What Must the Investigators Prove in a Falsified Medicines Case?

Law enforcement reports that a substance of unknown origin, imported from China as a dietary supplement, was used to produce the drug in a clandestine laboratory. It was then sold to private clinics and cosmetology practices, despite the State Service of Ukraine on Medicines and Drugs Control (the “SMDC”) declaring a batch of BIOPATID (solution for injection) labelled as manufactured by UNIKKA PHARMA LTD falsified and banning its sale, storage, and use as of 16 January 2026. 

Despite the ban, the drug remained in circulation and later appeared in new forms. On 16 September 2026, based on information from the Security Service of Ukraine, the SMDC banned two additional products: the PEN PEPTIDE BIOPATID injection pen and the BIOPATID KIT, which includes an injection pen and six vials. 

How often are criminal proceedings initiated under Article 321-1 of the CC? 

Law enforcement has significantly increased its focus on the circulation of medicines over the past year. Over the past year, law enforcement attention to the circulation of medicines has grown remarkably. This is borne out by the statistics of the Prosecutor General’s Office: in January–August 2026 alone, 51 criminal proceedings were registered under Article 321-1 of the CC. In comparison, 21 proceedings were recorded under this Article in 2021, 17 in 2022, 26 in 2023, 14 in 2024 and 21 in 2025. 

In other words, authorities detected more crimes involving falsified medicines in the first eight months of this year than in 2024 and 2025 combined. 

When is a medicine considered falsified, and what unlawful acts does Article 321-1 of the CC cover? 

Article 2 of the Law of Ukraine “On Medicines” defines a falsified medicine as a medicine that is deliberately labelled in a manner that is not identical (does not correspond) to the information (one or more items thereof) about the medicine of the same name entered in the State Register of Medicines of Ukraine, as well as a medicine that has been deliberately forged in any other way and does not correspond to the information (one or more items thereof), including its composition, about the medicine of the same name entered in the State Register of Medicines of Ukraine. 

Legislation links falsification to a drug’s non-conformity with the State Register of Medicines. In essence, this means deliberately creating the impression that the buyer or patient is receiving an original and/or officially registered drug in Ukraine. 

A similar scenario played out with the cancer drug Keytruda. The perpetrators ordered stickers, cardboard boxes and tags from a printing house, bought empty vials resembling the original containers online in Ukraine and China, and manufactured and packaged the drug in rented premises. They sold the product through websites with advertisements and order forms. The manufacturer’s laboratory detected the counterfeit after a batch had already been sold in the United States. 

Another similar case is currently under investigation. According to the investigation, an organised group set up the production of injectable drugs under the brands of manufacturers that either do not exist or are not registered in Ukraine, such as MALAY TIGER and Aburaihan Pharmaceutical, using testosterone propionate, a medicine registered in Ukraine. 

Article 321-1 of the CC imposes liability not only for manufacturing and selling falsified medicines, but also for purchasing, transporting, and storing them for sale. As a result, potential suspects include more than just those involved in illegal production. 

Case law reveals several other categories of violations that give rise to the registration of criminal proceedings under this Article: 

• purchasing a drug from an unidentified person without documents confirming its origin and subsequently reselling it to order (see the decisions in the Unified State Register of Judgments (the “USRJ”) here and here); 
• buying drugs in small batches without quality certificates or delivery notes for sale during one’s own business activities (see the USRJ decisions here and here); 
• splitting medicines listed in the State Register of Medicines into smaller vials and applying one’s own labelling indicating the manufacturer, batch and expiry date (see the USRJ decision here); 
• importing, storing and selling a drug with a lower-than-specified active substance content, which reached health care facilities through centralised public procurement (see the USRJ decision here); 
• selling a drug for cosmetology procedures in a dosage that the manufacturer has never produced (see the USRJ decision here). 

But is every medicine absent from the State Register of Medicines the subject of the crime under Article 321-1 of the CC? Each case must be assessed comprehensively. 

What must the prosecution prove, and how?  

First and foremost, that the subject of the crime is indeed a falsified medicine, which may be evidenced by: 

• conclusions on quality issued by the SMDC’s medicines quality control laboratories and certificates of analysis issued by state control laboratories, in particular the State Enterprise “Central Laboratory for Quality Analysis of Medicines and Medical Products” and state research laboratories of specialised institutes; 
• forensic expert opinions, which may, for example, establish that a batch fails to meet the requirements of the registration documents in terms of pH, quantitative content and identity of the active substance, etc.; 
• SMDC orders declaring medicines falsified and prohibiting their circulation. 

The investigation must specify which acts under Article 321-1 of the CC the individual committed, such as manufacture, production, purchase, transportation, shipment, storage for sale, or sale. Typically, charges involve several of these actions, each requiring details on the time, place, quantity of falsified medicines, and the individual’s specific conduct. 

When manufacture, purchase, transportation, shipment, or storage of falsified medicines is involved, the intent to sell must be proven. Evidence may include advertisements, price lists, buyer correspondence, large batch sizes, or receipt of payment. 

The most challenging element to prove is the individual’s awareness that the medicine is counterfeit. Investigators may rely on circumstances such as purchase from an unidentified person, absence of a quality certificate or delivery notes, or a purchase price significantly below market value. 

Criminal liability applies even if using a falsified medicine causes no harm to health. Purchase and storage for sale are considered completed crimes, regardless of whether the drug was used. Under parts 2 and 3 of Article 321-1 of the CC, prolonged health disturbances, death, or other serious consequences are aggravating factors that increase liability. 

The strongest evidence often comes from covert investigative actions, particularly operative purchases. In these cases, a buyer acting on law enforcement instructions acquires a suspect medicine, which experts then examine. 

Authorities also obtain additional evidence through searches, during which they seize medicines, accounting records, phones, and computers. 

What should clinics do to minimise risks? 

Criminal liability under Article 321-1 of the CC applies only to individuals. The owner, the head of the facility, a doctor or the person responsible for procurement may be notified of suspicion. 

Because the key circumstance the prosecution must prove is awareness that the product is falsified, the clinic’s main task is to keep documents confirming the origin of each medicine and to ensure it is entered in the State Register of Medicines and has not been banned from circulation. 

Considering the legislation on the circulation of medicines, this requires clinics to: 

• cross-check the name, pharmaceutical form, dosage, manufacturer and distributor of each medicine against the information in the State Register of Medicines; 
• check the SMDC register of orders and compare the banned items against the labelling, pharmaceutical form and batch numbers of the drugs held by the facility; 
• make sure that the supplier holds the relevant licence and that the drug’s supply chain is documented at every stage (from production to import); 
• ensure that a complete set of documents confirming the origin of medicines (delivery notes, quality certificates, etc.) is available, and check that the batch numbers stated in them match those on the packaging; 
• rule out any in-house splitting, repackaging or relabelling of drugs; 
• set out the internal incoming quality control procedure in writing and appoint a person responsible for it. 

Criminal proceedings related to the circulation of medicines can progress quickly. However, risks can be reduced in advance by properly verifying suppliers, the origin of medicines, and supporting documents. 

If criminal proceedings have already been initiated, or it has become known that investigative actions are underway, it is important to promptly assess the potential risks to the facility and its staff and define a legal position. 

Contributors to the article: 

• Kristina Razvina, Counsel at Criminal Law and White Collar Defence practice at GOLAW, Attorney at law 

• Anastasiia Shapoval, Attorney at law at Criminal Law and White Collar Defence practice at GOLAW