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Pharmaceuticals Expertise

  • End-to-end Registration Support
  • Authorized Local Agent Support
  • Manufacturing Site Approval Support
  • Import Registration Support
  • Sample Import License Support
  • Regulatory Affairs Consulting
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Overview of the Ukrainian
Regulatory Landscape

Ukraine’s pharmaceuticals market is one of the fastest growing sectors in the country. The Ministry of Health (MoH) is the Ukrainian Health Authority responsible for approving and rejecting the circulation of Drugs, Medical devices, Cosmetics and Food supplements in Ukraine. The State Expert Center (SEC) is the prominent Regulatory body under the Ministry of Health of Ukraine that carries out the preclinical study, clinical trials, and state registration of drugs. SEC works within the limits set by the laws - “On Medicinal Products” and “On Protection of the Population from Infectious Diseases”. It is also responsible for pharmacovigilance, standardization of medical care, development of relevant medical and technological documents, and draft regulations.

 

Industries We Serve

The Ministry of Health (MoH) is the Ukrainian Health Authority and the central executive body of the healthcare system. The MoH - Ukraine accepts applications for the pharma product registration and issues orders related to approval or rejection of the products. The State Enterprise - State Expert Center (SEC) is the prominent drug Regulatory Authority under the Ministry of Health, Ukraine, responsible for pharma product registration.

  • End-to-end Pharmaceutical Product Registration
  • Pharma Regulatory Consulting and Pharma Market Entry
  • Registration Pathways and License Management Services
  • Pharmaceutical Dossier Preparation, Review and Management
  • Query Support Management till Approval
  • Product Information Leaflet (PIL)
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Medical device registration in Ukraine is regulated by the State Administration on Medicines and Drugs Control, which is also known as the State Market Supervision Authority. Medical devices are allowed for use in Ukraine only after conducting the procedure of conformity assessment. The Ministry of Economic Development and Trade of Ukraine is the central body of executive power, which ensures the formation of a state policy in the sphere of technical regulation.

  • Authorized Agent support
  • Regulatory support for market access
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • End-to-end operational support and Device registration
  • Query Support Management till Approval
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A food supplement is commonly known as a Dietary supplement in Ukraine. It can be defined as a product taken in addition to the regular diet and has a concentrated source of nutrients, proteins, fats, carbohydrates, vitamins, and mineral substances. Food supplements are manufactured in the form of tablets, capsules, draggers, powders, and liquids. The Ukraine food registration, import and sale is regulated by the Ministry of Health (MOH) Ukraine.

  • Food Product Classification
  • Formula Review/Ingredients Assessment
  • Food Label and Claims Review
  • Compliance as per the New labeling Regulation
  • Claims Consultation and Substantiation
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A Cosmetic product has become a crucial aspect of an individual’s lifestyle. And hence, the increase in consciousness about external beauty has expanded the Ukrainian Cosmetics market. The industry is flourishing by the day; thus, the Regulatory standards for Cosmetics Registration in Ukraine are constantly updated. The Ministry of health (MOH) regulates the Cosmetic registration in Ukraine. The MOH – Ukraine develops & approves quality & safety standards and is responsible for issuing licenses to legal entities and individuals engaged in the delivery, production, and sale of cosmetics.

  • Authorized Local Representation
  • Cosmetics Classification, Cosmetic Formulation & Cosmetics Ingredient Review
  • Cosmetic Registration and Cosmetic Notification
  • Dossier Preparation, Review and Management
  • Registration Pathways and Cosmetic Import License Management Services
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About Freyr

Freyr is a leading, niche, full-service global Regulatory Solutions and Services Company supporting, Large, Medium and Small size global Life sciences companies, (Pharmaceutical | Generics | Medical Device | Biotechnology | Biosimilar | Consumer Healthcare | Cosmetics | Chemicals) in their entire Regulatory value-chain; ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions etc. to Post- Approval / Legacy Product Maintenance, Labeling, Artwork Change Management and other related functions.

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Our Regional Expertise

Being a Globally Local firm, we have our presence in the following countries, click to know more

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