by In2Pharma | May 9, 2019 | News
Belgium On February 8, 2019, the Belgian Official Gazette published a Royal Decree amending both the Royal Decree of 14 December 2006 on medicinal products for human and veterinary use and the Royal Decree of 21 January 2009 concerning instructions for pharmacists....
by In2Pharma | May 8, 2019 | News
EU With the Mutual Recognition Agreement between Europe and the US, inspections are to be mutually recognised in the future. The FDA’s approval of the EU Member States proceeds successively. Two more countries have recently been approved: Bulgaria and Cyprus....
by In2Pharma | Apr 25, 2019 | News
Belgium A new approved law on the saving measures for 2019 will enter into force on 1 April 2019. It contains the legislative amendments necessary for the implementation of the various cost-cutting measures decided in the framework of the National Institute for Health...
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...
