On 8 August 2016, the Cabinet of Ministers approved the Regulation On amendments to the Procedure of State Registration (Re-registration) of Medicines (the “Regulation”).
The Regulation is aimed at bringing the procedure of state registration (re-registration) of medicines in compliance with the recent amendments to the Law of Ukraine “On Medicinal Products” regarding facilitation of the state registration of pharmaceutical products, which became effective on 16 June 2016 (for details please refer to our previous Law-Now on this matter).
The Regulation simplifies the procedure of state registration of medicines for treatment of oncological diseases, HIV/AIDS, viral hepatitis and tuberculosis that are registered by the competent authorities of the United States, Switzerland, Japan, Australia, Canada and the European Union. The Regulation also reduces the term for medicines’ registration to 10 business days.
The introduced amendments will simplify access for foreign medicines into the Ukrainian market, in turn, decreasing the price of medicine for the consumer.
Law: Regulation of the Cabinet of Ministers of Ukraine On amendments to the Procedure of state registration (re-registration) of medicines, dated 8 August 2016.