Singapore legislation
Regulation 2
of Medicines (Licensing, Standard Provisions and Fees) Regulations
Regulation 2
Definitions
In these Regulations —“Authority’s website” means the Authority’s Internet website at http://www.hsa.gov.sg;“Chinese proprietary medicine” has the same meaning as in the Medicines (Traditional Medicines, Homoeopathic Medicines and other Substances) (Exemption) Order (O 6);“competent drug regulatory agency” means a national regulatory authority participating in the World Health Organization’s Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce, and listed as such on the World Health Organization’s website;“licensing authority” means the Chief Executive of the Authority;“major variation”, in relation to a medicinal product, means any change to the product specifications of the medicinal product that relate to any of the following:
the indications of the medicinal product;
the dosage recommendations of the medicinal product;
the patient groups for the medicinal product; (d)clinical trial information on the medicinal product;“psychotropic substance” has the same meaning as in the Medicines (Export Licence for Psychotropic Substances) Regulations (Rg 9);“reference drug regulatory agency” means a national regulatory authority, specified by the Authority on the Authority’s website, from whose regulatory decisions the Authority takes reference.
Definition
“Authority’s website” means the Authority’s Internet website at http://www.hsa.gov.sg;
Definition
“Chinese proprietary medicine” has the same meaning as in the Medicines (Traditional Medicines, Homoeopathic Medicines and other Substances) (Exemption) Order (O 6);
Definition
“competent drug regulatory agency” means a national regulatory authority participating in the World Health Organization’s Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce, and listed as such on the World Health Organization’s website;
Definition
“licensing authority” means the Chief Executive of the Authority;
Definition
“major variation”, in relation to a medicinal product, means any change to the product specifications of the medicinal product that relate to any of the following:
the indications of the medicinal product;
the dosage recommendations of the medicinal product;
the patient groups for the medicinal product; (d)clinical trial information on the medicinal product;
Definition
“psychotropic substance” has the same meaning as in the Medicines (Export Licence for Psychotropic Substances) Regulations (Rg 9);
Definition
“reference drug regulatory agency” means a national regulatory authority, specified by the Authority on the Authority’s website, from whose regulatory decisions the Authority takes reference.