Adopted the Law of Ukraine “On Amending the Law of Ukraine ‘On Medications’ Regarding State Registration of Medications under Commitments”

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Adopted the Law of Ukraine “On Amending the Law of Ukraine ‘On Medications’ Regarding State Registration of Medications under Commitments”

Information Department of the Verkhovna Rada of Ukraine Secretariat
Published on 29 January 2021, at 15:11

The Law of Ukraine No. 4613 “On Amending the Law of Ukraine ‘On Medications’ Regarding State Registration of Medications under Commitments” provides that in emergency situations (spread of pathogen agents, toxins, chemical substances or radiation, during epidemics and pandemics) state registration of medications can be conducted in accordance with a new pattern – “under commitments,” in line with a procedure prescribed by the Government. In such case, the Ministry of Health will adopt the decision on state registration of a medication only if the following conditions are met:

- for objective reasons, full information on the effectiveness and safety of the medication in question is unavailable, but there is information on successful preclinical trials and certain phases of clinical trials with scientifically justified evidence;

- permission to urgently use the medication was given by a competent authority in the United States, Great Britain, Switzerland, Japan, Australia, Canada, China, India, at least one EU country, or if the medication was prequalified by the WHO;

- the known and potential benefit of the medication outweighs its potential risks.

The Law of Ukraine No. 4613 defines the documents that a manufacturer must submit for the state registration of a medicinal product under commitments for emergency medical use and the requirements that the medicinal product must meet at the time of registration.

The registration certificate is issued for a period of 1 year with the possibility of extension for another year. After fulfillment of all obligations provided by the applicant within the prescribed period, the validity of the registration certificate may be extended for up to 5 years.