European Anti-Fraud Office warns against Fraudsters Offering COVID-19 Vaccines
The European Anti-Fraud Office (Office européen de lutte antifraude - OLAF) has warned governments from dubious offers to provide them with COVID-19 vaccines.
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.
Labelling and Packaging Flexibilities for Covid-19 Vaccines
To facilitate the rapid deployment of the vaccine the European Commission (EC) recently published a document regarding labelling and packaging flexibilities for COVID-19 vaccines.
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.
Version 17 of the Q&As on Safety Features for Track & Trace
The European Commission has published Version 17 of the "Questions & Answers regarding the implementation of the rule on safety features for medicinal products for human use".
COVID-19: Beware of falsified medicines from unregistered websites
The European Medicines Agency (EMA) is urging the general public not to buy medicines from unauthorized websites and other vendors aiming to exploit fears and concerns during the ongoing pandemic.
Falsified Medicines: MHRA publishes Class 4 FMD Medicines Information
The Medicines and Healthcare products Regulatory Agency (MHRA) is currently investigating an incident where several medicines appear to have left the legal supply chain.
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.
It has hardly worked out anywhere: the falsification protection project has not been properly adapted EU-wide and discontentment is spreading amongst pharmacists.