Regulatory Reform Could Elevate Value-Added Medicines To Their ‘Rightful Place’, Says Narayan

Medicines For Europe Says EU Should Foster Patients Access To VAMs

Medicines for Europe is calling on the EU to recognize value-added medicines as its own separate group in its pharmaceutical legislation.

Arun Narayan
Narayan has called for official recognition of value-added medicines in EU legislature • Source: Viatris

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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