HA NOI — Foreign pharmaceutical companies who register their drugs or pharmaceutical products will get licensces within 30 working days if files are legal and valid, says a new circular from the Ministry of Health.
The revised circular, No 47/2011/TT-BYT, has replaced Circular 17/2001/TT-BYT regulating licensing time within three months. It also repeals the conditions on a registered company's minimum sales.
Under the new regulation, within 30 days after the ministry gets proper documentation, it will consider and grant licences to enterprises.
Drug licences will be valid now for five years from the registration date, extended from two years. Companies that want to continue their business must renew their licence three months before it turns invalid, according to the circular.
For vaccine and biological product registration of foreign companies, the licensing time also has been reduced from three months to 30 working days, with the validity also increased from two to five years.
"The circular is one step forward in administrative reform in the health sector," said the ministry's Drug Administration director Truong Quoc Cuong.
Cuong added that the circular aimed to create a level playing field for foreign and local pharmaceutical companies in Viet Nam to boost drug, vaccine and biological product manufacturing and trading.
The health ministry statistics reveal that Viet Nam currently has more than 400 foreign pharmaceutical companies that control 50 per cent of the US$2billion pharmaceutical market. — VNS