04/02/2019 (Agence Europe) – The schedule of interinstitutional negotiations in the EU on the export of generic medicines is being clarified, now that the European Parliament and the Council have adopted their respective positions (see EUROPE 12174, 12178). According to our information, a first meeting is scheduled for 7 February and a second meeting for 14 February. The Romanian Presidency hopes to reach an agreement on this draft regulation, presented in May 2018, which aims to address the competitive disadvantage faced by EU-based generic and/or biosimilars manufacturers compared to their non-EU counterparts. As a reminder, the main stumbling block is likely to be a new derogation introduced by MEPs to allow manufacturers to build up, during the last two years of validity of the certificate, a stock of generic medicines that can be directly marketed when it expires. (SPj)