Singapore legislation
Regulation 9
Regulation 9
Persons who do not require manufacturer’s licences
A person may, without a manufacturer’s licence, manufacture an active ingredient if —
the active ingredient is intended to be used for any purpose other than in the manufacture of a relevant health product;
the active ingredient is manufactured solely for use in the manufacture of a relevant health product that is intended to be used only for a non‑clinical purpose;
the active ingredient is manufactured solely for use in the manufacture of a relevant health product (whether it is manufactured in Singapore or elsewhere) that is intended to be used only in clinical research (whether conducted in Singapore or elsewhere);
the person holds a manufacturer’s licence (other than a manufacturer’s licence only for primary or secondary packaging) for a therapeutic product and the active ingredient is intended for use in the manufacture of a therapeutic product by that person; or
the person holds a manufacturer’s licence (other than a manufacturer’s licence only for secondary packaging) for a CTGT product and the active ingredient is intended for use in the manufacture of a CTGT product by that person.