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Collection content
114 result(s) found, displaying 91 to 100
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User guideThis user guide describes how to change sponsor details in the Product Information (PI) and labels for prescription medicines
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User guideA user guide on how to change sponsor details in PI and labels.
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FormsSponsors should note that the Bioequivalence Study Information Form (BSIF) has been amended
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User guideElectronic data interchange for ICSR submission using the E2B R2 format
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FormsChecklist to assist in a priority review designation application
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User guideThis is a step-by-step guide for agents and sponsors who wish to apply for Priority review, Provisional determination or Orphan drug designation of a prescription medicine.
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FormsUse these forms to request a meeting and to record agenda items and outcomes.
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FormsA revised CPD template for Biological medicines and vaccines is now available for sponsors
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User guideQuestions and answers for drafters/submitters