Brochure | June 29, 2015

European Union Pharmaceutical Legislation

Source: PRA Health Sciences

In July 2012, a series of pharmaceutical legislation became effective in the European Union (EU), which included new requirements for Marketing Authorization Holders (MAH).

90-Day Reporting
Electronic 90-day-reporting of all non-serious adverse reactions occurring in the EU will become mandatory once full functionality of the EudraVigilance database is implemented (some Member States require 90-day reporting already). This means that ongoing processing of non-serious reports must take place, and companies can no longer have a large backlog of cases waiting to be processed in the hope for some “down time” to clear this.