Marketing authorisations

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null My question is related to the submission of an answer package to a pending Type II variation application. Can the package be sent in the eCTD format?

My question is related to the submission of an answer package to a pending Type II variation application. Can the package be sent in the eCTD format?

The electronic service process can be started when the case involves a new marketing authorisation application, a variation application or the renewal of a marketing authorisation. However, the transfer to an electronic service process should not be made in the middle of a pending approval process (i.e. do not submit answers to questions in the eCTD format, if the related application has not been submitted in the eCTD format).

 

17 Nov 2015