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2011 Falsified Medicines Directive (FMD) presentations from ESM and EDQM on implementation

Presentations on the Falsified Medicines Directive.

The 2011 Falsified Medicines Directive requires EU Member States to implement systems to ensure the verification and authentification of medicines by 2017/18.

Two systems are currently in development to deliver this:
The European Stakeholder Model (a collaboration between EFPIA, PGEU, EAEPC and GIRP);
EDQM’s E-tact system

Community pharmacies are expected to conduct a bar code scan of the secondary package of medicines at the point of dispensing to check its authenticity.

Similar requirements are envisaged for hospital pharmacy, but it is still unclear WHEN in the process between delivery and administration that this might take place i.e. when the medicine arrives into the hospital pharmacy; when the medicine leaves the hospital pharmacy; or close to when the medicine is administered to the patient.

2013 GA discussion was inconclusive with an apparent resolution to simply permit each country to interpret the Directive as it believes appropriate.

The meeting provides an opportunity for EAHP Board Members to become better informed about the potential opportunities and threats from implementation of this Directive, and best next steps for EAHP to take in relation to the Directive.

The meeting also provides an opportunity for EAHP to inform the specification and project teams of EDQM and ESM about the key needs and working environment in hospital pharmacy.

Some opportunity also exists to promote bar coding to the single unit, with reference as well to care home/residential home use and potential patient scanning with smartphones.

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EAHP Forum

All the EAHP team is working on providing a Forum that can help connect all the members in Conversations and Groups to talk about important matters for the European Hospital Pharmacist.

The Forum will be accessible for all the EAHP members, you don’t have to create a new account to browse and participate.

Conversations and groups

The Conversations will be moderated by our team to provide documents and relevant topics for the community.

The Groups will connect all members that share a category. Members who work on the same assocation, on the same hospital, that have the same role, etc.

Stay tuned for the realase of the forum. Soon on EAHP.