Citation, commencement and interpretation

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(7);

“the Homoeopathic Products Regulations” means the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994(8).

Amendment of the Homoeopathic Products Regulations

2.—(1) In regulation 14 of the Homoeopathic Products Regulations(9) (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(10) (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(11) (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”.

Amendment of regulation 3 of the Medical Devices (Consultation Requirements) (Fees) Regulations 1995

3.  In regulation 3 of the Medical Devices (Consultation Requirements) (Fees) Regulations 1995(12) (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”.

Amendment of the General Fees Regulations

4.—(1) In paragraph (1) of regulation 2 of the General Fees Regulations(13) (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(14) 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(16) (interpretation of Schedule 3),

after the words “Directive 75/318/EEC(15) 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(17) (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.

Revocation

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(18) are hereby revoked.

Regulation 4(5)

SCHEDULE

Explanatory Note

(This note is not part of the Regulations)

These Regulations make further amendments to 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(19) by introducing a new registration procedure for the marketing of certain homoeopathic medicinal products for human use. Regulation 2 of these Regulations amends the Homoeopathic Products Regulations by increasing the amounts of the capital fees payable for applications for certificates of registration and for variations of certificates of registration, and the amount of the periodic fee payable by holders of certificates of registration, by an average overall of 14%.

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(20) 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 14%.

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) to (3) of these Regulations contains amendments to provisions of the General Fees Regulations that relate to limited use drugs. These changes are consequential amendments relating to the new scheme for designating medicinal products as orphan medicinal products set out in Regulation (EC) No. 141/2000 of the European Parliament and of the Council. Regulation 4(4) of these Regulations amends paragraph 4 of Part III of Schedule 3 to the General Fees Regulations, limiting the occasions when a higher rate periodic fee is payable in connection with the holding of a marketing authorization in respect of a new active substance, a limited use drug or a derivative of such a substance or drug.

There is also a package of changes to the General Fees Regulations relating to: the levels of capital fees payable for applications for marketing authorizations, manufacturers' licences, wholesale dealers' licences, clinical trial certificates and export certificates; capital fees payable for variations and renewals of such authorizations, licences and certificates; periodic fees payable in connection with the holding of certain authorizations and licences; and the fees payable in connection with site inspections (regulation 4(5) and the Schedule). Fees have been increased by an average overall of 14%.

Regulation 5 revokes provisions of the Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1999 which are spent as a result of the coming into force of these Regulations.

A Regulatory Impact Assessment 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.