GMP News - Counterfeit Medicines


New Case of Counterfeits Suspected at German Company

Again, the company Orifarm must recall batches because of suspicion of falsification. The company located in Leverkusen, Germany has received information from the Greek Competent Authority according to which falsified blisters emerged. Read more about the current case of counterfeits.



Stakeholder Workshop from 26 February 2016

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.



EMA's Provisions regarding the Implementation of the Counterfeit Directive

The date for the implementation of the safety features is now mandatory through the EU Delegated Regulation:  February, 9th 2019. This new requirement will also have direct impact on the marketing authorisation of medicinal products. For this, the EMA has published an implementation plan for the introduction of the safety features.  Read more about EMA's new provisions.



Court Judgement: A Medical Product can not be Marketed Anymore if it has Left the Legal Supply Chain

The distribution channel and the storage of medicinal products have been strictly regulated since the introduction of the new EU Good Distribution Practice Guideline (EU GDP Guideline). Now, a German Court has decided a case in which a medicinal product had seemingly the quality required but had left the legal supply chain temporarily. Read more about the court judgement and the consequences for the GDP environment.



Important Publication of the Delegated Regulation complementing the Anti-Counterfeiting Regulation

The European Commission has published the Delegated Regulation of the Commission to complement the anti-counterfeiting regulation. This regulation defines the future technological and organisational requirements with regard to safety features. It is important that the date for the implementation is imperative: the 9 February 2019. Find out more about the "Delegated Regulation of the EU Commission".



Counterfeit Medicines - A current Case shows that also medium-sized Companies are affected

The issue of counterfeit medicines is often played down as it only affects the expensive blockbuster products anyway - mostly just products of the large pharmaceutical manufacturers. However, this is just as much a misconception as the belief that the products only show up in the internet trade and cannot be sold in the legal supply chain. Read more about a current counterfeit case affecting the company Desitin.



MHRA informs about huge Counterfeit Case

The Medicines and Healthcare Products Regulatory Agency (MHRA) has published a press release about a huge counterfeit case. Read more about the operation Pangea VIII.



India's Track&Trace System for the Export of Medicinal Products

On 1 April the Indian Ministry of Commerce and Industry has supplemented a paragraph that substantiates the actual requirements and the timeline for the implementation of the Track and Trace system for the export of medicinal products. Read more about the Indian Track&Trace System.



Two more Cases of Counterfeiting in the legal Supply Chain

Just recently we reported about the counterfeited HIV drug Viread (Tenofovir) from Gilead and how the counterfeited Viread packs had penetrated into the legal supply chain. At that time a parallel importer had detected the deviations and could therefore stop the further distribution. Now, promptly another two cases came up. Read more about the counterfeiting of the drug Humira.



Counterfeiting in Reimport of Viread in the legal Supply Chain

Counterfeit medicines in the legal supply chain are increasingly becoming a problem. Experts are sure that counterfeiters will try more and more to sell fake medicines not only via the Internet, but through "infiltrating" them into the legal supply chain - meaning pharmaceutical wholesalers and pharmacies. Another case became known now. Read more in the news about the counterfeit drugs in the legal supply chain.



EU vs US: what are the new Track and Trace Requirements?

Currently, drug supply chain traceability and verification systems are implemented in the EU and the US. Unfortunately the approaches are slightly different. Read more.



Product Tracing in the USA

With the Drug Supply Chain Security Act (DSCSA) and the related implementation plan over a ten year period dated from 2013 new requirements were defined in the USA which are to improve the traceability of prescription drugs within the supply chain. Now the start has been postponed by means of an FDA Guideline that was released already in December 2014. Read more.



New USP Proposals on "Supply Chain Integrity"

In a publication in the Pharmacopeial Forum, the USP describes the future USP chapters planned for Good Distribution Practices (GDP). The new Chapter <1083.4> focuses on the supply chain integrity and security. More information can be found here in the News.



EU's Counterfeits Directive - Current Information of the EU Commission regarding the Implementation of Safety Features

Further information has now been released about EU Commission's delegated acts on the Counterfeit Directive after a workshop involving stakeholders took place on 28 April 2014. Read more here about the recommendations made for the implementation of future safety features.



Integrity and Security of Medicinal Products Supply Chains - New Instructions in the US-American Pharmacopeia (USP)

The revision of the General Chapters on Good Distribution Practices (GDP) has highlighted in a new USP chapter the safety and integrity of the supply chains for starting materials and medicinal products. More information can be found in the News.


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