Amendment of Schedule 1 to the principal Regulations
5.—(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(1) 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;”.
OJ No. L55, 11.3.95, p. 7.