Singapore legislation
Regulation 4
of Medicines (Medicinal Products as Clinical Research Materials) Regulations 2016
Regulation 4
Manufacture, assembly and import of clinical research materials
Subregulation 1
A manufacturer of any clinical research material, or an importer of such material, must ensure that the material is of the correct identity and conforms with the applicable standards of strength, quality and purity for that material.
Subregulation 2
A person who assembles any clinical research material must ensure that the material is of the correct identity.