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United BioSource Corporation (UBC)

phone +44 (0) 208.834.0100
email contact@ubc.com
web http://www.ubc.com/europe
email 26-28 Hammersmith Grove London, W6 7HA, United Kingdom

Pharmacovigilance and Risk Management Information in Centralised Applications in the EU

Getting a new medication approved for the EU market through the centralised procedure can be complex and needs expertise. The new EU pharmacovigilance legislation (Good Vigilance Practice, GVP) is now in effect and applicants need to be fully compliant. It is critical to have a thorough understanding of the regulatory process and requirements, and the expectations with regards to the pharmacovigilance system and the risk management plan. Ensuring consistency and an appropriate level of detail in the documentation submitted as part of the approval process will help prevent unnecessary delays.
Pharmacovigilance and Risk Management Information in Centralised Applications in the EU
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