Medicines Act 1975 · 2020 Revised Edition · Part 2 · Licences and Certificates Relating to Medicinal Products
5. General provisions as to dealing with medicinal products
Feedback & supportExcept in accordance with a licence granted for the purposes of this section (called in this Act a product licence) a person must not in circumstances to which this section applies —
sell, supply or export any medicinal product;
procure the sale, supply or export of any medicinal product; or
procure the manufacture or assembly of any medicinal product for sale, supply or export.
A person must not import any medicinal product except in accordance with a product licence or an import licence.
import
“import” means import into Singapore whether by land, sea or air and “export” has a corresponding meaning;
In relation to an imported medicinal product, this section applies to circumstances in which the person selling, supplying or exporting the medicinal product in question, or procuring the sale, supply or export or the manufacture or assembly for sale, supply or export of that product, has himself or herself imported the product or procured its import.
In relation to any medicinal product which has not been imported, this section applies to any circumstances in which the person selling, supplying or exporting the medicinal product in question, or procuring the sale, supply or export or the manufacture or assembly for sale, supply or export of that product, is responsible for the composition of the product.
manufacture
“manufacture”, in relation to a medicinal product, includes any process carried out in the course of making the product, but does not include dissolving or dispersing the product in, or diluting or mixing it with, some other substance used as a vehicle for the purpose of administering it;
For the purposes of subsection (4), a person is taken to be responsible for the composition of a medicinal product if —
composition
“composition”, in relation to a medicinal product, means the ingredients of which it consists and the proportions, and the degrees of strength, quality and purity, in which those ingredients are contained in it respectively;
the person procures the manufacture of the product to the person’s order by another person, where the order specifies, or incorporates by reference to some other document, particulars of the composition of the product ordered, whether those particulars amount to a complete specification or not; or
the person manufactures the product otherwise than pursuant to an order which fulfils the conditions specified in paragraph (a).