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LAW OF UKRAINE

of May 22, 2022 No. 2271-IX

About introduction of amendments to the Law of Ukraine "About medicines" concerning restriction of circulation of medicines which production is located in the territory of the Russian Federation or the Republic of Belarus, and also concerning export of medicines from Ukraine

The Verkhovna Rada of Ukraine decides:

I. Introduce in the Law of Ukraine "About medicines" (Sheets of the Verkhovna Rada of Ukraine, 1996, No. 22, Art. 86 with subsequent changes) such changes:

1. Twenty third Article 9 to add part with offers of the following content: "State registration of medicines it can be refused or according to the procedure, established by the central executive body providing forming and realizing state policy in the field of health care, state registration of medicines can be cancelled by the termination or reducing effective period of the registration certificate of medicine if by results of examination and/or consideration of the registration materials enclosed to the application for state registration, re-registration of medicine or modification of registration materials on medicine it will be revealed that one, several or all production phases of medicine are made by the companies which production capacities are located in the territory of the state aggressor of (Russian Federation) or Republic of Belarus. State registration of all or separately determined central executive body providing forming and realizing state policy in the field of health care, medicines in the procedure established by it can be cancelled by cancellation of the registration certificate or is temporarily stopped by suspension of action of the registration certificate before decision making by the central executive body providing forming and realizing state policy in the field of health care about renewal or cancellation of state registration in case of factual determination that the applicant (the owner of the registration certificate) of these medicines or the representative authorized by it directly or indirectly are connected with subjects of managing, including their representatives, their separate divisions (branches, representations), licensees, applicants, producers and suppliers, performing straight line or the mediated activities for production of medicines in the territory of the state aggressor of (Russian Federation) or Republic of Belarus, or after February 23, 2022 made transactions with participation at least at one of production phases of any medicine or AFI by the company located in the territory of the state aggressor of (Russian Federation) or Republic of Belarus provided to such company in use the pharmaceutical tangible or intangible assets or the related patents, permissions, licenses, registration certificates, the rights and other documents necessary for production of pharmaceutical products, including medicines, and also productions of AFI, performed transfer them in employment (lease) or alienated them directly or indirectly in property of residents of the state aggressor of (Russian Federation) or Republic of Belarus for production of pharmaceutical products. The decision on cancellation of state registration of medicine in the cases provided by the fifth offer of this part can be accepted not earlier than in three months after decision making about temporary suspension of action of the registration certificate on this medicine in coordination with the Cabinet of Ministers of Ukraine if the applicant (the owner of the registration certificate) continues the activities provided by the fifth offer of this part. ".

2. Add Article 18 with part two of the following content:

"For action of warlike situation in Ukraine the Cabinet of Ministers of Ukraine on representation of the central executive body which provides forming and realizes state policy in the field of health care can stop temporarily export of medicines in case of failure to provide of needs of health care system of Ukraine in such medicines in full".

II. Final provisions

1. This Law becomes effective from the date of, its publication following behind day, and is effective before completion of three-months term after the termination or cancellation of warlike situation.

2. To the Cabinet of Ministers of Ukraine in two weeks from the date of entry into force of this Law:

bring the regulatory legal acts into accord with this Law;

provide adoption of the new regulatory legal acts necessary for implementation of this law;

provide reduction by the ministries and other central executive bodies of their regulatory legal acts in compliance with this Law.

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