New Version of the Q&As on Safety Features for Track & Trace
The European Commission has published Version 18b of the "Questions & Answers" on safety features. In particular the update took into account the new ISO standard for Packaging Tamper verification features.
GDP-Non-Compliance-Report for German Wholesale Distributor
The Competent Authority of Germany (Bezirksregierung Düsseldorf) has entered a new GPD Non-Compliance Report dated into the EudraGMDP database due to serious GDP violations at a German wholesaler. The case involves trading of falsified medicinal products and storage of expired medicinal products in regular stock. Furthermore, there are doubts on the reliability of the Reponsible Person and the CEO due to an ongoing criminal procedure.
Track & Trace: Amendment of the Delegated Regulation on Safety Features
On 17 March 2021, the Delegated Regulation (EU) 2021/457 was published in the Official Journal of the European Union. It amends the Delegated Regulation 2016/161 regarding an exemption from the obligation for wholesalers to decommission the unique identifier (UI) of medicinal products exported to the UK.
Track & Trace: Do Medicinal Products have to be Decommissioned when Distributed to the UK?
Due to the Brexit, the question arises whether medicinal products have to be decommissioned in advance when distributed to the UK. Now, the European Commission has decided on a transition period for decommission with regard to exports to the UK.
FDA Guidance for Industry concerning Wholesale Distributor Verification Requirement for Saleable Returned Drug Products published
The U.S. Food and Drug Administration (FDA) has published the final guidance for industry entitled "Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies".
Swissmedic publishes Information concerning an official Warning from Brazil regarding Falsified Medicinal Product
The Swissmedic has been informed by the Brazilian Health Regulatory Agency ANVISA that Brazil has suspended all imports of medicinal products from three Turkish wholesalers. In this regard, an information for Swiss companies was published.
When complying with the requirements of the Anti-Counterfeiting Directive, the status message "recall" for recalled batches is of great relevance for the entire supply chain. What has to be considered here?
Fraud in the Supply Chain: Beware of false Offers during Corona Crises
During the current Sars-CoV-2 outbreak, there are sometimes delivery problems with medicines, medical devices and protective equipment. Unfortunately, this also brings up many fraudsters, as a case revealed by Interpol shows.