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European Medicines Agency (EMA)
Article 16a

Article 16a

Variations shall be classified in different categories depending on the level of risk to public health and the potential impact on the quality, safety and efficacy of the medicinal product concerned. Those categories shall range from changes to the terms of the marketing authorisation that have the highest potential impact on the quality, safety or efficacy of the medicinal product, to changes that have no or minimal impact thereon.
The procedures for examination of applications for variations shall be proportionate to the risk and impact involved. Those procedures shall range from procedures that allow implementation only after approval based on a complete scientific assessment to procedures that allow immediate implementation and subsequent notification by the marketing authorisation holder to the Agency.

The Commission is empowered to adopt delegated acts in accordance with Article 87b in order to supplement this Regulation by:


specifying the categories in which variations shall be classified; and


establishing procedures for the examination of applications for variations to the terms of marketing authorisations.