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SQA Regulatory Surveillance Summary 3 | Monthly Update 2021

SQA

Commission Extends Transparency and Authorization Mechanism for Exports of COVID-19 Vaccines, 11 March 2021. The EC has extended until the end of June 2021 the transparency and authorization mechanism for COVID-19 vaccine exports. The mechanism provides for authorizations of exports of COVID-19 vaccines outside the EU.

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SQA Regulatory Surveillance Summary | Monthly Update 2023 – January

SQA

Until EUDAMED is brought fully online, a series of performance study application/notification documents have been created to support performance study procedures with respect to the IVDR (see MDCG 2022-19). Additional details are provided with respect to the validity of certificates and “sell-off” periods.