European Falsified Medicines Directive
FMD Leading Software Solutions
Being FMD fully compliant has never been so easy
EasyFMD software solution for pharmaceutical wholesalers, hospitals, retail pharmacies and 3PLs reduces the regulatory and logistic burden of being Falsified Medicines Directive FMD (2011/62/EU) compliant making the process of recording the medicinal packs serial numbers fast and simple to allow you to achieve end-to-end traceability.
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Multiple languages available including English, German, Spanish, French, Italian, Polish, Greek and Bulgarian
Quick Pharm Solutions EasyFMD Aggregation Edition is an easy-to-use application that provides aggregation capabilities for wholesalers and manufacturers through the HSE Aggregation Hub.
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Find out what is inside a case or pallet by scanning the code on the outside, without having to open the case to get the serial number of each individual pack-level product.
NEW
e-Pil
Electronic Patient Leaflet Software
With e-Pil you can:
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Easy access to the Pil by pharmacists and patients
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Reduce costs and environmental impact
Global Medicine Aggregation Software
Our global aggregation software solution allows you to
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Scan all packs to aggregate
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Print unique QR Code and dispatch
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Scan unique QR Code at Goods in to download full shipment data
Serialisation Managed Service
Serialisation Managed Service solution for pharmaceutical manufacturers and Market Authorisation Holders
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Connectivity to EMVO
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Cost effective solution
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Save time
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FMD (2011/62/EU) compliant
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CMO integration
Staff Training Software
Quick Pharm Solutions Staff Training Software for the Pharmaceutical Industry – includes SOPs (standard operating procedures)
Staff Training Software for the Pharmaceutical Industry includes
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SOP Types
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SOPs and the associated training documents
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Job Specifications
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Staff Maintenance
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Accreditation
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Full audit history and reporting
What is FMD or Falsified Medicines Directive?
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This directive was introduced to stop falsified medicines or medicines that are disguised as authentic but may contain toxic ingredients or wrong dosages from entering the supply chain. The lack of quality and safety checks of these medicines pose a risk to the patients and a serious threat to global health.
The Falsified Medicines Directive (2011/62/EU) (amending Directive 2001/83/EC) or FMD introduced by the European Parliament Council was published on 1 July 2011 and applies since 2 January 2013. This directive sets measures to ensure that medicines are safe and strict rules to control its trade such as:
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Mandatory unique identifier in the form of a 2D data matrix (barcode) and anti-tampering device (ATD) on the outer packaging of the medicines
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A standardised EU-wide symbol to identify legal online pharmacies
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More rigorous rules on import of active pharmaceutical ingredients
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Reinforced requirements of record-keeping for wholesale distributors
How does FMD affect the management of medicines?
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Since the directive requires a unique identifier (UI), prescription only medicines must have a product code that identifies its name, common name, the pharmaceutical form, strength, pack size and type, a serial and batch number, expiration date and the national reimbursement number. The UI has to be printed on the pack as a barcode and also be readable by a human.
“Manufacturers will place the safety features on the packaging of prescription only medicines and upload the data into the European repository system prior to placing the product on the market. The 2D barcode will need to be scanned at various points in the supply chain to verify that it is an ‘authentic’ medicine,” the MHRA said.
And when a medicine is supplied to a patient, the unique identifier must be scanned from the FMD system, to prevent any duplication of a legitimate identifier for use on a falsified medicine, which will be checked against data in the national repository.
What’s the standalone app FMD solution for you?
EasyFMD software solution for pharmaceutical wholesalers, hospitals and retail pharmacies reduces the regulatory and logistic burden of being Falsified Medicines Directive FMD (2011/62/EU) compliant making the process of recording the medicinal packs serial numbers fast and simple to achieve an end-to-end traceability.
If you are:
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Individual community pharmacy
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Larger pharmacy chain
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Hospital
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Wholesaler
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Any other organisation
And are obliged to verify the authenticity of medicines and/or decommission packs via your National Medicines Verification System NMVS
If you are:
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Manufacturers
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parallel importers
And are required to integrate fully with the European Hub (EMVO).
What EasyFMD can do for you
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Easily allows you to connect to your National Medicines Verification System (NMVS) so you can meet your obligations arising from the Falsified Medicines Directive (2011/62/EU)
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You don’t need to upgrade your current dispensing system because EasyFMD is a standalone application
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You don’t need expensive hardware upgrades because the software will run on your existing PCs (running Windows 7 or greater).
What Direct Connect Manager can do for you
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Seamlessly upload Product Master Data
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Scan, verify and record serial numbers of all packs received at goods inwards
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Decommission recorded packs prior to repackaging
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Serialise packs and upload serial numbers
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Handle all relevant responses and alerts from the EMVO