On August 12, 2014 was adopted the Law "On Amendments to the Law of Ukraine “On Medicinal Products" concerning the improvement of the order of providing the population with medicinal products intended for the treatment of socially dangerous and life-threatening diseases" (hereinafter - the Law). On August 18, 2014 the Law was directed to the President of Ukraine for signature, after which it will be officially published.
It is provided that to the application for the state registration of a medicinal product intended solely for the treatment of tuberculosis, HIV / AIDS, viral hepatitis, cancer and rare (orphan) diseases that is registered by the competent authority of the United States or the European Union as a medicinal product, shall be included only:
Registration decision shall be made within 7 days.
A written undertaking of manufacturer to produce the appropriate medicinal product for supply to Ukraine on the same production facilities as used in the manufacture of medicinal products, intended for use in the United States or members countries of the European Union, can be included to application instead of a certified copy of a document confirming that conditions of production of the medicinal product submitted for registration comply with the requirements for the production of medicinal products in Ukraine.
It is also provided for that such medicinal products may be imported into the customs territory of Ukraine without state registration upon decision of the Ministry of Health. The purpose of such import should be medical support of military personnel, soldiers and officers that perform tasks during the ATO, the state of emergency, the special period, if the documents confirming the registration and use of medicinal products in such States are available.
The Law enters into force on the day after the day of its publication, and shall come into effect in one month after its entry into force, except for the provisions concerning the importation of medicinal products for the needs of the ATO, which shall come into effect simultaneously with the entry into force of the come into effect.
It should also be noted that on August 14, 2014 the draft Law "On Amendments to the Law of Ukraine "On Medicinal Products" (regarding the improvement of the order of providing the population with medicinal products)" (hereinafter - the Draft) was submitted for public review.
According to the Draft it is offered a simplified procedure for the registration of original (innovative) medicinal products by the Ministry of Health of Ukraine within 5 days. In addition to medicinal products registered by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) (under centralized procedure), the simplified procedure will also be applied to products registered by:
The document provides for that the requirement to provide a document, confirming that conditions of production of the medicinal product submitted for registration comply with the requirements set out for the production of medicinal products in Ukraine, shall be canceled during the registration of medical immunobiological preparations used for the preventive vaccinations.
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