Off-patent industry trade group Medicines for Europe is advocating for a defined place in the European pharmaceutical ecosystem for value-added medicines, giving them their own dedicated regulatory pathway and data exclusivity incentives.
This would be done through a new Article 10.7 of the EU Directive 2001/83/EC, which the organization has been recommending since last year. (Also see "Three Pillars Must Support Value Added Medicines In EU" - Generics Bulletin, 23 February, 2021
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