Ukraine: State Registration of Medicines Simplified

CMS Cameron McKenna,
Kyiv, Ukraine, Wed, June 08, 2016

On 31 May 2016, draft law No. 4484 simplifying the procedure for registration of medicines in Ukraine (the “Law”) was adopted by the Ukrainian Parliament. The Law is now awaiting the President’s signature and will become effective on the day after its official publication.

If signed by the President, the Law will:

- reduce the term for the state registration of medicines in Ukraine from one month to ten days; and

- introduce the simplified procedure of the state registration of medicinal products already registered by the competent authorities in the Unites States of America, Switzerland, Japan, Australia, Canada or registered under the centralised procedure by the competent authority of the European Union. Currently, the simplified procedure applies only to the registration of certain foreign medicines (such as medicines for the treatment of oncological diseases, HIV/AIDS, viral hepatitis and tuberculosis).

The Law is expected to increase competition in the Ukrainian pharmaceutical market by providing simpler access for foreign medicines into Ukraine and thus bringing down the price of medicine for Ukrainian patients.

Legislation: Draft Law on Introducing Amendments to Article 9 of the Law of Ukraine “On Medicinal Products” regarding Simplification of the State Registration of Pharmaceutical Products No. 4484 dated 20 April 2016.

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