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Registration of Medicinal products in Ukraine

Any medical products, which will be imported in Ukraine for local sales, should go for the registration procedure first. The registration procedures are carrying by The State Expert Center (SEC) under Ministry of Health in Ukraine. The requirement of documents and procedures are under EU guideline since 2005.

The expert evaluation are carries by SEC of following medical products:

  • Finished Medicinal Products
  • Active Parmaceutical Ingredients (APIs)
  • Immunobiological Products
  • Medicinal Products in-bulk

 

General requirements for registration procedure:

  • Filling an Application for registration;
  • Registration form (Legal and administrative details of Application);
  • Registration dossier in ICH CTD format, consisting of 5 Modules;
  • Part of Translation of registration dossier in into Ukrainian;
  • Some specific documents provided by manufacturer as below:
  • The quality control methods (QCM ) for the medicinal product which included composition, release and storage specifications, detailed method descriptions, data on the manufacturers, packaging description, shelf-life and storage conditions.
  • Instruction or leaflet of medical product use.
  • Details on Layout and packaging on the primary and secondary packaging of the medicinal product.
  • Some of documents should be Notary and legalized e.g POA, COPP, Mfg Lic, GMP certificate (Local).

 

Fee for registration of medical products by SEC.

Depending on types of medicinal products, the official fee of expert evaluation cost also varies but there are 3 major payments as below:

  • Payment to SEC for expert evaluation of registration Dossiers.
  • Payment to State Treasury of Ukraine as a Gos Poshlena.
  • Payment for lab. Analysis or quality control of Medical products if require (Optional).

 

Our action:

Follow up all the whole registration procedure starting from filling an application to receive the registration certificate of medical products.