Key changes in the regulation of medicines in Ukraine

In recent months, several legislative acts have been adopted that significantly affect the regulation of medicinal products, specifically:

• A ban on advertising information on the labeling and information about persons other than the Manufacturer and MAH (marketing authorization holder), which comes into effect on January 18, 2025;
• Parallel import of medicines purchased by an authority that conducts procurements in the healthcare sector, which comes into effect on January 1, 2025;
• Serialization of medicinal products becomes mandatory on January 1, 2028;
• Restrictions for medical and pharmaceutical workers regarding advertising and promotion, which come into effect on December 18, 2024;
• Possibilities for off-label use of medicinal products.

   
Changes regarding labeling 

On September 18, 2024, the Law of Ukraine No. 3910-IX “On Amendments to the Law of Ukraine ‘On Medicinal Products’ Regarding the Labeling of Medicinal Products” (referred to as “Law 3910”), adopted on August 21, 2024, came into force.

Law 3910 prohibits the placement of advertising information on medicinal product packaging, as well as information about other legal entities or individuals who are not the manufacturer of the medicinal product or the MAH.

This ban does not apply to:

• Medicines imported with labeling and instructions in the original language for specialized procurement organizations;
• Medicines imported as humanitarian aid;
• Unregistered medicinal products whose import is allowed in cases defined by Article 17 of the Law of Ukraine “On Medicinal Products.”

In case of violation of the labeling requirements, the Ministry of Health of Ukraine decides to temporarily suspend the registration certificate for such a medicinal product until the labeling is brought into compliance.

Law 3910 also introduces changes prohibiting the retail and wholesale trade and/or import of medicinal products with labeling that contains advertising information or information about other legal or physical persons.

These changes come into effect on January 18, 2025.

We recommend reviewing the primary and secondary packaging for any information prohibited by Law 3910 (including logos and phone numbers of third parties) and making necessary changes if necessary.

   
Parallel import

On July 27, 2024, the Law of Ukraine No. 3860-IX “On Amendments to Certain Laws of Ukraine Regarding the Parallel Import of Medicinal Products” (hereinafter referred to as “Law 3860”) came into force, with its provisions taking effect from January 1, 2025, except for some provisions that will come into force at a different time.

Law 3860 defines the specifics of the state registration of medicinal products that can be procured by a person authorized to conduct procurement (procurement organization) in the healthcare sector, specifically:

• Both registered and unregistered medicines can be bided in the tender of a specialized procurement organization, in case if unregistered products are registered in the USA, Switzerland, Japan, Australia, Canada, or EU member states, or registered by EMA under the centralized procedure;
• Special procedures for the registration of medicinal products registered by the aforementioned competent authorities are established after the winner of the procurement procedure is determined;
• GMP confirmation for such medicinal products is performed either separately or simultaneously with state registration under the above procedure;
• Medicines registered under this procedure may only be circulated for free supply to the structural divisions of health departments of state administrations or licensed business entities, based on procurement results funded by the state budget, for the execution of programs and implementation of centralized healthcare measures.

Law 3860 introduces amendments to the Law of Ukraine “On Medicinal Products” from 2022, with some provisions regarding parallel import taking effect from January 1, 2025.

As for pharmacovigilance, Law 3860 establishes that until the entry into force of the Law of Ukraine “On Medicinal Products” dated 2022, business entities that have obtained permission for the parallel import of medicinal products are required to ensure the functioning of a pharmacovigilance system under current legislation.

    
Serialization (2D coding)

Cabinet of Ministers Resolution No. 1121, dated September 26, 2024, approved the Regulation on the national system for the verification of medicinal products and the Procedure for applying safety features to the packaging of medicines. 

Operators of the pharmaceutical market may voluntarily apply safety features and use the national system for the verification of medicinal products from January 1, 2026, and it will be mandatory from January 1, 2028. Medicinal products placed on the market before January 1, 2028, without safety features on their packaging, may be sold in Ukraine until their expiration date.

The safety features include a unique identifier and an anti-tampering device. The unique identifier must be applied in the form of a machine-readable two-dimensional barcode GS1 DataMatrix. The structure of the code must ensure the identification of the medicinal product code, the packaging serial number, the batch number, and the expiration date.

The resolution establishes a national organization for the verification of medicinal products (hereinafter referred to as the “Organization”), which will create, maintain, and administer a centralized database for the verification of medicinal products. The financing of the Organization is assigned to the MAH’s of registration certificates subject to serialization. The State Service of Ukraine on Medicines and Drugs Control is designated as the state verification control body. 

By January 1, 2026, the Ministry of Health of Ukraine must approve the following lists:

• Prescription medicinal products to which safety features will not apply on a mandatory basis;
• Non-prescription medicinal products to which safety features will apply on a mandatory basis.

    
Promotion Restrictions 

On September 18, 2024, the Law of Ukraine No. 3911-IX “On Amendments to Certain Laws of Ukraine Regarding the Regulation of Specific Issues in the Fields of Healthcare, Rehabilitation, Social Protection, and State Registration of Certain Sanitary Measures” (referred to as “Law 3911”), adopted on August 21, 2024, came into force. It will be implemented starting December 18, 2024, except for some provisions that will come into effect at a later date.

Law 3911 introduces changes to various legislative acts, including the Fundamentals of health legislation of Ukraine. The responsibilities of medical and pharmaceutical workers and rehabilitation specialists have been expanded to include:

• Being honest and impartial in professional interactions, including those related to advertising or promotional activities;
• Not using their authority, position, or related opportunities for personal gain;
• Prescribing and dispensing medicinal products, medical devices, and assistive rehabilitation devices without being influenced by private interests;
• Acknowledging responsibility to the patient.

A revised list of restrictions for medical and pharmaceutical workers and rehabilitation specialists has been introduced. During their professional activities, they are prohibited from:

• Directly or through others, demanding, asking for, or receiving undue benefits for prescribing or dispensing specific medicinal products, medical devices, or assistive rehabilitation devices;
• Directly or through others, receiving samples of medicinal products, medical devices, or assistive rehabilitation devices for use in their professional activities (except for cases related to clinical trials and certain other exceptional cases approved in the Law “On Medicinal Products” of 2022);
• Directly or through others, demanding, asking for, or receiving souvenirs and branded products to promote medicinal products, medical devices, or assistive rehabilitation devices;
• Directly or through others, demanding, asking for, or receiving gifts, bonuses, premiums, cashback, or the right to participate in any game, lottery, competition, or event where the condition of participation is the prescription or dispensing of specific products;
• Advertising medicinal products, medical devices, or assistive rehabilitation devices, including prescribing them on forms containing advertising information and mentioning manufacturers or trademarks;
• Prescribing medicinal products, medical devices, or assistive rehabilitation devices on forms that would allow further monitoring of the frequency of their prescription by the doctor or rehabilitation specialist;
• Refusing to provide or providing inaccurate information at the request of the consumer during the sale of a medicinal product about the availability of medicines with the same active ingredient (by international nonproprietary name), form, and dosage, including hiding information about the availability of such medicines at a lower price.

    
Off-label use 

Law 3911 also amends the Fundamentals of health legislation of Ukraine by addressing the off-label use of registered medicinal products. The changes establish the conditions under which a medicinal product can be prescribed off-label, including deviations from indications, age restrictions, dosage, and methods of administration not specified in the instructions.