Modern Manufacturing Practices

The Falsified Medicines Directive is legislation passed by the European Union Parliament, which aims to increase the security of the manufacturing and delivery of prescription medicines across Europe and protect patients and prevent falsified medicines from entering the supply chain.

Having come into force in February 2019, the new regulations require manufacturers to place safety features on all prescription medicines marketed in the European Union, and contribute financially to the establishment of an IT verification system that allows the assessment of the authenticity of a medicine at the time of supply to the patient.

Under the Directive, all new packs of prescription medicines placed on the market in Europe have to bear two safety features: a unique identifier (UI) in the form of a 2D data matrix (barcode) and an anti-tamper device (ATD).


The HK Pharma team have worked closely with their Swiss manufacturing partner to ensure that their products comply fully with the requirements and timings of the Directive and continue to be reliably supplied to the wholesale distribution network in the UK – despite the concurrent uncertainties surrounding BREXIT.

The HK values of Integrity, Partnership, and Reliability help to ensure that the Company is continually focused on reliably delivering a growing number of high quality products which make a difference to patients’ lives, but at responsible prices which can help to save valuable resources for Health Services around the world.


The HK Pharma team are constantly liaising with healthcare decision-makers to try and better understand current prescribing challenges, with a view to sourcing and delivering solutions which provide better value in the UK and internationally.

Please use the Contact Us page if you would like any further information relating to this news item or would like a member of the team to get in touch.

Further information regarding the Directive, and its implementation, can be found on the ABPI website

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