The Medicines (Products for Human Use) (Fees) Regulations 2016

Outgoing mutual recognition applications

37.—(1) The fee payable for regulatory assistance under regulation 17 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 authorisation was granted in the United Kingdom (the application relating to that authorisation 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 £41,573;

(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 £2,564;

(c) each subsequent application for regulatory assistance (“subsequent application”), the fee is £27,308; 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 £2,564.

(3) In the case where the application to the licensing authority relates to a medicinal product for which a marketing authorisation 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 £10,753;

(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 £2,564;

(c) each subsequent application for regulatory assistance (“subsequent application”), the fee is £7,133; 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 £2,564.

(4) In the case where the application to the licensing authority relates to a medicinal product for which a marketing authorisation 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 £4,282;

(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 £2,564;

(c) each subsequent application for regulatory assistance (“subsequent application”), the fee is £3,567; 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 £2,564.

(5) In the case where the application to the licensing authority relates to a medicinal product for which a marketing authorisation 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 £2,564;

(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 £2,564;

(c) each subsequent application for regulatory assistance (“subsequent application”), the fee is £2,564; 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 £2,564.

(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 16.