Singapore legislation

Regulation 18

of Health Products (Therapeutic Products) Regulations 2016

Regulation 18

Requirements for issue of wholesaler’s licence

For the purposes of section 24(2)(a)(i) of the Act, the requirements that must be satisfied for the issue, to an applicant, of a wholesaler’s licence for a therapeutic product are that —

(a)

the applicant is able to provide and maintain, or ensure the provision and maintenance of, such staff, premises, equipment and facilities for the handling, storage and distribution of the therapeutic product as are necessary to prevent the deterioration of the therapeutic product while it is in the applicant’s ownership, possession or control; and

(b)

the applicant is able to comply with the Authority’s Guidance Notes on Good Distribution Practice for wholesalers set out on the Authority’s website.