The Safety Features Delegated Act is a key element of The Falsified Medicines Directive. It was formally adopted by the European Commission on the 2nd October 2015 and was published in the Official Journal of the European Commission on the 9th February 2016.[i]
In our previous blog, "Key Considerations when Planning a Warehouse", we looked at the various different areas that need to be considered when planning a warehouse.
As outlined in our blog “The Falsified Medicines Directive: New Logo for Online Pharmacies” one of the legislative measures of The Falsified Medicines Directive, detailed the requirement for a common, EU-wide logo to identify legal online pharmacies.¹
When it comes to trying to choose an ERP System vendor, there are so many different options and considerations, it is often difficult for businesses to know where to begin their search. Added to that, once a vendor is chosen, it is hard to establish whether all of the necessary requirements will be met, whether the project will be completed to budget and whether it will be completed on time.
The Falsified Medicines DirectiveThe recent EU legislation regarding Pharmaceutical Traceability, the Falsified Medicines Directive, came into force in January 2013. One of the legislative measures of this directive outlined the need for a common, EU-wide logo to identify legal online pharmacies.¹
Counterfeit and Falsified Pharmaceuticals
Counterfeit and falsified products, specifically counterfeit pharmaceuticals, are becoming an epidemic in industry today throughout the world. According to the United States Food and Drug Administration, it is estimated that counterfeits make up more than 10% of the global medicines market.[i] The World Health Organization (WHO) has also estimated that more than 50% of medication and pharmaceuticals purchased online are falsified.[ii]
Why is Product Traceability so important today?
Product Traceability has become an extremely prevalent issue in recent years, particularly in relation to the Pharmaceutical, Medical Devices, Dental, Cosmetic, Food and Tobacco industries.
According to the WHO (World Health Organization):"А counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging."[1]
As a field service professional, you may well have been the first of your friends to carry a mobile phone. Your company may have been early adopters of mobile and wireless technology. Today, children carry mobile phones and its hard to find companies who do not make use of smart phones, handheld computers, GPS or other technology to support field operations.
Traceability has always been a key issue in the Pharmaceutical Industry. However, recently its importance, and in particular the requirements for batch tracking, have increased immensely, and will continue to do so for a number of reasons.