Amendment of Schedule 1 to the principal Regulations
7.—(1) Schedule 1 to the principal Regulations (capital fees for applications for, and variations to, licences and certificates) shall be amended in accordance with the following paragraphs of this regulation.
(2) In paragraph 1 of Part I—
(a)in the definition of “active ingredient”, the word “therapeutic” shall be omitted and after the word “efficacy” there shall be inserted “(whether therapeutic, diagnostic or otherwise)”;
(b)in the definition of “complex application”—
(i)for “(a) to (n)” there shall be substituted “(a) to (q)”;
(ii)at the end of sub-paragraph (m), “or” shall be omitted;
(iii)after sub-paragraph (n), the following paragraphs shall be inserted—
“(o)the application is for the grant of a product licence for a medicinal product which is to be administered by way of a metered dose inhaler;
(p)the application is for the grant of a product licence for a medicinal product which is in a powdered form and is to be administered by way of inhalation; or
(q)the application relates to a medicinal product—
(i)which is administered to the site of action by a different route from that used in relation to any other medicinal product which contains the same active ingredient as the product in question and,
(ii)in respect of that other product, a product licence (other than a product licence of right) has previously been granted in the United Kingdom.”;
(c)in the definition of “simple application”—
(i)after the word “means” there shall be inserted “(a)”,
(ii)at the end there shall be inserted—
“or (b) an application, made no later than three months after the expiry of a product licence, which is for a product licence containing identical provisions to those contained in the expired licence and which is made by the person who held the expired licence;”.
(3) In Part II (capital fees for applications for licences and certificates)—
(a)in Column 1 of the Table in paragraph 1, in entry 1(a)(i) for “paragraph 5 of Chapter III of Part 3 of the Annex to Council Directive 75/318/EEC(a)” there shall be substituted “paragraph 5 of Schedule 2 to the Applications Regulations”;
(b)in paragraph 4—
(i)in sub-paragraph (1), in the definition of “primary applicant”, before “; and” there shall be inserted “or that party to a joint development who first makes an application for a product licence relating to a different dosage form or strength of that new active ingredient”,
(ii)at the beginning of sub-paragraph (2) there shall be inserted “Subject to sub-paragraph (3) below,”,
(iii)after sub-paragraph (2) there shall be inserted the following sub-paragraph—
“(3) Where a primary applicant and one or more secondary applicants each submit an application for a product licence to the licensing authority, both or all of which applications relate to identical dosage forms and strengths of the medicinal product to which the joint development relates—
(a)where the amount payable by the primary applicant is that in respect of a complex application, the fee payable under regulation 4(a) by each secondary applicant shall be that in respect of a standard application under paragraph 1 above;
(b)where the amount payable by the primary applicant is that in respect of a standard application, the fee payable under regulation 4(a) by each secondary applicant shall be that in respect of a simple application under paragraph 1 above.”;
(c)for sub-paragraph (2) of paragraph 7, there shall be substituted—
“(2) The fee payable under regulation 4(a) shall be £500 where an application for a wholesale dealer’s licence—
(a)relates to anything done in a registered pharmacy by or under the supervision of a pharmacist and amounting to wholesale dealing, where such dealing constitutes no more than 15% of the total turnover of the saleof licensed medicinal products carried on at that pharmacy; or
(b)does not relate to anything done in a registered pharmacy but where the applicant’s total turnover of the sale by way of wholesale dealing of licensed medicinal products does not exceed £30,000.”.
(4) In Part III (capital fees for variations of licences and certificates)—
(a)in paragraph 1—
(i)the word “and” after sub-paragraph (a) shall be omitted,
(ii)after sub-paragraph (a) there shall be inserted—
“(aa)in the case of an application relating to a product licence (parallel import) to which paragraph 3 or 4 does not apply, £325; and”;
(b)in paragraph 2—
(i)at the beginning, there shall be inserted “Subject to paragraph 2A,”,
(ii)for “paragraph 5 of Chapter III of Part 3 of the Annex to Council Directive 75/318/EEC” there shall be substituted “paragraph 5 of Schedule 2 to the Application Regulations”;
(c)after paragraph 2, there shall be inserted the following paragraph—
“2A. Paragraph 2 shall not apply where the first application for variation of the product licence relates to a particular therapeutic area in respect of which the applicant would be entitled (had he not already held a product licence) to apply for a product licence without, under paragraph 5 of Schedule 2 to the Applications Regulations, having to provide the results of tests or trials in accordance with paragraph 8 of Schedule 1 to those Regulations”.