GMP News - Counterfeit Medicines


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.



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.



Swissmedic specifies Requirements for RPs

The current edition of the Swissmedic Journal 05/2017 and the Technical Interpretation I-SMI.TI.17 specify the requirements with regard to the independence and the obligation of presence of the Swiss QP.



New CMDh Q&A Document on the Implementation of the EU Falsified Medicines Directive

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".



Pro Generika - New Shareholder in the securPharm Manufacturer Database

On 15 March 2017, a common press release was published to announce the joining of Pro Generika e.V. as shareholder in the ACS PharmaProtect GmbH (ACS). ACS was founded in 2012 with the aim of developing and operating the manufacturer database in Germany. Read more about the joining of Pro Generika e.V. in the ACS PharmaProtect GmbH.



Use of the Data Matrix Code - Which Regulations apply to Coding?

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.



Delegated Regulation on the Anti-Counterfeiting Directive - New EU Requirements and State of Implementation

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 has released version 5 of its Questions and Answers on safety features and the German initiative securPharm has just published the Status Report for 2017. Read more about the SecurPharm Status Report 2017 and about the EU's Q&A document on safety features.



New FDA Guidance: When is a Product considered "Suspect"?

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 Medicines in the Legal Supply Chain

The Drug Commission of German Pharmacists (AMK - Arzneimittelkommission) regularly informs about batch recalls - e.g. due to quality defects. Now, there have been more and more reports about batch recalls due to counterfeit medicines. According to a report of the German newspaper "Deutsche Apotheker Zeitung" edition 5/2017, the company axicorp Pharma is facing such a counterfeits case. Read more about it here.



Counterfeit of medicines causes 37,000 job losses in EU Pharma Industry

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



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".


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