Ensuring data privacy in Article 57 database


The European Medicines Agency recommends that the contact email addresses for Pharmacovigilance enquiries in the individual product entries in the Article 57 database (xEVMPD) do not contain personal data, but only a functional and operating email address. The MAHs will have until 04 June 2018 to update their product entities in the xEVMPD database to ensure that the pharmacovigilance enquiry email address does not contain personal information.

Do you need help with current pharmacovigilance requirements? Medfiles Pharmacovigilance team is happy to help you!

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