Medicinal products must undergo registration and marketing approval by the Ministry of Health of Ukraine before their use and sale in the country can be legally permitted.
The standard registration procedure involves extensive dossier reviews, compliance assessments, facility inspections, and expert evaluations that comprise an elaborate and lengthy approval process lasting over a year. This ensures rigorous evaluation of safety, quality and efficacy per regulatory requirements.
However, the prolonged timelines pose barriers in accelerating access to critical medicines addressing urgent public health priorities or unmet medical needs.
To enable faster patient reach for such products, the Ministry of Health of Ukraine has implemented various expedited programs and fast-track registration pathways.
These provide two main mechanisms for accelerated approval of medicines compared to the standard procedure:
1) Condensed Review Timelines: Shorter decision making timeframes through expedited but equally stringent assessment by experts. This leverages approvals and insights from comparable mature regulators.
2) Streamlined Dossiers: Simplified formats for the registration dossiers, waiving certain local studies or enabling flexibility on specific elements. However, core safety/efficacy data is still required.
It is vital to note that such fast-track registration mechanisms are only applicable to medicinal products meeting the eligibility criteria and categories specified in the legal orders and resolutions establishing these pathways. They include aspects such as:
- Already approved via centralized EMA pathway
- Critical for priority healthcare needs in Ukraine
- Supplied under specialized procurement programs
- Qualifying emergency use COVID vaccine approvals
The primary expedited medicine registration routes currently effective in Ukraine are enabled through:
1) Section 9, Chapter V, Order 426: Fast-track evaluation for EMA-approved products
2) Section 10, Chapter V, Order 426: Fast-track evaluation for healthcare priority medicines
3) Order 1245: Fast-track registration via recognition of approval by mature regulators – U.S., Switzerland, Japan, Canada etc.
4) Order 1391: Fast-track registration by authenticating approval of procurement supplies by competent authorities
5) Resolution 95: Emergency use approval for COVID vaccines authorized by major regulators globally
The subsequent sections will provide comprehensive details on each accelerated registration pathway regarding its regulatory basis, eligible scopes, qualifying criteria, timelines, dossier requirements and key procedural aspects for market authorization in Ukraine.
Fast-Track Registration in Ukraine for European Medicines Agency (EMA) Approved Medicinal Products
Legal Basis: This expedited registration route for medicines already authorized via the centralized EMA procedure is officially enabled through Section 9, Chapter V of Order #426 issued by the Ministry of Health (MoH) of Ukraine.
It defines a condensed regulatory review process compared to the 12+ month standard registration pathway.
Eligible Scope: Medicinal products that have received EU-wide marketing authorization by EMA through its centralized approval procedure can qualify for this fast track pathway in Ukraine.
Timelines:
The specialized expert committee evaluation and decision making timeline is 45 working days. However, this excludes periods for:
- Initial submission and validation of registration application
- Payment settlement for state fees
- Response time frame allowed for any deficiencies raised during assessment
- Final issuance of marketing approval certificate after positive opinion is adopted
Registration Dossier Requirements and Format: While the assessment rigor and data requirements remain unchanged, certain flexibilities in terms of format and medium of the registration documents are permitted:
- Module 1 and 2 need to be submitted in paper/hard copy as per CTD structure
- Module 3 Quality data, Module 4 Non-Clinical data, and Module 5 Clinical data can be provided in electronic copy
- Quality Information Summary (QIS), Specimen Labeling, Package Inserts can also be submitted electronically
- Must be accompanied by the Assessment Report issued by EMA documenting scientific approval
Key Considerations:
- Assessment basis is concurrence with quality, safety and efficacy profile approval granted by EMA
- Allows electronic submission for certain parts of dossier, avoiding extensive hard copy requirements
- Any identified gaps may warrant additional data requirements or queries from assessors
Fast-Track Registration in Ukraine for Medicines Addressing Key Healthcare Priorities and Unmet Needs
Legal Basis:
Section 10, Chapter V of Order #426 by the Ministry of Health enables expedited registration for medicines catering to healthcare priorities in Ukraine.
Eligible Scope: The following categories of medicinal products are eligible:
- Innovative products not yet launched in Ukraine for addressing tuberculosis, HIV, viral hepatitis and other socially dangerous diseases
- Oncology medicines already approved by mature regulators – U.S., U.K., Switzerland, Japan, Canada, Australia or via EMA centralized pathway
- Vaccines and toxoids prequalified by WHO demonstrating assured quality and established benefits
- Medicines supplied via specialized procurement programs for priority healthcare needs
Timelines, Dossier Requirements and Considerations: Provided separately for each eligible product category. Please refer to the relevant provisions of the legal basis cited.
Fast-Track Registration Pathway Via Recognition Route for Medicines in Ukraine
Legal Basis: Order No. 1245 issued on 17 November 2016 by the Ministry of Health, Ukraine enables expedited registration for medicinal products already approved by the following mature regulators:
- U.S. Food and Drug Administration (FDA)
- Swissmedic
- Pharmaceuticals and Medical Devices Agency (PMDA), Japan
- Health Canada
- Therapeutic Goods Administration (TGA), Australia
- European Medicines Agency (EMA) through centralized procedure
It allows abbreviated review by recognizing scientific opinions adopted by the above authorities known for their stringent assessment standards globally.
Eligible Scope: Any market authorization granted by FDA, Swissmedic, PMDA, Health Canada, TGA or EMA centralized procedure makes the medicinal product eligible for this fast track if registration is sought within the approved brand name, strength, dosage form and manufacturing sites.
Registration Dossiers Required: The application and registration dossier must comprise:
- A copy of the authorization issued in the reference country
- The complete common technical document (CTD) submitted for approval to the reference regulator without any gaps
- All post-approval variation approvals pertaining to safety, efficacy and quality changes
- Draft Quality Information Summary (QIS), labeling specimens and package insert documents proposed for Ukraine. Translations may be needed.
Review Timeframe:
The verification assessment and approval decision will be provided within 10 business days – excluding periods allowed for application submission procedures, payment confirmations, responding to clarification queries and issuance of the final certificate if positive opinion.
Key Considerations:
- Data must match entirely to the reference submission without any gaps
- All variation approvals by reference agency need submission
- Up to 30 business days to address any deficiencies noted
The expedited pathway thus enables companies to register medicines critically needed in Ukraine leveraging prior rigorous scientific review and approvals by these recognized mature regulatory bodies. It avoids unnecessary duplication of efforts.
Fast-Track Registration in Ukraine Via Authenticity Route for Procured Medicines
Legal Basis: Order No. 1391 issued by the Ministry of Health, Ukraine defines an expedited registration process for medicines procured by specific authorized entities.
It requires verification of prior approval granted by mature regulatory authorities instead of undergoing complete independent review of quality, safety and efficacy data.
Eligible Products: Medicines which meet ALL the following criteria can apply under this authenticity route:
1) Procured by either:
- State Enterprise “Medical Procurements of Ukraine”
- International procurement organizations – UNDP, UNICEF, Crown Agents
AND
2) Already approved by one of these regulatory authorities:
- U.S. Food and Drug Administration (FDA)
- Swissmedic
- Pharmaceuticals and Medical Devices Agency (PMDA), Japan
- Therapeutic Goods Administration (TGA), Australia
- Health Canada
- European Medicines Agency (EMA) – centralized procedure
OR
Prequalified by World Health Organization (WHO)
Registration Dossier for Submission: The application must comprise:
- Approval certificate issued by above reference authority
- Complete technical document submitted to such reference agency
- Post-approval variation authorization documents
- Product Assessor Report or WHO Prequalification statement
- Proposed Ukrainian version of Quality Summary, Labeling, Inserts
- Mock-up Specimens showing graphics/artwork design
Review Process and Timeframe:
- Strictly involves authenticity verification of submitted reference registration evidence
- 5 business day decision timeline
- Excluding submission, payment and certificate issuance periods
Key Considerations:
- Supply restrictions – only to defined procurement programs
- No option for additional data requests or clarifications
- No variation applications or renewals permitted after registration
- Needs new application submission for any changes
The pathway thus allows accelerated registration for donor and tender based procurement of medicines having established quality, efficacy and safety with mature regulators.
Expedited Emergency Use Approval Pathway for COVID-19 Vaccines in Ukraine
Legal Basis: The Resolution No. 95 issued by the Cabinet of Ministers of Ukraine on February 3, 2021 enables accelerated registrations and emergency use authorizations for COVID vaccines and immunobiological medicinal products already approved by major global regulators.
It allows reliance on rigorous benefit-risk assessments completed by such recognized reference authorities in light of the unprecedented public health emergency situation posed by the COVID-19 pandemic.
Eligible Scope of COVID-19 Vaccines: Vaccines which have either:
Full regulatory approval OR Emergency use authorization granted by one of the below mature reference regulators are eligible to apply via this expedited pathway in Ukraine:
- European Medicines Agency (EMA)
- Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
- Swissmedic, Switzerland
- U.S. Food and Drug Administration (FDA)
- Health Canada
- Pharmaceuticals and Medical Devices Agency (PMDA), Japan
- Therapeutics Goods Administration (TGA), Australia
- National Medical Products Administration (NMPA), China
- Central Drugs Standard Control Organisation (CDSCO), India
Dossier for Submission: The application must be accompanied by:
- Reference country authorization certificate
- Assessment report with expert risk-benefit conclusions
- Risk management plans if applicable
- Proposed Ukrainian labeling, packaging and leaflets
- Instructions for use in original and Ukrainian language
Review Timeframe:
An expert committee will verify registration materials and conduct benefit-risk evaluation within 5 business days – excluding submission, payment and certificate issuing periods.
Key Provisions:
- Initial approval granted for 1 year, can be renewed if benefit-risk remains positive
- Total validity should not surpass emergency use tenure awarded by reference regulator
- Original packaging from reference market can be imported and supplied
The resolution has thus enabled prompt availability of COVID vaccines with proven efficacy and safety data through the emergency access pathway.
Leverage Delta Medical’s Expertise Across Expedited and Standard Registration Pathways
As a leading regulatory consultancy in Ukraine with over 22 years of experience, Delta Medical has unmatched expertise across all standard and expedited approval pathways for medicines and healthcare products.
Whether you seek to adopt one of the fast-track routes to accelerated Ukrainian patient access through EMA recognition, priority review, authenticity verification or emergency authorization, or undergo standard assessment – our extensive local team can support across every stage and requirement.
We offer end-to-end regulatory services encompassing:
- Strategy Consulting and Dossier Preparedness Reviews
- Establishing new marketing authorizations via optimal pathways
- Managing complex product re-registrations and renewal extensions
- Planning and submissions for post-approval variations including manufacturing site changes
- Pharmacovigilance system establishment and local contact person outsourcing solutions
- Recognizing or facilitating GMP compliance inspections for manufacturing sites supplying Ukraine
With over 45 regulatory affairs, medicine access and pharmacovigilance experts – many holding MDs and PhDs – we have one of Ukraine and CIS’s largest regulatory teams. Fluent in English and top CIS languages, we communicate smoothly while navigating nuances.
Having enabled market access for over 136 international healthcare manufacturers through 780+ product registrations, our experience allows advising the optimal registration pathway for your product’s expedited patient access or the standard route if preferred.
As a Ukraine based consultancy audited by European manufacturers, you can rely on compliance with international quality system standards.
Contact us to discuss your Ukraine registration needs and leverage our end-to-end expertise for accelerated registrations.
