Delegated Regulation to the Falsified Medicines Directive (FMD) 2011/62/EU, published on February 9 2016, will come in to force by February 2019. The new regulation will require manufacturers to place safety features on all medicines and contribute financially to the establishment of an IT verification system that will allow the assessment of the authenticity of a medicine at the time of supply to the patient.
The Directive on the Falsified Medicines was legislation passed by the European Union Parliament, which aimed to increase the security of the manufacturing and delivery of medicines in Europe and provide protection to patients from falsified medicines in the legal supply chain of pharmaceuticals.
Now, pharmaceutical manufactures across Europe must begin to enact requirements of the published Delegated Regulation to the FMD in advance of the regulation coming in to force in 2019.
Below provides background on the 2011 Directive alongside an overview of what is required for the implementation of the Delegated Regulation (EU 2016/161) in the UK by 2019.
For more details, please contact Dr Rick Greville.