The transfer of marketing authorisations (MAs) from one legal entity to another is a common part of merger and acquisition activity within the pharmaceutical industry. While this is usually a fairly straightforward regulatory process it is often complicated by commercial and stock control issues. It is further complicated by the variety in the procedures to be followed market by market in terms of documentation, timescale for approval and implementation requirements. This article gives a flavour of how to handle projects of this nature, with some specific country examples to highlight the diversity of processes.

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