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The European Medicines Agency (EMA) issued its implementation guidance in March 2020. Journal of Pharmaceutical Sciences 109 (2020):1427–1438. Published March 2020. Published March 2020. December 2020. October 2020. Journal of Pharmaceutical Sciences (2021). doi:10.1016/j.xphs.2021.09.046. 2021.09.046.
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