Romania’s National Medicine Agency (ANM) on February 8 withdrew the institute’s license to market injectable medicines, including vaccines, as the institute was no longer in line with the EU good manufacturing practice regulations.
Following the agency’s decision, the institute has undertaken to carry out a series of works and verify its production lines for anti-tuberculosis and pandemic vaccines, until April 15. The agency assured it would issue a new license if the institute follows these steps closely.
The institute’s measures target a series of works on its water and air piping systems, its air, water and temperature devices, small infrastructure works, as well as checkups on its parameters for the two vaccine production lines.