The New Law on Medicinal Products in Ukraine

The principal provisions of Ukraine’s new Law on Medicinal Products become applicable on 1 January 2027. They change the rules for marketing authorisation holders, product authorisation, manufacturing and supplies into Ukraine. Some provisions already apply, while certain obligations are deferred until 2028. Companies should review their authorisations, licences and supply channels against the transitional rules.

This overview is intended for international pharmaceutical manufacturers, marketing authorisation holders, importers, distributors and investors operating in or entering Ukraine.

1. When the new medicinal products law applies

2. Pharmaceutical rules already in effect

3. Marketing authorisation holders and Ukrainian representatives

4. Medicinal product authorisation and dossier requirements

5. Manufacturing and GMP requirements

6. Supplies from the EU and other countries

7. Transitional rules for existing authorisations

8. Pharmacovigilance and preparations for the 2028 requirements

9. Compliance checklist for pharmaceutical companies

Frequently asked questions

How DLF can help

1. When the new medicinal products law applies

Law of Ukraine No. 2469-IX of 28 July 2022 “On Medicinal Products” entered into force on 18 August 2022. Its principal provisions become applicable on 1 January 2027, when Law No. 123/96-VR of 4 April 1996 is repealed. Until 1 January 2027, the 1996 law applies as amended.

The reform has several stages. Parallel-import and electronic-dossier rules already apply, while specified requirements for active pharmaceutical ingredients, investigational medicines, verification and pharmacy practice become applicable on 1 January 2028. Certain parallel-import provisions are linked to Ukraine’s accession to the EU.

Key changes and transitional dates

2. Pharmaceutical rules already in effect

Labelling. Since 18 January 2025, promotional information and information about persons other than the manufacturer or applicant holding the registration certificate have been prohibited on inner and outer packaging. Statutory exceptions cover, among other cases, specified procurements in foreign-language packaging, humanitarian aid and permitted imports of unregistered medicines.

Parallel imports. A special regime has applied since 1 January 2025 to EU/EEA medicines released for the exporting country’s market. The product must be identical or similar to a medicine registered in Ukraine in its qualitative and quantitative composition of active substances, pharmaceutical form, strength or dosage, and route of administration, and have at least the same indications. The similarity must not result in a therapeutic difference. Alternatively, the law allows parallel imports where both products are reference medicines, or both are generics, in Ukraine and in the exporting country. An import licence and a parallel import authorisation valid for 5 years are required. Sales through pharmacies and their branches are prohibited; this restriction must be considered when arranging public procurement and supplies to healthcare facilities.

Promotion. Healthcare and pharmaceutical professionals have been prohibited from receiving samples for professional use since 1 August 2012. The restrictions were expanded on 18 December 2024. The current rules cover healthcare professionals, pharmaceutical professionals and rehabilitation specialists, with exceptions for specified clinical trials and investigations. They also restrict branded promotional items, benefits conditional on prescribing or dispensing products, and the use of prescription forms containing promotional information.

Price regulation. Maximum wholesale prices must be declared in the National Price Catalogue for products covered by the relevant procedure. Under Resolution No. 439, the price of qualifying generic or similar biological products must not exceed 75% of the declared price of the corresponding original product, calculated per dosage-form unit. External reference pricing uses prices in 8 specified countries. The wholesale supply and distribution mark-up must not exceed 8%, unless legislation provides otherwise. The Cabinet of Ministers sets maximum wholesale and retail mark-ups; the applicable rules depend on the product category and funding source.

Electronic dossiers. Since 18 August 2025, eCTD submissions have been mandatory for new authorisation applications, subject to the established exceptions. The law also provides for this format for renewals, indefinite extensions and dossier variations. Until 1 January 2027, according to the State Expert Centre, renewal and variation applications may still be filed under the current procedures.

Regulator. The State Service of Ukraine on Medicines and Drug Control was renamed the Ukrainian Pharmaceutical Agency on 3 October 2026. Resolution No. 1209 defers the entry into force of the Agency’s new governing regulation until 1 January 2027.

Bolar provision. Since 5 June 2025, the research and preparatory activities specified by law for the authorisation of medicinal products, including generics and biosimilars, do not infringe patent or supplementary protection certificate rights. A person intending to submit authorisation materials under this exception must notify each relevant patent and/or certificate holder in writing at least 80 calendar days before submission. The exception does not permit commercial sales that infringe existing intellectual property rights.

3. Marketing authorisation holders and Ukrainian representatives

Under the new law, a marketing authorisation holder may be a legal entity or individual entrepreneur registered in Ukraine, or a person registered in the EU or an EFTA state party to the EEA Agreement. Holders from countries with stringent regulatory authorities (SRA countries) may qualify for specified product categories; the Ministry of Health approves the country list. It includes the USA, Japan, Canada, Switzerland and Australia. The exception covers the specified categories of orphan and innovative medicines, advanced therapy medicinal products (ATMPs), medicines for HIV prevention or treatment, treatments for haemophilia and cancer, and vaccines. For medicines to be procured by specialised organisations or the person authorised to conduct healthcare procurement, the authorisation holder may also be a person registered in another country.

An EU/EEA holder that is not registered in Ukraine must appoint a Ukrainian representative under a written agreement and/or power of attorney defining the representative’s rights and duties. The representative must be a legal entity or individual entrepreneur registered in Ukraine. The representative does not replace the Authorised Person responsible for batch certification and release or the person responsible for pharmacovigilance.

Existing holders from other jurisdictions should first examine the transitional rules and product-specific exceptions. Where necessary, options may include establishing a company in Ukraine or an eligible EU/EEA structure, or transferring the authorisation to an eligible person. The law does not impose a general requirement to transfer every existing authorisation by 1 January 2027.

4. Medicinal product authorisation and dossier requirements

Under the new system, a marketing authorisation normally lasts 5 years. A renewal application must be filed at least 9 months before expiry. A favourable benefit-risk balance may lead to indefinite renewal; justified pharmacovigilance grounds may instead require a further 5-year renewal. Special rules apply to certain procedures.

The principal review periods are:

• The standard period is 210 calendar days from receipt of the application. The clock is stopped while deficiencies are corrected or additional documents or explanations are provided.
• A special period of no more than 30 days applies to the statutory categories of orphan, innovative and other medicines authorised in SRA countries or through the EU procedure involving EMA, and to vaccines for which technology has been transferred to Ukraine pursuant to a WHO decision.

Alongside the electronic dossier, the new system provides for a Summary of Product Characteristics (SmPC) for healthcare and pharmaceutical professionals and a package leaflet for patients. The leaflet must include standard wording inviting reports of adverse reactions. Statutory exceptions to a separate leaflet include cases where the required information already appears on the packaging.

For qualifying reference products, the law provides 5 years of data exclusivity, with a possible 1-year extension of the relevant period under specified conditions. These periods depend, among other things, on the Ukrainian application for the reference product being filed within 2 years of its first worldwide authorisation; exceptions also apply. Generic development, testing and dossier assessment are permitted within the limits set by law. Where data exclusivity applies, a generic may be entered in the register only after the protection period has expired. The Bolar provision concerns patent rights and does not shorten that period.

5. Manufacturing and GMP requirements

The new law requires premises, personnel and quality-control arrangements to be checked against licensing conditions and GMP before a manufacturing licence is granted. GMP compliance is confirmed by inspection or, where the prescribed conditions are met, recognition of an official SRA-country document. GMP obligations already apply under the existing licensing conditions.

A Ukrainian manufacturing licence holder must have at least one Authorised Person on its staff with the required qualifications and experience. That person is responsible for batch certification and release and for confirming compliance with the applicable requirements and the authorisation dossier.

Contract manufacturing must be reflected in the authorisation dossier. A written agreement must allocate the parties’ manufacturing and quality-control duties and identify the person responsible for batch certification and release. The statutory requirements for the parties’ licences and GMP documentation must also be observed.

6. Supplies from the EU and other countries

The procedure for bringing medicinal products into Ukraine under Resolution No. 287 takes effect on 1 January 2027. It distinguishes supplies handled by importers, parallel importers and distributors. The general rules below concern authorised finished products; APIs and investigational medicines are subject to separate requirements.

EU/EEA distribution. A licensed Ukrainian distributor may bring in medicines manufactured by a licensed EU/EEA manufacturer and released by its Authorised Person for export to Ukraine. This channel follows wholesale-distribution rules rather than the ordinary procedure requiring a separate import licence. GDP, batch-quality checks by the distributor’s responsible person and the other statutory conditions remain applicable.

Imports from other countries. The importer needs the appropriate licence and its own Authorised Person. Batches manufactured and quality-controlled in SRA countries may be exempt from repeat laboratory testing in Ukraine where the conditions, including GMP and equivalent quality controls, are fulfilled. The manufacturer’s certificate does not displace the other batch-certification and release requirements. Other batches undergo the prescribed tests in the importer’s own or a contracted laboratory certified or authorised by the regulator, subject to other statutory exceptions.

Batch notifications. Importers and parallel importers submit electronic information within 3 working days after the batch certificate is issued. Distributors submit it within 3 working days after the quality check is completed. The regulator enters the information in the relevant state register no later than the next working day.

7. Transitional rules for existing authorisations

Fixed-term certificates. Certificates issued before the new law entered into force on 18 August 2022 and bearing an expiry date remain valid for the term stated in them. Subsequent renewal follows the rules applicable when the relevant application is filed.

Indefinite certificates. Certificates issued without a time limit before 18 August 2022 retain their indefinite status. Within 5 years of that date, until 18 August 2027, holders may apply to exchange them free of charge for an extract from the State Register of Medicinal Products without changing the dossier or providing additional materials. The exchange is not a new authorisation.

Transitional placement on the market. Products registered before 18 August 2022 benefit from a 5-year period for placement on the market under the previous rules, ending on 18 August 2027. Products lawfully placed on the market under that rule may remain in circulation until their shelf life expires.

Dossier adaptation. Holders must align their registration materials, labelling and packaging with the new law within 5 years of its operative date. The general adaptation deadline is 1 January 2032. It does not replace an authorisation’s expiry date or the specific requirements applicable to an individual medicine.

8. Pharmacovigilance and preparations for the 2028 requirements

Pharmacovigilance. From 2027, the new law sets out a more detailed pharmacovigilance framework; existing duties continue to apply in the meantime. Holders must ensure the continuous availability of a person responsible for pharmacovigilance, maintain a Pharmacovigilance System Master File (PSMF), operate a risk-management system and submit Periodic Safety Update Reports (PSURs) under the applicable rules. If the responsible person does not reside in Ukraine, a contact person living and working in Ukraine is required. The law provides for recording adverse reactions and submitting the relevant information electronically, with deadlines and reporting frequency governed by the specific procedures. The new law provides for an annual fee payable by authorisation holders for using their personal account in the pharmacovigilance database. The Cabinet of Ministers determines the amount and payment arrangements.

Serialisation. Safety features become mandatory on 1 January 2028 for prescription medicines, subject to the Ministry of Health’s exclusions, and for non-prescription medicines on its specified list. They comprise a unique identifier in GS1 DataMatrix format and an anti-tampering device. Voluntary implementation is possible from 1 January 2026, but only after the announcement that the relevant national verification-system data repository has entered production operation. Medicines placed on the market before 1 January 2028 without those safety features may be sold until expiry.

Other requirements from 2028. From 1 January 2028, manufacturers, importers and wholesalers of active pharmaceutical ingredients (APIs) permitted to circulate in Ukraine will be subject to registration with the state regulator. The registration form must be filed at least 60 days before the relevant activity begins, with changes to the registered particulars reported annually. The licensing requirement for imports of investigational medicines other than APIs, and the requirement to follow Good Pharmacy Practice (GPP) in retail sales, also become applicable on that date.

9. Compliance checklist for pharmaceutical companies

Requirements already in effect

• Review labelling, sample-receipt rules and promotion restrictions.
• Check price declarations and applicable mark-ups for the product category.
• Ensure eCTD submissions for the registration procedures covered by the law.
• Update references to the regulator’s name, distinguishing the renaming from its new powers.

By 1 January 2027

• Check the holder’s eligibility and applicable transitional rules.
• Where required, appoint the representative by agreement and/or power of attorney.
• Review manufacturing licences, GMP evidence, Authorised Persons and contract-manufacturing agreements.
• Classify each supply route and establish the applicable laboratory-testing conditions.
• Prepare electronic batch notifications within 3 working days of the relevant event.
• Align the pharmacovigilance system, responsible persons, PSMF and reporting arrangements.

By 18 August 2027

• Consider the voluntary exchange of indefinite certificates issued before 18 August 2022.
• Review the end of the transitional placement period for products registered before 18 August 2022.

By 1 January 2028

• Implement safety features for products covered by serialisation, taking account of exclusions.
• Prepare API-operator registration and review the new licensing rules for investigational medicines; allow 60 days before starting the relevant API activity.
• Prepare retail pharmacies to meet GPP requirements.

By 1 January 2032

• Align the relevant registration materials, labelling and packaging with the new law.

Frequently asked questions

Must existing medicines be re-registered by 1 January 2027?

There is no general requirement to re-register every medicine by that date. Certificates issued before 18 August 2022 are covered by separate transitional rules depending on their duration. The adaptation deadline of 1 January 2032 does not remove the need to renew fixed-term authorisations on time.

Can a US or Japanese company hold an authorisation under the new law?

Yes, for the statutory product categories covered by the SRA-country exceptions or other special procurement rules. The general procedure applies eligibility requirements for persons in Ukraine and the EU/EEA. Existing authorisations must be assessed under the transitional provisions.

How will supplies from the EU and other countries change?

From 2027, qualifying EU/EEA supplies through a licensed distributor follow a separate route. Imports from other countries require the appropriate licence and an Authorised Person. An SRA-batch exemption from laboratory testing does not remove the other quality and batch-release requirements.

When does serialisation become mandatory?

From 1 January 2028 for prescription and specified non-prescription medicines, subject to the exclusions. Voluntary participation from 2026 depends on confirmed technical readiness. Products placed on the market before 2028 without safety features may be sold until expiry.

Must a licence be reissued because the regulator was renamed?

No. Resolution No. 1209 does not require licences to be reissued solely because the authority’s name changed. New licensing requirements must be met once they become applicable.

Is generics research permitted before patent protection expires?

Yes, within the research and authorisation activities covered by the Bolar provision. The relevant patent and/or supplementary protection certificate holders must be sent written notice at least 80 calendar days before the authorisation materials are submitted. The exception does not permit commercial sales that infringe existing rights and does not displace the separate data-protection rules.

How DLF can help

DLF attorneys-at-law supports international pharmaceutical manufacturers, marketing authorisation holders and distributors entering Ukraine or adapting to the new rules. The team reviews authorisation and representative arrangements, licensing requirements, import conditions and supply contracts, assesses intellectual property risks and structures relationships with Ukrainian partners. Relevant practice areas include contract law and intellectual property law.

Igor Dykunskyy, LL.M., Partner and Attorney-at-law, DLF attorneys-at-law.

Contact: +380 44 384 24 54, [email protected].

This material provides general information. The application of the approaches described depends on the circumstances of the particular matter and requires a separate legal assessment.