Draft Law On Abolition of Licensing API Promulgated

On May, 26, 2014, the Ministry of Healthcare of Ukraine promulgated the Draft Law of Ukraine ‘On Introduction of Amendments Into Certain Laws of Ukraine (In Terms of Abolition of Licensing Imports of Active Pharmaceutical Ingredients)’.

The present document shall foresee introduction of amendments into certain provisions of the Law of Ukraine ‘On Medicinal Products’ and the Law of Ukraine ‘On Licensing Certain Types of Business Activities’ for the purpose of abolition the requirements for licensing active pharmaceutical ingredients (‘API’- hereinafter) as of January, 1, 2015. In case if the draft law is adopted, the below shall come into force:

1. It shall be allowed to import in the territory of Ukraine the medicinal products that are registered in Ukraine contingent upon quality certificate for the series of a medicinal product that is issued by the producer as well as the license for imports of medicinal products (other than AFI) that is issued to the importer (producer or the entity that represents the producer of medicinal products in the territory of Ukraine) as statutory prescribed.
2. The business activities related to medicinal products, psychoactive substances and precursors, production of medicinal products, wholesale and retail of medicinal products, imports of medicinal products (other than AFI) and safeguarding activity shall be subject to licensing in accordance with the Law of Ukraine 'On Licensing of Certain Types of Business Activities' with the view to the specifics envisaged in the laws of Ukraine ‘On Drugs, Psychoactive Substances and Precursors’, ‘On Medicinal Products’ and ‘On Safeguarding Activities’.

In the Executive Summary to the Draft Law the Ministry of Healthcare of Ukraine specified that the Draft Law was elaborated to deregulate, stimulate entrepreneurship and ensure balance of entrepreneurship and state interests.