by In2Pharma | Aug 10, 2020 | News
Europe In 2018, nitrosamine impurities, including N-nitrosodimethylamine (NDMA), were found in blood pressure medicines known as ‘sartans’. This led to some product recalls and strict new manufacturing requirements for sartans, based on a regulatory...
by In2Pharma | Jun 11, 2020 | News
Europe Marketing authorisation holders (MAHs) are asked to take precautionary measures to mitigate the risk of nitrosamine formation or presence during the manufacture of all medicines containing chemically synthesised active substances. The MAHs were obliged to...
by In2Pharma | Jun 11, 2020 | News
Belgium According to the financing law of FAMHP, a declaration of the number of packages of medicines sold on the Belgian market must be submitted annually to define the yearly contributions. Up to now, every marketing authorization holder and wholesaler of medicines...