definiens: means all approvals authorizations, registrations, amendments and supplements thereto, granted by a Regulatory Author ity and which are necessary for the Commercializati on of a Product for one or more indications in a country or regulatory jurisdiction, which may include satisfa ction of all applicable regulatory and notification requirements, but which shall exclude any pricing and reimburse ment approvals . Regulatory Approval in the U.S. is in re spect of Section 6.2 constituted by final regulator y approval by the FDA of a New Drug Application in accordance wit h the U.S. FD&C Act and Regulatory Approval in the EU is in respect of Section 6.2 constituted by final r egulatory approval issued on the basis of a full an d complete dossier in accordance with Directive 2001/83 / EC of 6 November 2001 ( as amended ) on the Community code relating to medicinal products for human use