Adapting company strategies to serialisation

Falsified medicines are counterfeit drugs that reach the market illegally. They have not been approved and may contain ingredients which are of poor quality and/or at the incorrect dose. Notably, falsified medicines pose significant health risks to patients, as well as jeopardise the legitimacy of pharmaceutical companies, tarnishing consumers’ trust and prospective generated revenue. In this article, HiTech Health takes a look into the serialisation requirements and key considerations for orphan drugs used to treat rare diseases.

As of 9th February 2019, the European Union Falsified Medicines Directive (FMD) came into effect. Marketing Authorisation (MA) holders of approved medicines are now required to place two new safety features on the packaging of their products; a unique 2-dimensional barcode which allows for identification of the medication and an anti-tampering device on the packaging of the product. Similarly, in the United States, the Drug Supply Chain Security Act (DSCSA) was brought into effect by the FDA in November 2018 to ensure serialisation of all medications. The introduction of FMD and DSCSA requires each party involved in the supply chain process to verify the authenticity of the product, preventing the entry of falsified medicines into the marketplace.

Overall, companies have started adopting a strategic business view for serialisation, identifying benefits beyond regulatory compliance, such as an approach to safeguarding brand reputation, ensuring patient safety and actively contributing to an effective management of the supply chain.


5 key parameters to serialise, verify and store your product

Orphan drugs must comply with current serialisation regulations in the same manner that any other authorised pharmaceutical product is required to. However, orphan drugs face several unique challenges when it comes to serialisation compliance. They are typically of very high value and they are often distributed in small quantities directly to hospitals, speciality practices or patients’ homes. All drugs must now be serialised at the package level using a 2D DataMatrix barcode that provides accurate and contemporaneous information on the drug product identifier, lot number and expiration date. Generally, hospitals, pharmacies and distribution centres will scan the 2D DataMatrix barcode when the drugs arrive at their facility or at the point of dispensing. The quantity of orphan drugs that enter legal supply chains may be much less than other medicines and, generally, the supply chain is patient-centric focused, with a more direct access to the final consumer.  As orphan drugs are often shipped in small quantities direct to patients or their primary care physicians, there may be challenges in ensuring the required serialisation hardware and software are available to verify if the medicine is legitimate or could potentially have been falsified.

Being involved in the development, manufacturing and distribution of orphan drugs, one must be aware of how and where patients will receive the medication. In order to comply with FMD and DSCSA, orphan drug serialisation must follow a process that aligns with the key parameters of serialisation, verification and storage:

  1. Secondary packaging serialisation uses a 2D DataMatrix barcode. If required, serialisation is completed at the sealed case level, using a 2D DataMatrix or linear barcode. Data must be machine and human readable that include orphan drug product identifier, lot number and expiration date.
  2. Cold-chain distribution needs to be successfully controlled and managed with anti-tampering devices.
  3. The orphan drug product received by the patient, doctor, pharmacy or speciality distribution centre will have the 2D DataMatrix barcode scanned at arrival or at the point of dispensing.
  4. The serialisation software will verify the orphan drug product identifier and ensure that the drug is not falsified. The software should respond to requests for verification from authorised users to verify the product identifier, including the serial number, within 24 hours at most.
  5. Serialisation data on all orphan drugs must be stored in an active, readily available location for a minimum of five years past the date of manufacture.


Many orphan drugs, like immunotherapies, are fragile in their composition and have specific packaging requirements as well as temperature-controlled shipping and storage needs. When selecting a packaging partner for orphan drug products, it is critical to conduct due diligence processes to ensure your selected partner can comply with serialisation regulations and the challenges of handling small quantities of sensitive products.


Identify the most appropriate solution for your unique needs

For orphan drugs, where product flexibility is paramount, effective packaging solutions are key in the EU multi-lingual market. Traditional packaging and labelling might result in product waste. Limited shipments of material to several countries could be facilitated using multi-lingual packaging. Further, if you are manufacturing a drug for a small patient population, it is imperative to have controls on your inventory and effective management of the supply chain. During distribution, will the serialisation hardware and software be usable in every destination that the orphan drug is distributed to? By targeting orphan drug providers, counterfeiters can possibly take advantage of newly introduced serialisation systems and create new revenue streams from high value orphan drugs. The validation and qualification of your chosen serialisation software and hardware units is a paramount step in ensuring you have a robust supply of orphan drugs to patients.


It is apparent that applying a unique identifier at the level of the individual product unit is now a core requirement for all medicines with no distinctions. Overall, the primary drivers for serialisation include the ability to control and monitor a highly complex distribution network from manufacturer to consumer, in which products possibly change hands several times. Authentication of orphan drugs at various levels in the supply chain becomes very difficult without data sharing across the supply chain. From our experience, process flexibility is key in the supply chain of orphan drugs and, therefore, there is the need of an integrated cross-functional process and systems at every stage of the supply chain to allow for clear and effective delivery of high quality orphan drugs to patients.

At HiTech Health we focus on strategies that can optimise the process, continuing to promote product quality. Get in touch if you wish to discuss your orphan drug development processes and supply chain models with one of our experts.

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