Registration of medicinal products, dietary supplements and cosmetics in Ukraine

Registration of medicines, dietary supplements and cosmetics in Ukraine

12 years in the pharmaceutical market
116 released medicinal products
105 partners

About service

We provide our partners with services of the highest quality and any degree of complexity. In the course of work, the specialists of BIOSCIENCE GROUP make every effort to assist our partners professionally and satisfy all questions asked.

  • Registration of medicinal products for a complete dossier (stand-alone dossier), for biosimilars, original medicinal products.

The term of the expert assessment according to the legislation is 210 working days

  • Registration of generic, hybrid medicinal products.

The term of the expert assessment according to the legislation is 90 working days

  • Registration of medicinal products with well-studied medical use.

The term of the expert assessment according to the legislation is 90 working days

  • Registration of medicinal product with fixed combination.

The term of the expert assessment according to the legislation is 90 working days

  • Registration of medicinal products in bulk.
  • Registration of medicinal products that are subject to procurement by specialized international organizations. Order of the Ministry of Health of Ukraine No. 1391 dated 15.06.2020 (called as “authenticity” procedure).

The term of the expert assessment according to the legislation is 5 working days

  • Preparation of a package of documents for assessing the quality (certification) of medical devices in Ukraine.
  • Preparation of a package of documents confirming compliance with safety and quality requirements, labeling necessary for the import and sale of dietary supplements and medical nutrition in Ukraine.
  • Receiving conclusions of the sanitary service for cosmetic products, preparation of labeling for import and sale on the territory of Ukraine.

Other services

Re-registration of medicinal products in Ukraine, amendments, full life cycle support of medicinal products

According to the legislation, submission of the Application for state re-registration of the finished medicine

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GMP confirmation, certification

GMP confirmation, certification, re-registration, changes, full life cycle support of medicinal products

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Please fill out the contact form and you will be contacted

+38 050 463 82 66

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