RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

Regulatory Focus™ > News Articles > Consultation Opened on Impact of 'Black Symbol' on Industry

Consultation Opened on Impact of 'Black Symbol' on Industry

Posted 26 November 2012 | By Ansis Helmanis

The European Commission has opened a consultation on the time needed by companies to implement product packaging changes under the new EU pharmacovigilance law.

Under that legislation, companies are required to incorporate a black symbol on certain drug products subject to additional monitoring because of their specific safety profile.

The Commission is considering the need for phasing in the black symbol in the summary of product characteristics (SmPC) and the package leaflet of products.

The concept paper for public consultation invites stakeholders to comment on how much time a marketing authorization holder needs to adapt and print the updated product information (summary of product characteristics and patient leaflet. Comments must be submitted by 10 January 10 2013.

Read more:

Read all Breaking News from RegLink


© 2022 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.