§314.80 or any other applicable C.F.R., the keeping of records of serious adverse events or adverse drug experiments required by applicable legislation and REMS requirements. Mikah is responsible for responding to all adverse event reports received by health and/or health professionals who comply with a product. Prior to the first commercial sale of a product, the Parties enter into a Pharmacovigilance Agreement in which pharmacovigilance responsibilities are assigned in accordance with this Section (the „Pharmacovigilance Agreement“). Mikah shall ensure that a pharmacovigilance infrastructure is in place to fulfil its obligations under this Agreement and the Pharmacovigilance Agreement. All costs out of pocket shall be shared equally by the Contracting Parties. 5.6 Verification of records . . .
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