Section 45

investigating whether any provision of this Act has been or is being contravened;

investigating any complaint or matter in respect of which the Director may take action under section 42;

assessing whether the practices and procedures of a research institution, a researcher or an institutional review board in relation to any human biomedical research are in compliance with this Act and the regulations made under this Act; and

assessing whether the practices and procedures of a tissue bank in relation to any tissue banking activity are in compliance with this Act and the regulations made under this Act.

inspect and make copies of and take extracts from, or require the occupier or any person having the management or control of, the premises to provide copies of or extracts from, any book, document, record or electronic material;

inspect and make copies of and take extracts from, or require the occupier or any person having the management or control of, the premises to provide copies of or extracts from, any medical record of any person who has been or who is being treated or examined at the premises, even though the prior consent of such person has not been obtained;

inspect any apparatus, appliance, equipment or instrument used or found in the premises;

inspect any test or procedure relating to any human biomedical research that has been or is being conducted in the premises;

inspect, test, examine, remove and detain any biological material or organism or any product of human biomedical research found in the premises; and

inspect, test, examine and remove any container, article and other thing that the authorised officer reasonably believes to contain or to have contained any biological material or organism or any product of human biomedical research that has been or is being conducted in the premises.

any biological material or organism or any product of human biomedical research; or

any book, document, record, apparatus, appliance, equipment or instrument,which the authorised officer reasonably believes to be the subject matter of, or to be connected with the commission of, an offence under this Act.

the authorised officer who seized the article or document must give written notice of the seizure to the person from whom it was seized, if the name and address of that person are known;

the article or document may be kept or stored in the premises or place where it was seized or may, at the authorised officer’s direction, be removed to any other place to be kept or stored; and

the authorised officer may —

mark, seal or label the article or document in such manner as the officer thinks fit for the purpose of indicating that it is under detention; and

lock or seal the whole or part of the premises or place in which the article or document is being detained.

interferes, tampers with, removes or otherwise disposes of the article or document;

alters, counterfeits, defaces, destroys, erases or removes any mark, seal or label placed by the authorised officer under subsection (5)(c)(i); or

opens, breaks or otherwise tampers with the lock or seal placed by the authorised officer on the whole or part of any premises or place under subsection (5)(c)(ii),shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 2 years or to both.

require any person —

to furnish any information within his or her knowledge; or

to produce any book, document, record, electronic material, article or thing within his or her possession for inspection by the authorised officer and make copies of such book, document or other record, or to provide the authorised officer with copies of such book, document or other record;

examine orally any person supposed to be acquainted with the facts and circumstances of any serious adverse event, contravention or suspected contravention, or related safety issues with respect to any matter under this Act, and must —

reduce to writing any statement made by the person so examined who is bound to state truly the facts and circumstances with which the person is acquainted;

read the statement over to the person so examined; and

require the person so examined to sign the statement, after correction, if any; and

require, by written order, the attendance before the authorised officer of any person, being within the limits of Singapore, who, from information given or otherwise, appears to be acquainted with the facts and circumstances of matters under this Act, and that person must attend as so required.

obstructs, hinders or impedes an authorised officer in the exercise of the officer’s powers under this section; or

without reasonable excuse, fails to comply with any order or requirement of an authorised officer under this section or to produce any book, document, record, electronic material, article or thing which that person is required by or under this Act to produce to an authorised officer,shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 2 years or to both.