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.
The European Commission has published an aide memoire for Good Distribution Practices (GDP) inspection of wholesalers’ compliance with Commission Delegated Regulation (EU) 2016/161 for safety features.
Track & Trace: EMVO stakeholders call for inspections
Seven months into the operational phase a significant number of manufacturers and supply chain actors have not yet connected to the EU verification system. Now, the EMVO stakeholders encourage the NCAs to undertake inspections on all supply chain actors.