Ukraine Pharma Reform 2027: The New Law on Medicinal Products

On 2 July 2026, Cratia and CMS Ukraine held a joint webinar, “Ukraine Pharma Reform 2027: What International Pharma Companies Must Do Now”. Maksym Bagrieiev, Managing Partner of Cratia, and Borys Danevych, Partner, Global Co-Head and CEE Head of Life Sciences & Healthcare at CMS, reviewed the legal and practical changes affecting pharmaceutical companies supplying the Ukrainian market.

The webinar covered transitional periods; the new regulatory authority, the Ukrainian Pharmaceutical Agency; changes to the requirements for marketing authorisation holders and Ukrainian representatives of non-resident holders; the new procedure for submitting applications for regulatory procedures and changes to the assessment process; the transition to eCTD; the new product information framework (Summary of Product Characteristics and package leaflet); serialisation; the new distinction between importation and distribution; GMP confirmation; changes to pharmacovigilance; annual fees; and many other topics. Particular attention was given to requirements for which preparations must be made before 2027 and to matters that have yet to be addressed in implementing legislation.

The webinar and this overview reflect the legislation in force and the draft implementing legislation available at the time of the webinar.

Implementation and transitional provisions

Most provisions of the new Law of Ukraine “On Medicinal Products” No. 2469-IX will apply from 1 January 2027. The Law brings Ukrainian medicines regulation closer to the EU framework, principally Directive 2001/83/EC. Certain requirements, including mandatory serialisation and additional obligations for active pharmaceutical ingredients (APIs), are scheduled for 1 January 2028. 

The transitional provisions require particular attention. The new Law provides for a five-year transitional period during which existing registration dossiers for medicinal products must be brought into compliance with the new requirements. However, the current version of the Law contains a significant legal inconsistency: the five-year period runs from the date on which the Law entered into force, namely 28 July 2022, which would mean that the transitional period ends on 28 July 2027. At the same time, the general understanding and the approach currently under discussion are that the intended five-year transitional period should run from 1 January 2027 to 31 December 2031.

Amendments to the Law are expected to resolve this inconsistency, but they have not yet been formally adopted.

There is also uncertainty over procedures submitted before 2027 but completed afterwards. The approach discussed envisages completion under the previous rules by the Ministry of Health (MoH) and State Expert Centre (SEC), but the allocation of responsibilities and legal basis need to be settled. Companies should assess the position of each product by authorisation date, validity period and registration route rather than assume that one transitional rule applies to the entire portfolio.

Ukrainian Pharmaceutical Agency

The Ukrainian Pharmaceutical Agency (UPA) is expected to become the sole central authority responsible for state registration, clinical trials, licensing, quality control, pharmacovigilance and GxP compliance inspections. It will take over the functions of two existing authorities, the State Expert Centre of the Ministry of Health of Ukraine and the State Service of Ukraine on Medicines and Drugs Control, as well as the approval of decisions on registration, renewal and variations, which currently rests with the Ministry of Health.

For registration procedures, this will change the sequence of steps and shorten timelines: the UPA alone will receive applications, conduct assessments, make decisions and enter the relevant information in the State Register.

State registration will be confirmed by information in the electronic State Register rather than a paper registration certificate. The marketing authorisation holder or its Representative will be able to obtain an extract from the Register.

The Agency’s remit will extend beyond medicinal products to include medical devices, cosmetic products, bioimplants, blood products and other regulated categories.

Marketing authorisation holders and representation in Ukraine

The new Law restricts the jurisdictions in which a Marketing Authorisation Holder (MAH) may be established. The general rule covers Ukraine, EU Member States and EFTA states participating in the European Economic Area: Iceland, Liechtenstein and Norway.

For specified categories of medicines, MAHs established in countries with Stringent Regulatory Authorities (SRAs) may also qualify. The SRA category is broader than the EU/EEA and includes the EU Member States, United States, Japan, Canada, Switzerland, United Kingdom, Australia, Iceland, Liechtenstein, Norway, Israel and New Zealand. Proposals to extend SRA-based MAH eligibility to all product categories were discussed, but have not been presented as adopted requirements.

Foreign MAHs will need to appoint a Representative in Ukraine. The Representative acts under an agreement and/or power of attorney and supports interaction with the authority, electronic submissions, deficiency responses, GMP procedures and access to the applicant’s e-cabinet.

The Representative’s details must also be reflected in product information. The Law requires the name and location of the MAH and, where applicable, its Representative on the secondary packaging, or primary packaging where secondary packaging is absent. The draft assessment procedure requires the Representative’s name, address and telephone number in the package leaflet.

Appointment does not transfer the MAH’s responsibility for the product. Nor does it automatically make the Representative an importer, distributor, batch-release Qualified Person or local pharmacovigilance contact. These functions should be distinguished in contractual arrangements, with procedures for forwarding patient enquiries, adverse-event reports and quality complaints to the responsible teams.

Registration procedures and scientific advice

Under the new submission model, the application and dossier are submitted together, with confirmation of payment of the state fee. This removes the interval currently available between application and dossier submission, which may reach 90 calendar days plus a further 20 days in specified circumstances.

Translations, administrative documents, technical sections and eCTD publishing will therefore need to be completed before filing. The previous separation into preliminary and specialised assessment is not retained in the same form for new registrations and renewals; the draft still provides a preliminary completeness check for variations.

The procedures discussed provide for a standard assessment period of 210 calendar days. A 30-calendar-day priority route applies to qualifying SRA/EMA-authorised products, including innovative/original and orphan medicines, advanced therapy medicinal products, HIV, haemophilia and oncology treatments, and vaccines. A separate 150-calendar-day accelerated procedure may be available for products of significant public-health interest, subject to justification. The timelines presented also include up to 60 calendar days for API registration and 45 days for a parallel import permit, which is distinct from a marketing authorisation.

Special procurement procedures have their own documentary requirements. Eligibility for procurement should not, by itself, be assumed to confer eligibility for the 30-day route.

The Law limits suspension of the assessment clock for additional information to six months from the start of the suspension. The draft also sets a nine-month deadline after completion of scientific assessment for providing valid GMP confirmation.

Scientific advice will offer a paid pre-submission procedure for questions on regulatory strategy, dossier requirements and eligibility for particular routes. It may be useful for well-established-use applications, complex generics, hybrids and line extensions. Questions should be product-specific and supported by the relevant documentation; the outcome is recorded in an advice protocol. The draft provides that the relevant registration, renewal or variation application cannot be submitted until the advice procedure is completed. Since advice may take several months, it should be scheduled before a time-critical filing.

Ukrainian eCTD requirements

From 1 January 2027, all submissions for initial registration, renewal and variations will be required exclusively in electronic Common Technical Document (eCTD) format, including applications for active pharmaceutical ingredients (APIs) and in-bulk products.

Ukraine uses the ICH eCTD 3.2.2 structure for Modules 2-5, but Module 1 is national. It has Ukrainian technical specifications and validation criteria, and certain documents require a qualified electronic signature compliant with Ukrainian legislation. For foreign MAHs, the Representative in Ukraine will need appropriate authority to sign the relevant documents. An electronic signature used for EU submissions should not be assumed to meet Ukrainian requirements.

Selected national documents must also be supplied as editable Word files in the “Working documents” folder. The Ukrainian dossier has a separate lifecycle, including its own identifier and sequence history.

An EU-validated submission is therefore not automatically ready for Ukraine. We recommend checking the national Module 1, signing arrangements and publishing software before preparing submissions with fixed deadlines. Reference-country assessment reports and product information may support a reliance application, but still need to be incorporated into a technically valid Ukrainian package.

Renewals and variations

From 1 January 2027, renewal applications must be submitted at least nine months before MA expiry, compared with the current general deadline of 180 calendar days. The draft procedure provides a filing window between 12 and nine months before expiry.

This deadline applies to the application and full dossier. MAs expiring in 2027 require early review: for products expiring in June, July or August, the nine-month date falls in 2026, before the new Law applies.

Separately, Resolution No. 377, effective from 1 June 2026, ends the wartime automatic-extension mechanism and provides a six-month period, until 1 December 2026, for affected MAHs to submit renewal applications. According to comments from representatives of the State Expert Centre of the Ministry of Health of Ukraine, once the new Law enters into force, it will no longer be possible to maintain the validity of marketing authorisations granted under these procedures or under the recognition procedure (Ministry of Health Order No. 1245) through renewal or variations.

Renewal assesses the product’s benefit-risk balance. Minor updates may be included, but new indications, significant quality changes and shelf-life extensions require separate variations.

The familiar variation categories remain: IA, IA IN, IB and II, alongside MAH transfers, urgent safety restrictions and changes requiring additional registration. The draft permits grouping where the relevant conditions are met or UPhA agrees, including identical Type IA changes across several dossiers.

The general assessment period is up to 120 calendar days. For qualifying priority products, the draft provides 30 working days for the first variation and 10 working days for each additional parallel change. The proposed deficiency-response period is 20 working days.

For labelling or package leaflet changes that do not affect the SmPC, the draft introduces a 90-day procedure under which the change may be implemented if the authority has not issued a negative opinion. MAH transfers may include directly related administrative updates without a separate variation.

Safety-related deadlines need to be incorporated into local procedures. Urgent safety restrictions require immediate notification and submission within 48 hours; newly identified hazardous properties leading to restrictions require immediate notification and submission within 15 days; and safety changes to the SmPC must be submitted within 60 calendar days of learning that the change is needed. The draft also provides notification within 15 calendar days for changes to the QPPV, local PV contact or PSMF location.

Product information, labelling and serialisation

Ukraine will replace the existing Instruction for Medical Use with a Summary of Product Characteristics (SmPC) and package leaflet. The SmPC is intended for healthcare professionals and is approved through the MA decision; the leaflet must provide patient-understandable information consistent with the SmPC.

As of the date of the webinar, the procedure and mechanism for transitioning from the existing instructions for medical use to these two documents had not been established. Packaging changes are also expected to be required to include details of the marketing authorisation holder and its Representative and to ensure consistency with the updated product information.

The Law requires packaging mock-ups to be submitted. However, the procedure for their approval or acknowledgement remained insufficiently described in the materials reviewed. The Ukrainian Methods of Quality Control document, or at least its regulatory function, is expected to remain relevant because the Law continues to refer to approved specifications and analytical methods.

For certain publicly procured medicines registered under Article 25, original-language labelling and product information may be accepted, subject to certified Ukrainian translations accompanying the packs and confirmation of the procurement purpose.

Mandatory serialisation starts on 1 January 2028 under the framework established by Cabinet of Ministers Resolution No. 1121. Safety features comprise a unique identifier and an anti-tampering device. Prescription medicines are covered unless exempted; non-prescription medicines are covered only where included in the applicable list.

The identifier is carried in a GS1 DataMatrix code containing the product code, serial number, batch number and expiry date. Products placed on the market before the mandatory date without safety features may remain in circulation until expiry. Manufacturers should coordinate Ukrainian artwork changes, regulatory submissions and verification-system arrangements with their packaging and serialisation teams.

GMP confirmation

Confirmation of GMP compliance will continue through two pathways: recognition of an acceptable GMP document issued by a stringent regulatory authority (SRA), resulting in the issuance of a Ukrainian GMP compliance conclusion; or an inspection procedure, resulting in the issuance of a GMP certificate.

The draft recognition procedure distinguishes between products manufactured entirely in SRA countries and those with at least one stage outside SRA territory. The latter may require additional documents, including a Site Master File, inspection report and evidence of registration in an SRA market showing the relevant sites.

The final batch-release location is therefore insufficient to determine the route. Bulk manufacture, primary and secondary packaging, quality control and release must all be considered.

The draft provides an initial review within three working days and an assessment period of up to 30 calendar days. Deficiencies must generally be corrected within 10 working days, with a further 10 working days available where justified. Requests to foreign authorities may suspend the procedure.

Remote assessment is envisaged where an on-site inspection is impossible, including for security reasons, but is subject to restrictions and cannot be used twice consecutively. It is unavailable in specified higher-risk cases, including sites without a previous Ukrainian or SRA inspection, inspections more than three years old, critical or numerous major findings, and insufficient evidence of corrective action. Companies should not assume that an existing SRA certificate or an EU release site removes the need to document the entire manufacturing chain.

Import, distribution and quality control

The new Law and Cabinet of Ministers Resolution No. 287 distinguish between import and distribution according to the applicable supply route.

Medicinal products manufactured and released for export to Ukraine by the Qualified Person of a manufacturer licensed in the EU or an EFTA state that is a party to the EEA Agreement are supplied under the distribution model. A licensed Ukrainian wholesale distributor performs quality verification through its Responsible Person and submits the required batch information to the UPA.

Switzerland, the United Kingdom, the United States, Canada and Israel are not covered by the distribution model based on EEA participation, despite their status as countries with stringent regulatory authorities (SRAs).

Medicinal products that do not fall within this model require a licensed importer. The importer’s Qualified Person is responsible for batch certification and release, including the necessary quality control. Information on the importer must be included in the registration dossier by submission of the relevant variations. 

Manufacturing chains involving multiple jurisdictions also require attention. The webinar highlighted uncertainty regarding medicinal products whose batches are released in the EU/EEA but for which certain manufacturing stages take place outside that territory. Previously, during public events, representatives of the State Service of Ukraine on Medicines and Drugs Control expressed the following position: if even one manufacturing stage takes place outside the EU/EEA, placing the medicinal product on the market should be treated as importation.

As the new distribution/import model takes effect at the same time as the new Law, with no transitional period, it is advisable to assess the supply model and submit an application to add the importer(s) to the registration dossier as early as possible, while still in 2026.

Where Ukrainian laboratory testing is required, it must demonstrate compliance with the approved dossier and quality-control methods. Exemptions may apply to products manufactured, quality-controlled and released in SRA countries. Results from the General European OMCL Network may also support batch certification. The proposed batch-notification period is three working days following the relevant release or verification step.

APIs are addressed separately. Registration of APIs and in-bulk products becomes voluntary; unregistered materials may be imported for manufacturing registered finished products where included in the relevant dossiers. From 1 January 2028, additional API GMP/GDP requirements apply. Imported APIs will require written confirmation from the exporting country’s competent authority unless the country is an EU Member State or appears on the applicable equivalence list.

Pharmacovigilance

The draft pharmacovigilance procedure introduces electronic interaction through UPhA’s database and the MAH’s personal e-cabinet. MAHs will need to submit safety reports electronically and monitor reports concerning their products in the authority’s database.

Qualification requirements are more detailed for the QPPV of a Ukraine-based MAH and the local pharmacovigilance contact person. The draft requires a Master’s degree in specified medical or pharmaceutical specialties, an internship and pharmacovigilance specialisation within one year of appointment where not already held.

The new Law requires the MAH to have a pharmacovigilance responsible person continuously at its disposal, rather than expressly requiring employment within the MAH’s staff. This supports contractual arrangements, while responsibility for the system remains with the MAH.

Regulatory pharmacovigilance inspections will replace the existing authority audit model and may cover applicants before registration as well as authorised products. The draft provides for risk-based planned inspections and targeted inspections following safety or compliance concerns. An absence of inspection during the previous four years is also identified as a basis for planned inspection.

Failure to eliminate critical deficiencies within the prescribed period may lead to suspension of the marketing authorisation. We recommend reviewing local qualifications, access arrangements, safety-variation timelines and inspection readiness together, including the availability of the Pharmacovigilance System Master File and evidence that corrective actions have been implemented.

Annual payments and supply obligations

In addition to procedure-specific fees, the proposed funding model includes annual payments for pharmacovigilance, access to the PV database/e-cabinet and state supervision and control.

The draft envisages calculation by the MAH according to the number of authorisations, with 50% payable by 31 March and 50% by 30 September, followed by payment reports. Verification-system charges are separate and should also be considered when budgeting for serialisation.

MAHs will have to notify UPhA of first placing on the Ukrainian market and decisions not to market or to discontinue supply. Temporary or permanent discontinuation requires at least two months’ advance notice. Sales and circulation data must be supplied on request. MAHs and wholesale distributors must also ensure adequate and continuous supply to meet patient needs within their respective responsibilities.

The Law also introduces a three-year sunset clause: registration may be terminated where a product is not placed on the market within three years of registration or is absent for three consecutive years. Exceptions may be granted on public-health grounds. These obligations make documented market-status information relevant to maintaining the authorisation.

Advertising, promotion and market access

The new rules distinguish public advertising from promotion to healthcare professionals, with MAH responsibility for promotional activities. Medical representative visits, professional websites and publications, samples, sponsored events and educational grants will need to be assessed under the applicable promotional requirements.

The changes discussed include restrictions on advertising reimbursed medicines and products containing narcotic or psychotropic substances or precursors, a prohibition on child-targeted advertising, and an INN requirement for single-active-ingredient medicines. The webinar also addressed the removal of the existing “Self-medication can be harmful to your health” warning.

For public procurement and reimbursement, the National Essential Medicines List remains important. Separate registration provisions apply to medicines intended for procurement by Medical Procurement of Ukraine, including under managed entry agreements, and international organisations. Registration strategy should be considered alongside the intended procurement route and health technology assessment requirements.

CMS also addressed the distinction between the Ukrainian and EU exclusivity models. The model discussed provides five years of marketing exclusivity calculated by reference to the first authorisation of the reference medicinal product in Ukraine or the EU/EEA, including authorisation under the EU centralised procedure, with a possible one-year extension for qualifying new indications. It does not reproduce the EU’s separate orphan or paediatric exclusivity regimes. Originator and generic companies should assess protection periods against the Ukrainian provisions rather than assume EU rules apply automatically.

Cratia supports pharmaceutical companies with registration, renewal and variations, preparation of eCTD dossiers in accordance with Ukrainian requirements, GMP confirmation, local pharmacovigilance, product information and regulatory quality matters. Our team of more than 80 professionals combines in-depth knowledge with many years of experience, understands the requirements of the new legislation, and helps partners prepare for them and bring their dossiers into compliance with the new Law. We are also ready to:

• act as the Marketing Authorisation Holder’s Representative in Ukraine and provide comprehensive registration, pharmacovigilance and quality support;
• prepare eCTD submissions in accordance with national requirements and the UA M1 specification for initial registration, renewal, variations and baseline submissions;
• develop a pharmacovigilance quality system for a new Applicant and provide the services of a local contact person or a Qualified Person Responsible for Pharmacovigilance;
• support confirmation of a manufacturer’s GMP compliance through recognition or inspection;
• assist with the transition to serialisation, update labelling and bring packaging artwork into compliance with the new requirements.

For advice on how the new Law will affect your medicinal products in Ukraine, contact us at info@cratia.ua, call +38 044 332 42 94, or visit our office for a meeting.