The new PV legislation that will come into effect from 2 July 2012 will bring about substantial change in most Regulatory/PV departments.
- MAHs to submit information to the EMA electronically on all medicinal products for human use authorised or registered in the European Union. And ensure this information is updated as it changes.
- MAHs are required to inform the Agency of any new or varied marketing authorisation granted in the EU as of 2 July 2012.
- 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.
- Post authorisation safety and efficacy studies.