Law of Ukraine

"On Amendments to Article 9 of the Law of Ukraine "On Medicines"

Date of entry into force:
November 30, 2011

The Law of Ukraine "On Medicines" regulates legal relations related to creation, rebgistration, manufacturing, quality control and sale of medicines, determines the rights and obligations of enterprises, institutions, organizations and citizens, as well as the authority of state executive power bodies and officials in this sphere.

Article 9 of the Law of Ukraine "On Medicines" establishes the procedure for state registration of medicines.

According to the Law, if a medicine registered based on the complete registration information submitted (hereinafter referred to as "reference/original medicine") is first registered in Ukraine, state registration of another medicine containing the same active component as the reference/original medicine is possible no earlier than five years after the day of the first registration of the reference/original medicine in Ukraine, unless otherwise envisaged by Article 9 of the Law of Ukraine "On Medicines". This requirement does not apply to cases when the applicant received the right to reference and/or use the registration information of the reference/original medicine according to the law, or submitted complete registration information that adheres to the requirements to registration information for a reference/original medicine.

The above term may be extended to six years, if during the first three years following state registration of the reference/original medicine, the Ministry of Health Care of Ukraine or a body authorized by it allowed its use based on one or more indications deemed as having special advantage over the existing ones. The rules and criteria for determining indications that have special advantage over the existing ones are established by the Ministry of Health Care of Ukraine. The above term is set in case the application for state registration of a reference/original medicine in Ukraine was submitted within two years after the date of its first registration in any other country.

According to the law, in order to ensure public health, the Cabinet of Ministers of Ukraine may allow an entity determined by the Cabinet of Ministers of Ukraine to use a patented invention (utility model) related to such medicine without the consent of the patent holder.

The Law envisages that application for state registration of a medicine shall be accompanied with a certified copy of a document that confirms the conformance of manufacturing conditions of the medicine submitted for registration to the requirements to manufacture of medicines in Ukraine, issued by the central executive power body in the issues of medicines according to the procedure determined by the Ministry of Health Care of Ukraine.
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