Regulatory Guidelines and Standards
For application of Controlled Drugs Manufacturing Licence (CDML), the applicant should be a pharmacist registered with the Singapore Pharmacy Council. Suitable persons should be appointed to oversee the production and QC activities, as well as the security of the CDs handled in the manufacturing premises.
Controlled Drugs (CD) are substances listed in the Misuse of Drugs Act and Regulations, and Psychotropic substances (PSY) are substances listed in the Medicines (Export Licence for Psychotropic Substances) Regulations.
The applicant should familiarise himself or herself with the following legislations:
The Misuse of Drugs Act
The Misuse of Drugs Regulations
Copies of these legislations are available at the following:
SNP Corporation Ltd (Legal Publishing)
1 Kim Seng Promenade #18-01/06
Great World City East Tower
Singapore 237994
Tel No.: 68269691
Email: lpcrsg@snpcorp.com
Website: http://www.snpcorp.com/webshop



