Regulation 9
Conditions of clinical trial certificates
of Medicines (Clinical Trials) Regulations 2016
Subregulation 1
The Authority may issue a clinical trial certificate for a principal investigator subject to such conditions as the Authority thinks necessary and may, from time to time, by notice in writing to the sponsor —
modify or remove any condition of the certificate; or
attach any new condition to the certificate.
Subregulation 2
The conditions referred to in paragraph (1) may include a condition requiring the sponsor to obtain and maintain insurance to provide compensation in the event of injury or loss arising from the clinical trial on such terms as the Authority may approve.
Subregulation 3
The Authority may refuse to issue, or suspend or revoke, any clinical trial certificate.
Subregulation 4
Any person aggrieved by a refusal, suspension or revocation referred to in paragraph (3) may appeal to the Minister, whose decision is final.