Ukraine 2026: Practical Challenges for Cosmetic Imports and the Role of the Responsible Person

This article was prepared following a Cosmetica Italia Servizi webinar dedicated to the new regulatory framework for cosmetic products in Ukraine.

On 30 June 2026, the Pharma Navigation team joined approximately one hundred other participants at the Cosmetica Italia Servizi webinar, “Exporting to Ukraine: Is Your Company Ready for the New Rules?”

The event was organised for Italian manufacturers, cosmetic brand owners, exporters, and companies already operating in or planning to enter the Ukrainian market. The main focus was the full application of Ukraine’s new cosmetic products regulatory framework from 3 August 2026 and the practical role of the Responsible Person in Ukraine.

For Pharma Navigation, participation in this type of international professional discussion has significant practical value. European manufacturers need not only to understand Ukrainian legal requirements but also to establish an effective working model with their Responsible Person and importers. This includes defining procedures for transferring documentation, protecting confidential formulations, adapting the Product Information File, completing product notifications, and updating information after a product has been placed on the market.

These matters form part of Pharma Navigation’s daily work supporting foreign manufacturers and Ukrainian distributors.

3 August 2026: A Change in the Regulatory Model, Not Merely Another Deadline

The Technical Regulation on Cosmetic Products, approved by Resolution No. 65 of the Cabinet of Ministers of Ukraine dated 20 January 2021, entered into force on 3 August 2024. A transitional period was introduced to allow the market to adapt. Once this period ends, imported cosmetic products must be prepared in accordance with the new regulatory model.

This model includes:
• verification of product formulations against Ukrainian requirements;
• appointment of a Responsible Person;
• availability of a compliant PIF and CPSR;
• evidence of compliance with Good Manufacturing Practice;
• adaptation of product labelling;
• notification before the product is placed on the market;
• ongoing management of complaints, undesirable effects, and product changes.

The Ukrainian Technical Regulation is based on Regulation (EC) No 1223/2009. However, a product that is lawfully marketed in Italy or another EU Member State does not automatically become ready to be placed on the Ukrainian market.

EU compliance provides a strong foundation, but it does not replace the Ukrainian regulatory procedure.

For the Ukrainian market, a product requires a locally established Responsible Person, national notification, documentation accessible to the Ukrainian authorities, adapted labelling, and clearly documented contractual arrangements between the manufacturer, importer, and Responsible Person.

The Most Challenging Issues for European Manufacturers

The large number of questions raised during the webinar demonstrated that the main difficulties concern not the general principles of European cosmetic regulation, but their practical application in Ukraine.

Participants were particularly interested in the following issues:

• how the transitional arrangements will apply to future shipments;
• who should act as the Responsible Person when several importers are involved;
• where the PIF must be kept and which parts must be translated into Ukrainian;
• whether providing only the CPSR is sufficient;
• how to protect the quantitative formulation and other confidential documentation;
• who may sign or validate the safety assessment for the Ukrainian market;
• how different SKUs, shades, and packaging variants should be notified;
• when Ukrainian labelling must be applied, how the Responsible Person function may be transferred to another entity.

These questions confirm that the principal challenge is not merely the completion of an electronic notification form. Companies must restructure the way they manage documentation, regulatory responsibilities, and the exchange of information.

We hope that professional educational events of this kind will improve regulatory awareness among European manufacturers and suppliers. Better awareness should facilitate the exchange of information and technical documentation with Ukrainian Responsible Persons, shorten product preparation timelines, and reduce the risk of disruptions to cosmetic product supplies in Ukraine.

Transitional provisions: The Specific Batch Matters, Not the Brand’s Market History

One of the most important practical clarifications concerned the application of the transitional provisions to products already present on the Ukrainian market before 3 August 2026.

The fact that a brand or product was sold in Ukraine before this date should not be interpreted as an automatic authorisation to continue importing new batches under the previous rules. A distinction must be made between batches placed on the market before the cut-off date and subsequent shipments of the same product.

The manufacturing date alone does not prove that a product was placed on the Ukrainian market. To rely on the transitional provisions, companies should retain customs declarations, invoices, delivery notes, warehouse records, batch numbers, and other documents confirming the date and quantity of the specific products placed on the market.

Pharma Navigation’s Practical Recommendation

For remaining stock placed on the market before 3 August 2026, companies should create a separate batch-specific evidence file.

This file should make it possible to clearly establish:
• the identity of the product;
• the batch number;
• the date on which the product entered the Ukrainian market;
• the relevant quantity;
• the supporting documents on which the application of the transitional arrangements is based.

Such a file provides much stronger evidence than a general statement that the brand has been present in Ukraine for many years.

The Responsible Person as the Centre of the Compliance System

Every cosmetic product placed on the Ukrainian market must be linked to a Responsible Person established in Ukraine.
One Responsible Person may manage numerous products, product lines, and brands. However, the Responsible Person’s role must be clearly defined for each product.

The Responsible Person:
• verifies the formulation, labelling, and product claims;
• ensures the availability of the CPSR and PIF;
• verifies GMP documentation;
• completes the product notification;
• communicates with market surveillance authorities;
• handles complaints;
• coordinates corrective actions.

The appointment of a Responsible Person is therefore not merely nominal representation or technical access to the notification portal. It involves the transfer and performance of substantive regulatory functions and responsibilities.

Can a Distributor Act as the Responsible Person?

In the case of imported cosmetic products, the importer will generally assume the role of the Responsible Person unless this role has been transferred to another entity established in Ukraine that has formally accepted the relevant functions and responsibilities. The practical question is therefore not simply whether a distributor may act as the Responsible Person, but whether this model is optimal for the manufacturer and the entire supply chain.

A PIF may contain:
• the full quantitative formulation;
• raw material specifications;
• information about suppliers and manufacturing processes;
• impurity data;
• test results;
• other commercially sensitive information.

Providing the complete dossier to a distributor may create confidentiality risks and make the manufacturer dependent on a single distribution channel.

This issue is particularly important for brands that work with several importers, plan to change distributors, or do not wish to disclose their complete formulations to every commercial partner.

Where several importers are involved, it may be advisable to appoint one Responsible Person to centrally manage the PIF, notifications, updates, and communication with the authorities.

An Independent Responsible Person as an Alternative to the Distributor Model

Appointing an independent specialised company allows regulatory functions to be separated from commercial distribution activities.

Under this model, the manufacturer provides the documentation to the independent Responsible Person, while distributors do not automatically receive access to the complete PIF.

A single documentation and notification system may be used when working with several importers. A change of commercial partner therefore does not require the entire regulatory function to be transferred.

Pharma Navigation provides independent Responsible Person services in Ukraine.

The relationship is formalised through:
• a Responsible Person Appointment Agreement;
• a Technical Agreement;
• a Non-Disclosure Agreement.
These documents define the allocation of responsibilities, documentation exchange procedures, confidentiality requirements, and the parties’ interaction after the products have been placed on the market.

The PIF Must Be Accessible in Ukraine

A European manufacturer may already have a complete PIF maintained in Italy or another EU country. However, this is insufficient if the Ukrainian Responsible Person does not have actual access to the documentation and cannot provide it promptly to the market surveillance authority.

The PIF must:
• remain under the control of the Responsible Person;
• be physically or electronically accessible in Ukraine;
• be kept up to date;
• be made available to the competent authorities upon a substantiated request.

A model under which the Responsible Person receives the dossier from the manufacturer only after an inspection has started does not reflect the substance of the Responsible Person’s responsibilities.

The CPSR does not replace the complete PIF.

Part B of the safety report cannot be considered separately from Part A, the formulation, raw material characteristics, impurity data, microbiological quality, stability, packaging, exposure assessment, and product labelling.

Where a contract manufacturer does not provide a complete PIF, the brand owner may provide the underlying technical documentation from which a dossier can be prepared or adapted for the Ukrainian market.

Does the Entire PIF Have to Be Translated into Ukrainian?

The language requirement was one of the most widely discussed issues during the event.

The organisers’ written responses suggested a more practical approach than the mechanical translation of every page of the dossier.

Depending on the product, part of the original documentation may remain in English, while key sections, safety-related documents, and technical summaries are prepared in Ukrainian.

The principal objective is not a word-for-word translation of the archive, but the regulatory adaptation of the PIF.

This process includes:
• analysing the European dossier;
• identifying documentation gaps;
• verifying compliance with Ukrainian requirements;
• preparing local documents;
• ensuring consistency between the PIF, CPSR, labelling, and notification data.

CPSR and the Qualifications of the Safety Assessor

The Cosmetic Product Safety Report is a mandatory part of the PIF.

The key criterion for a safety assessor is the possession of appropriate qualifications and compliance with the requirements of Ukrainian legislation.

Even where a European CPSR has been properly prepared for the EU market, it is necessary to verify whether:
• the underlying data are sufficient;
• the assessment complies with Ukrainian requirements;
• the conclusions can be properly substantiated before the Ukrainian authorities.

The most reliable approaches remain:
• preparation of the CPSR by a qualified safety assessor who meets Ukrainian requirements;
• appropriate review and validation of the European report for use in Ukraine.

The assessment should not be reduced to the formal signing of an existing document.
The assessor must review the underlying data, exposure calculations, toxicological profiles of the ingredients, microbiological quality, stability, packaging, labelling, and intended conditions of use.

Ukrainian Notification Is Not a Copy of the CPNP Submission

Ukraine’s electronic cosmetic product notification system was launched on 1 December 2025.
The notification must be submitted by the Responsible Person or its authorised employees.

The following information is entered into the system:
• product identification details;
• product category;
• product name;
• country of origin;
• shades and variants;
• a graphic file of the product labelling;
• formulation information;
• information on CMR substances;
• information on nanomaterials;
• other specific product characteristics.

During the webinar, the speakers emphasised that access to the portal is linked to personal electronic identification. A formulation cannot simply be attached as a PDF, and bulk upload functionality does not eliminate the need to verify critical information for each individual product.

Material changes to previously notified information must also be reflected in the system.

According to an estimate presented during the webinar, the actual time required to complete a Ukrainian notification may be 10 to 20 times greater than the time typically required for a CPNP submission.

For portfolios containing hundreds of products, shades, and variants, notification becomes a separate regulatory project. It requires advance preparation of the data and verification of formulations, labelling files, and commercial configurations.

Product, Formula, Shade, or SKU?

A prudent practical approach is to assess each product in its specific commercial configuration.

Differences in any of the following may require the creation of a separate variant, an update to an existing notification, or a new notification:
• formulation;
• shade;
• fragrance;
• function;
• product name;
• barcode;
• packaging;
• labelling;
• product claims.

Not every design change automatically creates a new product.

However, changes affecting the product’s identification or the information entered in the notification system must be assessed separately by the Responsible Person.

This issue is particularly relevant to decorative cosmetics, hair dyes, fragrances, and product lines with numerous variants.

Labelling: Translating the European Label Is Not Enough

Ukrainian product labelling must simultaneously comply with:
• the Technical Regulation on Cosmetic Products;
• Ukrainian language legislation;
• consumer protection requirements;
• requirements concerning the accuracy and substantiation of product claims;
• any specific requirements applicable to the relevant product category.

Mandatory consumer information must be available in Ukrainian. At the same time, INCI names should not be translated as ordinary text because they form part of an international nomenclature. Arbitrary transliteration may distort the information.

A Ukrainian-language sticker may be used provided that it:
• contains accurate information;
• is legible and durable;
• does not obscure other mandatory information;
• is applied before the product is made available to the consumer.

However, relabelling after importation may create risks during customs clearance or regulatory inspections. The stage at which the Ukrainian sticker is applied should therefore be determined before the products are shipped.

What Ukrainian Distributors Should Do Before Future Shipments

A general recommendation to “audit the product portfolio” is no longer sufficient. For shipments made after 3 August 2026, distributors should implement an internal regulatory release mechanism before products are approved for dispatch.

An order or shipment of a new batch should not receive final approval until:
• the Responsible Person has been appointed;
• contractual arrangements and confidentiality obligations have been established;
• a sufficient documentation package has been obtained;
• the PIF and CPSR have been adapted;
• the formulation has been reviewed;
• the Ukrainian labelling has been approved;
• the notification has been completed.

The parties should also define in advance:
• how documentation will be updated;
• how product changes will be reported;
• how complaints will be transferred;
• how the manufacturer, importer,
Responsible Person will cooperate after the product has been placed on the market.

This reduces the risk of a situation in which products have already been manufactured, paid for, or shipped, but cannot be properly notified because the PIF is incomplete, the formulation is unavailable, the CPSR is unacceptable, or the labelling has not been approved.

Conclusion

The Cosmetica Italia Servizi webinar demonstrated that Ukraine’s cosmetic products regulatory reform affects not only local importers, but also the regulatory, contractual, and commercial processes of European manufacturers.

After 3 August 2026, an EU notification, a European PIF, or a brand’s long-standing sales history in Ukraine will no longer be sufficient on its own.

For each cosmetic product, companies must ensure:
• the appointment of a clearly identified Responsible Person;
• the availability of accessible and properly adapted documentation;
• an appropriate safety assessment;
• compliant Ukrainian labelling;
• completion of the national notification;
• an ongoing system of regulatory support and product compliance maintenance.

Pharma Navigation treats notification not as an isolated administrative action, but as the final stage of a comprehensive product market-readiness process.

The company provides independent Responsible Person services in Ukraine, adapts European PIFs to Ukrainian requirements, coordinates the preparation or review of CPSRs, assesses formulations and product claims, develops compliant labelling, and completes cosmetic product notifications.