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Post authorisation EU (Renewals-5 years and the infinite,exceptional…
Post authorisation EU
Renewals-5 years and the infinite,exceptional circumstance 5 years only and conditional annual
Addendums is anything changed to quality,non-clinical and clinical
Article 61(3) notifications-change to labelling not related to the Smpc-requires 30 days notification
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Urgent safety restriction-triggered by the MH,NCA or EMA in the event or to prevent a risk to human health,new emerging safety information concerning in particular the SmPC,therapeutic indications,posology,contraindications and warnings
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INN-international non-proprietary name,has to be sendt 4-6 months pre MAA to ensure no conflict
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Extensions-changes to active substance,changes of strength,pharmaceutical form and route of administration and additional dosage form
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