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Question: ArrayAfter the holder transfers the drug, does the original holder still need to keep records and data? If necessary, how long is the storage period
Answer: According to Article 115 of China's "Quality Management Standards for Pharmacovigilance", if a holder transfers a drug marketing license, they shall simultaneously transfer all relevant records and data of pharmacovigilance to ensure that they are not lost during the transfer process. There is no requirement on whether or how long the original holder will keep it. Therefore, in response to this situation, it is recommended that the holder clarify whether and for how long the process should be preserved, or that both parties sign an agreement to reach an agreement, so that there is evidence to follow in the future. In principle, the holder is the main body responsible for establishing and maintaining a drug vigilance system. If the drug marketing license is transferred, the original holder does not need to continue to assume this obligation and responsibility, unless otherwise explicitly agreed by both parties.