Accelerated and simplified procedures for registration of medicines in Ukraine
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In order to import and sell medicinal products in Ukraine, it is necessary to undergo the registration procedure. Such a procedure may take from 2-4 months to more than half a year, depending on the quality of preparation and timing of expert examinations. We have already talked in detail about the stages and period of registration here.
However, there is a list of groups of drugs for which there is a somewhat simplified registration procedure in Ukraine. Today, we will talk about them, and about how the registration procedure differs for different groups of drugs.
If you want to get an answer and a solution specific to your case, please contact our specialists for a personal consultation.
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What groups of drugs are subject to shortened or simplified registration procedures?
Expedited or simplified part of the registration procedure can be stage of the registration procedure in cases where the drug has already been “tested” by a certain organization with a high level of trust (the list is approved by regulations of Ukraine), or if the need to get the drug available as soon as possible is extremely high.
For example, an accelerated expert examination is envisaged for those drugs, which are intended for treatment of especially dangerous diseases, including oncological diseases. The law specifies the list and designation of drugs that can pass through such an expedited procedure.
In fact, the period of their specialized investigation is reduced to 45 business days, which does not include the time for the initial expert investigation of the application and some other terms for consideration. In addition, part of the Dossier can be submitted electronically.
The same applies to vaccines and immunobiological preparations, which are required for prophylaxis against dangerous diseases, including Covid-19, if this vaccine or preparation has already been registered in the reference country (European Union countries, USA, PRC, etc.).
Such a procedure requires its own package of documents, which will confirm the registration of the vaccine or permission for its emergency use in these countries. The period of expert investigation of the benefit/risk ratio will be only 5 business days. The registration certificate will be issued for 1 year instead of 5 years, but it can be extended.
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Accelerated registration procedure for drugs already approved in other countries
There are also accelerated procedures for those drugs that have already been tested and registered in other countries defined in the regulations of Ukraine.
Thus, the expedited registration option is provided for drugs that have already been approved by the EMA - the European Medicines Agency. For these medicinal products the period of specialized testing is also reduced to 45 business days, and a part of the Dossier can be submitted in electronic form. In this case, in addition to the package of documents, one shall submit a report from the EMA with the evaluation of the drug.
Ukraine provides for the registration of medicinal products under the “recognition” procedure. This means that medicinal products registered by the competent authorities of the USA, Switzerland, Japan, Australia and Canada may undergo an accelerated registration procedure in Ukraine.
The Application for such medicinal products must be submitted with additional documents and information about registration in the country of reference. The application is considered within 10 business days. In addition, the term for reply to comments is shortened to 30 business days.
All information provided regarding the drug must match the data already approved in the reference country.
Our team offers you professional preparation for the procedure and organization of the process. You can find out the cost of drug registration with us here.
Do you want to pass the registration of medicinal products in Ukraine as soon as possible and without any problems? Don’t hesitate to contact us! We will develop an optimal algorithm of actions for you and take control of the whole process.
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