The newly revised Good Supply Practice for Pharmaceutical Products (GSP) was adopted at the executive meeting of the Ministry of Health and will go into effect on June 13th, 2013. The revised rules establish higher standards for quality controls in drug distribution and supply chain management. Pharmaceutical companies will have a 3-year transition period before compliance becomes mandatory. After 2016, companies not in compliance will be banned from conducting their pharmaceutical distribution business.
The main contents of the new GSP are:
- It requires a comprehensive computer information system
- Companies will need to equip their warehouses with temperature and humidity auto-monitoring systems
- It requires standard documentation for the sale of all drugs and documentation to travel with all drug shipments
- It requires better quality assurance practices for all drug transportation providers
- It requires electronic drug monitoring systems and gives specific provisions on operation processes
- It requires that legal representatives or responsible persons for drug retailing companies be licensed pharmacists.
More detailed instructions on the transition, operating requirements and technical provisions will be issued separately as appendixes of the new GSP in the near future.