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109 result(s) found, displaying 91 to 100
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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
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User guideDossier requirements for literature based submissions.
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User guideInformation on requirements of a systematic literature search
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User guideSteps to register a new fixed combination medicine.
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FormsSubmission dossier checklist for prescription medicines
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Medicine shortage alertsSupply constraints will continue until 31 January 2027.