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 1998 and shall come into force on 1st April 1998.

(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 1(2) of the Homoeopathic Products Regulations (interpretation)-

(a)after the definition of "the Act" there shall be inserted the following definition-

""administrative variation" means a variation of the provisions of a certificate of registration which does not require, in the opinion of the licensing authority, medical, scientific or pharmaceutical assessment;"; and

(b)after the definition of "homoeopathic medicinal product" there shall be inserted the following definition-

• ""standard variation" means a variation of the provisions of a certificate of registration which, in the opinion of the licensing authority, requires medical, scientific or pharmaceutical assessment and which requires in respect of any homoeopathic medicinal product to which that certificate relates-

  (a)

  the replacement of an excipient used in the manufacture of the product with a comparable excipient;

  (b)

  the replacement of a reagent indirectly associated with the manufacturing process of the product or which disappears from that process with a comparable reagent;

  (c)

  a change to the qualitative composition of the container or other form of packaging immediately in contact with the product;

  (d)

  a minor change to the method of manufacture of a homoeopathic stock included in the product;

  (e)

  a change to the specification of any reagent or excipient used in the manufacture of the product;

  (f)

  a change to the finished product specification of the product;

  (g)

  a change to the test procedure for any raw material used in the manufacture of the product;

  (h)

  a change to the test procedure for the product;

  (i)

  a change to the test procedure for the container or other form of packaging immediately in contact with the product;

  (j)

  a change to comply with a supplement to the European Pharmacopoeia or any national pharmacopoeia of a member State;

  (k)

  a change to the shape of the container in which the product may be placed on the market;

  (l)

  an additional pack size in which the product may be placed on the market;

  (m)

  a change to the approved storage conditions for the product;

  (n)

  a change to the shelf life of an unopened container of the product or to the shelf life of the product after the container has been opened for the first time; or

  (o)

  a change to the dimensions of an approved dosage form of the product (for example, tablets) which does not entail a change to the quantitative composition or the mean mass of the product;".

(2) In regulation 11 of the Homoeopathic Products Regulations (variation of certificates)-

(a)after the words "certificate of registration" there shall be inserted the words "for an administrative variation or a standard variation"; and

(b)the words from "which relate to" to the end of the regulation shall be omitted.

(3) For regulation 14 of the Homoeopathic Products Regulations (fees for variations of certificates) there shall be substituted the following regulation-

"Fees for variations of certificates

14.-(1) The fee payable by an applicant in connection with an application for an administrative variation of a certificate of registration pursuant to regulation 11 of these Regulations shall be-

(a)unless sub-paragraph (b) applies, a fee of £75;

(b)where more than one application for an administrative variation is made at the same time by the same applicant and the applications are for identical variations-

(i)in respect of the first application considered by the licensing authority, a fee of £75, and

(ii)in respect of each other application so considered, a fee of £37.50.

(2) The fee payable by an applicant in connection with an application for a standard variation of a certificate of registration pursuant to regulation 11 of these Regulations shall be-

(a)unless sub-paragraph (b) applies, a fee of £150;

(b)where more than one application for a standard variation is made at the same time by the same applicant and the applications are for identical variations-

(i)in respect of the first application considered by the licensing authority, a fee of £150, and

(ii)in respect of each other application so considered, where further medical, technical or scientific assessment is required, a fee of £150,

(iii)in respect of each other application so considered, where no further medical, technical or scientific assessment is required, a fee of £75.".

(4) In regulation 15(1) of the Homoeopathic Products Regulations (fees payable by holders of certificates), for "£15" there shall be substituted "£10".

(5) 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 "£100" there shall be substituted "£90",

(ii)for "£300" there shall be substituted "£270", and

(iii)for "£500" there shall be substituted "£450"; and

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

(i)for "£250" there shall be substituted "£225",

(ii)for "£450" there shall be substituted "£400", and

(iii)for "£650" there shall be substituted "£585".

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(9) (fees)-

(a)in paragraph (1)(a), for "£2,125" there shall be substituted "£1,910";

(b)in paragraph (1)(b), for "£5,950" there shall be substituted "£5,355";

(c)in paragraph (2)(a), for "£530" there shall be substituted "£475";

(d)in paragraph (2)(b), for "£1,485" there shall be substituted "£1,335";

(e)in paragraph (3)(a), for "£2,125" there shall be substituted "£1,910";

(f)in paragraph (3)(b), for "£5,950" there shall be substituted "£5,355";

(g)in paragraph (4)(a), for "£530" there shall be substituted "£475";

(h)in paragraph (4)(b), for "£1,485" there shall be substituted "£1,335";

(i)in paragraph (5)(a), for "£27,200" there shall be substituted "£24,500"; and

(j)in paragraph (5)(b), for "£6,800" there shall be substituted "£6,120".

Amendment of the General Fees Regulations

4.-(1) In the following provisions of the General Fees Regulations-

(a)paragraph 6(2)(b) of Part II of Schedule 1;

(b)paragraph 5(2)(c) of Schedule 2;

(c)the definitions of "reduced rate fee" and "standard fee" in paragraph 1 of Part I of Schedule 3; and

(d)paragraph 8(2)(a) of Part III of Schedule 3,

for "£30,000" there shall be substituted "£35,000".

(2) In paragraph 1 of Part III of Schedule 1 to the General Fees Regulations (capital fees for applications for variations to marketing authorizations, licences and certificates-marketing authorizations)-

(a)in the definition of "Type II Application", for the words "an application for a Type II complex variation" there shall be substituted the words "a Type II Complex Variation Application";

(b)for the words ""Type II complex variation" means" there shall be substituted the words ""Type II Complex Variation Application" means an application for"; and

(c)for sub-paragraph (b) of what, by virtue of the preceding sub-paragraph, is the definition of "Type II Complex Variation Application" there shall be substituted the following sub-paragraph-

"(b)which is considered a "major variation" within the meaning given in article 3.1(b) of Commission Regulation (EC) No. 541/95(10) and which is-

(i)supported by data which comprises or includes the results of clinical trials or physico-chemical, biological, microbiological or pharmacological and toxicological tests, or

(ii)accompanied by evidence relating to post-marketing experience which is information of any type described in Section H of Part IV of the Annex to Council Directive 75/318/EEC(11) (clinical documentation); or".

(3) In paragraphs 2(c) and 3(c) of Part III of Schedule 1 to the General Fees Regulations, for the words "complex variation", at each place where they occur, there shall be substituted the words "Complex Variation Application".

(4) In paragraph 14 of Part III of Schedule 1 to the General Fees Regulations, for the words "application for a Type II complex variation" there shall be substituted the words "Type II Complex Variation Application".

(5) In paragraph 1(1) of Part II of Schedule 3 to the General Fees Regulations (periodic fees for licences-calculation of turnover), for the words "year which ends on the 31st December preceding the beginning of that" there shall be substituted the words "period of 12 months preceding the commencement of the relevant".

(6) In the table in paragraph 1 of Part III of Schedule 3 to the General Fees Regulations (periodic fees for licences-marketing authorizations), entry 2(f) in column 1 and entry 2(f) in column 2 shall be omitted.

Changes to fees in the General Fees Regulations

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

6. The Medical Devices (Consultation Requirements) (Fees) Amendment Regulations 1996(12) are hereby revoked.

Regulation 5

SCHEDULE

Explanatory Note

(This note is not part of the Regulations)

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(13) by introducing a new registration procedure for the marketing of certain homoeopathic medicinal products for human use. These Regulations introduce a new category of permissible variation of certificates of registration, allowing for certificates to be varied in some circumstances where medical, scientific or pharmaceutical assessment is required (regulation 2(1) and (2)). The fee payable in respect of variations is £75 (for administrative) or £150 (for standard), reduced by half in respect of certain applications for identical variations (regulation 2(3)). The periodic fee payable by holders of certificates of registration is reduced from £15 to £10 (regulation 2(4)), and the capital fees for applications for the grant of certificates of registration are reduced by an average overall of 10% (regulation 2(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(14). Regulation 3 of these Regulations amends regulation 3 of the Consultation Requirements Regulations by reducing the amounts of all the fees specified in those Regulations by an average overall of 10%. As a consequence, the Medical Devices (Consultation Requirements) (Fees) Amendment Regulations 1996 are revoked (regulation 6).

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. These Regulations change the turnover threshold for reductions on certain of the fees for small businesses from £30,000 to £35,000 (regulation 4(1)). They also change the definition relating to major complex variation applications which applies for the purposes of Part III of Schedule 1 to the General Fees Regulations so that the higher major complex variation application fee is now generally payable in respect of applications which must include evidence relating to certain studies, tests or trials and which require substantial assessment resources on the part of the licensing authority (regulation 4(2) to (4)). Dates relating to the calculation of turnover for periodic fees' purposes are made consistent with the dates relating to other calculations under Schedule 3 (regulation 4(5)), and a periodic fee will no longer be charged for homoeopathic product licences of right or for anthroposophic products (regulation 4(6)). There is also a package of changes relating to the levels of certain capital fees payable for applications for marketing authorizations, manufacturers' licences, wholesale dealers' licences, clinical trial certificates and export certificates; 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 certain site inspections (regulation 5 and the Schedule). No fees have been increased. Most of the capital fees have been reduced, by amounts varying between 0.5% and 65%; periodic fees have been reduced by an average overall of 14%; and just under half of the fees for site inspections have been reduced, by amounts varying between 0.5% and 26%.

A Regulatory 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.