Department of the Medicines Quality Control

FUNCTIONS

The Department for Medicines Quality Control according to the delegated tasks performs regulatory, human rights, supervisory, organizational and evaluation functions within the framework of the state quality control of medicinal products:

• Takes part in formulation and consultations of draft legislation and regulations regarding issues related to the Department’s competencies.
• Prepares decisions (directives) of the State Service of Ukraine on Medicines and Drugs Control on prohibition (termination) of manufacturing, trade, storage and use of medicinal products which appeare to be not in compliance with the requirements determined by the regulatory framework and regulatory documents including the ones received regarding alerts on side-effects and/or death as a result of consumption of series of medicinal products before investigation into the causes.
• Monitors activities of the regional authorities of the State Service of Ukraine on Medicines and Drugs Control within Department’s competencies to ensure adherence to Ukraine’s legislation on quality of medicinal products including legislation on administrative offences.
• Develops and improves mechanisms for interaction with the regional authorities of the State Service of Ukraine on Medicines and Drugs Control within its competence.
• Ensures state quality control of medicinal products at every stage of their circulation including those that are purchased with funding from the state and local budgets.
• Jointly with other structural units of the State Service of Urkaine on Medicines and Drugs Control prepares materials and participates in arrangements of training seminars for inspectors, laboratories employees, wholesale suppliers of medicinal products, distributors, pharmacists on issues relevant to the Department’s competencies.
• Ensures state quality control of medicinal products while importing them to the customs territory of Ukraine.
• Within its competencies develops and makes proposals on improvement of mechanisms for interaction with manufacturers (representatives of foreign manufacturers) of medicinal products for prompt detection of poor-quality, falsified and unregistered medicinal products.
• Consolidates and prepares information for meetings on issues relevant to the state quality control of medicinal products.
• Analyzes indicators of activities of the regional authorities of the State Service of Ukraine on Medicines and Drugs Control within Department’s competencies.
• Supervises activities of the regional authorities of the State Service of Ukraine on Medicines and Drugs Control and subordinated laboratories within its competencies to ensure quality of medicinal products, and within the legislation on administrative offences.
• Develops standard forms to document performance and reporting of the regional authorities of the State Service of Ukraine on Medicines and Drugs Control
  and laboratories dealing with quality control of medicinal products within the Department’s competencies.
• Organizes and conducts activities in due course on recognition of laboratories authorized by the State Service of Ukraine on Medicines and Drugs Control to perform quality control of medicines.
• Analyses and consolidates documents containing urgent notifications of the regional authorities of the State Service of Ukraine on Medicines and Drugs Control on detected poor-quality, falsified and unregistered medicinal products, including medicinal products that do not correspond the requirements and regulations and prepares information letters to the regional authorities of the State Service of Ukraine on Medicines and Drugs Control on detected poor-quality medicinal products on the territory of Ukraine.
• Monitors measures applied by the regional authorities of the State Service of Ukraine on Medicines and Drugs Control on withdrawal of poor-quality, falsified, and unregistered medicinal products, and medicinal products, which do not correspond the requirements, determined by the regulations, within its competencies.
• Conducts state quality control to ensure adherence to the requirements of quality and safety of medicinal products while their circulation.
• Organises and ensures in due course sampling of medicinal products to conduct their state quality control.
• Organizes and consolidates the data base containing information on poor-quality, falsified, unregistered medicinal products, and medicinal products which do not correspond the requirements, determined by the regulations, and forbidden by decisions (directives) of the State Service of Ukraine on Medicines and Drugs Control.
• Considers complaints and requests for public information, addresses requests of citizens and business entities, manufacturers, representatives of foreign entities in Ukraine on issues related to the Department’s competencies.
• Provides preparation of information sheets on issues related to medicinal products quality.
• Collaborates in due course with foreign medicines regulatory authorities and international organizations (regulatory authorities of CIS countries, EMA, PIC/S, WHO etc.) within its competencies.
• Participates in coordination and discharge of responsibilities according to the international treaties, conventions, agreements, memorandums and other international documents on issues relevant to the Department’s competencies.
• Prepares information sheets to the regional authorities of the State Service of Ukraine on Medicines and Drugs Control on poor-quality and falsified medicinal products detected by the foreign medicines regulatory authorities and international organizations.
• Ensures information exchange with law-enforcement authorities on falsified medicinal products detected and forbidden by decisions (directives) and on other issues exhibiting the indicia of a crime.
• Prepares letters to cancel decisions (directives) of the State Service of Ukraine on Medicines and Drugs Control on a basis of positive outcomes of additional quality control procedures.
• Collaborates in due course with other executive authorities, organizations and services established by the President of Ukraine, local self-government bodies, relevant bodies of foreign countries, international organizations, labour units, employers’ organizations and business entities, institutions, organizations on issues relevant to the Department’s competencies.
• Participates in preparation of reports on outcomes of the state quality control of medicinal products to the Cabinet of Ministers of Ukraine, Ministry of Helath of Ukraine and other executive authorities (as required).
• Prepares proposals on the state policy formulation in the field of accreditation of pharmaceutical quality control laboratories and improvement of pharmaceutical quality management system, participates in implementation of the mentioned state policy.
• Examines laboratories of different forms of property with further possibility of their accreditation.
• Within its competencies inspects business entities whether their activities are carried out in compliance with requirements of the legislation on quality of medicinal products, while their storage, distribution and use.
• Controls regional authorities of the State Service of Ukraine on Medicines and Drugs Control to provide timely plan-schedules of ispections of business entities in the field of medicinal products quality control.
• Addresses in compliance with the Law of Ukraine “On the Basic Principles of State Supervision (Control) over Business Activity” approvals of the regional authorities of the State Service of Ukraine on Medicines and Drugs Control of conducting uncsheduled inspections of business entities which dealth with pharmaceutical manufacturing, wholesale and retail trade and use of medicinal products.
• Analyses conclusions of expert institutions on detected discrepancy regarding medicinal products.
• Draws up reports on administrative offences while inspecting business entities and imposes administrative penalties.
• Drafts plan-schedules for inspecting business entities in accordance with the Law of Ukraine “On the Basic Principles of State Supervision (Control) over Business Activity”.
• Addresses copies of registration certificates of medicinal products, quality control methods (including labeling text of a registration sertificate), instructions for use of medicinal products, provided in due course by the SE “State Expert Center of the Ministry of Health of Ukraine” and/or holders of registration certificates, their representatives to the State Service of Ukraine on Medicines and Drugs Control, inputs received and proceeded information into the Unified Automated Information System (UAIS).
• Addresses requests of business entities on medicine packaging mockups and inputs the information into the Unified Automated Information System (UAIS).
• Performs other functions in accordance with other delegated assignments.