# The Medicines (Products for Human Use-Fees) Regulations 2008, Paragraph 5: Outgoing mutual recognition applications


As regards the fee payable under regulation 16 in connection with an application—
(a) to which paragraph 13(a) of Part 3 of Schedule 1 applies—
(i) 25% of that fee shall be payable at the time when, in connection with the application or set of applications for regulatory assistance, a request is made pursuant to the second sub-paragraph of Article 28.1 of the 2001 Directive for an assessment report to be prepared or updated, and
(ii) 75% of that fee shall become payable within 30 days following written notice from the licensing authority that the regulatory assistance is at an end;
(b) to which paragraph 13(b), (c) or (d), of Part 3 of Schedule 1 applies—
(i) 50% of that fee shall be payable at the time when, in connection with the application or set of applications for regulatory assistance, a request is made pursuant to the second sub-paragraph of Article 28.1 of the 2001 Directive for an assessment report to be prepared or updated, and
(ii) 50% of that fee shall become payable within 30 days following written notice from the licensing authority that the regulatory assistance is at an end,
if the applicant so requests in writing.

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Source: https://www.legislation.gov.uk/uksi/2008/552/schedule/4/paragraph/5 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-4/paragraph-5
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.