Art. 61.3 Procedure

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• CMDh Standard Operating Procedure for Article 61(3) changes to patient information and the notification for product information amendment under Article 61(3) (not accompanying a variation change) (October 2011) [Track version]

• Flowchart for the Article 61(3) procedure (July 2007)

• Notification Form (June 2024) [PDF] [Tracked​​​​​​​]