Spring Intro 2023

30/03/2023

How ? Stability data

• EU/US data package (Zone II) may be accepted in some ROW Markets but also need to consider hotter/more humid countries • Zone III (30°C/35% RH) to Zone IVb (30°C/75% RH) stability data • Real time data often required to support the proposed shelf life • Typically 12 months real time data plus 6 months accelerated (3 batches of product)

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How ? Manufacturing sites

• Less flexibility in the supply chain for ROW • Some markets are only able to register 1 manufacturing site i.e. they cannot 'dual source‘ • 1 manufacturer site • 1 packaging site • Stability data is site specific • For some countries this requirement is applicable for all stages of manufacture e.g. Singapore, Thailand, Mexico, Middle East, China • For some countries multiple manufacturing sites may be registered, however a separate NDA submission is required for each manufacturing site e.g. China, Vietnam or Hong Kong • Manufacturing Source country also has a potential impact on the speed of availability of a CPP.

Top Tip: It is key to consider long term supply strategy and future site transfers

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