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.
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.
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.
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.
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.
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.
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.
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.
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".
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.
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.