GMP News - Counterfeit Medicines


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.



Track and Trace: What to do with Recalls?

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?



Version 18 of the Q&As on Safety Features for Track & Trace

The European Commission has published the 18th version of the "Questions & Answers" on safety features.



Can the Application of Safety Features be outsourced?

Safety features may be applied by external manufacturers and suppliers. This has now been clarified in a Question and Answer document.



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.



Falsified Medicines: New EU Aide Memoire for GDP

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.



Track & Trace: Still ongoing issues

It has hardly worked out anywhere: the falsification protection project has not been properly adapted EU-wide and discontentment is spreading amongst pharmacists.


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