Singapore legislation
Regulation 10
Regulation 10
Persons who do not require importer’s licences
A person may, without an importer’s licence, import an active ingredient if —
the person holds a manufacturer’s licence and the active ingredient is required for use in, or for the purpose of carrying out, the manufacture of any active ingredient, in accordance with the conditions of the manufacturer’s licence;
the person is a specified healthcare service licensee and the active ingredient is imported for the purposes of compounding a therapeutic product in accordance with regulation 46 of the Health Products (Therapeutic Products) Regulations 2016;
the person holds a pharmacy licence and the active ingredient is imported for the purposes of compounding a therapeutic product in accordance with regulation 48 of the Health Products (Therapeutic Products) Regulations 2016;
the person manufactures a laboratory‑developed test under regulation 3B of the Health Products (Medical Devices) Regulations 2010 and the active ingredient is imported only for the purposes of manufacturing the laboratory‑developed test;
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 imported for use in the manufacture of a therapeutic product by that person;
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 imported for use in the manufacture of a CTGT product by that person;
the person holds a manufacturer’s licence for a medical device, other than a manufacturer’s licence that authorises the manufacture of medical devices only by way of secondary assembly, and the active ingredient is imported for use in the manufacture of a medical device by that person; or
the active ingredient is imported solely for use in the manufacture of a relevant health product in Singapore that is intended to be used only in clinical research (whether conducted in Singapore or elsewhere) and the person, before importing the active ingredient, gives the Authority notice of the import in the form and manner, and within the time, specified on the Authority’s website.