License for import of drugs in Ukraine

Просмотров: 5464

Term and cost

The cost of firm’s service related to obtainment of license for import of pharmaceutical drugs - not fixed.

The cost does not include the official payment for the license issuance (the payment is provided after a decision about issuance of pharmaceutical drugs import license is made).

It takes us about one month to obtain a license for import of drugs in Ukraine.

What we do
  • advise Client on all matters related to preparation of documents and help to prepare them;
  • submit the documents to the licensing body;
  • support consideration of application by the licesning body;
  • obtain the license based on power of attorney granted by the Client.
Samples
Name Download
License application (in Ukrainian)File size: 175 Kb, File format: doc
Application for issuance of copy of the license (in Ukrainian)File size: 125 Kb, File format: doc
List of medicines (in Ukrainian)File size: 1536 Kb, File format: xls

Required documents

List of the required documents depends on whether our firm performs primary filling out of an application for the license obtainment or a Client provides an application that was filled out beforehand.

Until the 1st of December 2013 the license for import of pharmaceutical drugs is issued based on licensee’s application (other documents are not required). The application must be submitted together with a CD which stores information about imported pharmaceutical drugs.

Since the 1st of December 2013 the application will have to be submitted together with a copy of importer’s dossier.

Important to know
  • Validity term of the license for import of drugs is unlimited;
  • In order to obtain licenses for import of pharmaceutical drugs a licensee must have a license for sale of pharmaceutical drugs;
  • The license is issued by the State Administration of Ukraine on Medicinal Products;
  • License requirements are approved by the Order number 143 of the Ministry of Healthcare of Ukraine dated 20.02.2013;
  • Procedure of inspection conduction prior to license issuance is approved by the Order number 168 of the Ministry of Healthcare of Ukraine dated 27.02.2013;
  • License for import of pharmaceutical drugs in Ukraine allows to import only those drugs that were listed by an importer;
  • When conducting transactions with narcotic substances or precursors it is required to have a separate license;
  • Licensee’s staff must include “an authorized person” that must have pharmaceutical, biological or biotechnical education and employment record of at least 2 years that is in compliance with the requirements.
Successfully rendered services
The license was obtained in March of 2013

License for import of medicines that was issued for a limited liability company.

Our team
Ask a question
Related publications
All related materials
Доп. меню
Публикации по теме Отзывы Наш опыт Проекты