Singapore legislation
Regulation 4
Regulation 4
Requirements for issue of manufacturer’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 manufacturer’s licence for a therapeutic product are that —
the applicant is able to provide and maintain, or ensure the provision and maintenance of, such staff, premises, equipment and facilities as are necessary for carrying out the stages of the manufacture of the therapeutic product to be authorised by the licence;
the applicant is able to provide and maintain, or ensure the provision and maintenance of, such staff, premises, equipment and facilities for the handling and storage 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;
the applicant is able to conduct all manufacturing operations in such a way as to ensure that the therapeutic product is of the correct identity and conforms with the applicable standards of strength, quality and purity for that therapeutic product; and
the applicant is able to comply with the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co‑operation Scheme Guide to Good Manufacturing Practice for Medicinal Products in relation to the manufacture of the therapeutic product.