Falsified Medicines Directive. The Next Steps

by | Jan 25, 2016 | Blog

Changes are planned for ensuring product authenticity. Big changes. The Falsified Medicines Directive (FMD), transposed into UK law in January 2013, will become a Delegated Act within the first quarter of 2016 – and along with this- going some way to completing the interventions first recommended in 2013 legislation. Although not immediately, this will have a significant impact on how the products will be presented, and when records are kept and updated – for Manufacturers, Wholesalers and Pharmacists alike.

Firstly, a quick recap on the impact the FMD has had so far. Its inception brought about the strengthening of controls and checks on the movement of medicines, going further than just encouraging the use of legitimate supply chains, but ensuring it – along with transparency and a collective will for compliance. It also made clearer, and less ambiguous, the requirements for exporting medicines to countries outside the European Economic Area (EEA) and the registering of “brokering” activities.

Crucially, also, was the clear obligations placed on licence holders to be more aware of, and report, suspected falsified medicines. Incorporating the concept of false representation – Identity (Inc., packaging and labelling), source (Manufacturer, country of manufacturing and origin) and history (distribution and storage records). The impact and importance of the Internet Logo for distance selling is described in detail in an earlier blog by my colleague Kim Peck.

All measures that are largely being achieved and are affective-  so some further measures, initially side-lined to determine what form they would take, will now be applied to enhance and ensure the safety and authenticity of medicines. Firstly, certain products will require mandatory seals and unique pack identification. These unique identifiers (UI’s) will be in the form of 2D barcodes. Each barcode to at least denote the manufacturer’s code, a serialisation number, batch number and expiry date. Initially, this stipulation will mainly apply to Prescription only Medicines (POM’s). Medicinal products not subject to prescription (P’s and GSL’s) will not require this safety feature, unless especially listed as such by the commission.

The next phase will include what is being referred to as a Data Repository – an accessible database holding all the UI information. Namely, a central bank of data that is updated by the manufacturers with the products’ information and used for verification by wholesalers (at each stage in the chain). The wholesaler who finally supplies the product to a dispensary or healthcare provider will also be responsible for decommissioning from the Data Repository that particular UI information. This decommissioning notion will also apply for exports, disposals and samples. Furthermore, only wholesalers who have decommissioned stock will be able to then recommission (i.e. returns for resale) that same stock back (under appropriate authority) into the repository.

Written by Brian Lindsay

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