GMP News - Counterfeit Medicines

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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26.09.18

Version 10 of EU Q&As on Safety Features: Specific Questions on Bundle Packaging

The safety features required for the implementation of the Anti-Counterfeit Directive will have to be implemented by the 9th February 2019. The European Commission released version 10 of the questions and answers catalogue on safety features in July 2018. The specific question of bundle packaging has also been addressed. Get more information about bundle packaging in EU's Q&A document on the safety features.

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19.09.18

CMDh Clarifications on the Implementation of the Falsified Medicines Directive

In April 2018, the CMDh published a document to clarify questions which arose from the original Q&A document dated March 2017 on the implementation of the Falsified Medicines Directive. Read more about the document "CMDh clarifications on questions received on the implementation of the Falsified Medicines Directive".

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12.09.18

New Questions and Answers on Safety Features - EU Q&As Version 10 published!

The safety features required for the implementation of the Anti-Counterfeit Directive will have to be implemented by the 9th February 2019. The European Commission released version 10 of the questions and answers catalogue on safety features in July 2018. Get more details about the revised Q&A document of the EU on safety features.

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20.06.18

2D Matrix Codes: which countries are already connected to the European Hub?

There is not much time left until the safety features have to be implemented. These features are required to comply with the Falsified Medicines Directive, which will enter into force on 9 February, 2019. Meanwhile, a number of national data storage and retrieval systems have joined the EU Hub, as the European Medicines Verification Organisation (EMVO) reported.

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20.06.18

Product tracing - new FDA requirements

The FDA has published a draft guidance which is to standardise the data traceability of products. Find out how long traceability data for products need to be stored according to the new FDA guideline "Standardization of Data and Documentation Practices for Product Tracing".

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13.06.18

Falsified Medicines Directive - securPharm status report for 2018

There isn't much time left until the safety features required in the future will have to be implemented in order to comply with the Falsified Medicines Directive which will enter into force on 9 February, 2019. The German initiative securPharm has published a status report in this issue for the year 2018. Read more about the "securPharm Status report 2018".

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06.06.18

ICMRA recommendations on track & trace implementation

In October 2017, the ICMRA adopted recommendations on the implementation of Track and Trace (T&T) Systems to emphasise the importance of the complexity of these systems. This is relevant for regulatory authorities as well as for the pharmaceutical industry. Find out more about the ICMRA T&T recommendations.

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09.05.18

Protection from Falsification of Medicinal Products - only a few Months until Track & Trace Start!

In a securPharm press release, it is pointed out that the new protection system for pharmaceuticals will be launched on 9 February 2019. It is strongly recommended to join soon, since it may be a close call for individual manufacturers otherwise. Find out more about the securPharm press release.

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