GMP News - Counterfeit Medicines

28.10.20

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?

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07.10.20

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.

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19.08.20

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.

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29.04.20

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.

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22.04.20

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".

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30.03.20

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.

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30.03.20

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.

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17.02.20

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.

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02.10.19

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.

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11.09.19

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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07.08.19

Version 15 of the Q&As on Safety Features

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.

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24.07.19

Safety Features - how is it progressing?

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.

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17.07.19

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.

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08.05.19

Q&As on Safety Features - Version 14

The European Commission published version 14 of the Q&A´s on Safety features for medicinal products for human use.

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26.02.19

Brexit: Safety Features & Multi-Country Packs

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.

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