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

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(1) 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(2) (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.

(1)

OJ No. L 55, 11.3.95, p. 7.

(2)

OJ No. L 147, 9.6.75, p. 1; amended by Council Directive 83/570/EEC (OJ No. L 332, 28.11.83, p. 1), Council Directive 87/19/EEC (OJ No. L 15, 17.1.87, p. 31), Council Directive 89/341/EEC (OJ No. L 142, 25.5.89, p. 11), Commission Directive 91/507/EEC (OJ No. L 270, 26.9.91, p. 32) and Council Directive 93/39/EEC (OJ No. L 214, 24.8.93, p. 22).