The European Medicines Agency (EMA) is recommending that marketing authorisation holders submit any Type IAIN and Type IA variations for 2016 by the end of November. This will enable the agency to acknowledge the validity of the submissions before the agency’s closure during the Christmas and New Year period. The agency will be closed between 23 December 2016 and 2 January 2017.
Marketing authorisation holders are also advised to submit any Type IB variations or groupings of Type IB and Type IA variations for a start of procedure in 2016 by 13 December 2016. For submissions received on or after 14 December 2016, the procedure may not start until January 2017.
As ever, variations require careful planning and with the end of the year looming fast, companies need to consider not only internal priorities but also compliance regarding Type IA changes; Type IAIN variations must be notified to the EMA or national competent authority immediately following implementation. Whilst Type IA variations do not require immediate notification, they should be notified to the EMA or national competent authority usually within 12 months of implementation.
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