EMA Procedural Advice for Users of the Centralized Procedure

On 13 January 2021 the EMA updated 3 guidance on pre-/post-authorization procedural advice for users of the centralized procedure or for generic/hybrid applications.

These documents address a number of questions which users of the Centralized Procedure may have. It provides an overview of the EMA position on issues, which are typically addressed during the course of Pre-Submission Meetings.

The Agency emphasizes the importance of Pre-Submission Meetings with applicants. Pre-Submission Meetings (which should take place approximately 7 months prior to the anticipated date of submission of the application) are a vital opportunity for applicants to obtain procedural, regulatory and legal advice from the EMA. The product team is available to address any questions MAHs may have regarding their pre-/post-authorization or for generic/hybrid applications.

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