Test your readiness for the new PV legislation

The new PV legislation that will come into force from the 2nd July 2012 will bring about substantial change in most Regulatory/Pharmacovigilance departments.

Regulatory Impact
•	MAHs to submit information to the EMA electronically on all medicinal products for human use authorised or registered in the European Union.
•	MAHs to ensure above information is updated as it changes.

Pharmacovigilance Impact
•	All serious ADRs to be reported to Eudravigilance within 15 days (including consumer reports) and non-serious within 90 days.
•	PV System Master file (PSMF) to replace the DDPS.
•	Regular internal audit of PV system with the main findings recorded in the PSMF.

These changes present a number of challenges to PV and related departments. To help you assess if your organisation is ready for them, PW have developed two questionnaires:

1. Quick Survey to Assess Readiness for the 2012 Legislation
The impact of the legislation is wider than just the PV or regulatory activities. The questions below help to identify areas of the business where more effort may be needed. Please complete the questions here and we will send you some information that may help to address your needs.

2. Survey to Rate your Status with Regards to the 2012 Legislation
This survey focuses on the detailed activities that need to be addressed as a result of the legislation. Please complete the questions here and we will send you some information that may help to address your needs.

Test your readiness for the new PV legislation The new PV legislation that will come into force from the 2nd July 2012 will bring about substantial change in most Regulatory/Pharmacovigilance departments.

Test your readiness for the new PV legislation

The new PV legislation that will come into force from the 2nd July 2012 will bring about substantial change in most Regulatory/Pharmacovigilance departments.