# The Medicines (Products for Human Use-Fees) Regulations 2008, Paragraph 6: Refusal of application for grant of marketing authorization, traditional herbal registration or clinical trial authorisation


Where an application for the grant of a marketing authorization or traditional herbal registration, or an application for a clinical trial authorisation is refused by the licensing authority and—
(a) the information contained in it, or submitted with it, was not sufficient to enable a full medical, scientific or pharmaceutical assessment to be undertaken; and
(b) if the applicant had withdrawn it before it was refused, part of the fee payable in respect of it would have been refunded or waived under paragraph 3;
there shall be refunded or waived the amount which would have been refunded or waived if the application had been withdrawn before it was refused by the licensing authority.

---
Source: https://www.legislation.gov.uk/uksi/2008/552/schedule/5/paragraph/6 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-5/paragraph-6
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.