Singapore legislation
Regulation 16
of Health Products (Clinical Research Materials) Regulations 2016
Regulation 16
Records of receipt and supply
Subregulation 1
A person who supplies any clinical research material (including a manufacturer or an importer of the material who supplies the material) must keep records relating to every receipt (where applicable) and every supply by the person of the material, in order to permit proper evaluation to be made of the accountability of the material.
Subregulation 2
The records referred to in paragraph (1) include all of the following:
the proprietary name or description of the clinical research material;
the identification number of the clinical research material (including the control number, lot number, batch number or serial number);
where applicable, details of each receipt of the clinical research material by the person (whether as a result of an import by, or a supply to, the person), namely —
the date on which the material was received;
the quantity of the material received; and
the name and address of the person from whom the material was received;
details of each supply of the clinical research material by the person, namely —
the date on which the material was supplied;
the quantity of the material supplied; and
the name and address of the person to whom the material was supplied.
Subregulation 3
In addition to any records required to be kept under this regulation, where the clinical research material is pharmacy‑only medicine that is supplied to a subject, the person making the supply must also keep records of all of the following:
the name, identity card or other identification document number, and contact details, of the subject;
the strength of the material supplied;
the dosage, and the frequency and purpose of the treatment for which the supply is made.
Subregulation 4
In addition to any records required to be kept under this regulation, where the clinical research material is supplied to a subject against a valid prescription given by a qualified practitioner, the person making the supply must also keep records of all of the following:
the name, identity card or other identification document number, and contact details, of the subject;
if the material is supplied by a qualified pharmacist or a person acting under the supervision of a qualified pharmacist, the name and the address of the qualified practitioner who signed the prescription.
Subregulation 5
The records referred to in paragraphs (3) and (4) must be made on the day of the supply to which the records relate or, if that is not reasonably practicable, the next day.