Singapore legislation
Regulation 27
Regulation 27
Protection of confidential information
Subregulation 1
For the purposes of section 66(2)(d) of the Act, the Authority may —
disclose confidential information relating to an investigational health product —
for any purpose with the consent of the person who applied for authorisation for, or notified the Authority of, the clinical trial to which the information relates; or
as the Authority considers necessary to protect the health or safety of members of the public; or
disclose confidential information relating to an investigational health product to a Government department or statutory body for the purposes of facilitating or assisting such Government department or statutory body in carrying out its duties if, in the opinion of the Authority, the Government department or statutory body, as the case may be, will take reasonable steps to ensure the information is kept confidential.
Subregulation 2
The power to grant consent under paragraph (1)(a)(i) may be exercised by a person other than the person referred to in that paragraph if —
the person referred to in paragraph (1)(a)(i) —
has notified the Authority in writing that the other person may grant the consent; and
has not notified the Authority in writing that the other person’s authority to grant the consent has been withdrawn; or
the rights of the person referred to in paragraph (1)(a)(i) in respect of the relevant confidential information have been transferred to the other person, and the person or the other person has notified the Authority in writing of the transfer.