Counterfeit medicines are becoming more sophisticated and the risk of falsified products entering the legitimate supply chain for a medicinal product has increased significantly over recent years. Harmonised European legislative measures come into force on 9th February 2019 and have been taken to best ensure that medicines remain safe and supply chains are appropriately controlled in order to mitigate patient risk as far as possible. The defined measures will ensure that those who are authorised to supply medicines, such as wholesalers and pharmacies, will be able to verify the authenticity of the product throughout the supply chain and up to the point of dispensing.
These additional measures apply to all marketed Prescription Only Medicines (POM) and any listed OTC products specified due to higher risk of falsification.
What do Marketing Authorisation Holders (MAHs) need to do and by when:
Safety Features – Tamper Evidence & Serialisation
The Regulation contains two parts:
The unique identifier (UI) – the UI is encoded in a two-dimensional barcode and contains a product code and unique serial number.
The Anti-Tamper Device – to allow determination of if the product packaging has been tampered with.
These requirements mean changes to registered artwork, packaging materials and packaging operations, all of which require time to develop, validate, register and implement. Multi-country packs will need careful consideration.
The UI data is required to be uploaded to a central database to enable traceability by pack throughout the supply chain.
EMVO and NMVO registration
A harmonised European Medicines Verification System (EMVS) is required which supports this database.The EMVS, which includes the European hub passes the pack and unique identifier data uploaded by the MAH to the national repositories. Connections to the European hub are managed by the European Medicines Verification Organisation (EMVO).
MAHs need to initiate (if not already done so) the on-boarding process with the EMVO and develop their connection to the European Hub, and also register with the relevant National Medicines Verification Organisations (NMVO). All MAHs should have registered with the NMVO in time to enable testing of the system and upload data to EMVS prior to February 2019. There are fees associated with both the EMVO and NMVO.
IT and other Operational Requirements
MAHs will need to partner with an appropriate IT platform provider who provides an end to end service and potential for support of compliance reporting. Consider who your Contract Manufacturing Organisation (CMO) has partnered with to leverage efficiencies.
At the distributor level, management of individual packs and unique serial numbers presents significant additional work in inventory management. The term aggregation describes a system whereby a case with a serial number containing individual units with unique serial numbers can be linked. This makes it possible to scan the case’s barcode and determine the identity of all the contents within the case. Aggregation offers clear efficiencies throughout the supply chain but is not a legal requirement at present.
How can S-cubed help you?
S-cubed has experience with multi-national pharma companies as well as virtual organisations with wholly outsourced manufacturing operations. As part of our GDP services, we can help you establish your strategy and manage the plan to meet the requirements of the FMD as appropriate for your specific operations and business model.