34.—(1) The fee payable under regulation 16 (application to the licensing authority for regulatory assistance in connection with obtaining recognition according to the procedure laid down in Title III, Chapter 4 of the 2001 Directive of a single United Kingdom marketing authorization in another EEA State or in other EEA States) is the fee specified in sub-paragraphs (2) to (5).
(2) In the case where the application to the licensing authority relates to a medicinal product for which a marketing authorization was granted in the United Kingdom (the application relating to that authorization is referred to in this paragraph as the “original application”) and the original application had been a major application or would fall within the meaning of a major application, in respect of—
(a)the first application for regulatory assistance (“the first application”), the fee is £44,934;
(b)any other application for regulatory assistance meeting the condition in sub-paragraph (6) and made at the same time as the first application, the fee is £2,769;
(c)each subsequent application for regulatory assistance (“subsequent application”), the fee is £29,516; and
(d)any other application for regulatory assistance meeting the condition in sub-paragraph (6) and made at the same time as any subsequent application, the fee is £2,769.
(3) In the case where the application to the licensing authority relates to a medicinal product for which a marketing authorization was granted in the United Kingdom and the original application had been a complex application or would fall within the meaning of a complex application, in respect of—
(a)the first application for regulatory assistance (“the first application”), the fee is £11,623;
(b)any other application for regulatory assistance meeting the condition in sub-paragraph (6) and made at the same time as the first application, the fee is £2,769;
(c)each subsequent application for regulatory assistance (“subsequent application”), the fee is £7,709; and
(d)any other application for regulatory assistance meeting the condition in sub-paragraph (6) and made at the same time as any subsequent application, the fee is £2,769.
(4) In the case where the application to the licensing authority relates to a medicinal product for which a marketing authorization was granted in the United Kingdom and the original application had been a standard application or would fall within the meaning of a standard application, in respect of—
(a)the first application for regulatory assistance (“the first application”), the fee is £4,628;
(b)any other application for regulatory assistance meeting the condition in sub-paragraph (6) and made at the same time as the first application, the fee is £2,769;
(c)each subsequent application for regulatory assistance (“subsequent application”), the fee is £3,855; and
(d)any other application for regulatory assistance meeting the condition in sub-paragraph (6) and made at the same time as any subsequent application, the fee is £2,769.
(5) In the case where the application to the licensing authority relates to a medicinal product for which a marketing authorization was granted in the United Kingdom and the original application had been a simple application or would fall within the meaning of a simple application, in respect of—
(a)the first application for regulatory assistance (“the first application”), the fee is £2,769;
(b)any other application for regulatory assistance meeting the condition in sub-paragraph (6) and made at the same time as the first application, the fee is £2,769;
(c)each subsequent application for regulatory assistance (“subsequent application”), the fee is £2,769; and
(d)any other application for regulatory assistance meeting the condition in sub-paragraph (6) and made at the same time as any subsequent application, the fee is £2,769.
(6) The condition referred to in sub-paragraphs (2) to (5) is that all applications fall within the meaning given to a set of applications in regulation 15.