Singapore legislation
Regulation 5
of Medicines (Medicinal Products as Clinical Research Materials) Regulations 2016
Regulation 5
Supply only as clinical research material
Subregulation 1
A person who manufactures, assembles, imports or is supplied with any clinical research material under regulation 3 must only supply the material for the purpose of being used in clinical research in accordance with the protocol for the research.
Subregulation 2
Despite paragraph (1), the person may supply the clinical research material for a purpose other than that specified in that paragraph if the Authority has allowed such supply.
Subregulation 3
To avoid doubt, as from the time that the Authority has allowed the supply for a purpose other than that specified in paragraph (1) —
the clinical research material in question ceases to be clinical research material; and
nothing in these Regulations prevents clinical research material which ceases to be such, from being subject to any law relating to medicinal products.