(1)    These Regulations may be cited as the Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1999 and shall come into force on 1st April 1999.

(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.

(1)    In regulation 14 of the Homoeopathic Products Regulations (fees for variations of certificates)—

(a)    in paragraph (1)(a), for “£75” there shall be substituted “£80”;

(b)    in paragraph (1)(b)(i), for “£75” there shall be substituted “£80”;

(c)    in paragraph (1)(b)(ii), for “£37.50” there shall be substituted “£40”;

(d)    in paragraph (2)(a), for “£150” there shall be substituted “£155”;

(e)    in paragraph (2)(b)(i), for “£150” there shall be substituted “£155”; and

(f)    in paragraph (2)(b), for heads (ii) and (iii) there shall be substituted the following heads—

“(ii)    in respect of each other application so considered, where further medical, technical or scientific assessment is required, a fee of £155,

(iii)    in respect of the second to thirtieth applications so considered, where no further medical, technical or scientific assessment is required, a fee of £77.50, and

(iv)    in respect of each other application so considered, where no further medical, technical or scientific assessment is required, a fee of £38.75.”.

(2)    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 “£90” there shall be substituted “£95”,

(ii)    for “£270” there shall be substituted “£285”, and

(iii)    for “£450” there shall be substituted “£470”; and

(b)    in column (3) (fees for other applications)—

(i)    for “£225” there shall be substituted “£235”,

(ii)    for “£400” there shall be substituted “£420”, and

(iii)    for “£585” there shall be substituted “£615”.

In regulation 3 of the Medical Devices (Consultation Requirements) (Fees) Regulations 1995 (fees)—

(a)    in paragraph (1)(a), for “£1,910” there shall be substituted “£2,005”;

(b)    in paragraph (1)(b), for “£5,355” there shall be substituted “£5,620”;

(c)    in paragraph (2)(a), for “£475” there shall be substituted “£500”;

(d)    in paragraph (2)(b), for “£1,335” there shall be substituted “£1,400”;

(e)    in paragraph (3)(a), for “£1,910” there shall be substituted “£2,005”;

(f)    in paragraph (3)(b), for “£5,355” there shall be substituted “£5,620”;

(g)    in paragraph (4)(a), for “£475” there shall be substituted “£500”;

(h)    in paragraph (4)(b), for “£1,335” there shall be substituted “£1,400”;

(i)    in paragraph (5)(a), for “£24,500” there shall be substituted “£25,725”; and

(j)    in paragraph (5)(b), for “£6,120” there shall be substituted “£6,425”.

(1)    In paragraph 6(a) of Part III of Schedule 1 to the General Fees Regulations (capital fees for applications for, and variations to, marketing authorizations, licences and certificates—fees payable in connection with an application for variation of a marketing authorization (parallel import)), after head (vi) there shall be inserted the following head—

“(vii)    subject to paragraph 6(b) of Schedule 5, a change consequential upon any or any combination of the following—

(aa)    a change of ownership of the United Kingdom marketing authorization in respect of which the marketing authorization (parallel import) was granted,

(bb)    a change to the number of the United Kingdom marketing authorization in respect of which the marketing authorization (parallel import) was granted,

(cc)    a change to the name of the holder of the United Kingdom marketing authorization in respect of which the marketing authorization (parallel import) was granted,

(dd)    a change to the address of the holder of the United Kingdom marketing authorization in respect of which the marketing authorization (parallel import) was granted,

(ee)    a change of ownership of the marketing authorization for the product in the country where the product originates,

(ff)    a change to the number of the marketing authorization for the product in the country where the product originates,

(gg)    a change to the name of the holder of the marketing authorization for the product in the country where the product originates,

(hh)    a change to the address of the holder of the marketing authorization for the product in the country where the product originates,

where the change has been occasioned by the taking over of an existing business, whether by purchase, merger or otherwise,”.

(2)    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.

Regulation 2(5) and 3 of the Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1998 are hereby revoked.

Signed by authority of the Secretary of State for Health

Hayman

Parliamentary Under Secretary of State,

Department of Health

25th February 1999

Signed by authority of the Secretary of State for Wales

Jon Owen Jones

Parliamentary Under Secretary of State,

Welsh Office

5th March 1999

Sam Galbraith

Parliamentary Under Secretary of State,

Scottish Office

25th February 1999

Jeff Rooker

Minister of State,

Ministry of Agriculture, Fisheries and Food

25th February 1999

Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on 1st March 1999.

D C Gowdy

Permanent Secretary

Sealed with the Official Seal of the Department of Agriculture for Northern Ireland on 24th February 1999.

P Small

Permanent Secretary

We consent,

Bob Ainsworth

Jim Dowd

Two of the Lords Commissioners of Her Majesty's Treasury

3rd March 1999

These Regulations further amend the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 (“the Homoeopathic Products Regulations”), the Medical Devices (Consultation Requirements) (Fees) Regulations 1995 (“the Consultation Requirements Regulations”) and the Medicines (Products for Human Use—Fees) Regulations 1995 (“the General Fees Regulations”).

The Homoeopathic Products Regulations implemented in part Council Directive 92/73/EEC by introducing a new registration procedure for the marketing of certain homoeopathic medicinal products for human use. Regulation 2 of these Regulations makes further amendments to the Homoeopathic Products Regulations: introducing further discounts in respect of the fees payable for multiple identical applications for standard variations of certificates of registration by providing for a reduction of 75% in certain cases; and otherwise increasing the level of the capital fees payable in respect of applications for the grant of certificates of registration and for variations by an average overall of 5%.

The Consultation Requirements Regulations prescribe the fees which are payable where a notified body consults the competent body in accordance with Council Directive 93/42/EEC concerning medical devices. Regulation 3 of these Regulations amends regulation 3 of the Consultation Requirements Regulations by increasing the amounts of all the fees specified in those Regulations by an average overall of 5%.

The General Fees Regulations make provision for the fees payable under the Medicines Act 1971 relating to marketing authorizations, licences and certificates in respect of medicinal products for human use. Regulation 4(1) of these Regulations amends Part III of Schedule 1 to the General Fees Regulations in order to widen the category of applications for variations of marketing authorizations (parallel import) which attract the lower level fee. There is also a package of changes relating to the levels of: the capital fees payable for applications for marketing authorizations, manufacturers' licences, wholesale dealers' licences, clinical trial certificates and export certificates; capital fees for variations and renewals of such authorizations, licences and certificates; periodic fees payable in connection with the holding of certain authorizations and licences; and fees payable in connection with site inspections (regulation 4(2) and the Schedule). Fees have been increased by an average overall of 5%.

Regulation 5 revokes two provisions which are spent as a result of the coming into force of these Regulations.

A Regulatory Impact Appraisal in relation to these Regulations has been placed in the libraries of both Houses of Parliament, and copies can be obtained from the Medicines Control Agency, Room 2102, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.