EU Shifts To Centralized OTC Process At Member States’ Expense – GSK Exec
This article was originally published in The Tan Sheet
Europe's development of a centralized process for approving nonprescription pharmaceuticals is sapping the resources of the regulatory agencies of European Union member states, a GlaxoSmithKline regulatory executive says
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Central process will doubtless attract other switches, but countries will determine whether drug is still sold from pharmacies.
Europe's nonprescription drug industry wants to revamp European Union over-the-counter regulations and open market access by streamlining the product approval process, standardizing advertising rules and extending exclusivity protections
The European Medicines Agency's support for a marketing authorization for orlistat in Europe signals a key step in GlaxoSmithKline's plan to launch a nonprescription version of the weight-loss drug in that part of the world, the company says