European Medicines Agency (EMA) Addresses Industry Concerns by Reducing the Mandatory Data Requirements for EVMPD

On January 30, 2012, representatives from EMA met with Life Sciences executives to addresses some of the challenges the industry is facing to comply with the new EVMPD electronic submission requirements that go into effect on July 2, 2012.

At the meeting EMA presented 3 different options for data-requirements.  All of the industry representatives present voted for Option 3.

With the approval of Option 3, EMA will not ask for the following mandatory data elements/set for medicinal products by July 2012:

• Additional Monitoring
• Location of the Pharmacovigilance System Master File
• Description of packaging information
• Regulated documents
  • Condition of marketing authorization
  • Labeling
  • Package Leaflet
• Structured Substance Information is now optional

SmPC is the only required document.

To help Life Sciences firms prepare for the new regulations EXTEDO has been running a series of webinars and seminars that provide details about the new EVPMD standard and strategies firms can employ to meet the compliance challenges.

If you need help preparing for the new electronic submission requirements please contact us.

You can access a copy of the January 30, 2012, EMA presentation <media 449 _blank>here</media>.

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