Singapore legislation
Regulation 9
of Medicines (Medicinal Products as Clinical Research Materials) Regulations 2016
Regulation 9
Records of receipt and supply
Subregulation 1
A person who supplies any clinical research material (including a manufacturer, a person who assembles 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 and traceability 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.