Ukrainian government to simplify procedure for registration of imported drugs

17 March 2013

The Pharma Letter

The government of Ukraine plans to simplify the procedure of registration of drugs, imported to the country from the European Union. According to an official representative of the Ukrainian State Drugs Service, all the companies, whose drugs are registered by the European Medicines Agency will pass the procedure for their registration in Ukraine only by filing a single application to the country’s Ministry of Health.

If everything goes ahead correctly, the registration procedure of new drugs in Ukraine will not take more than 30 days, compared to the current 120-240 days.

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In addition, the adoption of new rules will also allow the start of imports of those drugs to Ukraine which, so far, was impossible due to bureaucratic hurdles. Among them are drugs for the treatment of rare diseases, which are supplied in limited volumes and for which registration has been simply unprofitable.

Problems with existing procedure

According to the existing registration procedure, along with the applying to the Ministry of Health, all the imported drugs to Ukraine are currently subject to examination by the Center for Drug Evaluation and Research.

In other words, at the initial stage the applicant company submits the documents to the Ministry of Health, which passes them to the Center for Drug Evaluation and Research, which examines the efficacy, safety and quality of the drugs (which takes up to 90-120 days). After that, the results of examinations are submitted to the Ministry of Healthy, which makes a decision about the registration during the period of 30 days.

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