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.
The European Commission published version 15 of the Q&A´s on Safety features for medicinal products for human use. The new version includes a revision of the Q&A on safety features relating to IMPs.
The MHRA will be issuing a series of blog posts regarding the implementation of the FMD over the next few months. The first post looks at the robustness of incoming checks.
Track & Trace in Russia - One More Standard in Place?
The introduction of a Europe-wide serialization system (often simplified to "Track & Trace") has brought great challenges to pharmaceutical manufacturing companies. In addition, many countries outside Europe are preparing serialization systems. Internationally speaking, Russia is already very far advanced. Read more about the new requirements for Track&Trace in Russia.
Will it be necessary to transfer information about the unique identifier uploaded to the UK repository between 9 February 2019 and the Brexit date to another repository? EMA recently published the answer to this and other related questions.
Final FDA Guidance on Public Warning and Notification of Recalls
The FDA strengthens the process for issuing a public warning about a voluntary recall and for notification of recalls. Read more about FDA´s final guidance on Public Warning and Notification of Recalls.