Establishment of registration, Application types and procedures

Medicinal products are allowed for import, sale, and use in Ukraine only after their registration and in case of compliance with the quality and safety requirements.

Ministry of Health of Ukraine (MoH of Ukraine) performs state registration of medicines based on the expert assessment (evaluation) of registration materials. State Expert Center (commonly referred as SEC) of the Ministry of Health of Ukraine is the competent authority responsible for the expert evaluation. 

There are several routes of registration:

• “Standard” registration, approved by the MoH Order No. 426;
• Fast-track registration through “recognition”, approved by the MoH Order No. 1245;
• Fast-track registration through “authenticity verification”, approved by the MoH Order No. 1391;
• Emergency use authorization of vaccines for COVID-19 prevention, approved by the Resolution of the Cabinet of Ministers No. 95.

Marketing authorization (state registration) under the “standard” and “recognition” procedures is granted for five years. After renewal, the authorization is issued without expiry, except for the cases if the Ministry approves an additional 5 year period for pharmacovigilance reasons. 

The certificate is issued with shorter validity under the “authenticity verification” and “emergency use authorization” procedures. 

The marketing authorization is issued on the name of the Marketing Authorization Holder (MAH). Marketing Authorization Holder (MAH) can be a resident or non-resident of Ukraine. MAH is responsible for the quality, safety, and efficacy of the medicinal product during its circulation in Ukraine.

The MAH is not required to create a Representative office or a subsidiary in Ukraine. However, the MAH must establish and maintain the safety (pharmacovigilance) and quality management system in Ukraine. 

Since 2006 our company supports the pharmaceutical business in regulatory affairs, pharmacovigilance, and quality. We are a leading regulatory consultant in Ukraine and 11 countries of the CIS region. We have deep expertise in various types of Applications and procedures. We offer: consultation, development of registration strategy; internal assessment of the registration dossier (feasibility study/gap analysis); establishment of registration of any type of the Application and any type of the procedure;  for representative offices: back-office operations (preparation of the dossier or any parts thereof without submission).

“Standard” registration

The type of the Application defines the requirements and content of the registration dossier, procedures and timelines of the expert assessment.

Registration in Ukraine does not require the medicinal product to be registered in the MAH’s or manufacturer’s country. However, product registration in the EU or other countries with high regulatory requirements is considered an advantage. If the medicinal product is registered in the EU, the Application types in Ukraine usually correspond to the types of procedures in Europe (however, there may be exceptions, e.g. well-established use).

Order of the MoH No. 426 includes the following types of medicinal products in terms of requirements to the Application and the registration materials:

• medicinal product with a full (autonomous) dossier;
• generic product, hybrid medicinal product or biosimilar;
• medicinal product with a well-established medical use (WEU);
• medicinal product with a fixed combination;
• informed consent;
• traditional medicinal product;
• medicinal product from in bulk products.

The concept of submission of Application in Ukraine does not correspond to the common term used in EU practice, which means submission of the complete registration dossier. Submission and expert evaluation of the Application form (the registration form) and payment of the state fees in Ukraine are prior steps before submitting the registration dossier. 

The registration dossier

Requirements to the registration dossier depend on the selected Application type and are described in the Order of the MoH No.426.

The registration dossier is based on the ICH CTD format consisting of 5 Modules. The dossier should be consistent with all national requirements, e.g. specific national documents, requirements to the language, execution, etc.

Part of the documentation is translated into Ukrainian or prepared in Ukrainian:

• registration form (Application) and it’s annexes; 
• Module 1 – translated into Ukrainian entirely;
• Module 2 – chapters 2.3, 2.4 and 2.5. are translated (if necessary);
• Module 3 – chapters 3.2.P.5.1 and 3.2.P.5.2 are translated;
• Also, the following specific national documents are developed in Ukrainian:
  • QCM – quality control methods of the medicinal product, which include the composition of the product, specification for release and storage, detailed description of the methods, information about the manufacturers, description of the packaging system, shelf life and storage conditions;
  • instruction for the use of the medicinal product;
  • packaging labeling – information to be printed on the primary and secondary packaging of the medicinal product.

The dossier is submitted in hard copy. In some cases, certain parts of the dossier may be submitted in electronic form. 

The Registration dossier has strict presentation requirements: cross-numbering of pages, table of contents, no more than 250 pages in a file, file identification, etc. The Registration dossier is submitted in several non-identical copies, depending on the Application type.

Expert assessment procedure

The registration begins from the moment of submission of the registration form (Application) to the MoH of Ukraine. The registration procedure may be roughly divided into the following stages:

1. Preliminary stage (prior to submission of the Application):

• Filling, translation and preparation of the registration dossier, preparation of the national forms;
• Obtaining preliminary consultations / scientific advice (if necessary);
• Submission of the Power of Attorney to the SEC of the MoH of Ukraine and signing of the Contract for expert works.

2. Submission and expert evaluation of the registration form (Application) and payment:

• Submission of the registration form (Application) to the MoH of Ukraine;
• The evaluation (assessment), responding to deficiencies (if necessary);
• Obtaining a positive opinion;
• Obtaining invoices for the state fees;
• Making payments; 
• Obtaining confirmation of the payment receipt.

3. Submission and expert evaluation of the registration dossier:

• Submission of the registration dossier (Modules 1-5);
• Initial expert evaluation: verification of completeness of the materials (according to the type of the Application);
• Responding to deficiencies of the initial expert evaluation (if necessary);
• Specialized expert evaluation (assessment);
• Responding to deficiencies of the specialized expert evaluation, corrections of instructions and labeling;
• Laboratory quality control of samples (if necessary);
• Recommendation (opinion) of the medicinal product’s registration;
• Transfer of the documentation to the Ministry of Health.

4. Final stage:

• Formation of the draft Order of the Ministry of Health.
• Signing of the Order of the Ministry of Health on registration of the medicinal product and publication in the official gazette; 
• Entering the medicinal product in the State register of Ukraine.
• Issuance of the original marketing authorization and it’s annexes. 

The language of the correspondence is Ukrainian. 

Confirmation of compliance with GMP requirements should be submitted till the recommendation (opinion) of the medicinal product’s registration. MAH must apply for confirmation to SMDC in parallel with the registration procedure.

Specialized expert evaluation timelines 

Period of expert assessment depends on the Application type: 

• not more than 210 business days: medicinal products submitted for registration with a full (autonomous) dossier, immunobiological medicinal products, biosimilars;
• not more than 90 business days: for other types of medicinal products (generic drugs, well-established use);
• not more than 45 business days: for orphan drugs and medicinal products for the treatment of socially dangerous diseases (HIV, viral hepatitis, tuberculosis, oncological diseases). 

These timelines do not include:

• documentation analysis and translation, development of national forms and documents, filing and assembling of the registration dossier;
• period of initial expertise of the registration form;
• payment of state fees and receipt of payment confirmation;
• clock stops for the deficiencies; 
• time required to import samples and standards, as well as to perform laboratory analysis (if necessary);
• finalizing actions after the expert evaluation (verification/proofreading of the draft marketing authorization and it’s annexes);
• signing the Order on registration of the medicinal product and issuance of the original certificate.

Marketing authorization certificate 

After the first registration under the “standard” procedure, the marketing authorization is issued for 5 years. The certificate consists of:

• the marketing authorization itself, printed on the special form with a hologram;
• annex: approved quality control methods (QCM) of the medicinal product;
• annex: approved instruction for medical use of the medicinal product;
• annex: text to be printed on the package;

All approved variations (of any type) are an integral part of the marketing authorization.

Registration of package artworks

MAH must submit package artworks (mock-ups) to the Unified Automated Electronic System (UAES) of the SMDC after product registration but before importing. 

Graphic mock-ups are prepared according to the package labeling text approved during registration. The mock-up includes the size, color codes, information in Braille (if applicable), protective elements, and technical information. Minimum font size – 7 Didot points.

Graphic mock-ups in color, cover letter and copy of the marketing authorization certificate are submitted to the SMDC of Ukraine. In case of the absence of deficiencies, the SMDC places the mock-up in the electronic system.

Each imported batch of medicinal products is subject to mandatory visual quality control, including control of the package’s consistency with the registered mock-ups. Even insignificant differences may lead to comments and suspension of the opinion on the quality and the requirement to laboratory quality control.

Our services

Since 2006 we support the pharmaceutical business in regulatory affairs, pharmacovigilance, and quality. We are a leading regulatory consultant in Ukraine and 11 countries of the CIS region. Our extensive team has the necessary knowledge, experience, and skills and is proficient in English.

We have provided regulatory services for more than 200 manufacturers of medicines, many of which recommend us as a regulatory partner. 

We offer: 

• consultation, development of registration strategy;
• establishment of new registration, renewals, and variations;
• establishment and maintaining a pharmacovigilance system, outsourcing the functions of the local contact person;
• confirmation of manufacturing conditions with GMP requirements through recognition or inspection.

In addition to the main services, we also offer:

• translation of the scientific, medical, technical, and legal documentation;
• back-office operations: preparation of the registration dossier or any of its parts without submission;
• development and pre-printing verification of labeling artworks and instructions for use;
• medical writing of parts of the registration dossier;
• development of documentation and import licensing;
• writing of documentation for inclusion of the medicinal product in the National List (HTA).