £3,618 | |
Paragraph 2(a)(ii) | £4,654 | £6,645 | |
Paragraph 2(a)(iii) | £5,610 | £8,010 | |
Paragraph 2(a)(iv) | £9,578 | £13,676 | |
Paragraph 2(b)(i) | £2,751 | £3,928 | |
Paragraph 2(b)(ii) | £5,610 | £8010 | |
Paragraph 2(b)(iii) | £8,782 | £12,539 | |
Paragraph 2(b)(iv) | £15,926 | £22,740 | |
Paragraph 2(c)(i) | £1,005 | £1,563 | |
Paragraph 2(c)(ii) | £2,717 | £3,879 | |
Paragraph 2(c)(iii) | £4,035 | £5,761 | |
Paragraph 2(c)(iv) | £7,512 | £10,726 | |
Paragraph 2(cc)(i) | £1,518 | £2,243 | |
Paragraph 2(cc)(ii) | £4,048 | £5,856 | |
Paragraph 2(cc)(iii) | £7,590 | £10,914 | |
Paragraph 2(d) | £221 | £240 | |
In column 2 in the Table in paragraph 2(f)25 | |||
Entry for “none” | £1,023 | £1,461 | |
Entry for “1 to 4” | £1,226 | £1,751 | |
Entry for “5 to 20” | £2,035 | £2,906 | |
Entry for “21 to 100” | £4,059 | £5,796 | |
Entry for “101 to 500” | £9,119 | £9,484 | |
Entry for “more than 500” | £16,203 | £16,850 | |
Paragraph 4A(1)(b) | £3,000 | £4,284 | |
Paragraph 4A(1)(c) | £4,000 | £5,712 | |
Paragraph 5(1) | £499 | £712 | |
Paragraph 5(1) | £1,095 | £1,563 | |
In column 2 in the Table in paragraph 5(3)26 | |||
Entry for “none” | £1,023 | £1,461 | |
Entry for “1 to 4” | £1,226 | £1,751 | |
Entry for “5 to 20” | £2,035 | £2,906 | |
Entry for “21 to 100” | £4,059 | £5,796 | |
Entry for “101 to 500” | £9,119 | £9,484 | |
Entry for “more than 500” | £16,203 | £16,850 | |
Paragraph 5A(a)27 | £3,542 | £5,057 | |
Paragraph 5A(b) | £5,060 | £7,225 | |
Paragraph 5A(c) | £10,120 | £14,450 | |
Paragraph 5D(1)(a)28 | £600 | £800 | |
Paragraph 5D(1)(b) | £1,100 | £1,300 | |
Paragraph 5D(1)(c) | £1,100 | £1,300 | |
Paragraph 7(4)(a)29 | £3,000 | £4,284 | |
Paragraph 7(4)(b) | £5,000 | £7,139 | |
Paragraph 7(4)(c) | £10,000 | £14,279 | |
Paragraph 7(4)(d) | £15,000 | £21,418 | |
Paragraph 7(4) | £3,000 | £4,284 | |
Part III of Schedule 3 | Periodic fees for marketing authorizations and licences | ||
In column 2 of the Table in paragraph 1 | |||
Entry 1 | £14,768 | £17,278 | |
Entry 2(a) | £6,080 | £7,114 | |
Entry 2(b)(i) | £1,521 | £1,780 | |
Entry 2(b)(ii) | £759 | £888 | |
Entry 2(b)(iii) | £247 | £289 | |
Entry 2(c)(i) | £666 | £779 | |
Entry 2(c)(ii) | £333 | £390 | |
Entry 2(c)(iii) | £123 | £144 | |
Entry 2(d)(i) | £275 | £322 | |
Entry 2(d)(ii) | £137 | £160 | |
Entry 2(d)(iii) | £60 | £70 | |
Entry 2(e) | £75 | £88 | |
Paragraph 2(a) | £338 | £395 | |
Paragraph 2(b) | £167 | £195 | |
Paragraph 2(c) | £71 | £83 | |
Paragraph 3(a) | £6,080 | £7,114 | |
Paragraph 3(b) | £4,105 | £4,803 | |
Paragraph 7(2) | £304 | £356 | |
Paragraph 8(1) | £187 | £219 | |
Paragraph 8(2) | £112 | £131 | |
Paragraph 1030 | £200 | £234 |
These Regulations make further amendments to the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 (“the Homoeopathic Products Regulations”), the Medical Devices (Consultation Requirements) (Fees) Regulations 1995 (“the Devices Regulations”) and the Medicines (Products for Human Use—Fees) Regulations 1995 (“the General Fees Regulations”).
The General Fees Regulations make provision for the fees payable under the Medicines Act 1971, and other fees payable in respect of Community obligations, relating to marketing authorizations, licences and certificates in respect of medicinal products for human use. Regulation 2 and the Schedule to these Regulations provide for a number of the fees payable by virtue of the General Fees Regulations to be increased. The increases are of amounts between 4% and 42.8%, Most capital fees have been increased by amounts between 10% and 19%, periodic fees have been increased by 17% and all but two of the inspection fees have been increased by 42.8% (the remaining two inspection fees have both been increased by 4%).
Regulation 2 also provides for certain provisions of the General Fees Regulations to be revoked. Those provisions provided for particular fees to be payable in respect of manufacturer’s licences where those licences related solely to import of medicines from third countries. The revocation of those provisions means that the fees payable in respect of such licences will be the same as for other manufacturers' licences (i.e for manufacturer’s licences which do not relate solely to import of medicines from third countries).
A full Regulatory Impact Assessment of the effect that this instrument will have on the costs of business has been placed in the libraries of both Houses of Parliament and copies may be obtained from the Medicines and Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ