New eco-designed pharmaceuticals packaging that benefits from sustainable serialisation


CATEGORY: Sustainability and environment BRAND: ALL4PACK Paris

Since 9 December 2019, a directive on fake medicines has been in operation. All boxes of drugs on the European market are now tracked using its 2D Datamatrix barcode.

This method enables the pharmaceutical serialisation of products, i.e.: their integration on a European platform. Once the drug is recorded after being manufactured, Europe notifies the French database that the drug is to be sold on the French market. It is then up to the pharmacists to scan the packaging when delivering it to patients, in order to check the products out of the database and justify their legal sale.


What developments have there been in pharmaceutical packaging?

Pharmaceutical packagings are more than just simple containers: they have been developed according to very strict regulations. This concerns in particular the primary packaging, which is in direct contact with the drug itself, and which therefore needs to be designed so that it does not alter the formula in any way. The secondary packaging is the box or pack which contains the primary packaging and which is not in contact with the product.

Two decades ago, when talking of design, it all seemed peripheral to this sector of activity, on account of the strict levels of regulation in this domain. Yet, today, design helps patients to use the product, by serving an instructional purpose and thus making design a tool of utility.

The primary packaging must enable delivery of a drug in all its forms (solid, liquid or paste). Its form and its convenience must enable patients to understand how to self-administer the product, for example by facilitating the dosage or clarifying precisely when the drug needs to be taken.


Preservatives, indeed, are a good example of the importance of pharmaceutical packaging. Suitable packaging makes it possible to change the formulation of drugs and do without preservatives, while guaranteeing a longer shelf life.

Another example is the injectable drugs sector, which is one of the most innovative while being one of the most regulated, as the products are directly in contact with the blood. Regulations or pharmaceutical serialisation are therefore no impediment to innovation.


Where do european regulations fit in?

In Europe, regulations are there to protect the health of patients, and the latest regulations concern fake drugs. Indeed, according to the WHO, counterfeiting accounts for one in 10 drugs sold.

To combat this phenomenon, directive 2011/62 concerns all packaging given to patients. Each box is serialised, and therefore identified as unique in Europe. No other packaging can claim to have the same identifier, which authenticates and secures the drug. All players in the supply chain have a role to play in these checks when receiving their orders.

The laboratory generates a unique serial number associated with the pharmaceutical packagings for publication in a European database, and each number is meant for one market, associated with marketing clearance. These unique numbers are directed toward the destination countries. Each product is associated with a batch, and in the near future they may be associated with a parcel and a pallet.


About Datamatrix

Datamatrix is a 2D pharmaceutical serialisation method which clarifies all information relating to the packaging. It is less restrictive than 1D code, as it is easier to read. Many markets other than pharmaceuticals are therefore also turning toward Datamatrix.

This form of pharmaceutical serialisation is read by all stakeholders in the supply chain, and so needs to be marked efficiently on the packaging. Once a product is marked, the laboratory checks that this marking can effectively be read, to ensure its unique tracking the entire length of the chain.


The product leaves the lab and the lab enters the information in the European pharmaceutical serialisation database, which itself then informs the French platform. The drugs are sent to wholesalers who conduct the logistics operations for the laboratories. Next come the distributors, then any parallel importers, and finally the pharmacies.


A question of authentication

The risk of finding counterfeit drugs in pharmacies is very low, since these are identified and highly regulated circuits both in France and throughout Europe. In reality, counterfeiting tends to concern more remote countries with less regulated and less structured distribution.


If a laboratory is incapable of putting in place pharmaceutical serialisation and publishing in the European database, its drugs quite simply cannot be sold. Most laboratories are therefore today in compliance with these requirements. Only the Internet represents a real problem, with many counterfeit drugs being trafficked on the web. Today it is web users who need to take care and act responsibly, because they cannot count on regulatory protection where Internet transactions are concerned.


The pharmaceutical serialisation system exists to authenticate the steps in the chain and not for the traceability of products, unlike the food industry with the blockchain. In pharmaceuticals, it is the stakeholders who are identified.

An unidentified stakeholder has no role in the distribution chain and will often be synonymous with a producer of fake drugs. The key is to identify the stakeholders and give them roles to limit their capacity to act within the chain, and hence secure the distribution network.


Currently, the Datamatrix is the simplest and cheapest authentication solution for pharmaceutical packaging. In the words of Annette Freidinger-Legay, “as Darwin might have said, it is ultimately the function that creates the organ, and it is also a function that creates the packaging, whether we’re talking about serialisation, convenience or observance. This leaves lots of room for development for pharmaceutical packaging.”



    Annette FREIDINGER-LEGAY, Consultant for ALL4PACK Paris

    Pascale GAUTHIER, Pharmacian



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