Medipha Santé supports you in:

• Strategy

• Compliance with the requirements for each type of variation

• Preparation of supporting documents

• Submitting variations according to the appropriate procedure

• Renewals

• Pharmacovigilance (Medipha Santé can provide the function of “local QPPV”)

• Management of the expiry of marketing authorizations (sunset clause)

• Literature Watch

• Regulatory monitoring

• Implementation of a Safety Data Exchange Agreement (SDEA)

• Maintaining the local PSMF

• Maintenance of opening authorizations, GDP certificate

 

 

In accordance with Article L.5121-1-3 of the Public Health Code, please see below for the list of active ingredients of medicines for which Medipha Santé is the holder and/or operator.