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

Medical devices

Conformity assessment service (certification) of medical devices, which depends on the product class:

  • Self-declaration and registration at the State Service of Ukraine on Medicines and Drugs Control;

  • Conformity assessment employing manufacture audit;

  • Accelerated and simplified procedure with partial EU certificate recognition;

  • Batch certification.

We offer: process organization, assistance in preparing a package of documents and implementation of the procedure in a short time frame.

Cosmetic products

Placement of cosmetic products on the Ukrainian market

We offer:

  • outsourcing the service of a quality person in Ukraine;

  • file preparation with information on the product;

  • safety report preparation;

  • product notification;

Dietary supplements

Compliance Confirmation of dietary supplements with the requirements of the current legislation of Ukraine for placing on the market.

We provide assistance in preparing a set of permits, labelling and advise on the import and sale of products in 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

More
GMP confirmation, certification

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

More

Ready to cooperate?

Please fill out the contact form and you will be contacted

+38 050 463 82 66

    Ready to cooperate?
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