(1) The National Competent Authority may grant an authorization for a clinical trial where —
(a) the applicant —
(i) has complied with the requirements of section 13,
(ii) has at his or her disposal suitable and sufficient trial sites, technical equipment and control facilities as to the storage of the investigational medicinal product or investigational medical device,
(iii) if a notice has been given under section 14(2), has provided the information requested by the National Competent Authority;
(b) the National Competent Authority has established that the particulars under section 13(2)(b)(i) are accurate.
(2) Where the National Competent Authority grants an authorization for a clinical trial, the National Competent Authority shall issue a written authorization, without conditions or subject to conditions upon payment by the sponsor of the prescribed fee.
(3) Where the National Competent Authority refuses an application, the National Competent Authority shall give a notice in writing to the sponsor setting out the grounds for refusing the application for authorization to conduct the clinical trial.
(4) Where a sponsor is given a notice under subsection (3), he or she may, within a period of 14 days, or such extended period as the National Competent Authority may in any particular case allow, from the date on which the notice was received, send an amended application to the National Competent Authority for further consideration.
(5) The National Competent Authority shall consider an amended application and, not later than 60 days from the date on which the original application was received —
(a) issue a written authorization to the sponsor under subsection (2); or
(b) give a notice in writing to the sponsor setting out the grounds for refusing the application.
(6) Where an authorization is granted with conditions or refused, the applicant may, within 30 days from receipt of the written authorization, appeal in writing to the Appeals Board, setting out the grounds on which the appeal is made.