
1 

(1) These Regulations may be cited as the Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000 and shall come into force on 1st April 2000.
(2) In these Regulations–
 “the General Fees Regulations” means the Medicines (Products for Human Use—Fees) Regulations 1995;
 “the Homoeopathic Products Regulations” means the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994.
2 

(1) In regulation 14 of the Homoeopathic Products Regulations (fees for variations of certificates)–
(a) in paragraph (1)(a), for “£80” there shall be substituted “ £90”;
(b) in paragraph (1)(b)(i), for “£80” there shall be substituted “ £90”;
(c) in paragraph (1)(b)(ii), for “£40” there shall be substituted “ £45”;
(d) in paragraph (2)(a), for “£155” there shall be substituted “ £176”;
(e) in paragraph (2)(b)(i), for “£155” there shall be substituted “ £176”;
(f) in paragraph (2)(b)(ii), for “£155” there shall be substituted “ £176”;
(g) in paragraph (2)(b)(iii), for “£77.50” there shall be substituted “ £88”; and
(h) in paragraph (2)(b)(iv), for “£38.75” there shall be substituted “ £44”.
(2) In regulation 15(1) of the Homoeopathic Products Regulations (fee payable by holders of certificates), for “£10” there shall be substituted “£11”.
(3) In the Table in Schedule 2 to the Homoeopathic Products Regulations (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 “£95” there shall be substituted “£108”,
(ii) for “£285” there shall be substituted “£325”, and
(iii) for “£470” there shall be substituted “£535”; and
(b) in column (3) (fees for other applications)–
(i) for “£235” there shall be substituted “£267”,
(ii) for “£420” there shall be substituted “£478”, and
(iii) for “£615” there shall be substituted “£701”.
3 
In regulation 3 of the Medical Devices (Consultation Requirements) (Fees) Regulations 1995 (fees)–
(a) in paragraph (1)(a), for “£2,005” there shall be substituted “ £2,285”;
(b) in paragraph (1)(b), for “£5,620” there shall be substituted “ £6,406”;
(c) in paragraph (2)(a), for “£500” there shall be substituted “ £570”;
(d) in paragraph (2)(b), for “£1,400” there shall be substituted “ £1,596”;
(e) in paragraph (3)(a), for “£2,005” there shall be substituted “ £2,285”;
(f) in paragraph (3)(b), for “£5,620” there shall be substituted “ £6,406”;
(g) in paragraph (4)(a), for “£500” there shall be substituted “ £570”;
(h) in paragraph (4)(b), for “£1,400” there shall be substituted “ £1,596”;
(i) in paragraph (5)(a), for “£25,725” there shall be substituted “ £29,326”; and
(j) in paragraph (5)(b), for “£6,425” there shall be substituted “ £7,324”.
4 

(1) In paragraph (1) of regulation 2 of the General Fees Regulations (interpretation), after the definition of “medicinal product” there shall be inserted the following definition–“
 “orphan medicinal product” has the meaning given in article 2(b) of Regulation (EC) No. 141/2000 of the European Parliament and of the Council of 16th December 1999 on orphan medicinal products;”.
(2) In Column 1 of the Table set out in paragraph 1 of Part II of Schedule 1 to the General Fees Regulations (which contains a list of types of application for a marketing authorization in connection with which a capital fee is payable), for the words “any such application” in entry 1(a) there shall be substituted the words “any application relating to an orphan medicinal product or a product”.
(3) In the following provisions–
(a) paragraphs 4 and 5 of Part III of Schedule 1 to the General Fees Regulations (which relate to the capital fee payable for the first application for a variation of a marketing authorization granted in respect of a limited use drug); and
(b) paragraph 1 of Part I of Schedule 3 to the General Fees Regulations (interpretation of Schedule 3),
after the words “Directive 75/318/EEC applies”, at each place where they occur, there shall be inserted the words “or which is in respect of an orphan medicinal product”.
(4) In paragraph 4 of Part III of Schedule 3 to the General Fees Regulations (which relates to the periodic fees payable in connection with the holding of certain marketing authorizations)–
(a) before sub-paragraph (3) there shall be inserted the following sub-paragraph–“
(2A) The fee payable in respect of–
(a) a new active substance in accordance with entry 1 of the Table set out in paragraph 1; or
(b) a derivative of a new active substance in accordance with paragraph 3,
shall only be payable for the five relevant fee periods following the fee period during which the marketing authorization was granted.”;
(b) in sub-paragraph (4)(a), for the words “each fee period mentioned in sub-paragraph (1),” there shall be substituted the words “the five relevant fee periods following the fee period during which the marketing authorization was granted,”;
(c) in sub-paragraph (5), for the words “sub-paragraphs (1), (2) and (3) ” there shall be substituted the words “sub-paragraphs (2A) to (4)”; and
(d) for sub-paragraph (6) there shall be substituted the following sub-paragraph–“
(6) In connection with the holding of a marketing authorization in respect of a limited use drug or a derivative of a limited use drug–
(a) where turnover exceeds £200,000, until the expiry of the five relevant fee periods following the fee period during which the marketing authorization was granted, the periodic fee payable shall be the fee that would be payable if the drug were, respectively, a new active substance or a derivative of a new active substance;
(b) where turnover does not exceed £200,000 or where a periodic fee has been payable in respect of the limited use drug or derivative of a limited use drug for five relevant fee periods following the fee period during which the marketing authorization was granted, the periodic fee payable shall be the fee payable in respect of a prescription only medicine in accordance with entry 2(b)(i) of the Table set out in paragraph 1.”.
(5) In each provision of the General Fees Regulations specified in the entries in column (1) (the content of which is described in column (2)) of the Schedule to these Regulations, for the amount specified opposite that provision in column (3) of that Schedule there shall be substituted the amount specified opposite that provision in column (4) of that Schedule.
5 
Regulations 2(1)(a) to (e) and (2), 3 and 4(2) of Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1999 are hereby revoked.
Signed by authority of the Secretary of State for Health
Hunt
Parliamentary Under Secretary of State,
Department of Health
1st March 2000Hayman
Minister of State, Ministry of Agriculture, Fisheries and Food
6th March 2000D.C. Gowdy
Permanent Secretary,
Department of Health, Social Services and Public Safety
6th March 2000P. Small
Permanent Secretary,
Department of Agriculture and Rural Development
3rd March 2000We consent,
Bob Ainsworth
Greg Pope
Two of the Lords Commissioners of Her Majesty’s Treasury
6th March 2000
SCHEDULE
Regulation 4(5)


Column (1) Column (2) Column (3) Column (4)
Provision in the General Fees Regulations Subject matter Old amount New amount
Regulation 6 Applications for certificates by exporters of medicinal products
Paragraph (1)(a)  £85 £96
Paragraph (1)(b)  £30 £34
Paragraph (1)(c)(i)  £30 £34
Paragraph (1)(c)(ii)  £15 £17
Regulation 10 Renewals of clinical trial certificates £1,575 £1,795
Regulation 11(1) Renewals of certain manufacturer’s licences £90 £102
Part II of Schedule 1 Capital fees for applications for authorizations, licences and certificates
In column 2 of the Table in paragraph 1(1)
Entry 1(a)  £18,900 £21,545
Entry 1(b)  £40,425 £46,085
Entry 1(c)  £57,750 £65,835
Entry 2(a)  £11,025 £12,568
Entry 2(b)  £15,750 £17,955
Entry 3(a)  £4,040 £4,605
Entry 3(b)  £5,775 £6,584
Entry 4  £1,575 £1,795
Entry 5  £1,050 £1,196
Entry 6  £260 £296
Paragraph 5(1)(a)  £100 £114
Paragraph 5(1)(b)  £190 £216
Paragraph 5(1)(c)  £1,730 £1,972
Paragraph 6(1)  £680 £775
Paragraph 6(2)  £500 £570
Paragraph 6(4)  £220 £250
Paragraph 7  £12,180 £13,885
Part III of Schedule 1 Capital fees for applications for variations of authorizations, licences and certificates
Paragraph 2(a)  £155 £176
Paragraph 2(b)  £355 £404
Paragraph 2(c)  £5,250 £5,984
Paragraph 3(a)  £240 £274
Paragraph 3(b)  £430 £490
Paragraph 3(c)  £8,190 £9,336
Paragraph 6(a)  £100 £114
Paragraph 6(b)  £210 £239
Paragraph 7(a)  £95 £108
Paragraph 7(b)  £190 £216
Paragraph 8  £95 £108
Paragraph 9  £220 £250
Paragraph 10  £95 £108
Paragraph 11  £155 £176
Paragraph 12  £80 £90
Schedule 2 Fees for inspections
Paragraph 2(a)(i)  £1,640 £1,870
Paragraph 2(a)(ii)  £3,045 £3,470
Paragraph 2(a)(iii)  £3,675 £4,190
Paragraph 2(a)(iv)  £6,300 £7,182
Paragraph 2(b)(i)  £1,785 £2,034
Paragraph 2(b)(ii)  £3,675 £4,190
Paragraph 2(b)(iii)  £5,775 £6,582
Paragraph 2(b)(iv)  £10,500 £11,970
Paragraph 2(c)(i)  £630 £718
Paragraph 2(c)(ii)  £1,764 £2,010
Paragraph 2(c)(iii)  £2,635 £3,003
Paragraph 2(c)(iv)  £4,935 £5,625
Paragraph 2(d)  £120 £136
Paragraph 5(1)  £330 £376
Paragraph 5(1)  £725 £826
Part III of Schedule 3 Periodic fees for marketing authorizations and licences
In column 2 of the Table in paragraph 1
Entry 1  £10,710 £12,209
Entry 2(a)  £4,200 £4,788
Entry 2(b)(i)  £1,050 £1,197
Entry 2(b)(ii)  £525 £598
Entry 2(b)(iii)  £170 £194
Entry 2(c)(i)  £460 £524
Entry 2(c)(ii)  £230 £262
Entry 2(c)(iii)  £85 £97
Entry 2(d)(i)  £190 £216
Entry 2(d)(ii)  £95 £108
Entry 2(d)(iii)  £42 £48
Entry 2(e)  £52 £59
Paragraph 2(a)  £235 £268
Paragraph 2(b)  £115 £131
Paragraph 2(c)  £48 £55
Paragraph 3(a)  £4,200 £4,788
Paragraph 3(b)  £2,835 £3,232
Paragraph 7  £210 £239
Paragraph 8(1)  £130 £148
Paragraph 8(2)  £78 £89