GMP News - Counterfeit Medicines

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.

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.

In March the CMDh published a new Q&A document to provide further guidance on the implementation of the EU Falsified Medicines Directive. Please find more information about the "CMDh clarifications on questions received on the implementation of the Falsified Medicines Directive".

securPharm has released coding regulations by means of the Data Matrix Code. The document also addresses the automated identification of medicinal product packages in the pharmaceutical supply chain. In addition, requirements about clinic packs are also available. Read more about the securPharm regulations on the coding of medicinal products subject to mandatory verification.

In December 2016, the FDA published a guideline setting specific requirements on how trading partners can identify suspect products and inform the FDA about them. Read more information about FDA's current document "Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification" here in this News.

Counterfeit medicine is an increasing problem for public health and economy. This is no longer a problem of certain regions such as Asia and Africa. It has now also become an issue in the EU and US. The European Union Intellectual Property Office (EUIPO) published a press release on 29 September 2016 in which they state that fake medicines cost the EU pharmaceutical sector 10.2 billion Euro every year. Read more about the latest figures on counterfeit medicines

The Delegated Regulation of the EU has set the deadline for the implementation of the safety features which will be binding as of 9th February 2019. The European Commission has published the summary of a workshop to inform all stakeholders of the recent publication of this Delegated Regulation. Read more about the Workshop on the Delegated Act on Safety Features.