1 Citation, commencement and interpretation
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.
S.I.1995/449; amended by S.I.1998/574, 1999/566 and 2000/592.
S.I.1995/1116; amended by S.I.1996/683, 1998/574, 1999/566, 2000/592 and 2000/3031.
S.I.1994/105; amended by S.I.1995/541, 1996/482, 1998/574, 1999/566 and 2000/592.
S.I.1994/3144; amended by S.I.1998/3105 and 2000/292.

2 Amendment of the Marketing Authorisations Regulations
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;”

;
OJNo. L1, 3.1.1994, p.3.
OJNo. L1, 3.1.1994, p.572.
(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 Amendment of the Homoeopathic Products Regulations
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.”

.
As amended by S.I.1998/574.
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”.
As amended by regulation 2(1) of S.I.2000/592.
3 In regulation 15(1) of the Homoeopathic Products Regulations (fees payable by holders of certificates), for “£11” there shall be substituted “£12”.
As amended by regulation 2(2) of S.I.2000/592.
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”.
As amended by regulation 2(3) of S.I.2000/592.

4 Amendment of regulation 3 of the Devices Regulations
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”.
As amended by regulation 3 of S.I.2000/592.

5 Amendment of the General Fees Regulations
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Reg. 5 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
Hunt Parliamentary Under Secretary of State, Department of Health
Hayman Minister of State, Ministry of Agriculture, Fisheries and Food
Bairbre de Brún Minister of Health, Social Services and Public Safety
Bríd Rodgers Minister of Agriculture and Rural Development
We consent,
Greg Pope Jim Dowd Two of the Lords Commissioners of Her Majesty’s Treasury