GMP News - Counterfeit Medicines

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.

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.

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.

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.

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.

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.