RPS makes recommendations for user requirement specifications for FMD

20 Jul 2016
The European Falsified Medicines Directive (FMD) was finalised in January 2013 and adopted into UK law in February 2013, where it came into force in August 2013. The Delegated Act which finalised the details of the directive was finally introduced in October 2015. The RPS has been working on the Directive with all relevant stakeholders since 2011 to shape the legislation so that it best reflects the views of UK pharmacists. We have influenced at home and in Europe to ensure the Directive is fit for purpose in the UK. We have been successful in introducing many changes to the original proposals.
The Directive introduces measures which aim to prevent the entry of falsified medicines into the legal pharmaceutical supply chain and will introduce scanning of individual packs prior to dispensing. 
This consultation is from the body set up to create the UK database and seeks views on the principles that define the new system.
The RPS is striving to ensure there will be safeguards on pharmacy-generated prescribing data, which must not be available to manufacturers and this is re-iterated throughout our consultation response. The operation must also be minimally disruptive to routine workflow and not delay patient access to medicines.
The recent EU referendum vote does not change the UK's obligations and we will continue to work with the UK authorities in the longer term to further influence the practicalities in whatever way possible.
You can find details of our previous work and the RPS policy on FMD, which outlines the additional safety features for which we are calling.


For further information please contact [email protected] or [email protected]