March 10, 2022
The Centralised Procedure – Assessment Procedure
The Centralized Procedure – Assessment Procedure Accelerated Assessment If the product is considered to be of major public health interest and is innovative, the accelerated assessment may be requested under Article 14(9). A request for accelerated assessment should be submitted as early as possible, but this must be at least 10 days before the CHMP…
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March 9, 2022
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 centralised procedure is as follows: Regulation No 726/2004 Regulation No 726/2004 replaced Regulation No 2309/93 as of 20 April 200. However, only Title IV was implemented at this date. Other Titles were implemented on 20…
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February 28, 2022
Application Routes in the EU – National Procedures
Application Routes in the EU – National Procedures National Procedures In the European Union (EU), the application routes for obtaining marketing authorisation for medicinal products can be categorised into two main procedures: the centralised procedure and the national procedures. The centralised procedure is applicable for certain types of medicinal products, such as biotechnology-derived products, orphan…
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February 28, 2022
Application Routes in the EU
Application Routes in the EU Application Routes National systems are accessible only for items that are limited to the market of one Member State. To make a public application, the candidate presents the application for enlistment to the specialists of the Member State in which marketing is desired. Nearby prerequisites should be followed, e.g., installation…
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February 3, 2022
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 of the Rules Governing Medicinal Products in the European Union (Eudralex), which is known as the Notice to Applicants. The Notice to Applicants has no lawful power and gives the orchestrated perspective of the EU…
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February 2, 2022
The EU Marketing Authorisation Application
The Eu Marketing Authorization Application PART I – FORMAT AND CONTENT OF APPLICATIONS Since 1995, ICH has been striving to develop common agreed content and structure for the key data sections (SAFETY, QUALITY, and EFFICACY) of regulatory submissions for drug products, in order to reduce the workload and duplicated data gathering that was required to…
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January 25, 2022
Discharging Routine Duties and the QP Code of Practice
Discharging Routine Duties and the QP Code of Practice Assuming the QP were to choose to do this large number of things themselves on a one-by-one basis, it would be hard to deliver more than 5 to 10 batches each week. The QP has no other option except to assign some of these obligations to partners. In any…
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