EGA member’s commitment regarding DCP slot booking launched at CMD(h) meeting
The European Generic medicines Association (EGA) officially launched the code of conduct on slot booking for Marketing Authorisation Applications (MAA) as the generic medicines industry’s contribution to the process of improving the functioning of the EU regulatory system.
Launching the code of conduct at the CMD(h) meeting, 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 recognise 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 endeavour to avoid any activity which has a negative impact on the resources of the Competent Authorities and commit to:
• informing the Authorities in advance about changes in their submission plans
• supporting an introduction of slot booking fees as partial compensation for blocked but unused resources of the Competent Authorities.
To avoid unnecessary pressure on the system and to eliminate practices which have an overall negative impact on use of resources, the EGA calls upon the Competent Authorities:
• to improve the visibility of available slots by the creation of a regularly updated Central Platform where all available slots in all MSs can be seen
• to allocate the slots no more than six months in advance and feedback to be given to the applicants within 2 weeks to avoid a sequential booking in another MS.
The system of booking slots to submit Marketing Authorisation Applications (MAA) has not been functioning correctly in the EU. The Heads of Medicines Agencies (HMA) and the Coordination Group for Mutual Recognition and Decentralised Procedures (CMD(h)) recently highlighted a large number of slot cancellations which has a disruptive effect on their resource planning and income. Due to the necessity to book the slots far in advance and the difficulties of predicting the exact moment of submission, some companies have been booking sequential slots in order to be in a position to submit the dossier whenever the development work is actually finished.
EGA members encourage all pharmaceutical companies operating in the EU to follow the commitment proposed by the EGA for the benefit of all partners involved in the MA process in the EU.
The EGA member’s commitment regarding DCP slot booking is available here.
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