Ukraine introduces updated labelling regulations for medicines

06/ 03/ 2025

On 18 January 2025, new labelling requirements for medicinal products in Ukraine went into force. These amendments restrict promotional information on labelling, prohibit references to entities other than the manufacturer or marketing authorisation holder (MAH) on packaging, and grant new powers to the Ministry of Health and the Quality Inspectorate to suspend marketing authorisations and circulation of non-compliant medicines. Pharmaceutical companies must address these regulatory changes and ensure compliance. In a previous Law-Now article, we provided analysis of the official interpretations from the Ukrainian Ministry of Health (MOH) and Quality Inspectorate, and insights into expected future regulatory amendments. This article will help companies navigate the new requirements and ensure they meet the necessary compliance standards. Background and timeline Ukraines regulatory landscape for medicinal product labelling has undergone significant changes. The following is a timeline of the key legislative and regulatory developments: Law No. 3910-IX – Adopted by Parliament: 21 August 2024. Entered into force: 18 September 2024 with full implementation on 18 January 2025. MOH Official Interpretation Letter: 19 November 2024: provides initial clarifications on the new labelling requirements. Link in Ukrainian Cabinet of Ministers Resolution No. 39 of 17 January 2025 (‘Resolution’). Entered into force: 18 January 2025, amending the marketing authorisation procedure for medicines, particularly on labelling and the fast-track procedure. Link in Ukrainian Quality Inspectorate Official Interpretation Letter: 16 January 2025: Clarifies various aspects of how the Inspectorate controls medicines, including labelling variations to dossiers and variations approval. Link in Ukrainian The MOH launched public consultations on the proposed amendments to several MOH Orders on 20 December 2024. These draft amendments concern the marketing authorisation dossier assessment, suspension of authorisation and suspension of circulation of medicines procedures. Link in Ukrainian Ban on promotional information Under the new law, any promotional information is prohibited on the labelling of medicinal products, including both primary and secondary packaging. This ban extends to logos, trade marks, claims and any information not directly related to the product’s medical use. The term promotional information is not defined in the legislation, leaving room for broad interpretation by regulators. MOH interpretation (19 November 2024) What is not considered promotional: Information that is aligned with the approved leaflet or Summary of Product Characteristics (SmPC). Symbols or pictograms that help clarify mandatory information and are useful for patients. The logos of manufacturers (and parent groups) or the MAHs, provided they are used in official business documentation. Information about the licensor and their logo is allowed, particularly in cases where the product is manufactured under a licence from the patent holder. This information is considered part of the manufacturers details, not advertising. A statement such as Manufactured under licence from [Licensor Name] and the inclusion of the licensor’s logo is not regarded as promotional if it aligns with the legal use of the licence and the product’s manufacturing. What is considered promotional: Information that is not directly aligned with the approved leaflet or SmPC, such as arbitrary elaborations or additional marketing claims. Information about a company that represents the manufacturer and/or applicant in Ukraine. Information about or logos of a distributor or pharmacy chain, including those using a private label model. For one medicine, use of several original layouts with the same labelling text but in different colours. Ban on mentioning entities other than the manufacturer or MAH A significant challenge arising from the new law is the ban on referencing legal entities other than the manufacturer or MAH. This prohibition extends to local representatives of foreign MAHs who have traditionally been included on the packaging for regulatory support, pharmacovigilance, and communications with healthcare professionals/responses to consumer complaints. MOH interpretation (November 19, 2024): The MOH suggested that contact information for local representatives be included in the patient information leaflet, especially by foreign manufacturers and MAHs. Draft amendments propose a restrictive approach prohibiting inclusion of details on local representatives on packaging. Thus, contact details of a local representatives can now only appear in the approved leaflet. Suspension of marketing authorisation and circulation The existing regulatory framework and proposed by the MOH Draft amendments to regulations provide two distinct procedures for non-compliance with labelling requirements: (a) Suspension of authorisation by MOH: The MOH can temporarily suspend the marketing authorisation of a product that does not meet labelling requirements (e.g. labels containing promotional information or references to unauthorised entities). MOH will reinstate a suspended authorisation as soon as the MAH brings a concerned product’s labelling into compliance with the requirements. (b) Suspension of circulation by the Quality Inspectorate: The Draft amendments proposed by the MOH will provide the Quality Inspectorate with the authority to suspend the circulation of medicines on the market if the product’s labelling does not comply with the new requirements. This is particularly relevant for imported products and those in circulation in pharmacies, and for wholesalers. The Quality Inspectorate, which is responsible for inspecting medicines during import quality control and market circulation, will thus scrutinise packaging compliance more rigorously. According to the Quality Inspectorate’s interpretation letter of 16 January 2025, any approved registration variations apply to batches released post-implementation of the variations. Products manufactured before the variations’ approval date must still meet the previously approved characteristics, including those related to labelling, as of the date of release. This could prevent the importation and commercialisation of medicines released in packaging aligned with pending regulatory variations, if they were released before the variations are approved by the MOH. Transition period and compliance: The law restricts the import and commercialisation of medicines non-compliant with the new labelling requirements as of 18 January 2025. However, the commercialisation of medicines (CoM) Resolution clarifies that: Products manufactured before 18 January 2025 can still be imported and used, even if their labelling does not fully comply with the new requirements. These products can be commercialised until their expiry date. For any products manufactured after 18 January 2025, full compliance with the new labelling requirements is mandatory. For enforcement purposes, the Quality Inspectorate is expected to rely on the batch release date when assessing compliance, rather than the manufacturing date. Remaining issues and concerns Lack of definition of promotional information: Although the MOH has provided some guidance, the absence of a clear definition of promotional information leaves room for broad interpretation by regulatory bodies. Both the State Expert Centre and Quality Inspectorate may have different interpretations, particularly when assessing regulatory dossiers and inspecting products in circulation. Ban on local representative information on packaging: The shift towards prohibiting local representative information on packaging (while allowing it on the leaflet) could create operational challenges for foreign manufacturers, as their local representatives often play an essential role in product distribution and consumer safety. Quality inspectorate considerations: The Quality Inspectorate’s letter of 16 January 2025, also raised concerns about the inspection of products released before the full implementation of the new labelling regulations on 18 January 2025. If the products are not in compliance with the approved labelling on the date of release, they may be flagged during importation or market circulation. Next steps and recommendations Review labelling practices: Pharmaceutical companies must review and update their labelling practices to ensure compliance with the new requirements, particularly regarding logos, trade marks, and references to entities other than the manufacturer or MAH. Submit variations early: Given the length of the approval process for registering variations, companies should submit variations as soon as possible to avoid compliance issues, particularly regarding labelling changes. Advocating for revision: Companies may consider advocating for a revision of the legislative ban on local representatives on packaging, a clear definition of promotional information, and the introduction of a fast-track procedure for the assessment and approval of variations to bring medicinal products into compliance with the newly adopted labelling requirements (as the current timeline for the assessment and approval of variations often exceed five months). Monitor enforcement: Companies are advised to monitor the amendments proposed by the MOH and stay informed on how the Quality Inspectorate and MOH interpret and enforce the labelling requirements, especially as they begin to assess the packaging and labelling of products imported after 18 January 2025. For more information on regulations governing Ukraine’s pharmaceutical industry, contact your CMS client partner or these CMS experts:

In a previous Law-Now article, we provided analysis of the official interpretations from the Ukrainian Ministry of Health (MOH) and Quality Inspectorate, and insights into expected future regulatory amendments. This article will help companies navigate the new requirements and ensure they meet the necessary compliance standards.

Background and timeline

Ukraine’s regulatory landscape for medicinal product labelling has undergone significant changes. The following is a timeline of the key legislative and regulatory developments:

Law No. 3910-IX – Adopted by Parliament: 21 August 2024. Entered into force: 18 September 2024 with full implementation on 18 January 2025.
MOH Official Interpretation Letter: 19 November 2024: provides initial clarifications on the new labelling requirements. Link in Ukrainian
Cabinet of Ministers Resolution No. 39 of 17 January 2025 (‘Resolution’). Entered into force: 18 January 2025, amending the marketing authorisation procedure for medicines, particularly on labelling and the fast-track procedure. Link in Ukrainian
Quality Inspectorate Official Interpretation Letter: 16 January 2025: Clarifies various aspects of how the Inspectorate controls medicines, including labelling variations to dossiers and variations approval. Link in Ukrainian
The MOH launched public consultations on the proposed amendments to several MOH Orders on 20 December 2024. These draft amendments concern the marketing authorisation dossier assessment, suspension of authorisation and suspension of circulation of medicines procedures. Link in Ukrainian

Ban on promotional information

Under the new law, any promotional information is prohibited on the labelling of medicinal products, including both primary and secondary packaging. This ban extends to logos, trade marks, claims and any information not directly related to the product’s medical use. The term ‘promotional information’ is not defined in the legislation, leaving room for broad interpretation by regulators.

MOH interpretation (19 November 2024)

What is not considered promotional:
Information that is aligned with the approved leaflet or Summary of Product Characteristics (SmPC).
Symbols or pictograms that help clarify mandatory information and are useful for patients.
The logos of manufacturers (and parent groups) or the MAHs, provided they are used in official business documentation.
Information about the licensor and their logo is allowed, particularly in cases where the product is manufactured under a licence from the patent holder. This information is considered part of the manufacturer’s details, not advertising.
A statement such as “Manufactured under licence from [Licensor Name]” and the inclusion of the licensor’s logo is not regarded as promotional if it aligns with the legal use of the licence and the product’s manufacturing.

What is considered promotional:

Information that is not directly aligned with the approved leaflet or SmPC, such as arbitrary elaborations or additional marketing claims.
Information about a company that represents the manufacturer and/or applicant in Ukraine.
Information about or logos of a distributor or pharmacy chain, including those using a private label model.
For one medicine, use of several original layouts with the same labelling text but in different colours.

Ban on mentioning entities other than the manufacturer or MAH

A significant challenge arising from the new law is the ban on referencing legal entities other than the manufacturer or MAH. This prohibition extends to local representatives of foreign MAHs who have traditionally been included on the packaging for regulatory support, pharmacovigilance, and communications with healthcare professionals/responses to consumer complaints.

MOH interpretation (November 19, 2024): The MOH suggested that contact information for local representatives be included in the patient information leaflet, especially by foreign manufacturers and MAHs. Draft amendments propose a restrictive approach prohibiting inclusion of details on local representatives on packaging. Thus, contact details of a local representatives can now only appear in the approved leaflet.

Suspension of marketing authorisation and circulation

The existing regulatory framework and proposed by the MOH Draft amendments to regulations provide two distinct procedures for non-compliance with labelling requirements:

(a) Suspension of authorisation by MOH:

The MOH can temporarily suspend the marketing authorisation of a product that does not meet labelling requirements (e.g. labels containing promotional information or references to unauthorised entities). MOH will reinstate a suspended authorisation as soon as the MAH brings a concerned product’s labelling into compliance with the requirements.

(b) Suspension of circulation by the Quality Inspectorate:

The Draft amendments proposed by the MOH will provide the Quality Inspectorate with the authority to suspend the circulation of medicines on the market if the product’s labelling does not comply with the new requirements. This is particularly relevant for imported products and those in circulation in pharmacies, and for wholesalers. The Quality Inspectorate, which is responsible for inspecting medicines during import quality control and market circulation, will thus scrutinise packaging compliance more rigorously. According to the Quality Inspectorate’s interpretation letter of 16 January 2025, any approved registration variations apply to batches released post-implementation of the variations. Products manufactured before the variations’ approval date must still meet the previously approved characteristics, including those related to labelling, as of the date of release. This could prevent the importation and commercialisation of medicines released in packaging aligned with pending regulatory variations, if they were released before the variations are approved by the MOH.

Transition period and compliance:

The law restricts the import and commercialisation of medicines non-compliant with the new labelling requirements as of 18 January 2025. However, the commercialisation of medicines (CoM) Resolution clarifies that:

Products manufactured before 18 January 2025 can still be imported and used, even if their labelling does not fully comply with the new requirements. These products can be commercialised until their expiry date.

For any products manufactured after 18 January 2025, full compliance with the new labelling requirements is mandatory.

For enforcement purposes, the Quality Inspectorate is expected to rely on the batch release date when assessing compliance, rather than the manufacturing date.

Remaining issues and concerns

Lack of definition of promotional information: Although the MOH has provided some guidance, the absence of a clear definition of ‘promotional information’ leaves room for broad interpretation by regulatory bodies. Both the State Expert Centre and Quality Inspectorate may have different interpretations, particularly when assessing regulatory dossiers and inspecting products in circulation.
Ban on local representative information on packaging: The shift towards prohibiting local representative information on packaging (while allowing it on the leaflet) could create operational challenges for foreign manufacturers, as their local representatives often play an essential role in product distribution and consumer safety.
Quality inspectorate considerations: The Quality Inspectorate’s letter of 16 January 2025, also raised concerns about the inspection of products released before the full implementation of the new labelling regulations on 18 January 2025. If the products are not in compliance with the approved labelling on the date of release, they may be flagged during importation or market circulation.

Next steps and recommendations

Review labelling practices: Pharmaceutical companies must review and update their labelling practices to ensure compliance with the new requirements, particularly regarding logos, trade marks, and references to entities other than the manufacturer or MAH.
Submit variations early: Given the length of the approval process for registering variations, companies should submit variations as soon as possible to avoid compliance issues, particularly regarding labelling changes.
Advocating for revision: Companies may consider advocating for a revision of the legislative ban on local representatives on packaging, a clear definition of promotional information, and the introduction of a fast-track procedure for the assessment and approval of variations to bring medicinal products into compliance with the newly adopted labelling requirements (as the current timeline for the assessment and approval of variations often exceed five months).
Monitor enforcement: Companies are advised to monitor the amendments proposed by the MOH and stay informed on how the Quality Inspectorate and MOH interpret and enforce the labelling requirements, especially as they begin to assess the packaging and labelling of products imported after 18 January 2025.

For more information on regulations governing Ukraine’s pharmaceutical industry, contact your CMS client partner or these CMS experts: