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The Centralised Procedure – Assessment Procedure

The Centralized Procedure – Assessment Procedure Accelerated Assessment If the product is considered to be of major public health interest…

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Application Routes in the EU – The Centralized Procedure

Application Routes in the EU – The Centralized Procedure Legislation and Eligibility A current framework of legislation that details the…

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Application Routes in the EU – National Procedures

Application Routes in the EU – National Procedures In the European Union (EU), the application routes for obtaining marketing authorisation…

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Application Routes in the EU

Application Routes in the EU National systems are accessible only for items that are limited to the market of one…

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Structure and Content of an EU MAA

Structure and Content of an EU MAA The necessities related to MAAs in the EU are held inside Volume 2…

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The EU Marketing Authorisation Application

The Eu Marketing Authorization Application PART I – FORMAT AND CONTENT OF APPLICATIONS Since 1995, ICH has been striving to…

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