LONDON--(BUSINESS WIRE)--With the introduction of the Falsified Medicines Directive (FMD), the EU has become a world leader in the fight against the growing threat of falsified medicines reaching patients.
More ambitious in scope than any comparable safe medicines regulation, the FMD requires that a unique identifier code and tamper evident safety feature must be provided for nearly all prescription medicines available in the EU.
Importantly, failure to comply with the regulation will prohibit the supply of medicines into the market, placing a significant obligation on pharma companies.
Against this background, a special forum will help all those in the EU medicines supply chain understand their new responsibilities and the measures involved in ensuring patient safety.
The Access to Safe Medicines Europe Forum* (ASM Europe) 2016 will address the key challenges facing pharma manufacturers and distributors in adapting to the requirements of the FMD.
The FMD came into force on 2 January 2013 and is currently being implemented around Europe. More recently in October 2015, the EC’s Health Directorate published its new Regulation specifying the characteristics of the unique identifier code.
This device will enable the tracking of every medicine package in the EU. It becomes mandatory by 2019, but with the years passing very quickly, it is essential pharma companies start preparing now to ensure compliance.
In addition, the Regulation also sets out the requirements for the ‘repositories system’, a digital store to record the unique identifier codes and tracking data for every coded medicine.
The Access to Safe Medicines Europe 2016 event will bring together 150 high level speakers and professionals from pharmaceutical manufacturers and distributors, packaging companies, public health and regulatory bodies and specialist technology and service providers.
Event speakers will explain how to meet the requirements of the FMD, examine its shortcomings and what pharma companies should consider over and above its requirements. There will also be speakers from countries within and outside the EU explaining what they are already doing in medicines supply chain control and monitoring.
*The Access to Safe Medicines Europe event will take place on 19-20 January 2016 at the Sheraton Skyline, Heathrow, London. Details: www.accesstosafemedicines.com