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EU Legislative Reform: Pan-EU Launch Requirement Will ‘Take Two To Tango’

 
• By Francesca Bruce

Companies are already used to uncertainty and will be able to adapt to the new product launch requirement in the EU’s legislative overhaul for the pharmaceutical sector, according to a commission representative.

Member states and Industry must both work to ensure EU reform package is a success • Source: Shutterstock

Despite skepticism from the pharmaceutical industry, a proposal to require companies to launch new products in all 27 EU member states in return for two years’ extra data exclusivity can work if both member states and industry make the effort, companies were told at the TOPRA (The Organization for Professionals in Regulatory Affairs) Symposium in Lisbon, Portugal, on 23 October.

“This is a system that needs investment from industry… but also from member states to facilitate this. You know what, we are going to need two to tango to actually...

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