
1 

(1) These Regulations may be cited as the Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001 and shall come into force on 1st April 2001.
(2) In these Regulations—
 “the Devices Regulations” means the Medical Devices (Consultation Requirements) (Fees) Regulations 1995;
 “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;
 “the Marketing Authorisations Regulations” means the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994.
2 

(1) In regulation 1(2) of the Marketing Authorisations Regulations (interpretation)—
(a) after the definition of “Community marketing authorisation” there shall be inserted the following definition—“
 “EEA State” means a contracting party to the Agreement on the European Economic Area signed at Oporto on 2nd May 1992 as adjusted by the Protocol signed at Brussels on 17th March 1993;”;
(b) after the definition of “the EMEA” there shall be inserted the following definition—“
 “parallel import licence” means a United Kingdom marketing authorisation granted by the licensing authority under these Regulations in respect of a relevant medicinal product which is imported into the United Kingdom from another EEA state in accordance with the rules of Community law relating to parallel imports”;
(c) the definition of “parallel import” shall be omitted; and
(d) for the definition of “United Kingdom marketing authorisation” there shall be substituted the following definition—“
 “United Kingdom marketing authorisation” means a marketing authorisation granted by the licensing authority under these Regulations and includes a parallel import licence.”.
(2) In regulation 4(1) of the Marketing Authorisations Regulations (applications for the grant, renewal or variation of a United Kingdom marketing authorisation), for the words “any provision of Community law affecting” there shall be substituted the words “the rules of Community law relating to”.
(3) In regulation 5 of the Marketing Authorisations Regulations (consideration, and grant or refusal, of an application for, or for renewal or variation of, a United Kingdom marketing authorisation)—
(a) in paragraph (1), after the word “provisions” at each place where it occurs, there shall be inserted the words “and (where applicable) the rules of Community law relating to parallel imports”;
(b) in paragraph (2), after the words “every authorisation” there shall be inserted the words “, other than a parallel import licence,”; and
(c) in paragraph (4), after the words “the 1965 Directive” there shall be inserted the words “or in relation to a parallel import licence”.
3 

(1) In regulation 1(2) of the Homoeopathic Products Regulations (interpretation), in the definition of “standard variation”—
(a) at the end of paragraph (n) the word “or” shall be omitted;
(b) at the end of paragraph (o) there shall be inserted the word “or”; and
(c) after paragraph (o) there shall be inserted the following paragraph—“
(p) a change following modification to the manufacturing authorisation.”.
(2) In regulation 14 of the Homoeopathic Products Regulations (fees for variations of certificates)—
(a) in paragraph (1)(a), for “£90” there shall be substituted “£95”;
(b) in paragraph (1)(b)(i), for “£90” there shall be substituted “£95”;
(c) in paragraph (2)(a), for “£176” there shall be substituted “£185”;
(d) in paragraph (2)(b)(i), for “£176” there shall be substituted “£185”; and
(e) in paragraph (2)(b)(ii), for “£176” there shall be substituted “£185”.
(3) In regulation 15(1) of the Homoeopathic Products Regulations (fees payable by holders of certificates), for “£11” there shall be substituted “£12”.
(4) 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 “£108” there shall be substituted “£113”,
(ii) for “£325” there shall be substituted “£341”, and
(iii) for “£535” there shall be substituted “£562”; and
(b) in column (3) (fees for other applications)—
(i) for “£267” there shall be substituted “£280”,
(ii) for “£478” there shall be substituted “£502”, and
(iii) for “£701” there shall be substituted “£736”.
4 
In regulation 3 of the Devices Regulations (fees)—
(a) in paragraph (1)(a), for “£2,885” there shall be substituted “£3,029”;
(b) in paragraph (1)(b), for “£6,406” there shall be substituted “£6,726”;
(c) in paragraph (2)(a), for “£570” there shall be substituted “£599”;
(d) in paragraph (2)(b), for “£1,596” there shall be substituted “£1,676”;
(e) in paragraph (5)(a), for “£29,326” there shall be substituted “£30,972”; and
(f) in paragraph (5)(b), for “£7,324” there shall be substituted “£7,690”.
5 

(1) In regulation 2(1) of the General Fees Regulations (interpretation)—
(a) in the definition of “authorised medicinal product”, the words “or marketing authorisation (parallel import)” shall be omitted;
(b) the definition of “marketing authorisation (parallel import)” shall be omitted;
(c) after the definition of “orphan medicinal product” there shall be inserted the following definition—“
 “parallel import licence” means a United Kingdom marketing authorisation granted by the licensing authority under the 1994 Regulations in respect of a relevant medicinal product which is imported into the United Kingdom from another EEA State in accordance with the rules of Community law relating to parallel imports;” and
(d) after the definition of “periodic fee” there shall be inserted the following definition—“
 “Periodic Safety Update Report” means a report prepared to meet the requirements of Council Directive 65/65/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products, as amended, and Council Directive 75/318/EEC on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products, as amended, and in accordance with the International Conference on Harmonisation and Committee on Proprietary Medicinal Products Guidance on clinical safety data management—Periodic Safety Update Reports for marketing drugs;”.
(2) Regulations 4A, 4B, and 4C of the General Fees Regulations shall be renumbered regulations 6A, 6B and 6C respectively.
(3) In regulation 6(2) of the General Fees Regulations (applications for certificates by exporters of medicinal products)—
(a) in sub-paragraph (a) for the words “up to four” there shall be substituted the word “two”; and
(b) in sub-paragraph (b) for the word “five” there shall be substituted the word “three”.
(4) In regulation 16(1) of the General Fees Regulations (time for payment in connection with applications or inspections) for “4C” there shall be substituted “6C”.
(5) In paragraph 1 of Part I of Schedule 1 to the General Fees Regulations (interpretation), in the definition of “standard application”, for the words “marketing authorisation (parallel import)”, there shall be substituted the words “parallel import licence”.
(6) In entry 5 in column 1 in the table in paragraph 1 of Part II of Schedule 1 to the General Fees Regulations (capital fees for applications for authorisations, licences and certificates), for the words “marketing authorisation (parallel import)” there shall be substituted the words “parallel import licence”.
(7) In paragraph 2 of Part IIA of Schedule 1 to the General Fees Regulations (outgoing mutual recognition applications), for “4B” there shall be substituted “6B”.
(8) In paragraph 1 of Part III of Schedule 1 to the General Fees Regulations (capital fees for variations of authorisations, licences and certificates), in the definitions of “Type I Application” and “Type II Application”, for the words “marketing authorisation (parallel import)”, at each place where they occur, there shall be substituted the words “parallel import licence”.
(9) In paragraph 6 of Part III of Schedule 1 to the General Fees Regulations—
(a) for the words “marketing authorisation (parallel import)”, there shall be substituted the words “parallel import licence”;
(b) in sub-paragraph (a)(i) to (vi) for the word “authorisation”, at each place where it occurs, there shall be substituted the word “licence”; and
(c) in sub-paragraph (a)(vii)(aa) to (dd) for the words “marketing authorisation (parallel import)”, at each place where they occur, there shall be substituted the words “parallel import licence”.
(10) In paragraph 1 of Part IV of Schedule 3 to the General Fees Regulations (types of marketing authorisation for which only one periodic fee is payable), for the words “Marketing authorisations (parallel import)” there shall be substituted the words “Parallel import licences”
(11) In paragraph 4A of Schedule 4 to the General Fees Regulations  (time for payment of capital fees - applications by small companies), for “4B” there shall be substituted “6B”.
(12) After paragraph 2 of Schedule 5 to the General Fees Regulations (waiver, reduction or refund of capital fees) there shall be inserted the following paragraph—“
2A 
Where an application is made for the variation of a marketing authorisation so as to demonstrate compliance with the “Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products” published by the European Commission in Volume 3 of its publication “The Rules Governing Medicinal Products in the European Union”, the fee payable under regulation 7(1) in connection with that application may be waived.”.
(13) In paragraph 6 of Schedule 5 to the General Fees Regulations—
(a) for the words “marketing authorisation (parallel import)”, at each place where they occur, there shall be substituted the words “parallel import licence”;
(b) for the words “where the authorisation” there shall be substituted the words “where the licence”;
(c) for the words “of that authorisation” there shall be substituted the words “of that licence”; and
(d) for the words “authorisation applies for a variation to the authorisation” there shall be substituted the words “licence applies for a variation to the licence”.
(14) In each provision of the General Fees Regulations 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 there shall be substituted the amount specified opposite that provision in column (4) of that Schedule.
Signed by authority of the Secretary of State for Health
Hunt
Parliamentary Under Secretary of State,
Department of Health
5th March 2001Hayman
Minister of State, Ministry of Agriculture, Fisheries and Food
6th March 2001Bairbre de Brún
Minister of Health, Social Services and Public Safety
7th March 2001Bríd Rodgers
Minister of Agriculture and Rural Development
7th March 2001We consent,
Greg Pope
Jim Dowd
Two of the Lords Commissioners of Her Majesty’s Treasury
8th March 2001
SCHEDULE
Regulation 5(14)


Column (1) Column (2) Column (3) Column (4)
Provision in the General Regulations Subject matter Old amount New amount
Regulation 6 Applications for certificates by exporters of medicinal products  
Paragraph (1)(a)  £96 £100
Paragraph (1)(b)  £34 £44
Paragraph (1)(c)(i)  £34 £44
Paragraph (1)(c)(ii)  £17 £22
Regulation 10 Renewals of clinical trial certificates £1,795 £1,885
Regulation 11(1) Renewals of certain manufacturer’s licences £102 £107
Part II of Schedule 1 Capital fees for applications for authorisations, licences and certificates  
In column 2 of the Table in paragraph 1(1)   
Entry 1(a)  £21,545 £22,622
Entry 1(b)  £46,085 £48,389
Entry 1(c)  £65,835 £69,127
Entry 2(a)  £12,568 £13,196
Entry 2(b)  £17,955 £18,853
Entry 3(a)  £4,605 £4,835
Entry 3(b)  £6,584 £6,913
Entry 4  £1,795 £1,885
Entry 5  £1,196 £1,256
Entry 6  £296 £310
Paragraph 5(1)(a)  £114 £120
Paragraph 5(1)(b)  £216 £227
Paragraph 5(1)(c)  £1,972 £2,070
Paragraph 6(1)  £775 £814
Paragraph 6(2)  £570 £598
Paragraph 6(4)  £250 £262
Paragraph 7  £13,885 £14,579
Part III of Schedule 1 Capital fees for applications for variations of authorisations, licences and certificates  
Paragraph 2(a)  £176 £184
Paragraph 2(b)  £404 £424
Paragraph 2(c)  £5,984 £6,282
Paragraph 3(a)  £274 £288
Paragraph 3(b)  £490 £514
Paragraph 3(c)  £9,336 £9,802
Paragraph 6(a)  £114 £120
Paragraph 6(b)  £239 £251
Paragraph 7(a)  £108 £113
Paragraph 7(b)  £216 £227
Paragraph 8  £108 £113
Paragraph 9  £250 £262
Paragraph 10  £108 £113
Paragraph 11  £176 £185
Paragraph 12  £90 £95
Schedule 2 Fees for inspections  
Paragraph 2(a)(i)  £1,870 £1,964
Paragraph 2(a)(ii)  £3,470 £3,643
Paragraph 2(a)(iii)  £4,190 £4,400
Paragraph 2(a)(iv)  £7,182 £7,541
Paragraph 2(b)(i)  £2,034 £2,136
Paragraph 2(b)(ii)  £4,190 £4,400
Paragraph 2(b)(iii)  £6,582 £6,911
Paragraph 2(b)(iv)  £11,970 £12,568
Paragraph 2(c)(i)  £718 £754
Paragraph 2(c)(ii)  £2,010 £2,110
Paragraph 2(c)(iii)  £3,003 £3,153
Paragraph 2(c)(iv)  £5,625 £5,906
Paragraph 2(d)  £136 £143
Paragraph 5(1)  £376 £395
Paragraph 5(1)  £826 £867
Part III of Schedule 3 Periodic fees for marketing authorisations and licences  
In column 2 of the Table in paragraph 1   
Entry 2(a)  £4,788 £5,027
Entry 2(b)(i)  £1,197 £1,257
Entry 2(b)(ii)  £598 £628
Entry 2(b)(iii)  £194 £204
Entry 2(c)(i)  £524 £550
Entry 2(c)(ii)  £262 £275
Entry 2(c)(iii)  £97 £102
Entry 2(d)(i)  £216 £227
Entry 2(d)(ii)  £108 £113
Entry 2(d)(iii)  £48 £50
Entry 2(e)  £59 £62
Paragraph 2(a)  £268 £280
Paragraph 2(b)  £131 £138
Paragraph 2(c)  £55 £58
Paragraph 3(a)  £4,788 £5,027
Paragraph 3(b)  £3,232 £3,394
Paragraph 7  £239 £251
Paragraph 8(1)  £148 £155
Paragraph 8(2)  £89 £93