Department for Manufacture Licensing, Import of Medicines, Control over Compliance with Licensing Conditions and Certification

FUNCTIONS

The Department in accordance with the delegated assignments performs the following functions.

• Ensures licensing of economic activities in manufacture, import of medicinal products (except for API) including issuing, reissuing and termination of licenses.
• Ensures certification of quality of medicinal products for international trade and confirmation for exported active pharmaceutical ingredients.
• Ensures permormance of work on confirmation of compliance of medicinal products manufacture conditions with good manufacture practice requirements.
• Participates in preparation of proposals for formulation of state policy in licensing of economic activities in manufacture, import of medicinal products (except for API) (hereinafter – determined types of activity).
• Participates in preparation of proposals for formulation of state policy in certification of quality of medicinal products for international trade and confirmation for exported active pharmaceutical ingredients.
• Participates in preparation of proposals for formulation of state policy in confirmation of compliance of medicinal products manufacture conditions with good manufacture practice requirements.
• Takes part in formulation and consultations of draft legislation and regulations regarding issues related to the Department’s competencies.
• Participates in international cooperation in the field of licensing of certain types of economic activities and within its competencies in performance of functions established by international cooperation in the field of activity.
• Agganges work on conducting state supervision (control) of business entities that conduct economic activities on manufacture and import of medicinal products (except for API) in order to control adherence to the Licensing conditions for determined types of economic activities.
• Arranges work on conducting inspections prior to license issuing before starting new sites of carrying out activities or extending a range of activities and abidance by ligislation requirements on License conditions for determined types of economic activities.
• Collaborates with the Department for Wholesale and Retail Trade of Medicines on issues related to state supervision (control) of business entities that conduct economic activities on import of medicinal products (except for API) in order to control adherence to the Licensing conditions.
• Ensures conducting Work group meetings on licensing of manufacture, wholesale and retail trade of medicinal products (except for API) of the State Service of Ukraine on Medicines and Drugs Control.
• Prepares draft decisions of the State Service of Ukraine on Medicines and Drugs Control on licensing of certain types of economic activities.
• Prepares draft decisions of the State Service of Ukraine on Medicines and Drugs Control based on results of conducted inspections on abidance by License requirements for determined types of economic activities by licensees.
• 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.
• Ensures conducting expertise of submitted documents for obtaining a license or starting new sites of economic activities or extending a range of activities in manufacture, import of medicinal products (except for API).
• Ensures conducting of Work group meetings on assesment of results of medicinal products manufacture inspections on abidance by GMP requirements.
• Considers letters, requests, complains regarding violation of legislation while manufacturing of medicinal products and quality of manufactured medicinal products.
• 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.
• Ensures formulation and maintaining of the registers on manufacture, import of medicinal products (except for API).
• Ensures formulation, keeping, storage, refering and receiving of lisense cases.
• Ensures functioning of defined system processes of the quality management system of the State Service of Ukraine on Medicines and Drugs Control and regular improvement of its efficiency.
• Collaborates with the official authorized for performance of the quality management system of the State Service of Ukraine on Medicines and Drugs Control.
• Considers citizens’ letters, requests, complains within its competencies.