Registration of Medicinal Products in Ukraine

State registration of a medicinal product is the main procedure for obtaining access to the Ukrainian pharmaceutical market. During the registration process, the quality, safety and efficacy of the medicinal product are assessed, and the product information, Instructions for Medical Use and packaging materials are approved.

However, regulatory support does not end once the registration is granted. Throughout the entire lifecycle of a medicinal product, the registration dossier must be kept up to date, variations must be submitted, pharmacovigilance obligations must be fulfilled, the GMP status of manufacturing sites must be maintained, and requirements relating to import, quality control, labelling, advertising and promotion must be observed.

The Ukrainian regulatory system for medicinal products is currently in a transitional phase. In 2026, the main registration procedures continue to operate under the Law of Ukraine “On Medicinal Products” No. 123/96-VR, Resolution of the Cabinet of Ministers of Ukraine No. 376 and Order of the Ministry of Health of Ukraine No. 426. At the same time, the new Law of Ukraine “On Medicinal Products” No. 2469-IX has already been adopted, with its main regulatory model entering into force on 1 January 2027.

Certain elements of the new system are already in place. In particular, Ukraine has moved to the electronic eCTDformat for registration dossiers, and the Ukrainian Pharmaceutical Agency was established in 2026.

Which Authorities Regulate Medicinal Products

In 2026, different stages of the regulatory process are divided among several public authorities and institutions.

The Ministry of Health of Ukraine (MoH) adopts decisions on state registration and re-registration of medicinal products and, where provided by law, on relevant variations.

The State Expert Center of the Ministry of Health of Ukraine (SEC) performs the scientific and regulatory assessment of registration materials, evaluates data on the quality, safety and efficacy of medicinal products, participates in pharmacovigilance activities and prepares expert conclusions on the basis of which regulatory decisions are taken.

The State Service of Ukraine on Medicines and Drugs Control performs, among other functions, activities in the areas of licensing, GMP and state quality control of medicinal products imported into Ukraine.

As part of the regulatory reform, Resolution of the Cabinet of Ministers of Ukraine No. 739 dated 4 June 2026 established the Ukrainian Pharmaceutical Agency as a central executive authority with special status. The Agency is expected gradually to take over a significant part of the functions related to market authorisation of medicinal products and oversight of their quality, safety and efficacy.

Applicant and Marketing Authorisation Holder

State registration is carried out upon an application submitted by a person assuming regulatory responsibility for the medicinal product.

Under the currently applicable Procedure No. 426, the applicant, or holder of the registration certificate, is a legal entity or individual responsible for ensuring the efficacy, safety and quality of the medicinal product, carrying out pharmacovigilance activities in Ukraine and ensuring the accuracy and completeness of the information contained in the registration application and registration materials.

In practice, the responsibilities of the registration holder are not limited to the initial submission of the dossier.

After registration, the holder must, in particular:

keep the registration dossier up to date;
submit variations to the registration materials in a timely manner;
ensure the functioning of the pharmacovigilance system;
monitor new information concerning the safety of the medicinal product;
ensure that product information remains consistent with the approved registration materials;
maintain the appropriate GMP status of the relevant manufacturing sites;
monitor registration validity periods and submit re-registration documents on time;
ensure that labelling, Instructions for Medical Use, advertising and promotional materials comply with applicable legislation.

Accordingly, the choice of applicant and the organisation of its regulatory function should be determined before the registration procedure begins.

Types of Registration Applications

The scope of the registration dossier depends on the legal basis under which the medicinal product is submitted for registration.

Order of the Ministry of Health of Ukraine No. 426 provides for different types of applications and corresponding requirements for the supporting documentation.

The main options include:

Medicinal product with a full (stand-alone) dossier. This route is used where the applicant submits a complete dossier containing administrative, pharmaceutical, non-clinical and clinical data. This approach is typical, among other cases, for new medicinal products.

Application for a generic medicinal product. Instead of conducting a complete set of its own non-clinical and clinical studies, the applicant demonstrates the relationship of the product to the reference medicinal product and submits the required data on equivalence, including bioequivalence where applicable to the relevant pharmaceutical form.

Medicinal product with well-established medicinal use. For active substances with sufficiently long and documented medicinal use, part of the non-clinical and clinical data may be supported by appropriate scientific bibliographic references.

Application based on informed consent. This route may be used where the owner of the relevant non-clinical and clinical data authorises the applicant to use those materials.

Separate requirements also apply to fixed combinations, biological and biosimilar medicinal products, herbal medicinal products, traditional medicinal products and other special categories.

Correctly determining the type of application at the beginning of the project directly affects the scope of documentation, the need for additional studies and the overall regulatory pathway.

Standard State Registration under Ministry of Health Order No. 426

The main procedure for state registration in 2026 remains the procedure established by Order of the Ministry of Health of Ukraine No. 426 dated 26 August 2005 and Resolution of the Cabinet of Ministers of Ukraine No. 376 dated 26 May 2005..

The applicant submits an application and a registration dossier, after which the SEC carries out a specialised assessment of the materials.

Three key areas are assessed:

quality — composition, manufacture, control of starting materials and the finished product, specifications, analytical methods, stability, packaging materials and other pharmaceutical characteristics;

safety — non-clinical and clinical data, adverse reaction profile, potential risks and risk-minimisation measures;

efficacy — clinical evidence, consistency with the proposed indications and the benefit-risk balance.

For the standard procedure, the regulatory assessment period for many types of applications may be up to 210 working days.This period does not include statutory clock-stops, including the time required for the applicant to prepare responses to SEC questions.

In practice, the total duration of a registration project depends to a large extent on the quality of the source dossier and the speed with which the necessary documents can be obtained from the manufacturer.

Registration Dossier and the eCTD Format

The registration dossier for a medicinal product follows the Common Technical Document structure and consists of five modules.

Module 1 contains administrative and country-specific documentation.

Module 2 contains summaries and expert overviews of the quality, non-clinical and clinical documentation.

Module 3 covers quality documentation for the medicinal product.

Module 4 contains non-clinical study reports.

Module 5 contains clinical documentation.

Ukraine has moved from a paper-based dossier model to the international electronic eCTD — electronic Common Technical Document format..

From 18 August 2025, submission of registration materials in eCTD format became mandatory for applicants submitting medicinal products for new state registration..

The new Law No. 2469-IX establishes eCTD as the basis of the electronic lifecycle of the registration dossier. Part 6 of Article 13 provides for electronic submission in ICH eCTD format for state registration, re-registration, indefinite extension of registration and variations.

Recognition Procedure

For certain medicinal products, a special route under Order of the Ministry of Health of Ukraine No. 1245 dated 17 November 2016 may be used instead of the standard procedure..

As of 2026, Procedure No. 1245 applies to medicinal products registered by the competent authorities of:

the United States of America;
the United Kingdom;
the Swiss Confederation;
Japan;
Australia;
Canada;

as well as medicinal products registered under the centralised procedure by the competent authority of the European Union.

Procedure No. 1245 covers not only initial registration but also re-registration and variations to the registration materials during the validity of the registration certificate.

The SEC verifies the fact of registration of the medicinal product by the relevant competent authority and its use in the respective territory.

Registration of a medicinal product in a reference jurisdiction does not, however, automatically authorise the product for the Ukrainian market. The applicant must still submit the prescribed set of documents and complete the procedure established by Ukrainian legislation.

The SEC review period under Procedure No. 1245 must not exceed 10 working days,although the overall project timeline must also take into account document preparation and the subsequent regulatory decision-making stages.

Before starting a standard registration procedure for a product that is already authorised in the United States, the United Kingdom, Switzerland, Japan, Australia, Canada or under the EU centralised procedure, it is advisable first to assess whether Procedure No. 1245 can be used.

Registration of Medicinal Products for Centralised Procurement

A special procedure is available for certain medicinal products submitted for state registration for the purpose of procurement by an entity authorised to carry out healthcare procurement or by a specialised procurement organisation.

This procedure is regulated, in particular, by Order of the Ministry of Health of Ukraine No. 1391 dated 15 June 2020..

Under this pathway, a special scope of review is applied to the registration materials, focusing on confirmation of their authenticity and compliance with the conditions established by law for centralised procurement.

Whether this route can be used depends not only on the characteristics of the medicinal product, but also on the purpose of registration and the procurement mechanism.

Emergency Registration of COVID-19 Medicinal Products

For medicinal products, vaccines and other medical immunobiological products intended for the treatment and/or specific prevention of COVID-19, Ukrainian legislation provides a separate state registration mechanism subject to obligations for emergency medical use.

The applicable procedure is established by Resolution of the Cabinet of Ministers of Ukraine No. 1446 dated 29 December 2021..

The procedure provides separate timelines for each stage.

After receiving the application, the Ministry of Health forwards it to the SEC within one working day .

The SEC performs an expert assessment of the benefit-risk balance and verifies the authenticity of the registration materials within up to five working days from receipt of the required materials.

After receiving the SEC conclusion, the Ministry of Health has up to three working days to decide on state registration or refusal of registration.

Accordingly, the timelines for this procedure consist of several consecutive stages rather than one overall assessment period.

Labelling, Summary of Product Characteristics and Instructions for Medical Use

Preparation of labelling texts and Instructions for Medical Use is an integral part of the registration process.

The registration materials include, in particular:

the draft Summary of Product Characteristics (SmPC);
the text of the Instructions for Medical Use;
texts for the immediate packaging;
texts for the outer packaging;
packaging artwork where required by the applicable procedure.

The information in these documents must be consistent with each other and with the data contained in the registration dossier.

Particular attention should be paid to indications, contraindications, dosage, method of administration, adverse reactions, warnings, storage conditions, shelf life, composition and information on the manufacturer and applicant.

Ukrainian product information should not be treated merely as a literal translation of foreign documentation. It must be consistent with the source dossier while also complying with national requirements concerning the structure and content of medicinal product information.

Changes to the SmPC, Instructions for Medical Use or labelling after registration may also require an appropriate variation to the registration materials before the revised text is implemented on the market.

Registration Validity Period and Re-registration of a Medicinal Product

As a general rule, the initial state registration of a medicinal product is granted for five years.

Under the procedure applicable in 2026, re-registration documents must be submitted in advance — no earlier than one year and no later than 180 calendar days before expiry of the registration certificate.

Following re-registration, use of the medicinal product in Ukraine is generally authorised without a time limitation, unless the regulator determines that an additional re-registration is required, including for pharmacovigilance-related reasons.

Re-registration from 2027

The new Law No. 2469-IX changes the planning timeline for re-registration.

Under Part 3 of Article 35 of Law No. 2469-IX,an application for re-registration must be submitted no later than nine months before expiry of the state registration.

For medicinal products whose registration expires in 2027 or shortly thereafter, the re-registration calendar should be reviewed in advance, taking into account transitional provisions and the date on which the specific procedure begins.

GMP: Confirmation of Compliance with Good Manufacturing Practice

Registration of a medicinal product is closely linked to confirmation that manufacture complies with Good Manufacturing Practice (GMP) requirements..

The GMP confirmation procedure is governed by Order of the Ministry of Health of Ukraine No. 1130 dated 27 December 2012.

When preparing the project, the entire manufacturing chain described in the registration dossier should be reviewed, including bulk manufacture, primary and secondary packaging, quality control, batch certification and batch release, as well as relevant contract manufacturing sites.

Depending on the country of manufacture and the available GMP documentation, compliance may be confirmed through a documentary procedure or following an inspection of the manufacturing site.

GMP and PIC/S

Ukraine participates in PIC/S — the Pharmaceutical Inspection Co-operation Scheme,which promotes harmonisation of approaches to GMP inspections and cooperation between pharmaceutical inspectorates.

In practice, however, it is important to distinguish between a country's membership in PIC/S and the specific procedure for recognition of a foreign GMP document in Ukraine.

Under the current version of Procedure No. 1130, a simplified confirmation procedure based on a foreign GMP document is expressly provided for documents issued by the competent authorities of:

EU Member States;
the United Kingdom;
countries that have a mutual recognition agreement with the EU or Ukraine.

The Procedure also takes into account information from EudraGMDP/EudraGMP and the US FDA electronic register in the cases provided for by law.

Therefore, the existence of a GMP certificate issued by the regulator of a PIC/S participating country does not in itself always mean automatic documentary recognition without a Ukrainian inspection. For each manufacturing site, the country, issuing authority, status of the document, scope of certification and compliance with Procedure No. 1130 should be assessed.

If the manufacturer does not hold a document that can be used under the recognition procedure, the State Service of Ukraine on Medicines and Drugs Control may carry out a GMP inspection of the manufacturing site.

For this reason, the GMP strategy should be developed in parallel with the registration strategy rather than after completion of the dossier assessment.

Licensing of Medicinal Product Imports

State registration of a medicinal product and the right to import it are separate regulatory matters.

The Licensing Conditions for the manufacture of medicinal products, wholesale and retail trade in medicinal products and import of medicinal products, except for active pharmaceutical ingredients, are approved by Resolution of the Cabinet of Ministers of Ukraine No. 929 dated 30 November 2016..

The importer must comply with the organisational, staffing, documentation and other requirements of the Licensing Conditions, maintain an appropriate pharmaceutical quality system and ensure compliance with the requirements for receipt, storage, transportation, control and release of medicinal products.

Therefore, when a foreign manufacturer enters the Ukrainian market, it is necessary to determine separately:

who will be the registration holder;
who will act as the importer;
who will perform batch release;
where the medicinal product will be stored;
how the quality system and interaction between all participants in the supply chain will be organised.

State Quality Control of Imported Medicinal Products

Following importation, medicinal products are subject to a separate procedure of state quality control of medicinal products imported into Ukraine,established by Resolution of the Cabinet of Ministers of Ukraine No. 902 dated 14 September 2005.

A registered medicinal product is imported into Ukraine with the manufacturer's quality certificate — a certificate of analysis or batch certificate.

State control includes:

review of the submitted documents;
inspection of the consignment at its location;
reconciliation of quantities and batch numbers with customs documents;
visual inspection;
laboratory testing in the cases provided for by Procedure No. 902.

As a general rule, batches of a medicinal product imported into Ukraine for the first time are subject to laboratory testing.

However, the Procedure provides important exceptions. As a general rule, laboratory testing is not performed where the relevant manufacturing sites are located in EU Member States, the United Kingdom, the United States, Canada, Switzerland, New Zealand, Australia, Japan or Israel. Such batches undergo visual inspection unless specific grounds for laboratory testing exist.

Laboratory control may be ordered, in particular, where packaging is damaged, packaging does not correspond to the approved materials, signs of product non-compliance are identified, or regulatory information indicates possible quality issues.

Where laboratory testing is not required, state quality control is generally completed within up to eight working days from the date the application for issuance of the quality conclusion is submitted.

Accordingly, product registration, GMP confirmation, import licensing and quality control of an imported batch are four related but separate regulatory processes.

Pharmacovigilance

The Ukrainian pharmacovigilance system has been developed with reference to European legislation, including Directive 2001/83/EC and Regulation (EC) No 726/2004.

After a medicinal product enters the market, the registration holder must continuously monitor its safety profile.

In 2026, the principal subordinate regulatory act in the area of pharmacovigilance remains Order of the Ministry of Health of Ukraine No. 898 dated 27 December 2006..

Depending on the medicinal product and applicable regulatory requirements, the pharmacovigilance system of the registration holder covers:

collection and processing of adverse reaction reports;
assessment of the benefit-risk balance;
detection and assessment of safety signals;
preparation of periodic safety reports;
preparation and updating of the risk management plan;
maintenance of the Pharmacovigilance System Master File;
activities of the Qualified Person Responsible for Pharmacovigilance;
communication with regulatory authorities;
changes to medicinal product information where new safety data emerge.

New Pharmacovigilance Procedure from 2027

On 3 June 2026, the Ministry of Health adopted Order No. 740 “On Approval of the Pharmacovigilance Procedure.”.

The new Procedure enters into force simultaneously with the entry into force of Law No. 2469-IX,i.e. on 1 January 2027.

The new Procedure develops the pharmacovigilance system in line with the new Law and further approximation to European requirements and GVP.

For registration holders, this means that before the beginning of 2027 it is advisable to review:

the structure and documentation of the pharmacovigilance system;
functions of the responsible pharmacovigilance person;
the current status of the PSMF;
the risk management system;
processes for collecting and submitting information on adverse reactions;
periodic safety reporting;
signal management;
readiness for regulatory reviews and inspections of the pharmacovigilance system.

At the same time, many of these tools — PSMF, RMP, PSUR/PBRER, individual case reporting and signal management — are already used today. The 2027 reform primarily changes the regulatory architecture and further integrates the Ukrainian system with the European pharmacovigilance model.

Maintenance of a Medicinal Product Registration

Obtaining a registration certificate does not mean that the registration dossier remains unchanged for the following years.

The medicinal product, manufacturing process, analytical methods and safety information continue to evolve.

Therefore, the registration holder must ensure systematic regulatory maintenance of the registration .

This may include:

updating the registration dossier;
submitting variations;
maintaining valid GMP documentation;
updating pharmacovigilance documentation;
incorporating new safety information;
updating the Instructions for Medical Use and SmPC;
changing manufacturing sites;
changing analytical methods or specifications;
changing packaging;
extending shelf life;
monitoring re-registration timelines;
responding to regulatory changes in Ukraine and other countries.

For international medicinal products, it is important to have a process ensuring that significant changes approved in the country of origin or reference jurisdiction are assessed in a timely manner to determine whether they must also be submitted in Ukraine.

Variations to Registration Materials

Any significant change to a registered medicinal product should be assessed from the perspective of its regulatory status.

Variations may concern, in particular:

the manufacturer;
the manufacturer;
the manufacturing site;
the manufacturing process;
the composition of the medicinal product;
the source or manufacturer of the active substance;
specifications;
analytical methods;
immediate or outer packaging;
shelf life;
storage conditions;
indications;
dosage;
contraindications;
adverse reactions;
the text of the Instructions for Medical Use;
the SmPC;
labelling.

Depending on the nature and potential impact of the change, the relevant category and procedure apply. Regulatory practice includes, among others, minor variations of Type IA and Type IB,major Type II variations, while certain changes may require a new state registration.

The key principle is that a change should not simply be implemented in manufacturing or documentation without first assessing its regulatory status.

This is especially important for global products, where the same change may be implemented simultaneously in dozens of countries while the classification and submission timelines may differ.

For medicinal products registered under Procedure No. 1245, that Procedure also establishes a special pathway for variations to the registration materials.

Advertising of Medicinal Products

Advertising of medicinal products in Ukraine is regulated primarily by Article 21 of the Law of Ukraine “On Advertising.”.

Advertising to the general public is permitted not for every registered medicinal product, but only for medicinal products that:

are authorised for use in Ukraine;
are available without prescription;
are not included in the list of medicinal products prohibited from advertising.

Advertising must contain objective information about the medicinal product and must not exaggerate its properties.

Mandatory elements of the current regime include a recommendation to read the Instructions for Medical Use, a requirement to consult a doctor and the warning:

“Self-medication may be harmful to your health.”

The Law establishes requirements concerning the proportion of the advertising material occupied by this warning.

Advertising must not:

create the impression that medical consultation is unnecessary;
guarantee a therapeutic result;
state that use of the medicinal product is not associated with adverse reactions;
exaggerate the efficacy of the medicinal product;
create fear that health may deteriorate if the medicinal product is not used;
encourage self-diagnosis;
create the impression that the medicinal product is a food, cosmetic or ordinary consumer product;
justify the safety or efficacy of the product solely by reference to its “natural” origin.

Separate restrictions apply to the participation of healthcare professionals and persons whose appearance imitates that of a healthcare professional.

Regulatory review of advertising materials should therefore cover not only an individual slogan, but the full context of the communication: text, images, comparisons, efficacy claims, presentation of information and target audience.

Professional Promotion of Medicinal Products

Advertising to the general public should be distinguished from professional communication directed at healthcare and pharmaceutical professionals.

Under the current model, specialised publications, specialised websites and other professional channels may be used for professional audiences.

Information about a medicinal product must correspond to the approved product information.

From 2027, the new Law No. 2469-IX regulates promotion of medicinal products in significantly greater detail..

Article 87 of the Law expressly covers:

promotional materials for healthcare and pharmaceutical professionals;
activities of medical and sales representatives;
free professional samples;
conferences, seminars and symposia;
sponsorship of professional events;
reimbursement of costs related to participation in professional events;
prohibition of financial and material incentives for prescribing or dispensing a medicinal product.

Promotion must relate to a registered medicinal product and contain the required information in accordance with the SmPC.

The new Law also specifically defines information that is not considered promotion, for example certain reference materials, correspondence in response to an enquiry, or information concerning packaging changes and safety matters, provided that no promotional claims are included.

For companies with their own marketing, sales and medical teams, this means that not only patient-facing advertising but also SOPs governing medical representatives, professional presentations, samples, sponsorship activities and interactions with healthcare professionals should be reviewed.

What Will Change from 1 January 2027

The new Law of Ukraine “On Medicinal Products” No. 2469-IX restructures the regulatory system using a model significantly closer to European Union legislation.

For pharmaceutical companies, the main practical changes can be summarised in several areas.

New regulatory architecture. A significant part of the regulatory functions is expected to be concentrated in the new state control authority — the Ukrainian Pharmaceutical Agency.

New rules for state registration. The Law establishes a general procedure period of up to 210 calendar days, replacing the model under which the current procedure widely relies on working-day calculations.

eCTD becomes the basis of the dossier lifecycle. The electronic model extends to registration, re-registration, indefinite extension and variations.

The deadline for re-registration changes. Documents must be submitted no later than 9 months before expiry of the state registration.

A new pharmacovigilance system is introduced. Order of the Ministry of Health No. 740 will enter into force together with the new Law and will replace Procedure No. 898.

Promotion is regulated in greater detail. The new Law establishes specific rules for medical representatives, promotional materials, professional samples, events and interaction with healthcare and pharmaceutical professionals.

Terminology and the product information model are changing. The Ukrainian system continues to move towards the European model of the Summary of Product Characteristics (SmPC), the package leaflet, and integrated management of medicinal product information throughout the product lifecycle.

At the same time, the transition to the new Law does not mean that every procedure initiated in 2026 automatically starts again from the beginning on 1 January 2027. For each project, the transitional provisions, the submission date and the applicable specific regulatory acts must be taken into account.

How to Prepare a Medicinal Product for Registration in Ukraine

An effective registration project starts not with filing an application, but with an assessment of compliance with regulatory requirements..

Before the procedure begins, it is advisable to verify:

who will act as the applicant and future registration holder;
whether the product falls within the legal definition of a medicinal product and which procedure applies;
which type of registration application is optimal;
whether the registration dossier is ready for submission in Ukraine;
whether the dossier complies with eCTD requirements;
whether the quality, non-clinical and clinical documentation is sufficient;
whether the manufacturing sites comply with GMP requirements and how such compliance can be confirmed;
whether the Ukrainian SmPC, Instructions for Medical Use and labelling texts are ready;
whether a pharmacovigilance system has been established;
who will perform import and batch release;
which variations must be submitted to the registration materials before the medicinal product enters the market.

Such a preliminary assessment makes it possible to identify potential issues before the regulatory assessment begins and to establish a realistic registration project plan.

Key Regulatory Framework

When planning the registration and circulation of medicinal products in Ukraine in 2026–2027, the following regulatory acts should be taken into account, among others:

Law of Ukraine No. 123/96-VR dated 4 April 1996 “On Medicinal Products”.
Law of Ukraine No. 2469-IX dated 28 July 2022 “On Medicinal Products”.
Resolution of the Cabinet of Ministers of Ukraine No. 376 dated 26 May 2005 “On Approval of the Procedure for State Registration (Re-registration) of Medicinal Products and the Amounts of Fees for Their State Registration (Re-registration)”.
Order of the Ministry of Health of Ukraine No. 426 dated 26 August 2005 “On Approval of the Procedure for Examination of Registration Materials for Medicinal Products Submitted for State Registration (Re-registration), as well as Examination of Materials on Variations to Registration Materials During the Validity Period of the Registration Certificate”.
Order of the Ministry of Health of Ukraine No. 1245 dated 17 November 2016 “On Approval of the Procedure for Review of Registration Materials for Medicinal Products Submitted for State Registration (Re-registration), and Materials on Variations to Registration Materials During the Validity Period of the Registration Certificate for Medicinal Products Registered by the Competent Authorities of the United States of America, the United Kingdom, the Swiss Confederation, Japan, Australia, Canada, and Medicinal Products Registered under the Centralised Procedure by the Competent Authority of the European Union”.
Order of the Ministry of Health of Ukraine No. 1391 dated 15 June 2020 “On Approval of the Procedure for Verification of the Authenticity of Registration Materials for a Medicinal Product Submitted for State Registration for the Purpose of Procurement by an Entity Authorised to Carry Out Procurement in the Healthcare Sector or by a Specialised Procurement Organisation”.
Resolution of the Cabinet of Ministers of Ukraine No. 1446 dated 29 December 2021 “Certain Issues of State Registration of Medicinal Products, Vaccines or Other Medical Immunobiological Products for the Treatment and/or Specific Prevention of Acute Respiratory Disease COVID-19 Caused by the SARS-CoV-2 Coronavirus, Subject to Obligations for Emergency Medical Use”.
Order of the Ministry of Health of Ukraine No. 1130 dated 27 December 2012 “On Approval of the Procedure for Confirmation of Compliance of Medicinal Product Manufacturing Conditions with Good Manufacturing Practice Requirements”.
Resolution of the Cabinet of Ministers of Ukraine No. 902 dated 14 September 2005 “On Approval of the Procedure for State Quality Control of Medicinal Products Imported into Ukraine”.
Resolution of the Cabinet of Ministers of Ukraine No. 929 dated 30 November 2016 “On Approval of the Licensing Conditions for Conducting Business Activities in the Manufacture of Medicinal Products, Wholesale and Retail Trade in Medicinal Products, and Import of Medicinal Products (Except Active Pharmaceutical Ingredients)”.
Order of the Ministry of Health of Ukraine No. 898 dated 27 December 2006 “On Approval of the Pharmacovigilance Procedure”.
Order of the Ministry of Health of Ukraine No. 740 dated 3 June 2026 “On Approval of the Pharmacovigilance Procedure”.
Resolution of the Cabinet of Ministers of Ukraine No. 739 dated 4 June 2026 “Certain Issues Concerning the Establishment of the Ukrainian Pharmaceutical Agency”.
Law of Ukraine No. 270/96-VR dated 3 July 1996 “On Advertising”.
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency.

Regulatory Support from Pharma Navigation

Pharma Navigation supports medicinal products at different stages of their regulatory lifecycle — from assessing the feasibility of registration to maintaining an already registered product.

We can support either a specific stage or a full regulatory project.

Our support includes:

preliminary assessment of the regulatory strategy;
registration dossier readiness audit (gap analysis);
determination of the application type and optimal regulatory pathway;
assessment of eligibility for registration under Order No. 1245;
support with standard state registration;
preparation and review of eCTD submissions;
communication with the manufacturer regarding missing documentation;
adaptation of the SmPC and Instructions for Medical Use;
labelling review;
support with GMP procedures;
regulatory support for quality control;
pharmacovigilance;
variations to registration materials;
re-registration;
post-registration regulatory support (regulatory maintenance);
review of advertising and promotional materials;
assessment of the company's readiness for the legislative changes taking effect in 2027.

In our regulatory work, we focus not only on the formal possibility of submitting documents, but on the full lifecycle of the medicinal product, including:

registrationю
manufacture
import
market launch
pharmacovigilance
variations
re-registration and ongoing maintenance of the registration.