Singapore legislation
Section 12
Section 12
Factors relevant to determination of application for licence
(1)
Subject to the following provisions of this Part, in dealing with an application for a product licence the licensing authority must in particular take into consideration —
the safety of medicinal products of each description to which the application relates;
the efficacy of medicinal products of each such description for the purposes for which the products are proposed to be administered;
the quality of medicinal products of each such description, according to the specification and the method or proposed method of manufacture of the products, and the provisions proposed for securing that the products as sold or supplied will be of that quality; and
whether the grant of a product licence for the medicinal products to which the application relates will be in the public interest.
(2)
Where any such application indicates that the purposes for which the licence is required relate (wholly or partly) to medicinal products which have been or are to be imported, then in dealing with the application, insofar as it relates to those products, the licensing authority must also take into consideration in particular the methods, standards and conditions of manufacture of those products and may, if the licencing authority thinks fit, require the production by the applicant of any one or more of the following:
an undertaking, given by the manufacturer of any such products, to permit the premises where they are or are to be manufactured, and the operations carried on or to be carried on in the course of manufacturing them, to be inspected by or on behalf of the licensing authority;
an undertaking, given by or on behalf of the manufacturer of any such products, to comply with any prescribed conditions or any conditions attached to the licence by the licensing authority;
a declaration, given by or on behalf of the manufacturer of any such products, that, in relation to the manufacture of those products, any requirements imposed by or under the law of the country in which they are or are to be manufactured have been or will be complied with.
(3)
In dealing with an application for a manufacturer’s licence the licensing authority must in particular take into consideration —
the operations proposed to be carried out pursuant to the licence;
the premises in which those operations are to be carried out;
the equipment which is or will be available on those premises for carrying out those operations;
the qualifications of the persons under whose supervision those operations will be carried out; and
the arrangements made or to be made for securing the safekeeping of, and the maintenance of adequate records in respect of, medicinal products manufactured or assembled pursuant to the licence.
(4)
In dealing with an application for a wholesale dealer’s licence the licensing authority must in particular take into consideration —
the premises in which medicinal products of the descriptions to which the application relates will be stored;
the equipment which is or will be available for storing medicinal products in those premises;
the equipment and facilities which are or will be available for distributing medicinal products from those premises; and
the arrangements made or to be made for securing the safekeeping of, and the maintenance of adequate records in respect of, medicinal products stored in or distributed from those premises.