Skip To The Main Content
Parenteral Drug Association Connecting People, Science and Regulation ®

Regulatory News

PDA's Regulatory News is a source of pertinent news from all over the globe. This section is set up by distinct parts of the world so you can read what is crucial to you and your company.

Counterfeit Enters German Drug Supply Chain

Jul 5, 2017, 23:12 PM
News Source Link:
http://www.bfarm.de/SharedDocs/Pressemitteilungen/DE/2017/pm9-2017.html
RegulatoryNewsDate:
Jul 5, 2017, 16:43 PM

According to a June press release from the German Federal Institute for Drugs and Medical Devices, a batch of hepatitis C drug, Harvoni®, has entered the German drug supply chain. A patient notified authorities of a difference in the color of the product. Gilead Sciences, the manufacturer, recalled the batch; analysis showed that the product had been repackaging and relabeled.

Counterfeit Harvoni® batches have also been discovered in Israel, Japan and Switzerland over the past 18 months. The Federal Institute for Drugs and Medical Devices is working with EMA and other regulatory agencies to determine if other European markets have been affected.

regulatory-news-regions:
  • Europe