by In2Pharma | Oct 27, 2023 | News
Belgium On 16 October, the Belgian federal agency for medicines and health products (FAMHP) has introduced a new application for the effective management of marketing authorisation and vigilance dossiers. Data Tracking System (DTS) will replace 4 MeSeA applications:...
by In2Pharma | Apr 9, 2019 | News
Belgium The FAMHP Vigilance department has found several encoding errors in the Article 57 database of the EMA. Some medicines licensed in Belgium appear two or three times in the database, in two or three national languages. As a result, they are registered multiple...
by In2Pharma | Mar 15, 2019 | News
Europe EMA launched a five-month pilot study to increase the correct submissions of initial marketing authorisations applications (MAAs). The pilot is a result of the 2016 EMA survey that showed validation issues occur in 90% of all initial applications. The pilot...
