On March 16, 2023 the Court of Justice of the European Union (CJEU) rendered an important judgment[1] for the pharmaceutical industry as it brings some clarification on the test to assess if two products have the ‘same active substance’ and therefore belong to the same Global Marketing Authorisation (GMA). This is a crucial determination as products falling within the GMA of an existing product do not benefit from an independent period of regulatory data protection (RDP) and marketing protection.

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