Singapore legislation
Regulation 11
Regulation 11
Persons who do not require wholesaler’s licences
Subregulation 1
A person may, without a wholesaler’s licence, supply by wholesale any active ingredient if —
the person holds a manufacturer’s licence;
the active ingredient is manufactured by the person under the manufacturer’s licence;
the person is able to provide and maintain, or ensure the provision and maintenance of, such staff, premises, equipment and facilities for the distribution of the active ingredient as are necessary to prevent the deterioration of the active ingredient while it is in the person’s ownership, possession or control; and
the supply of the active ingredient is in accordance with any terms and conditions that the Authority may specify in the manufacturer’s licence.
Subregulation 2
A person may, without a wholesaler’s licence, supply by wholesale any active ingredient if —
the person holds an importer’s licence;
the person imported the active ingredient solely for the purpose of export; and
the supply of the active ingredient is in accordance with any terms and conditions that the Authority may specify in the importer’s licence.
Subregulation 3
A person may, without a wholesaler’s licence, supply by wholesale any active ingredient if the active ingredient is intended for use in, or for the purpose of carrying out, the manufacture of a relevant health product that —
is solely for a non‑clinical purpose; and
is not for any supply to the public.
Subregulation 4
A person may, without a wholesaler’s licence, supply by wholesale any active ingredient if the active ingredient —
is supplied for any purpose other than in the manufacture of a product for use on or by humans; or
subject to paragraph (5), is supplied 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).
Subregulation 5
In addition to paragraph (4)(b), if the active ingredient is supplied solely for use in the manufacture of a relevant health product in Singapore by the same person manufacturing the active ingredient that is intended to be used only in clinical research conducted in Singapore, the person must, before supplying the active ingredient, give the Authority notice of the supply in the form and manner, and within the time, specified on the Authority’s website.