Liability for Importing Prescription Drugs into Ukraine

Bringing in medicines from abroad for yourself or relatives is an ordinary situation for many Ukrainians. However, a prescription drug in a suitcase or an international parcel can result not only in a delay at customs but also in a report on the violation of customs rules or even a criminal case. Everything depends on what exactly is being imported, in what quantity and with what documents. The editorial team explains how the regulation is structured and where the boundaries of liability lie.

The legal basis and key concepts

The circulation of medicinal products in Ukraine is regulated primarily by the Law of Ukraine “On Medicinal Products” of 1996. It defines the requirements for the registration, manufacture, import, trade and dispensing of medicines. The general rule is that only registered preparations may be used and sold in Ukraine, and import for the purpose of sale requires a license.

The procedure for crossing the border is defined by the Customs Code of Ukraine of 2012, and liability for the violation of customs rules by its separate section. For preparations containing narcotic drugs, psychotropic substances or precursors, the special Law “On Narcotic Drugs, Psychotropic Substances and Precursors” of 1995 and the list of these substances approved by the Cabinet of Ministers apply.

Criminal liability is established by the Criminal Code of Ukraine. It has separate articles on the smuggling of potent substances, on the smuggling of narcotic drugs, psychotropic substances and counterfeit medicinal products, on the illegal circulation of poisonous and potent substances, and on the counterfeiting of medicines.

The concepts key to understanding are the “prescription”, “potent”, “narcotic or psychotropic” and “counterfeit” medicinal product. Whether it is enough simply to declare it at the border, whether special documents are needed, or whether import by a private individual is impossible at all, depends on the category to which the preparation belongs.

It should be borne in mind that legislation in this area changes regularly, in particular under martial law. Therefore, before a trip or an order, it is useful to check the current rules on the official resources of the State Customs Service and the Ministry of Health.

Categories of preparations: from ordinary to controlled

Ordinary prescription preparations — antibiotics, blood-pressure medications, hormonal contraceptives, most antidiabetic agents — have no special status with regard to import. For personal use they can, as a rule, be carried in a reasonable quantity, but customs may raise questions if the volume exceeds the needs of one person.

Potent and poisonous substances are a separate group, defined by special lists. The illegal movement of such substances across the border may be classified under the Criminal Code article on smuggling. Potent substances may include, in particular, certain hormonal preparations, so the status of a specific substance should be checked against the current lists.

The strictest regime is established for narcotic drugs, psychotropic substances and precursors. These include not only the obvious substances but also a number of ordinary medicines that are sold abroad on prescription — for example, some painkillers, sedatives, sleeping pills and medications for treating attention deficit disorder. They can be imported only with supporting medical documents and in a limited quantity, and some are prohibited from circulation in Ukraine altogether.

Unregistered and counterfeit medicinal products stand apart. An unregistered preparation for personal treatment can in some cases be imported under an established procedure, but the import of a counterfeit is already criminal liability regardless of the purpose.

Import for personal use

The general principle: a private individual may import medicinal products for their own treatment or the treatment of family members in a quantity corresponding to the course of treatment. In practice, customs assesses whether the volume matches the needs of one person and whether it is supported by medical documents.

It is recommended to carry a prescription or a doctor's statement with the name of the preparation under its international nonproprietary name, the dosage and the duration of treatment. If the document is in a foreign language, it is useful to have a translation. Preparations are better carried in the original packaging with the leaflet.

• check whether the active substance belongs to narcotic, psychotropic, precursor or potent substances;
• keep the medicines in your hand luggage together with the documents;
• do not exceed the quantity needed for the course of treatment;
• if in doubt, declare the preparations and go through the “red corridor”;
• do not carry medicines at the request of strangers.

Voluntary declaration is an important protection. If you have declared a preparation and customs concludes that its import is not permitted, the consequence will usually be a refusal of passage or seizure, rather than an accusation of concealment. An attempt to “get it through unnoticed”, on the other hand, sharply changes the legal assessment.

Administrative and criminal liability

If the preparation is not potent, narcotic or counterfeit, the main risks are linked to the violation of customs rules. The Customs Code provides liability, in particular, for the non-declaration of goods (Art. 472) and for the movement of goods with concealment from customs control (Art. 483). The sanctions include fines and confiscation of the goods.

Criminal liability arises when it comes to special categories of substances. Article 201 of the Criminal Code concerns smuggling, in particular, of poisonous and potent substances. Article 305 concerns the smuggling of narcotic drugs, psychotropic substances, their analogues, precursors or counterfeit medicinal products; for it the quantity and purpose of import are of secondary importance, while the punishment provides long terms of imprisonment.

After crossing the border, other articles may apply. The illegal acquisition, storage for the purpose of sale, and sale of poisonous or potent substances fall under Article 321, the circulation of counterfeit medicinal products under Article 321-1, and illegal actions with narcotic and psychotropic substances under separate articles of the section on crimes against public health.

In classification, courts rely on the conclusions of an expert examination: what substance exactly is contained in the preparation, whether it belongs to the controlled lists and in what quantity. Therefore “I did not know what was in it” is rarely an effective defense, especially if the preparation was imported without documents and concealed.

Postal shipments, sports preparations and common mistakes

Ordering medicines from abroad by post or courier service is the riskiest option. International shipments pass customs control, and the person in whose name the parcel arrived is regarded as the recipient. If controlled substances are found in it, it is precisely they whom law-enforcement bodies will have questions for.

Those who order preparations for sport must be especially careful: anabolic steroids, growth hormone, peptides, “fat burners” such as clenbuterol, preparations for “recovery after a cycle”. Some of them may have the status of potent substances or be unregistered in Ukraine. Besides legal risks, products from unofficial sources often have the wrong composition or dosage.

Common mistakes: importing a large quantity “in reserve”, carrying medicines in unlabeled containers, sending preparations “at an acquaintance's request”, ordering from sites without a license. Each of these can turn an everyday situation into a legal problem.

For athletes there is one more aspect — the anti-doping one. Even a legally imported preparation may contain a substance from the WADA Prohibited List. If treatment is necessary, it is worth obtaining a therapeutic use exemption in advance through the National Anti-Doping Center or the international federation.

Editorial conclusions

Liability for importing prescription drugs into Ukraine depends primarily on the category of the substance: ordinary prescription medicines, potent, narcotic and psychotropic, counterfeit.

For ordinary preparations the main risks are violation of customs rules: fines and confiscation. Smuggling of potent, narcotic, psychotropic substances and counterfeits entails criminal liability.

The best protection is medical documents, the original packaging, a reasonable quantity and voluntary declaration. Postal orders of sports preparations from unofficial sources carry the highest risks.

We also recommend reading our materials on the legal status of anabolic steroids in EU countries, and on anti-doping rules in Poland and Germany.

References

1. Закон України «Про лікарські засоби» від 04.04.1996 № 123/96-ВР.
2. Закон України «Про наркотичні засоби, психотропні речовини і прекурсори» від 15.02.1995 № 60/95-ВР.
3. Митний кодекс України від 13.03.2012 № 4495-VI.
4. Кримінальний кодекс України від 05.04.2001 № 2341-III.
5. Постанова Кабінету Міністрів України від 06.05.2000 № 770 «Про затвердження переліку наркотичних засобів, психотропних речовин і прекурсорів».
6. World Anti-Doping Agency. The Prohibited List. Montreal: WADA; оновлюється щорічно.