Pharmaceutical Product Serialisation EU

EU Pharmaceutical Serialisation Directive -Future of Pharma Smart Packaging

According to the estimates of World Health Organisation (WHO), 1 million people globally lose their lives due to falsified medicines. It is the most lucrative of all counterfeiting businesses, netting in  150-200 billion euros per year. In order to put a stop to this trend, the EU introduced a scheme, which went live on 9 February 2019, for the identification and serialisation of individual packs of medicine. The serialisation scheme has been initiated under the EU’s Falsified Medicines Directive (FMD) of 2011 in an effort to fight counterfeiting of drugs through regulation (1) which was issued in 2016 and establishes safety features for packaging on medical products and devices. The primary focus for the regulation was that all packaging on pharmaceutical products need to carry a unique identifier for individual packs or boxes.

This is an example of how packaging can do much more than their traditional roles of dispensing product information and protecting the contents from external environmental conditions like changes in temperature and moisture. With the EU defining standards for serialisation of pharmaceutical packaging, there is an opportunity for the industry to go a step further and use this serial item identifier to exchange more information via smart packaging and IoT connected smart products. The serialised identifier and data matrix code on the packaging can be used to power other innovative digital interactions and applications. Here, we will take a look at some extended applications for product serialisation and smart packaging that can help brands, manufacturers and consumers alike.

Supply Chain Integrity

Product serialisation on batch and individual levels offers more than just compliance to regulations. When combined with digital twins, it is an excellent means to keep track of all supply chain operations, track and trace data and more. Serialisation will involve establishing a unique identification for each individual pack of medicine and communicate the same to all participants down the supply chain. A digital twin works in a similar fashion, maintaining a unique identity and an associated digital record of each product throughout its lifecycle. This means that manufacturers can access information regarding products more quickly, including their associated distribution records, and easily track a product to the source during any product holds or recall situation.

Smart packaging will not just involve the upgrading of all packaging, but dedicated investments into a data aggregation system and software solutions in order to identify, maintain and connect serialised numbers and label content to the aggregator. These investments are an opportunity for brands and manufacturers to develop and implement smart packaging solutions for their pharmaceutical products as well as enjoy simpler, more transparent and cost-effective supply chains and stock control.

Interactive Packaging For Safer Medical Practices

Product serialisation and smart packaging can go beyond enhancing supply chain operations. They can transform the way healthcare professionals and patients interact with their medicines and medical devices. Smart packaging with digital labels on them, that can be scanned by smartphones and other similar devices, can contribute immensely to better health literacy and patient compliance. It is estimated that non-adherence to medication annually costs the EU 125 billion euros and causes 200,000 deaths.

A product’s digital twin can easily store relevant information without any space limitations, information which is easily accessible through a smartphone app. This information can range from dosage, expiry dates, number of tablets left, reminders to take medicine and additional instructions from doctors to detailed and easy to understand IFUs. It can also provide an interface for healthcare professionals to remotely update any changes or collect reliable and richer data such as side effects and efficacy of product from patients for research purposes.

We need to think and reinvent how we can extend the abilities of packaging to adapt to future requirements as we see a rise in cases of poor compliance to medication and an ageing population in the developing world. Smart intelligent packaging can bring healthcare professionals and patients closer, promote safer consumption of medicines and improve the overall quality of healthcare and clinical trials.

Combating Counterfeits

The primary reason for the introduction of the mandatory regulation for product serialisation by the EU has been to counter threats to drug integrity due to the vast number of falsified medicines floating in the market. Counterfeit medicines pose a serious public health risk as even a small amount of substandard ingredient in a product can harm or potentially kill a patient. According to the new EU regulation, the unique identifiers should comprise of a product code, a serial number based on a randomised algorithm, a reimbursement number according to the countries which the medicine is marketed in, a batch number and expiry date. These numbers should be encoded into a 2-dimensional barcode within a machine readable data matrix which can be easily and accurately deciphered using simple scanning equipment.  

Similar to this process, a unique identity in the form of a digital twin for each product can also be maintained on the internet. The digital twin stores information pertaining to its authenticity throughout the supply chain, being scanned and verified by each participant, from manufacturer to distributors.

Serialisation and digital twins ensure that each saleable package of medicine is accounted for by all possible participants within a supply chain, allowing stores selling them as well as consumers to verify the authenticity of each individual product.

In fact, tracking data at serial item and batch level can help combat counterfeit products. Smart packaging with expanded abilities can allow consumers to scan and then report counterfeit products, allowing brands to keep an eye on locations and sources for them.

The new regulations for product serialisation and technological advancements together provide an opportunity for brands and manufacturers to upgrade packaging into more than a covering with basic product information for its contents. Apart from adherence to regulations for accountability of individual packs of medication as well as optimized logistics, they open up a wide array of possibilities to deliver delightful and intelligent interactions to consumers. Smart packaging holds the potential to bridge the gap between healthcare professionals and patients. It is the key to making supply chain events more transparent and much more easy to track and trace at all points of action. Extended actions of smart packaging combined with serialisation such as these need not be restricted to just pharmaceutical products. We’re already seeing significant efforts to serialise everyday consumer products such as foods, groceries, cigarettes, cosmetics and more.