Singapore legislation

Regulation 14

of Health Products (Active Ingredients) Regulations 2023

Regulation 14

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 of a wholesaler’s licence for an active ingredient are that —

(a)

the applicant for the licence is able to provide and maintain, or ensure the provision and maintenance of, the staff, premises, equipment and facilities that are necessary for the proper handling, storage and distribution of the active ingredient to prevent the deterioration of the active ingredient while it is in the applicant’s ownership, possession or control; and

(b)

the applicant for the licence is able to comply with the requirements in the relevant Good Distribution Practice standard.