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—
“the Devices Regulations” means the Medical Devices (Consultation Requirements)(Fees) Regulations19957;
“the General Fees Regulations” means the Medicines (Products for Human Use—Fees) Regulations 19958; and
“the Homoeopathic Products Regulations” means the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 19949.
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
In Part II of Schedule 1 (capital fees for applications for authorizations, licences and certificates) 10, in paragraph 5, omit sub-paragraphs (1)(aa) and (3).
4
In Part III of Schedule 1 (capital fees for applications for variations of authorizations, licences and certificates) 11, in paragraph 7—
a
in sub-paragraph (a), at the end, insert “and”; and
b
omit sub-paragraph (aa).
5
In Schedule 2 (fees for inspections) 12, in paragraph 2—
a
in sub-paragraph (d), at the end, insert “and”; and
b
omit sub-paragraph (e).
6
In Part III of Schedule 3 (periodic fees for marketing authorizations and licences13, for sub-paragraph (1) of paragraph 7, substitute—
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
In the table in Schedule 2 (fees for applications for the grant of certificates of registration14—
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,