The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1998

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(1);

“the Homoeopathic Products Regulations” means the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994(2).

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(3) (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(4) 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(5) (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(6) are hereby revoked.

Signed by authority of the Secretary of State for Health

Jay

Minister of State

Department of Health

24th February 1998

Signed by authority of the Secretary of State for Wales

Win Griffiths

Parliamentary Under Secretary of State Welsh Office

27th February 1998

Sam Galbraith

Parliamentary Under Secretary of State Scottish Office

4th March 1998

Jeff Rooker

Minister of State Ministry of Agriculture Fisheries and Food

3rd March 1998

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

L.S.

Mr D. C. Gowdy

Permanent Secretary

27th February 1998.

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

L.S.

P. J. Small

Permanent Secretary

3rd March 1998.

We consent,

Graham Allen

Bob Ainsworth

Two of the Lords Commissioners of Her Majesty’s Treasury

5th March 1998