Traceability of medicines: The role of pharmaceutical packaging

Given the essential role of medicines for the well-being of society, ensuring their safety is a top priority. The traceability of medicines, made possible through their packaging, is a key element in safeguarding quality and provides reliable information on the treatments we take, protecting us from counterfeit or dangerous products.

Statistics measuring the size of the global counterfeit drug market vary greatly, especially in relation to the type of drugs analysed. The World Health Organisation (WHO) estimates that almost 10% of the medicines in circulation are counterfeit. This phenomenon is extremely dangerous: WHO estimates that around one million people worldwide die due to falsified medicines.

The benefits of traceability in the pharmaceutical sector

The term traceability refers to the collection, recording and making available of information related to the production and distribution process of a product. Even more than in other sectors, traceability has become a need and an opportunity in the pharmaceutical field, with several advantages in terms of:

  • Safety: introducing traceability systems for medicinal products will primarily help to detect counterfeit or non-compliant products and prevent their illegal distribution. In addition to guaranteeing the quality of the drug itself, these would ensure adequate quality standards along the entire supply chain.
  • Transparency: having linked data and making it available means enabling end-to-end visibility of the entire supply chain and ensuring that all actors, from producers to the end consumer, can readily access the information they need when needed;
  • Supply chain efficiency: traceability technologies optimise supply chain management, improving efficiency and reducing waste.
  • Regulatory compliance: the pharmaceutical sector is subject to strict regulations. Implementing traceability solutions enables companies to make sure they are complying with laws and regulatory requirements.

Current regulations for the traceability of medicines

Today, certain regulations are applied at EU level to ensure the traceability of medicines and to prevent their counterfeiting. The main directive introduced by the European Council on the subject, 2011/62/EU, introduces harmonised measures to ensure that trade in and data on medicinal products are strictly controlled.

Through the use of unique identifiers (UIs) and anti-tampering systems (ADTs), essential information on medicines is systematically collected, including:

  • Identity (packaging, labelling, designation or composition);
  • Origin: including manufacturer, country of manufacture and AIC (marketing authorisation) holder;
  • Logistical and documentary history.

The data are in turn managed by a European Hub and national repositories called NMVS (National Medicines Verification System).

In Italy, the EU Directive 2011/62/EC has been transposed through the Legislative Decree 17/2014. Our country has adapted and updated its national anti-counterfeiting system, managed by AIFA, which already provided for the application of a 'pharmaceutical security label', i.e. an identification code on self-adhesive backing applied directly on the packaging.

The role of pharmaceutical packaging in the anti-counterfeiting of medicines

The use of coding systems for the traceability of drugs must take into account the media required for their application and subsequent use. In this respect, the role of packaging is crucial, as identification numbers or barcodes are usually applied on labels or printed directly on secondary packaging.

Alongside these more traditional tools, innovative packaging solutions are becoming increasingly popular in the pharmaceutical sector that are able to support even faster and more secure coding by exploiting Internet of Things (IoT), cloud and big data technologies.

Furthermore, by transferring the tracking element directly onto the primary packaging, it avoids a number of risks related to the possibility of the secondary container also being altered. The trade mark would thus not only become an element to recall a serial number, but a real anti-counterfeiting element.

Intelligent packaging solutions for medicine traceability

The most effective means of combating counterfeit medicines lies in the production of smart packaging, as reported in the IMF report 'Anti-Counterfeit Pharmaceutical Packaging Market Outlook (2023-2033)'(1) , which estimated the anti-counterfeit pharmaceutical packaging market at $108.1 billion in 2033 and assumed that it will expand at an annual growth rate of 8.6% (CAGR) until 2027.

With this trend in mind, as some of the advanced solutions available today, we can list:

  • QR codes: two-dimensional codes can contain a vast amount of information, including product details, instructions for use and links to online resources. QR codes can be laser-imprinted directly onto the inside of glass or plastic packaging.
  • RFID: RFID (Radio-Frequency Identification) technology uses tags to track and identify products. These can be read without direct contact and allow rapid data acquisition.
  • NFC: NFC (Near Field Communication) tags work in a similar way to RFID. These are electronic labels that can be read immediately time when approached by a second enabled device. They also allow 'P2P' (peer-to-peer) communication, which enables the exchange of information between two NFC-equipped devices.
  • Holograms: simple, flexible holograms are customised and made unique, then applied to different types of media;

Beyond regulatory compliance objectives, harnessing primary packaging to implement new 'smart' solutions therefore offers unprecedented opportunities to improve the overall performance of the entire supply chain.

Furthermore, the integration of technologies such as artificial intelligence, IoT (Internet of Things) and automation could lead to the production of solutions that monitor drug administration and send alerts or data to patients and healthcare professionals, thus increasing adherence to therapy and enabling the production of drugs tailored to the specific needs of each patient.


1-"Anti-Counterfeit Pharmaceutical Packaging Market Outlook (2022-2027)" - FMI (Future Marketing Insights) - July 2022 -