Simplified and fast-track registration procedures

Medicinal products are allowed for import, sale, and use in Ukraine only after state registration. The Ministry of Health of Ukraine performs the registration of medicinal products based on the expert assessment of the Application and registration materials (registration dossier).

Several simplified and fast-track procedures have been approved in Ukraine to improve access to medicinal products. These procedures allow the expert assessment in a shorter period, simplified assessment procedure, or certain exemptions to the registration dossier. Such procedures apply only to certain groups of medicinal products.

There are several routes of fast-track registration: 

1. Fast-track expert evaluation of medicinal products approved by EMA under the centralized procedure (point 9 of Chapter V of the Order of MoH No. 426);
2. Fast-track expert evaluation of medicinal products for the treatment of socially dangerous diseases, rare (orphan) and oncological diseases, medicinal products for immunization against dangerous infectious diseases (point 10 of Chapter V of the Order of MoH No. 426);
3. Fast-track registration through “authenticity verification” of the approval in the reference state: USA, Switzerland, Japan, Australia, Canada or by EMA under the centralized procedure (Order of MoH No. 1245);
4. Fast-track registration through “authenticity verification” for medicinal products procured by specialized authorized procurement entities or organizations (Order of MoH No. 1391);
5. Emergency authorization use of vaccines and immunobiological drugs to prevent COVID-19 caused by SARS-CoV-2 coronavirus (Resolution of the Cabinet of Ministers of Ukraine No. 95).

A detailed description of each fast-track procedure:

Fast-track registration of EMA-approved medicinal products in Ukraine

This type of expedited registration is established by the “standard” registration procedure (Order of MoH No. 426) for medicinal products licensed by the European Medicines Agency (EMA).

The period of specialized expert assessment is 45 business days, excluding the terms for submission and initial expert evaluation of the Application (the registration form), payment of state fees, the clock stops for deficiencies, and issuance of the marketing authorization. 

There are also certain simplifications to the format of the registration dossier:

• Modules 1 and 2 in the CTD format are submitted in hard copy;
• Modules 3, 4, and 5 and the QCM, text of the labeling, and instruction for use may be submitted in electronic form.

The registration dossier must be accompanied by the EMA product assessment report.

Fast-track registration of medicinal products for the treatment of socially dangerous diseases

This procedure may be used in case of the “standard” procedure registration of the following types of medicinal products:

• original (innovative) medicines (the molecule is not presented at the Ukrainian market) for treatment of socially dangerous diseases (tuberculosis, HIV/AIDS, viral hepatitis), rare and oncological diseases registered in countries with high regulatory standards (USA, Switzerland, Japan, Great Britain, Australia or EMA under the centralized procedure);
• medicinal products for the treatment of tuberculosis, HIV/AIDS or viral hepatitis, which nave undergone the re-qualification procedure and have been included in the WHO list;
• vaccine and toxoids, which nave undergone the re-qualification procedure and have been included in the WHO list;
• medicinal products procured by specialized authorized procurement entities or organizations.

The period of specialized expert evaluation is 45 business days (30 business days for vaccines, toxoids and medicinal products procured by specialized procurement entities or organizations), excluding the terms for submission and initial expert evaluation of the Application (the registration form), payment of state fees, providing responses to comments and issuance of the marketing authorization. 

Parts of the registration dossier may be submitted in electronic form:

• Modules 1 and 2 in the CTD format are submitted in hard copy;
• Modules 3, 4 and 5, as well as the QCM, text of the labeling and instruction for use, may be submitted in electronic form.

Fast-track assessment under the “recognition” route

The Order of the Ministry of Health of Ukraine No. 1245 of 17.11.2016 includes an option of expedited registration of medicinal products registered by the competent authorities of the USA, Switzerland, Japan, Australia, Canada and medicinal products registered by the EMA under the centralized procedure.

For registration under this procedure, the Application must be submitted to the MoH in accordance with the form included in Annex 1 to the Order No. 1245, as well as the materials of the registration dossier:

• registration dossier identical to the one submitted in the reference country; 
• all variations approved in the reference country from the moment of registration;
• draft national specific documents: QCM, text of the labeling and instruction for use.

The period of assessment of the registration materials is 10 business days, excluding the timeline for submission and initial expert evaluation of the Application, payment of state fees, providing responses to comments, and issuing the marketing authorization certificate. 

Important features of the procedure:

1. Registration in Ukraine requires data identical to the data approved in the reference country (production sites, dosage, package size, etc.).
2. All variations approved in the reference country must be applied in Ukraine. 
3. The period for responding to deficiencies is 30 business days.

Registration under the “authenticity” procedure
This procedure applies to:

• medicinal products procured by the entity authorized for procurements in the field of healthcare (State Enterprise “Medical Procurements of Ukraine”),
• medicinal products procured by international specialized procurement organizations (UNDP, UNICEF, Crown Agents, etc.), 

and registered by competent authorities of the USA, Switzerland, Japan, Australia, Canada, medicinal products registered by ЕМА, under the centralized procedure.

For registration under this procedure, the Application must be submitted to the MoH in accordance with the form included in Annex 1 to Order No. 1391, as well as the materials of the registration dossier:

• document confirming registration in the reference country;
• registration dossier used as a basis for registration of the medicinal product in the reference country;
• all variations approved in the reference country from the moment of registration;
• medicinal product evaluation report prepared by the regulatory authority of the reference country, or the WHO pre-qualification report;
• text and graphic image of the package mock-up in the original language;
• draft national specific documents: QCM and instruction for use.

The period of consideration of the materials is five business days, excluding the terms for submission and initial expert evaluation of the Application, payment of state fees, and issuance of the marketing authorization certificate. 

Important features of the procedure:

1. The marketing authorization received under this procedure allows performing supply only to the specialized authorized procurement entities and organizations.
2. There are no deficiencies during the assessment process: either positive or negative decisions. Any incompliance means a negative result. 
3. The registered product can be supplied in the original package from the referent market. 
4. There are no variations or renewals for that procedure. Any change means submission of the new Application. 

Authorization of vaccines for emergency medical use

This procedure of authorization for emergency medical use of vaccines and other immunobiological medicinal products for prevention of COVID-19, on the basis of the registration or authorization for emergency use in the reference country: EU, USA, Great Britain, Switzerland, Japan, Australia, Canada, PRC or India.

For registration under this procedure, the Application must be submitted to the MoH in accordance with the form included in Annex 1 to the Resolution of the Cabinet of Ministers of Ukraine No. 95, as well as the materials of the registration dossier:

• registration or authorization for emergency use issued by a competent authority of the EU, USA, Great Britain, Switzerland, Japan, Australia, Canada, PRC or India;
• medicinal product assessment report issued by the regulatory authority of the reference country;
• evaluation and risk management approved by the regulatory authority of the reference country (if applicable);
• instruction for use and/or brief description of the medicinal product in the original language, as well as the Ukrainian translation thereof;
• package labeling text and mock-ups with translation into Ukrainian. 

The period for expert assessment of the benefit-risk ratio and verification of the registration materials is five business days, excluding the terms for submission and initial expert evaluation of the Application and issuance of the marketing authorization. 

Important features of the procedure:

1. The marketing authorization is issued for one year. The period may be extended if the benefit-risk ratio is not negative and no harmful properties are detected. The total validity period of the marketing authorization may not exceed the validity period of the authorization for emergency use in the reference country.
2. The registered product can be supplied in the original package from the referent market. Package mock-ups from different markets may be submitted for registration simultaneously.

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).