7 April, 2013
On 22 January 2013, the PRC Ministry of Health issued the revised Good Supply Practice for Pharmaceutical Distribution (“Revised GSP”), which will take effect 1 June 2013.
In replacing the current GSP (“2000 GSP”), the Revised GSP provides stricter requirements for:
– Warehousing Facilities (climate control and stock control systems);
– Employee Qualifications (the company officers responsible for quality
control, and retail operations, must be PRC-qualified pharmacists);
– Document Retention; and
– Pharmaceutical Quality Control.
The 2000 GSP will be “grand-fathered” for those PRC enterprises holding current GSP licenses, up to but not beyond renewal of current GSP or pharmaceutical trading licenses.
Homegrown Regulatory & Compliance Law Firms in China