Import of non-registered medicines and standards

Importation of non-registered samples, standards, special equipment and other materials for business and export of them outside of Ukraine is a complicated procedure, which also creates a number of additional problems for Representative Offices without the rights to conduct business activities. We are ready to assist you to obtain full package of necessary documentation for import and export, to carry out customs clearance under our name and deliver the necessary materials to the organization and / or country you specified.

The procedure for importation of non-registered medicinal products is approved by the Order of the Ministry of Health of Ukraine No. 237 dated April 26, 2011, “On Approval of the Procedure for Importation of Non-Registered Medicinal Products, Reference Materials, Reagents into the Territory of Ukraine” and describes the importation procedure:

  • samples of substances (including samples in the form of pellets, premix, granules, etc.) for chemical, physical, biological, microbiological, pharmacological, toxicological and other scientific research, as well as stability studies, development and approbation of analytical methods for nonclinical studies of their specific activity and safety;
  • medicinal products, reference products, placebo samples (comparator drugs) for clinical studies and scientific researches;
  • samples of medicinal products in dosage forms for state registration;
  • finished medicinal products for demonstrations in exhibitions, conferences without the rights for sale;
  • finished medicinal products for medical supplies (without the rights for sale) units of the armed forces of other states that are allowed to enter the territory of Ukraine in accordance with the law;
  • finished medicinal products for individual use by citizens;
  • in the events of natural disaster, catastrophe, epidemic disease, etc.;
  • importation into the territory of Ukraine of reference standards of medicinal products and/or impurity-substances, biological reference products (reference substances), reference spectra and reagents for conducting laboratory research of the quality of medicinal products;
  • for medical supplies (medicinal use) to military personnel and enlisted and commanding personnel who perform tasks during the counter-terrorism operations, states of emergency situation or special periods;
  • non-registered medicinal products for the treatment of rare (orphan) diseases developed exclusively for the treatment of rare (orphan) diseases and approved for the use in the territories of USA or the EU Member States.

We are ready to perform all the activities to obtain import license, customs clearance and delivery of samples, standards and reagents to the laboratory. Importation may be carried out under our name to eliminate the risks for the Representative Office.

We provide preliminary consultations free of charge, call us by phone +38 (068) 064-78-31, +38 (044) 223-61-67, or write to info@cratia.ua, or come to the meeting directly to our office.

We professionally perform registration of medicines, conformity assessment of medical devices, certification of cosmetics, disinfectants and special food products in Ukraine.
Our partners, international corporations and national manufacturers can best tell about our expertise and quality of work. For more than 15 years of work we have performed works for:

  • more than 150 manufacturers of medicines and active substances,
  • more than 800 manufacturers of medical devices and equipment,
  • more than 300 manufacturers of special food products and cosmetics.
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