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Information required for early identification of a need for pre-authorisation GMP inspections

Applicants are requested to provide the following information on their application proposed for accelerated assessment, in order to allow for identification of a need for pre-authorisation Good Manufacturing Practices (GMP) inspection. The information provided should be complete and in line with the content of the application dossier that will be submitted.

Click on this link for more information.

#GoodManufacturingPractices

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