The Medicines (Products for Human Use — Fees) Regulations 1995

In connection with a major application for a marketing authorization for which the fee payable is that specified in entry 1(c) of the Table in paragraph 1 of Part II of Schedule 1, the fee payable under regulation 4(a) shall, if the applicant so requests in writing, be payable as to 25% at the time of the application and as to 75% within 30 days following written notice from the licensing authority that the application has been determined.

3

In connection with a complex application for a marketing authorization, the fee payable under regulation 4(a) shall, if the applicant so requests in writing, be payable as to 50% at the time of the application and as to 50% within 30 days following written notice from the licensing authority that the application has been determined.

4

In connection with an application to which paragraph 4 of Part II of Schedule 1 applies, the fee payable under regulation 4(a) shall, if the applicant so requests in writing, be payable—

• (a) as to 50% of the aggregate payable in accordance with that paragraph at the time of the application; and

• (b) as to 50% of that aggregate within 30 days following written notice from the licensing authority that the application has been determined.

5

In connection with an application for a manufacturer’s licence or a wholesale dealer’s licence, the fee payable under regulation 4(a) shall, if the applicant so requests in writing, be payable as to 50% at the time of the application and as to 50% 12 months after that time.

6

In connection with an application for a marketing authorization, manufacturer’s licence or wholesale dealer’s licence, the fee payable in respect of an inspection at any site other than one named as a possible site for manufacture of a medicinal product by three or more applicants shall, if the applicant so requests in writing, be payable as to 50% within the period of 14 days referred to in regulation 16(2) and as to 50% 12 months after that date.

SCHEDULE 5 — WAIVER, REDUCTION OR REFUND OF CAPITAL FEES

1

Where the manufacture, assembly, sale or supply of medicinal products of a particular class or description will be, or is likely to be, interrupted for a period and in consequence thereof the health of the community will be, or is likely to be, put at risk, any capital fees payable under these Regulations in connection with an application for the grant of a marketing authorization or a manufacturer’s licence relating to a medicinal product falling within that class or description and made during that period or, if the period will, or is likely to, exceed 3 months, during the first 3 months of that period, shall be waived.

2

Where, at the specific written request of the licensing authority, an application is made for the variation of a marketing authorization so as to—

• (a) restrict any one or more of the indications, dosage or target population, or

• (b) add a contraindication or a warning or both of these,

as a consequence of new information having a bearing on the safe use of the product, the fee payable under regulation 7(1) shall be refunded or, if it has not yet been paid, shall be waived.

3

• (1) Subject to sub-paragraphs (2) and (3), where an application for the grant of, or for a variation to, a marketing authorization or a clinical trial certificate, or for the renewal of a clinical trial certificate is withdrawn before determination by the licensing authority, the following percentage of the fee otherwise payable under regulations 4(a), 7(1) or 10 in connection with that application shall be refunded or, if it has not yet been paid, shall be waived—

• (a) if the application has been received but no medical, scientific or pharmaceutical assessment thereof has begun, 90%;

• (b) except in a case to which sub-paragraph (c) applies. if medical, scientific or pharmaceutical assessment has begun but not been completed, 50%;

• (c) if a request for further information in connection with the application has been made by the licensing authority under section 44(1) (provision of information to licensing authority) of the Act, 25%.

• (2) In a case to which sub-paragraph (1)(a) applies, that provision shall not have effect so as to render an applicant liable to pay more than £1,500 in respect of the fee in connection with that application.

• (3) If an application for the grant of, or for a variation to, a marketing authorization or clinical trial certificate, or for the renewal of a clinical trial certificate, is withdrawn either after medical, scientific and pharmaceutical assessment has been completed or following consideration of that application by a committee established under section 4 (establishment of committees) of the Act or by the Medicines Commission, no refund or waiver of the fee payable under regulation 4(a), 7(1) or 10 in connection with that application shall be made under this paragraph.

4

Where an application for the grant of, or for a variation to, a manufacturer’s or a wholesale dealer’s licence is withdrawn before determination by the licensing authority, the following percentage of the fee otherwise payable under regulation 4(a) or 7(1) in connection with that application shall be refunded or, if it has not yet been paid, shall be waived—

• (a) if the application is withdrawn before any inspection in connection with that application has been made, 90%;

• (b) if such an inspection has been made, 50%.

5

Where the same site is inspected at the same time in connection with applications for the grant or variation of both a manufacturer’s licence and a wholesale dealer’s licence or during the currency of both such licences, the fee otherwise payable under these Regulations in respect of the inspection relating to the wholesale dealer’s licence shall be waived.

6

In relation to a marketing authorization (parallel import), the fee payable in respect of each such application shall be waived—

• (a) where the authorization relates to a medicinal product in respect of which a separate marketing authorization has been granted pursuant to the provisions of Council Directive 65/65/EEC in more than one member State, those marketing authorizations are indicated on the marketing authorization (parallel import) as having been validly granted in those member States and the holder of that authorization applies for the grant of a separate marketing authorization (parallel import) in respect of each marketing authorization which has been granted and so indicated; or

• (b) the holder of the authorization applies for a variation to the authorization solely relating to a change in the number of a marketing authorization referred to in sub-paragraph (a).

• (3) Where a marketing authorization is varied so as to include the provisions of another marketing authorization in the circumstances set out in paragraph 4(4) of Part III of Schedule 3, the fee payable in respect of that variation under regulation 7(1) shall be refunded or, if it has not yet been paid, shall be waived.

SCHEDULE 6 — ADJUSTMENT, REDUCTION OR REFUND OF PERIODIC FEES

1

Where, after payment of any periodic fee payable in accordance with the provisions of these Regulations, the marketing authorization in respect of which such a fee has been paid is either surrendered at the specific written invitation of the licensing authority, or is revoked by the licensing authority on a date earlier than the date of expiry stated in the marketing authorization, the licensing authority shall refund to the applicant the whole or any part of the difference between such periodic fee as has been paid and the amount of the periodic fee payable on the basis of the actual duration of the marketing authorization or licence up to the date of such surrender or revocation.

2

Any sums payable to the applicant by way of refund of any fees under the provisions of this Schedule may be treated as having been paid on account of any other fee which the applicant is liable to pay (whether by instalments or otherwise) under the provisions of these Regulations.

Signed

Signed by authority of the Secretary of State for Health

Tom Sackville — Parliamentary Under Secretary of State, — Department of Health — 22nd March 1995

John Redwood — Secretary of State for Wales — 23rd March 1995

Fraser of Carmyllie — Minister of State, The Scottish Office — 24th March 1995

Angela Browning — Parliamentary Secretary, Ministry of Agriculture, Fisheries and Food — 11th April 1995

Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on

F. A. Elliott — Permanent Secretary — 13th April 1995.

Sealed with the Official Seal of the Department of Agriculture for Northern Ireland on

J. Murray — Permanent Secretary — 19th April 1995.

We consent,

Tim Kirkhope — Andrew Mitchell — Two of the Lords Commissioners of Her Majesty’s Treasury — 20th April 1995

Explanatory note

(This note is not part of the Regulations)

These Regulations make provision for the fees payable under the Medicines Act 1971 in respect of marketing authorizations, licences and certificates relating to medicinal products for human use.

Parts II, III and V and Schedules 1 and 2 provide for capital fees to be payable in connection with applications for, or variations to, marketing authorizations, manufacturer’s licences, wholesale dealer’s licences, clinical trial certificates and certificates permitting the export of medicinal products and for associated inspections. Most of these fees were previously provided for by the regulations revoked by these Regulations but there are two exceptions—

• (a) a new category of fee is introduced in respect of decentralised incoming applications which are applications for marketing authorizations, in respect of which recognition is sought of any authorization already granted by another member State of the European Community;

• (b) Part III of Schedule I imposes a new scheme for the classification of fees for variations to marketing authorizations, based on that set out in Commission Regulation (EC) No. 541/95 (OJ No. L55, 11.3.95, p. 7).

In general the fees prescribed by these Regulations are the same or lower than those which they replace. Two exceptions occur in relation to applications for the variation of marketing authorizations. Here fees of £190 and £342 replace fees of £100 and £235 which have applied to applications for the variation of product licences. However, owing to a revision of the categories of variation many applications which previously would have attracted a fee of £325 will, under these Regulations, attract a fee of £190. Overall it is estimated that the new fee levels will result in a reduction of the yield from fees of about 4%.

Part VI of, and Schedule 3 to, the Regulations impose periodic fees to be payable in connection with the holding of marketing authorizations, manufacturer’s licences and wholesale dealer’s licences. The amount of the periodic fee varies according to the type of product and, in some cases, according to turnover. Excepted from the requirement to pay periodic fees are holders of clinical trial certificates and certain manufacturer’s licences who are required to pay fees on renewal of their certificates or licences (Part IV).

Regulation 23 contains transitional provisions.

Administrative provisions (Part VII, Schedules 4, 5 and 6) deal with time of payment and waiver or refund of both capital and periodic fees in specified circumstances. Special arrangements are provided in respect of the time of payment of capital fees by small companies and a new concession is introduced in respect of small companies who make complex applications for marketing authorizations (Schedule 4).

Part VIII of the Regulations revokes the earlier Regulations relating to fees for medicinal products for human use and also makes saving and transitional provisions.

An assessment of the cost to business of complying with these Regulations has been made, copies of which have been placed in the libraries of both Houses of Parliament and further copies of which may be obtained from the Medicines Control Agency, Department of Health, Room 1207, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.

Footnotes

[^f00001]: 1971 c. 69, as amended by section 21 of the Health and Medicines Act 1988 (c. 49); by virtue of section 1(3) of the 1971 Act expressions in that section have the same meaning as in the Medicines Act 1968 (c. 67), as amended by the Transfer of Functions (Wales) Order 1969 (S.I. 1969/388). The expression “the Ministers” is defined in section 1(1) of the 1968 Act as so amended. By virtue of regulation 9(12) of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (S.I. 1994/3144), references in section 1(1) and (2)(b) to a licence under Part II of the 1971 Act include a reference to a marketing authorization under those Regulations.

[^f00002]: In the case of the Secretaries of State concerned with health in England and in Wales by virtue of article 2(2) of, and Schedule 1 to, the Transfer of Functions (Wales) Order 1969; in the case of the Secretary of State concerned with agriculture in Wales by virtue of article 2(3) of, and Schedule 1 to, the Transfer of Functions (Wales) (No. 1) Order 1978 (S.I. 1978/272); in the case of the Northern Ireland Departments by Virtue of section 40 of, and Schedule 5 to, the Northern Ireland Constitution Act 1973 (c. 36) and section 1(3) of, and paragraph 2(1)(b) of Schedule 1 to, the Northern Ireland Act 1974 (c. 28).

[^f00003]: See section 129(6) of the Medicines Act 1968 (c. 67) as extended to include regulations made under the Medicines Act 1971 by section 1(3)(b) of that latter Act.

[^f00004]: S.I. 1994/3144.

[^f00005]: OJ No. L214, 24.8.93. p.1.

[^f00006]: OJ No. L22, 9.2.65, p. 369/65. The Directive was amended by Directives 75/319/EEC (OJ No. L147, 9.6.75, p.13); 83/570/EEC (OJ No. L332, 28.11.83, p. 1); 87/21/EEC (OJ No. L15, 17.1.87, p. 36); 89/341/EEC (OJ No. L142, 25.5.89, p.11); 89/343/EEC (OJ No. L142, 25.5.89, p. 16) and 93/39/EEC (OJ No. L214, 24.8.93, p. 22).

[^f00007]: OJ No. L55, 11.3.95, p. 7.

[^f00008]: S.I. 1971/1450; to which there are amendments not relevant to these Regulations.

[^f00009]: 1985 c. 6 as amended by section 13(1) of the Companies Act 1989 (c. 40) and by regulation 5(3) of the Companies Act 1985 (Accounts of Small and Medium-Sized Enterprises and Publication of Accounts in ECUs) Regulations 1992 (S.I. 1992/2452). On 1st March 1995 the figures specified in section 247(3) under the heading “Small company” applying to the turnover, balance sheet total and number of employees respectively were, £2.8 million, £1.4 million and 50.

[^f00010]: S.I. 1991/1474; amended by S.I. 1992/756 and S.I. 1994/696.

[^f00011]: S.I. 1992/756.

[^f00012]: S.I. 1994/696.

[^f00013]: OJ No. L147, 9.6.75. p. 13. Chapter III was replaced by Article 3 (1) of Directive 93/39/EEC (OJ No. L214, 24.8.93, p. 22).

[^f00014]: OJ No. L22, 9.2.65, p. 369/65. The Directive was amended by Directives 75/319/EEC (OJ No. L147, 9.6.75, p.13); 83/570/EEC (OJ No. L332, 28.11.83, p. 1); 87/21/EEC (OJ No. L15, 17.1.87, p. 36); 89/341/EEC (OJ No. L142, 25.5.89, p.11); 89/343/EEC (OJ No. L142, 25.5.89, p. 16) and 93/39/EEC (OJ No. L214, 24.8.93, p. 22).

[^f00015]: OJ No. L147, 9.6.75, p. 1. The Annex was replaced by the Annex to Council Directive 91/507/EEC (OJ No. L270, 26.9.91, p. 32).

[^f00016]: S.I. 1971/1450.

[^f00017]: OJ No. L55, 11.3.95,p. 7.

[^f00018]: OJ No. L147, 9.6.75, p. 1. The Directive was amended by Directives 89/341/EEC (OJ No. L142, 25.5.89, p. 11), 91/507/EEC (OJ No. L270, 26.9.91, p. 32) and 93/39/EEC (OJ No. L214, 24.8.93, p. 22).

[^f00020]: OJ No. L22, 9.2.65, p. 369/65. The Directive was amended by Directives 75/319/EEC (OJ No. L147, 9.6.75, p.13); 83/570/EEC (OJ No. L332, 28.11.83, p. 1); 87/21/EEC (OJ No. L15, 17.1.87, p. 36); 89/341/EEC (OJ No. L142, 25.5.89, p.11); 89/343/EEC (OJ No. L142, 25.5.89, p. 16) and 93/39/EEC (OJ No. L214, 24.8.93, p. 22).