The 10-year period after the marketing authorisation of an orphan medicine when similar medicines for the same indication cannot be placed on the market.
The 10-year period after the marketing authorisation of an orphan medicine when similar medicines for the same indication cannot be placed on the market.
In accordance with Article 8(3) of Directive 2001/83/EC, as amended, the evaluation of the potential…
View definitionA set of guidelines for the conduct of pharmacovigilance in the EU, drawn up based…
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