Information for Marketing Authorisation applicants
We kindly remind applicants, when preparing responses to requests related to national marketing authorisation procedures, to observe the following: please submit a summary of responses both in PDF format under Module 1 and in Word format (.docx) under the “Working document” folder of the eCTD sequence. The cover page should confirm that both versions are identical, when preparing the response document, applicants are encouraged to follow the recommendations provided in the guidance developed by the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), titled:...
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