GMP News - Counterfeit Medicines

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The FDA has published a draft guidance which is to standardise the data traceability of products.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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02.05.18

Version 9 of the EU Q&As on Safety Features published

Safety features, which will be mandatory in the future to put the Falsified Medicines Directive into practice, must be implemented by 9 February, 2019. The European Commission has published version 9 of their questions and answers on safety features in February 2018. Find more information on the EU's revised Q&A document on safety features.

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25.04.18

USA: when is a product suspicious, when is it illegitimate?

A new FDA guideline is supposed to help the industry in identifying suspicious or illegitimate products. All trade partners are asked to initiate specific actions if such products turn up. Find out more about the FDA instructions in suspicious and illegitimate products.

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29.11.17

Track & Trace: New Questions and Answers published by the EU

The next version 8.0 of the catalogue containing questions and answers on practical implementation and technical aspects of serialisation requirements as per delegated act EU 2016/161 has become available on 22 November. Find more information about version 8.0 of the Q&A on EU FMD DR regarding serialisation.

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22.11.17

USA: Track & Trace Realisation Postponed by a Year

In June, the FDA reported that the enforcement of requirements for the safety of supply chains will be postponed by a year. The new date is now November 27, 2018. Find out more about the change of the date in the FD&C Act.

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08.11.17

Positive Balance for Implementation of the Falsified Medicines Directive

The soon-to-be required safety features for the realisation of the Falsified Medicines Directive must be implemented by February 09, 2019. The German initiative securPharm strikes a positive mid-term balance. Read more on the securPharm press release.

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23.08.17

New questions and answers about safety features - Version 7 of the EU Q&As published

The soon-to-be mandatory safety features for the implementation of the Falsified Medicines Directive have to be implemented by February 9th, 2019. The European Commission has published Version 7 of the questions and answers about safety features in June 2017. Find out more about the revised Q&A document of the EU about safety features.

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19.07.17

EMA's updated Implementation Plan for the Introduction of Safety Features

The soon-to-be required safety features for the execution of the Falsified Medicines Directive have to be implemented by February 9th, 2019. The EMA has published an updated plan for the implementation of safety features on the packaging of centrally authorized products for human use. Read more about the EMA's implementation plan for safety features.

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