June 18, 2019

New EU Regulations Require QR Codes on Medicinal Packaging

Over recent years, QR codes have seen significant growth in popularity. From becoming the main avenue of payment in Asia to their recent introduction onto EU medicinal packaging, it looks like these two-dimensional codes are here to stay.
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A QR (or Quick Response) code offers several advantages over a regular barcode — which has led to this explosion in use.

The QR code is classified as a "two-dimensional" code. Also known as a matrix barcode, it's able to transfer a hundred times more data than the traditional barcode — simply because it can display information both vertically and horizontally.

As mentioned above, these codes are now used in Asia (especially South Korea and China) in the place of point-of-sale terminals. In China, two fintech companies, Tencent and Alipay, have essentially taken over the mobile-pay app market.

Alipay recently brought its app to Finland as part of a partnership with ePassi — where an estimated 550,000 Chinese tourists travelled in 2017. Finnish merchants saw a 300% increase in spending by Chinese tourists, who also stayed in the country twice as long. This can be attributed to the fact that in China, the mobile-pay apps have become almost ubiquitous.

Merchants can benefit from mobile-pay because they really only need their QR code on display — removing the need for expensive payment terminals.

It was in this manner that the QR code started to become more prevalent in the European Union. Many local banks have mobile pay apps that function within a certain city or country, but if a person travels very far outside of those places, the EU mobile pay apps become less useful.

It should be noted that Alipay extended the reach of their mobile wallet by 6,000 kilometres when they brought the app to Finland. If Alipay were to create a multilingual interface, they could potentially corner the mobile pay market in the EU.

Beyond that, it appears that the QR code has been so easily accepted into Asian daily life due to its simplicity. Shoppers only need to use their phone to scan a code, or have their own code scanned, in order to pay.

The emergence of package tracking with QR codes

QR codes on packing have also become more and more common. In recent years, the United States Department of Agriculture considered the inclusion of QR codes on food packaging — mainly to inform shoppers about the GMO status of their food.

Additionally, Bumble Bee Foods, a North American-based shelf-stable seafood company recently included QR codes on its packaging. Their goal is to boost the traceability of their canned yellowfin tuna (ahi), from the fishing port where it is caught to the processing facility, all the way to grocery store shelves in the United States.

This is made possible through Bumble Bee Food’s use of SAP, a cloud-based blockchain platform. The QR codes allow a shopper to scan the code in the grocery store and see where their food was caught and processed, and if it is sustainable and fair trade.

More recently, EU regulators required tobacco distributors to track the shipping and arrival of each individual carton of cigarettes. This intensive tracking process is only made possible through the use of QR codes — due to the fact that they are easy to quickly scan with any smart device and the data is immediately uploaded to a cloud.

One major benefit the QR codes provides, over regular barcodes, is that they can still be scanned even if damaged or dirty.

As EU regulators attempt to guarantee authenticity and traceability of products, it appears QR codes will be required more often.

QR codes in pharmaceutical packaging

The pharmaceutical industry is no exception. With more legislation upcoming, EU regulators are now requiring the two-dimensional codes on medicinal packaging, to allow identification of the products and verification of their authenticity.

Without mobile scanning and the technology behind QR codes, data collection of this magnitude would not be possible.

As of February 2019, the Delegated Regulation on the Safety Features (of medicinal packaging) took effect. These regulations concern “laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use". QR codes will be prominent among these safety features.

These new regulations apply to both prescription and non-prescription medicines. A Unique Identifier (UI) is now required, consisting of a product code, serial number, batch code, and expiry date. This information must be present on packaging in both a “human-readable” and QR code format.

Monitoring pharmaceuticals through mobile scanning and other technologies

While information given by mobile scanning cannot replace a print-format, QR codes give pharmaceutical companies an opportunity to provide more information.

The manufacturer of a medicinal product will host the information on a platform such as a website, web page (usually a stand-alone PDF), a smartphone app, or another application specifically designed to host the pharmaceutical information.

However, regulations require that patients must be able to access the information by typing the URL into a web browser, in case they do not have access to a smartphone or other mobile device.

Pharmaceutical manufacturers are required to provide statutory information about the medicine, but can also provide additional information — this could include an informational video to help educate both patient and doctor.

The mobile technology, such as a QR code, can be included on the product packaging or within the Package Leaflet.

Using this mobile technology, the manufacturer will assign a unique identifier and upload the information into a secure system, via a data-logger or other mobile device. This secure system will be created and managed by stakeholders, and overseen by the competent authorities. It will consist of a central “hub” of information, accessed remotely.

Once the product arrives at a pharmacy or hospital, the unique identifier will be checked for authenticity and then decommissioned.

These new regulations should help the pharmaceutical industry and hospitals prevent any tampering with medicines and help guarantee the product’s safety and authenticity.

Did you enjoy this article? Take a look at our related blog posts RFID vs QR as a Data Transmission Method and Three Reasons Data Logging is Vital for Your Pharma Company.

Considering the context of the post, I feel obligated to include a mention on how Logmore Is the Recommended Solution for Pharmacies in Finland.