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Falsified Medicine Directive

Meet the EU requirements for all pharmacies to ensure medicines are safe and their trade is rigorously controlled

fmd

What is EU FMD? (1)

EU FMD stands for the European Union Falsified Medicines Directive.(2)

The EU FMD was introduced in February 2019 and all 150,000 community pharmacies across the EU are required to
implement it.

The directive introduces harmonised EU measures to fight medicine falsification, ensure medicines are safe, and that the trade in medicines is rigorously controlled.

These measures include:

  • New, compulsory safety features – including a unique identifier and an anti-tampering device –

    on the outer packaging of medicines

  • A common, EU-wide logo to identify legal online pharmacies

  • Tougher rules on the import of active pharmaceutical ingredients

  • Strengthened record-keeping requirements for wholesale distributors

What does EU FMD mean for pharmacists and dispensing doctors?

Under the Directive, all new packs of prescription medicines placed on the market in Europe will have to bear
two safety features:

  • Unique identifier (UI) in the form of a 2D data matrix (barcode)

  • Anti-tampering device (ATD)

Each pharmacy needs at least one barcode scanner, and potentially an extra workstation, to be able to ‘decommission’ medicines from the EMVS (The European Medicines Verification System).

In the decommissioning process, a medicine will need to be authenticated: have its UI scanned and verified against a UK safety database called the National Medicines Verification System, or NMVS, before it is handed to a patient).

This is so a pharmacist can verify it is a genuine medicine, and not a counterfeit.

How does FMD work?

Manufacturers upload valid UI codes to a relevant National Medicines Verification System (NMVS) so pharmacies can check the status of each pack during the dispensing process.

The system then notifies you about products known to have been recalled, withdrawn, stolen or tampered with.

A European Medicines Verification System (EMVS) acts as a hub, linking the national systems together and allowing parallel trading of medicines to continue.(3)

Image removed.

Pfizer Inc. Schematic based on DIRECTIVE 2011/62/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL**
*Represents EU markets NMVS

 

What steps do pharmacists and dispensing doctors need to take?

EU FMD is designed to have a profound impact on the pharmaceutical supply chain across Europe, and on the daily operations of retail and secondary care pharmacies, and dispensing doctors.

The February 2019 deadline has now passed. If a dispensing operation has not implemented the changes, they will not be able to legally dispense medicines to the patients who rely on them.

If you have not implemented the necessary changes already, it is critical to act now by following these steps:

1. Contact your NMVO
2. Evaluate your scanning equipment needs
3. Selecting the interface software that will enable verification submissions 4. Test your systems and resolve any issues
before implementation

Where can I get additional information?

The TraceLink Pharmacy Application 
Gives pharmacists a secure and reliable way to meet all their FMD requirements. Supported by the TraceLink Life Sciences network, the app has been designed to provide a simple and cost-effective solution that lets dispensers and healthcare practitioners focus on delivering better patient care.

UK FMD Working Group for Community Pharmacy  
Royal Pharmaceutical Society 
The National Pharmacy Association  
Pharmaceutical Services Negotiating Committee 

References:

1. European Commission. Falsified medicines. Available at https://ec.europa.eu/health/human- use/falsified_medicines_en (last accessed 18 September 2019)

2. Directive 2011/62/EU of the European Parliament and of the Council. Available at https://ec.europa.eu/health/sites/health/files/files/eudralex/vol- 1/dir_2011_62/dir_2011_62_en.pdf (last accessed 18 September 2019)

3. UK FMD Working Group for Community Pharmacy. Available at https://fmdsource.co.uk/ (last accessed 18 September 2019)

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