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A generic marketing authorisation application rests on a single scientific bridge: proof that your product behaves in the body the way the reference product does.[…]

Almost every pharmaceutical company outsources something — a manufacturing step, analytical testing, storage, transport, calibration, a hosted computerised system. What no company can outsource is[…]

Greece’s low reference prices make it an attractive place to buy medicines and a difficult place to keep them. EOF’s response is a rolling export[…]

Between a European approval and a Greek reimbursement decision there is typically more than a year. Greece has a defined early access framework to bridge[…]

Entering the European market is not one establishment decision but several. Some roles must sit inside the EEA, some inside a specific Member State, some[…]

Almost every European country sets medicine prices partly by looking at what other European countries pay. That single fact turns a sequence of national pricing[…]

Greece is a full EU Member State with a mature regulatory authority, high pharmaceutical consumption and a price that travels well beyond its borders. It[…]

Pharmacovigilance inspections are not rare events to be prepared for once. Guidance expects marketing authorisation holders to be inspected at least once every four years,[…]

Greece does not pre-approve your promotional material — but it does require you to file it, it bans advertising reimbursed medicines to the public, and[…]

Labelling is the part of the dossier that companies leave until last and then discover cannot be rushed. User testing takes weeks and needs real[…]