Joint Statement of the EFPIA, GIRP and PGEU regarding Falsified Medicines

In a position paper issued in March 2011 the European Pharma Federation (EFPIA) and the umbrella organisation of pharmaceutical wholesalers in Europe (GIRP) together with the Pharmaceutical Group of the European Union (PGEU) agreed on the fact that more clarity is required on how best to use measures to provide better protection of the patients.

In this position paper, joint proposals were made that should be taken into account in the legal implementation, particularly through so-called delegated acts. In total, 10 core principles are described.

Safety features should be available and consist of a unique serial number placed on each pack together with packaging that would reveal if a pack has already been opened.

In concrete terms, companies that repack medicinal products are also addressed. In this case, the original serial number within the common database should be deleted and be replaced with a new serial number by the repackager. Of course, the original number and the new one should be associated in the database to ensure traceability of the product in the event of recalls or safety issues.

The situation at pharmacy level is also addressed. Verification should be instantaneous so that noticeable delays are avoided. It is expected from the systems to be developed to enable verification both at the time when a medicinal product enters pharmacy stock as well as at the point of dispensing to the patient.

The "Strategies against Falsified / Counterfeit Medicines" Conference will deal with discussions about the many activities engaged in the protection from counterfeit medicines. The active exchange between representatives from authorities, industry, universities and suppliers of products and systems to fight against falsified medicinal products will also be focused on during the conference. Find out more on the Website.

Please also see the position paper "Ten core Principles to protect Patients from Falsified Medicines".

Author:
Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)