Serialization of medicines – safety, law and technology

To ensure maximum safety for patients, the pharmaceutical industry uses drug serialization. What is the drug serialization system? What penalties apply for lack of drug serialization? We explain in this article.

What is medicine serialization and why is it important in pharmacy?

What is drug serialization and how does it work? Medicines serialization means assigning a unique serial number to each unit of medicinal products intended for sale.
In the pharmaceutical industry, drug serialization plays a key role in preventing counterfeiting and distribution errors. Each medicine unit receives its own individual number, allowing verification of authenticity and tracking throughout the entire supply chain.

Which medicines are subject to serialization – the black and white lists

Prescription medicines are subject to serialization. It does not apply to dietary supplements, medical devices, or over-the-counter (OTC) medicines, except for medicinal products listed in the EU Commission Delegated Regulation. According to the regulation, all products containing omeprazole in 20 mg and 40 mg doses, in any form, are subject to serialization (the so-called black list).
Medicinal products excluded from the serialization requirement (e.g., homeopathic medicinal products) are also included in the EU Commission Delegated Regulation, known as the white list.

Implementation of medicines serialization in Poland and Europe – legal context

Drug serialization is a legal requirement. The EU Commission Delegated Regulation was published in February 2016 and has been binding in all 28 EU Member States and 4 EFTA countries (Norway, Switzerland, Iceland, Liechtenstein) since February 9, 2019.

How medicines serialization works in practice – Step by Step

Drug serialization includes several actions – from assigning a serial number and encoding the data in a 2D format, to final authenticity verification at the pharmacy.

The drug manufacturer generates a unique identifier (UI) for each package unit and an anti-tampering device (ATD). So-called 2D codes in pharmacy include data such as: the product’s batch number, the serial number of the individual package, the expiration date, and the product code. These are printed on the drug packaging and registered in the European Medicines Verification System (EMVS), and in Poland also in the PLMVS system, which is part of the EMVS. The drug with the assigned serial number then goes to the pharmaceutical wholesaler and the pharmacy, where the pharmacist can scan the 2D codes.

Pharmacies follow specific procedures in case of alerts or verification issues

2D codes in pharmacies are scanned by the pharmacist. The system checks authenticity in real-time, and if the data matches, the medicine is marked as sold and can be dispensed to the patient.

If errors or discrepancies occur, the system generates an alert, the medicine is temporarily blocked, and the pharmacist cannot dispense it to the patient. It is also necessary to report the incident to the appropriate institutions – the drug manufacturer, pharmaceutical wholesaler, and the Chief Pharmaceutical Inspectorate. In the event of confirmed counterfeiting, appropriate procedures are initiated.

Technologies supporting serialization – 2D codes, IT systems and Kamsoft

Implementing drug serialization would not be possible without advanced technologies. 2D codes play an important role in this process – in pharmacy, they allow a large amount of data to be encoded in a small space on the packaging. Also crucial are: integrated IT systems and specialized pharmacy software such as Kamsoft. Kamsoft drug serialization enables effective monitoring of each drug package at all distribution stages.

What are the penalties for lack of medicine serialization?

Responsibility for the lack of drug serialization lies not only with pharmacies but also with drug manufacturers and pharmaceutical wholesalers. All these entities are obliged to comply with serialization requirements. Failure to do so may result in serious legal and financial consequences.

Examples of penalties – What does the law say?

Failure to comply with drug serialization obligations may result in serious legal and financial penalties:

• A pharmacy may face a fine of up to PLN 20,000;
• The Chief Pharmaceutical Inspector may impose a fine of up to PLN 500,000 on drug manufacturers;
• For criminal offenses related to the trade of medicinal products that violate serialization regulations, penalties may include restriction of liberty or imprisonment from 3 months to up to 5 years.

Medicine serialization and patient safety – What are the benefits?

The medicine serialization system enables rapid verification of a product’s authenticity. In case of discrepancies, such as incorrect amounts of active substances or expired products, it allows for immediate recall from the market, enhancing drug safety. Medicine serialization also eliminates the risk of counterfeit products entering the supply chain.

Medicine serialization – Frequently Asked Questions

I. What is drug serialization?

Drug serialization is a process that involves assigning a unique identification number to each packaging unit of a medicinal product.

II. Is drug serialization mandatory in Poland?

Yes, drug serialization has been mandatory in Poland since February 9, 2019.

III. What technologies support the serialization process?

The serialization process is supported by advanced technologies such as: 2D codes, integrated IT systems, and specialized pharmacy software.

IV. Are pharmacies required to verify serialization codes?

Yes, pharmacies are required to verify the serialization codes of medicines.

V. Which drugs require serialization and which are exempt?

Serialization applies to prescription drugs and certain over-the-counter medicines listed in the EU Commission Delegated Regulation (black list). Drugs exempt from serialization are included in the white list (e.g., homeopathic medicinal products).

VI. What is the difference between serialization and aggregation?

Aggregation involves linking unique identifiers of individual drug packages with larger logistic units – such as bulk cartons – which significantly improves supply chain management.

BIBLIOGRAPHY

1. Supreme Pharmaceutical Chamber (n.d.). Key information on drug serialization [online]. Available at: https://www.nia.org.pl/serializacja [accessed: 26.04.2025]
2. Practical Pharmacy (2019). Serialization of medicinal products [online]. Available at: https://farmacjapraktyczna.pl/prawo/serializacja-opakowan-lekow [accessed: 26.04.2025]
3. EU COMMISSION DELEGATED REGULATION (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules on the safety features appearing on the packaging of medicinal products for human use. Official Journal of the European Union.
4. DIRECTIVE 2011/62/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, regarding the prevention of the entry into the legal supply chain of falsified medicinal products. Official Journal of the European Union.
5. World of the Pharmaceutical Industry (2022). Serialization in the pharmaceutical industry. [online]. Available at: https://przemyslfarmaceutyczny.pl/artykul/serializacja-w-przemysle-farmaceutycznym [accessed: 26.04.2025]
6. Main Pharmaceutical Inspectorate – Gov.pl Portal (2019). Serialization of medicinal products [online] Available at: https://www.gov.pl/web/gif/serializacja-produktow-leczniczych [accessed: 26.04.2025]