EU generic drugmakers launch code of conduct on MAA slots

The European Generic medicines Association (EGA) says it has officially launched a code of conduct on slot booking for Marketing Authorization Applications (MAA) with the European Medicines Agency as the generic medicines industry’s contribution to the process of improving the functioning of the European Union regulatory system.

Launching the code of conduct at the Coordination Group for Mutual Recognition and Decentralized Products - human (CMDh) meeting this week, Beata Stepniewska, regulatory affairs director at the EGA, highlighted that although the cancellation of MMA slots is not only caused by EGA member companies, they recognize the importance of the proper functioning of the MAA process and commit themselves to adhering to a common policy regarding slot booking.

EGA members will endeavor to avoid any activity which has a negative impact on the resources of the Competent Authorities and commit to: