On March 29, 2013, The Ministry of Health issued in the Circular No10/2013/TT-BYT amending and supplementing a number of articles of Circular No02/2007/TT-BYT on conditions for drug business. In the circular, the “technology document” for applicants applying for a license in the drugs business will be the Good Practice Certificate. Applicants should submit the application for the so-called Good Practice Certificate together with an application for a license for drugs business, in case the Good Practice Certificate is not yet available. The Ministry of Health shall be the licensing authority in the case the practitioners are individuals working for foreign-owned enterprises. If foreign-owned enterprises have their business areas in manufacturing, testing, importing or maintaining drugs, the Provincial Department of Health shall be entitled by the Ministry of Health to grant certificates.
This circular shall take effect from May 14th, 2013.
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