Department for Wholesale and Retail Trade of Medicines


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	<h1 class="post_title">Department for Wholesale and Retail Trade of Medicines</h1>
	<div class="post_content"><p style="text-align: center;"><strong>FUNCTIONS</strong> </p>
<p>The Department for Wholesale and Retail Trade of Medicines in accordance with other delegated assignments performs the following functions.</p>
<ul>
	<li>Ensures implementation of the state policy in the field of licensing of pharmaceutical manufacturing, wholesale and retail trade, import of medicinal products (except for active pharmaceutical ingredients).</li>
	<li>Carries out activities on issuance, reissuance, and cancellation of licenses for certain types of economic activities.</li>
	<li>Conducts expert examination of documents submitted to obtain licenses for carring out economic activities.</li>
	<li>Arranges conducting and control over inspections of business activities prior to license issuing within the time frame defined by the license issuing procedure or prior to starting new sites of economic activities or extending of a range of activities.</li>
	<li>Prepares information for Work group meetings on licensing certain types of economic activities (hereinafter - Work group).</li>
	<li>Prepares draft decisions of the State Service of Ukraine on Medicines and Drugs Control on licensing of certain types of economic activities on the basis of outcomes of the Work group meetings.</li>
	<li>Considers applications regarding inputing changes into the The United State Register of Legal Entities, Individual Entrepreneurs and Public Organizations of Ukraine on starting new sites of economic activities of a licensee, termination of a separate subdivision’s activity and notifications on all data changes mentioned in the documents enclosed to the application for license obtaining.</li>
	<li>Ensures publication of information on taken desicions regarding certain type of economic activities on the official website of the State Service of Ukraine on Medicines and Drugs Control.</li>
	<li>Forms and keeps license registers of defined types of economic activities.</li>
	<li>Prepares information to the Unified licensed register on licensing of economic activity of defined types of economic activities.</li>
	<li>Ensures formulation, keeping, storage, refering and receiving of lisense cases.</li>
	<li>Ensures state control (supervision) on adherence to the requirements of licensing conditions for carrying out defined types of economic activities (hereinafter - Licensing conditions) in a way of organization and conducting uncsheduled inspections of certain types of economic activities.</li>
	<li>Ensures proper preparation of documents and outcomes of conducted inspections.</li>
	<li>Collaborates with the Department for Manufacture Licencing, Import of Medicines, Control over Compliance with Licensing Conditions and Certification on issues related to business entities that conduct economic activities on import of medicinal products (except for API) in order to control adherence to the Licensing conditions.</li>
	<li>Coordinates work in the development of schedules for inspections on adherence to the Licensing conditions and requirements of good manufacturing practices of the State Service of Ukraine on Medicines and Drugs Control.</li>
	<li>Approves annual plans for conducting scheduled inspections by the regional authorities of the State Service of Ukraine on Medicines and Drugs Control, approves condunct of unscheduled inspections of business entities that carry out certain types of economic activities within existing legislation.</li>
	<li>Distributes and coordinates conduct of scheduled and unscheduled inspections of business entities that carry out certain types of economic activities between Central and regional authorities of the State Service of Ukraine on Medicines and Drugs Control, ensures conduct of these inspections within the timelines determined by legislation.</li>
	<li>Provides leadership of the State Service of Ukraine on Medicines and Drugs Control with proposals to revoke licenses to carry out certain types of economic activities in cases determined by legislation.</li>
	<li>Analyses work indicators of the regional authorities of the State Service of Ukraine on Medicines and Drugs Control on issues related to the state control (supervision) on adherence to the requirements of licensing conditions for carrying out defined types of economic activities.</li>
	<li>Provides public information on work performed by the State Service of Ukraine on Medicines and Drugs Control within the licensing of defined types of economic activities, conduct of state control (supervision) on adherence to the requirements of licensing conditions for carrying out defined types of economic activities and requirements of good pharmacy practices including GDP, GSP.</li>
	<li>Ensures conduct of state control (supervision) on adherence to the requirements of good pharmacy practices including GDP, GSP.</li>
	<li>Prepares drafts of decisions of the State Service of Ukraine on Medicines and Drugs Control on compliance of business entities’ activities on distribution of medicinal products with requirements of good distribution practice.</li>
	<li>Prepares proposals on improvement of legislation that regulates manufature activities (in pharmacy conditions) of medicinal products, wholesale and retail trade of medicinal products.</li>
	<li>Consolidates practices of implementation of legislation, that regulates activities of defined types of economic activities.</li>
	<li>Ensures application of unified methodological approaches to the performance by the State Service of Ukraine on Medicines and Drugs Control and its regional authorities of functions related to licensing and inspecting defined types of economic activities.</li>
	<li>Participates in the development and discussions of draft regulations on licensing of certain types of economic activities, conduct of state control (supervision) on adherence to the requirements of licensing conditions for carrying out certain types of economic activities and requirements of good pharmacy practices including GDP, GSP.</li>
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