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EU Extends Pilot On Splitting Mutual Recognition/Decentralized Procedures

Executive Summary

Drug companies in the EU are getting more time to experiment with splitting their mutual recognition and decentralized procedure licences to help with their marketing strategies.

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End Of Road For ‘Too Complex’ EU Pilot Program On Splitting Marketing Licenses

EU regulators have pulled the plug on a pilot program on splitting mutual recognition and decentralized procedure licences. Instead of promoting harmonization of marketing authorizations across the EU and helping companies with their marketing strategies, it has led to more problems.

End Of Road For ‘Too Complex’ EU Pilot On Splitting Marketing Licenses

EU regulators have pulled the plug on a pilot program on splitting mutual recognition and decentralized procedure licences. Instead of promoting harmonization of marketing authorizations across the EU and helping companies with their marketing strategies, it has led to more problems.

Pharma Taken By EU Pilot On Merging MRP/DCP Lines

Drug companies have shown a huge interest in part of an EU pilot project that allows them to merge licences under the mutual recognition and decentralized procedures to suit their business strategies1,2. Generic and OTC drug makers submitted over 60 applications for merging their MRP/DCP lines, of which 10 have been admitted in accordance with the maximum permissible limit of the pilot.

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