The compliance deadline is fast approaching for the pan European Falsified Medicines Directive (FMD) 2011/62/EU.
The deadline date for compliance is 9th February 2019 and the objective of the FMD directive is to protect patients from falsified medicines within the legal authorised distribution and supply chain for prescription only medicines (POM’s) and certain over the counter (OTC) medicines.
The supply chain for POM’s includes pharmaceutical manufacturers, marketing authorization holders (MAH’s), wholesale distributors and parallel distributors all supplying patients via dispensing chemists, pharmacies and other authorized sources such as hospitals, prisons and schools.
The objective of FMD compliance is to verify the authenticity of medicine products using a pan-European system that will identify medicines with a tamper evident label or seal that contains the following information:
- Product Code (GTIN)
- Batch Number
- Expiry Date
- Random unique number
- 2D Barcode
Thoroughout the whole supply chain, FMD compliance will be controlled by seamless integration into the National Medicines Verification System (NMVS), this is at a national country level, for example in the UK the NMVS will be operated by SecurMed, the NMVS is then connected to the European Medicines Verification System (EMVS) via the EU Hub.
Our particular expertise and scope of supply is clearly focused on supplying the POM supply chain with FMD compliant tamper evident label or seal solutions, label printers, scanners, verification systems and software that can be fully integrated into the NMVS.
We will assess your specify requirements and provide a solution that is suited to your unique FMD labelling requirements. During careful consultation we will work closely with you to recommend the most appropriate and cost effective solution.
Initially this will involve the choice of a tamper evident label or seal, we have a large range of FMD complaint label materials and adhesives. We will then move on to the selection of a suitable label printer, scanner or verifier, if required.
The choice of tamper evident label material will be dependent on your specific labelling requirements and will include consideration of your medicine pack or carton size, its shape and its material type, typically a gloss finish card is used for most pharmaceutical medicine packaging and it is important to select the correct type of label material and adhesive so we can achieve a tamper evident seal that is fully FMD compliant.
Once we have selected the most appropriate type of label material and adhesive we may then add additional levels of tamper evidence such as security slits and perforations.
After carefully selecting the tamper evident label or seal we can then ensure we supply a label printer, scanner or verifier that is suited to your particular requirements and this can be dependent on many various factors such as your daily label print volumes, label size, printer location, integration, interface and your packing and label application requirements, as your labels may need to be hand, semi or fully automatically applied.
To discuss your specific FMD labelling requirements please call one of our FMD solutions team now on 0800 085 8850 or email email@example.com