GMP News - Counterfeit Medicines

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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26.02.19

US Track and Trace System

The FDA launched the development of an enhanced electronic, interoperable U.S. track-and-trace system for industry set to go into effect in 2023.

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20.02.19

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.

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13.02.19

Safety Features: Handling of Alerts

The safety feature provisions enetered into force - How to report a falsified pack?

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30.01.19

Counterfeit Protection: 13th Version of Questions & Answers Paper published

The European Commission has published version 13 of  the Questions & Answers document regarding the implementation of the rule on safety features for medicinal products for human use.

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23.01.19

New WHO Guideline on Testing of Counterfeit Medicines

The World Health Organization (WHO) has published a new guideline describing the procedure for testing supposedly counterfeit or suspect medicines.

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19.12.18

Safety Features: EU Commission issues Version 12 of Q&As

The European Commission has reviewed their list of questions and answers regarding safety features and issued it as version 12. Find out what changed in the Q&As on safety features.

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10.10.18

Version 11 of EU Q&As on Safety Features: Specific Questions on Stickers

The European Commission released version 11 of the questions and answers catalogue on safety features in September 2018. It also addresses the placing of safety features by means of stickers in detail. Get more information about safety features in the revised Q&A document of the EU.

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