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1 Oct 2014 A few days ago, the European Medicines Agency (EMA) finally adopted its policy on the proactive effective date for all other post-authorisation procedures. The Policy defined CCI as “Any information contained in the clinical reports These materials have been prepared for informational purposes.

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Chapter number, Chapter title, Date of release for public consultation Guideline on good pharmacovigilance practices (GVP): Module XVI Addendum I – Educational materials, (English only), adopted Guideline on good pharmacovigilance practices: Annex I - Definitions (Rev 3), (English only) . 1995-2016 EMA.

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