Pharmaceutical product serialisation legislation is being developed and approved across the World to ensure patient safety and prevent fraud. Achieving this across the supply chain is a major and very costly undertaking. Failure to comply with these legislative requirements will mean that pharmaceutical companies will not be able to sell products in the affected markets.

Serialisation legislation requires that every product pack is uniquely identified and registered in an external agency database, together with information about the product contained in the pack. Depending on the particular legislation, it may also be necessary to update the external agency database with product movement and change of ownership information, a significantly more complex requirement.

Whilst some pharmaceutical companies understand this legislation and have a clear strategy and program of capability implementation under way, others do not.

This series of articles outlines the requirements of serialisation and related product coding legislation, discusses what needs to be done to address it and identifies some next steps to effectively manage the risk.

This is one in a series of articles outlining the requirements of serialisation and related product coding legislation, discussing what needs to be done to address it and identifing some next steps to effectively manage the risk. Please help me improve the thinking by adding your comments and share this with others who may have a view.
To obtain an e-copy of our paper on the topic, go to www.be4ward.com or contact me directly at stephen.mcindoe@be4ward.com.