The Medicines (Products for Human Use—Fees) Amendment Regulations 1996

• Citation: S.I. 1996/683
• Sections: 7

Section 1 Citation, commencement and interpretation

(1) These Regulations may be cited as the Medicines (Products for Human Use—Fees) Amendment Regulations 1996 and shall come into force on 1st April 1996.

(2) In these Regulations “the principal Regulations ” means the Medicines (Products for Human Use—Fees) Regulations 1995 .

Section 2 Amendment of regulation 2 of the principal Regulations

In regulation 2(1) (interpretation) of the principal Regulations, for the definition of“change of ownership application” substitute—

“change of ownership application” means an application—

for—

a marketing authorization for a medicinal product in respect of which another person holds a marketing authorization;

a manufacturer’s licence for activities in respect of which another person holds a manufacturer’s licence; or

a wholesale dealer’s licence for activities in respect of which another person holds a wholesale dealer’s licence;

which refers to particulars which are in all material respects identical to the particulars of the marketing authorization, manufacturer’s licence, or wholesale dealer’s licence which is held by that other person; and

which includes a statement to the effect that that other person intends to cease the activities to which his marketing authorization or licence relates and has consented in writing to the making of the application.

and in this definition particulars do not include particulars relating to the name and address of the applicant, the labelling of any medicinal product or the content of any leaflet relating to such a product;

Section 3 Amendment of amounts specified in the principal Regulations

In each provision of the principal 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) substitute the amount specified opposite that provision in column (4).

Section 4 Amendment of regulation 14 of the principal Regulations

In regulation 14 (periodic fees) of the principal Regulations—

(a) in paragraph (4) omit “or licence”;

(b) at the end add the following paragraph—

(6) No periodic fee shall be payable in respect of the fee period during which a manufacturer’s or wholesale dealer’s licence is first granted except where—

(a) that licence is granted pursuant to a change of ownership application; and

(b) no periodic fee has been paid in respect of that fee period in connection with the manufacturer’s or wholesale dealer’s licence which is mentioned in that application in the statement of intention to cease activities.

Section 5 Amendment of Schedule 1 to the principal Regulations

(1) For paragraph 5(1)(b) (manufacturer’s licences) of Part II of Schedule 1 (capital fees for applications for marketing authorizations, licences and certificates) to the principal Regulations substitute—

(b) in the case of a change of ownership application, £180;

(c) in any other case, £1,690.

(2) In paragraph 6 (wholesale dealer’s licences) of Part II of Schedule 1 to the principal Regulations—

(a) in sub-paragraph (1) for “sub-paragraph (2)” substitute “sub-paragraphs (2) and (4)”;

(b) in sub-paragraph (2) for “The fee payable” substitute “Subject to paragraph (4), the fee payable”;

(c) after sub-paragraph (3) add

(4) The fee payable under regulation 4(a) in connection with a change of ownership application shall be £210.

(3) In paragraph 1 (marketing authorizations) of Part III (capital fees for variations) of Schedule 1 to the principal Regulations—

(a) in the definition of “Type II Application” omit “or a product licence of right”;

(b) in the definition of “Type II complex variation”—

(i) in sub-paragraph (a) after “following” insert “changes, other than a change to which paragraph 1 (changes to active substances) or paragraph 3 (changes to strength, pharmaceutical form and route of administration) of Annex II to Commission Regulation ( EC ) No. 541/95 applies”;

(ii) at the end of sub-paragraph (b) insert “or”;

(iii) for sub-paragraph (c) substitute—

(c) in the composition, manufacture or use of a medicinal product to which—

(i) paragraph (c), (e), (g), (h), (j) or (n) of the definition of complex application in this Schedule would apply where an application for a marketing authorization is made in respect of a medicinal product; or

(ii) paragraph (i) of that definition would so apply and the change is not a minor variation which satisfies the condition specified in point 11 (specifications, synthetic route and quality control procedures the same as those already approved or a European Pharmacopoeia Certificate of suitability covering the active substance submitted) of Annex I to Commission Regulation (EC) No. 541/95 .

(4) In paragraph 6(a) (fees for variation of marketing authorizations (parallel import)) of Part III of Schedule 1, after sub-paragraph (v) insert the following sub-paragraph—

(vi) the addition or deletion of the name and address of the suppliers of the medicinal product to which the authorization relates, or a change in the name, the address, or both the name and address, of the suppliers of that product;

Section 6 Amendment of Schedule 3 to the principal Regulations

(1) In paragraph 1 (interpretation) of Part I of Schedule 3 (periodic fees) to the principal Regulations, in the definition of “maintenance fee”, in sub-paragraph (b) for “the relevant calendar year” substitute “that period”.

(2) For paragraph 3 (derivatives of new active substances) of Part III (periodic fees for marketing authorizations and licences) of Schedule 3 to the principal Regulations substitute—

(3) Subject to paragraph 4, where a marketing authorization is held in respect of a derivative of a new active substance, the fee payable under regulation 14(3) shall be—

(a) where it has a different route of administration from that of the new active substance, £4,800;

(b) in any other case, £3,400.

(3) In paragraph 4 (transitional arrangements for periodic fees) of Part III of Schedule 3 to the principal Regulations omit sub-paragraphs (1) and (2).

(4) In Part IV (marketing authorizations for which a single periodic fee is payable) of Schedule 3 to the principal Regulations omit paragraph 2 (homoeopathic or anthroposophic products).

Section 7 Amendment of Schedule 5 to the principal Regulations

(1) In paragraph 3(1)(c) (withdrawal of application after a request to supply information) of Schedule 5 (waiver, reduction or refund of capital fees) to the principal Regulations, after “of the Act” insert “or in pursuance of a Community provision which applies to applications for marketing authorizations”.

(2) After paragraph 4 (fees for manufacturer’s and wholesale dealer’s licences) of Schedule 5 to the principal Regulations insert—

(4A)

(1) Where an application for the grant of a marketing authorization or a clinical trial certificate is refused by the licensing authority and—

(a) the information contained in it, or submitted with it, was not sufficient to enable a full medical, scientific or pharmaceutical assessment to be undertaken; and

(b) if the applicant had withdrawn it before it was refused, part of the fee payable in respect of it would have been refunded or waived under paragraph 3;

there shall be refunded or waived the amount which would have been refunded or waived if the application had been withdrawn before it was refused by the licensing authority.

(3) In Schedule 5 to the principal Regulations omit paragraph 6(3) (fees for variations).

(4) After paragraph 6 of Schedule 5 to the principal Regulations insert—

(7)

(1) Subject to sub-paragraphs (2) and (3), where an applicant applies to vary a marketing authorization in the circumstances set out in paragraph 4(4) of Part III of Schedule 3, the fee payable under regulation 7(1) shall be refunded or waived.

(2) Subject to paragraph (3), where an applicant on the same occasion submits more than one such application which relates to medicinal products containing the same active ingredients but no other active ingredient, sub-paragraph (1) shall apply only to one of those applications.

(3) Where in respect of any two or more of the applications mentioned in sub-paragraph (2) provision is made for fees of different amounts by paragraphs 13 and 14 of Part III of Schedule 1, sub-paragraph (1) shall apply to the application in respect of which those paragraph makes provision for the higher or highest fee