DECREE OF THE PRESIDENT OF UKRAINE
On Approval of the Regulations on the State Administration of Ukraine on Medicinal Products (SAUMP)
1. To approve the Regulations on the State Administration of Ukraine on Medicinal Products (SAUMP)(enclosed).
2. To determine that the State Administration of Ukraine on Medicinal Products (SAUMP)is a legal successor to the entitlements and mandates of the State Administration of Ukraine for Medicinal Products and Narcotics Control in terms of quality control and safety of medicinal products, including medical immunobiological preparations, medical equipment and medical devices that are out in circulation and/or applied in healthcare, that are approved for marketing in pharmacy institutions and their structural subdivisions as well as for the pharmaceutical manufacturing, retail and wholesale licensing.
3. The Cabinet of Ministers of Ukraine shall harmonise its regulations in accordance with this Decree within the upcoming three months.
4. This Decree shall enter into force after its publication.
President of Ukraine V.Yanukovych
Kyiv, April 8, 2011
No 440/2011
APPROVED
by the Decree
of the President of Ukraine
on April 8, 2011
No 440/2011
Regulations
On the State Administration of Ukraine on Medicinal Products(SAUMP)
1. The State Administration of Ukraine on Medicinal Products (SAUMP) is a central executive authority whose activities directed and coordinated by the Cabinet of Ministers of Ukraine through the Ukrainian Minister of Health.
The SAUMP is integrated into the system of healthcare executive authorities and is established to ensure implementation of the national policy in the areas of quality control and safety of medicinal products, including medicinal immunobiological preparations (hereinafter - medicinal products), medical equipment and medical devices that are out in circulation and/or applied in health care, that are approved for marketing in pharmacy institutions and their structural subdivisions (hereinafter – medical devices), as well as for the licensing of pharmaceutical manufacturing, wholesale and retail sale of medicines.
2. SAUMP is guided by the Constitution and Laws of Ukraine, Acts of the President of Ukraine and the Cabinet of Ministers of Ukraine, Decrees of the Ministry of Health of Ukraine, other legislative acts of Ukraine, as well as orders of the President of Ukraine and Minister of Health of Ukraine.
3. The mainSAUMP objectives are:
put forward proposals for the national policy-making in the areas of qualitycontrol and safety of medicinal products, medical devices and licensing of manufacturing, wholesale and retail sale of medicines;
implementation of the national policy in sphere of the state quality control and safety of medicinal products and medical devices;
licensing of activities in pharmaceutical manufacturing, wholesale and retail sale of medicinal products.
4. The SAUMP in accordance with its functions:
1) summarizes practice of legislative application on matters within its competence, develops proposals on improving legislative acts, acts of the President and the Cabinet of Ministers of Ukraine and in due course submits such proposalsto the Minister of Health of Ukraine for approval and inclusion into the Agenda of the Cabinet of Ministers of Ukraine;
2) exercises state control over compliance with the legislative requirements in:
quality and safety assurance of medicinal products and medical devices, including those procured by the state and local budgets, at all stages of their circulation, especially during their production, storage, transportation, sale by various economic entities, disposal and destruction, including requirements of good practices (manufacturing, distribution, storage, pharmacy);
enforcement of licensing conditions for pharmaceutical manufacturing, wholesale and retail sale of medicinal products, regardless of ownership and institutional subordination;
3) supervises over compliance with requirements of technical regulations on medical devices;
4) enforces a regulatory control over pharmaceutical import to the customs territory of Ukraine;
5) enforces state control and supervision of compliance with standards and technical requirements during transportation, storage and application of medicinal products, immunobiological preparations and medical devices;
6) takes samples of medicinal products and medical devices for their quality control in accordance with a set procedure;
7) provides binding notifications to eliminate violations of standards and technical requirements, compendial articles and manufacturing regulations, as well as to eliminate violations during production, storage, transportation and sale of medicinal products;
8) adopts decisions in due course on recalls and ban (suspension) production, marketing and usage of medicinal products and medical devices that donot comply with the requirements, specified by the regulatory acts and normative documents, as well as those imported into the territory of Ukraine and exported from the territory of Ukraine in violation of established procedure;
9) reports on administrative offences and review cases of administrative offencesif such arerequired by law;
10) approves passports for the pharmacy outlets (structural subdivisions) in accordance with an applicable legal procedure;
11) conducts sectoral attestation of the pharmaceutical quality control laboratories according to a set procedure;
12) conducts attestation of provisors and pharmacists according to a legislative procedure;
13) conducts the state registration of medical devices;
14) provides a one-time permission for importation of unregistered medical devices into the customs territory of Ukraine;
15) gives a conclusion about the quality of the imported medicinal product;
16) develops licensing conditions and issues licenses for manufacturing, wholesale and retail sale of medicinal products to the business entities;
17) establish, liquidate, reorganize institutions and enterprises, approves their regulations (statutes), appoints and dismisses their heads according to a set procedure, forming staff reserve on the positions of heads of enterprises, institutions and organizations within the sphere of competence of the SAUMP;
18) performs other functions within its competence of the management of public property, belonging to the sphere of its authority;
19) prepares the state order for personnel training in the relevant area;
20) exercises other powers determined by the laws of Ukraine and assigned to it by the President of Ukraine.
5. To ensure appropriate organization of activities the SAUMP:
1) provides within its authoritiesmeasures on prevention of corruption and control over such actions in the SAUMP Head Office, its territorial subdivisions, enterprises, institutions and organizations within the sphere of its competence;
2) according to a set procedure, recruits staff for the SAUMP Head Office and managerial positions in the territorial subdivisions, enterprises, institutions and organizations within the sphere of its competence, forms staff reserve in due course for appropriate positions, organizes initial training, re-training and skills upgrading ofthe civil servants and staff of the SAUMP Head Office and its territorial subdivisions;
3) supervises activities of the SAUMP territorial subdivisions;
4) arranges planning and financial activities at the SAUMP Head Office and its territorial subdivisions, enterprises, institutions and organizations within sphere of its competence, undertakescontrol offinancial and material resources usage;
5) organizes examination of public requests related to the activities conducted by theSAUMP, its territorial subdivisions, enterprises, institutions and organizations within sphere of its competence;
6) within its powers provides implementation of the state policy to protect State Secret and restricted information of state ownership, according to a set procedure supervises the status of safeguarding this information at the SAUMP Head Office, its territorial subdivisions, enterprises, institutions and organizations within sphere of its competence;
7) within its competence, fulfils an action plan of mobilization training and statemobilization preparedness;
8) according to the established rules performs arrangements for record-keeping and filing(archives) in the SAUMP Head Office;
9) prepares drafts of the state special-purpose programs for quality control of medicinal products and medical devices, participates in implementation of such programs.
6. In order to fulfil its functions, the SAUMP is authorized:
1) to involve academics and experts (upon their consent), staff from the central and local executive authorities into performance of designated agenda and investigation of some dedicated issues;
2) to receive information, documents and materials from the state and local authorities, enterprises, institutions and organizations of all types of ownership as well as other officials;
3) to convene meetings, set up commissions and working groups;
4) to use relevant databases of the state authorities, to access regulatory and governmental systems of communication, special communication networks and other technical devices;
5) to verify issues within its competence followed with binding notifications and orders.
7. The SAUMP enforces its powers directly as well as through its territorial subdivisions - the state administrations on medicinal products in the Autonomous Republic of Crimea, regions, cities Kyiv and Sevastopol.
Heads of the state administrations on medicinal products in the Autonomous Republic of Crimea, regions, cities Kyiv and Sevastopol, are at the same time Chief state inspectors, whereas their deputies are accordingly deputies of the chief state inspectors for quality control of medicinal products in a given territory.
8. Whilst carrying on its tasks, the SAUMP according to a set procedure collaborates with other executive authorities, auxiliary bodies and services, established by the President of Ukraine, local self-government bodies, certain bodies of foreign states and international organizations, trade unions and employer associations as well as the enterprises, institutions and organizations.
9. The SAUMP within its powers, based on the Constitution and Laws of Ukraine, acts and orders of the President of Ukraine, acts of the Cabinet of Ministers of Ukraine, orders of the Ministry of Health and Minister’s assignments, issue organizational-administrative directives, signed by the Head of SAUMP.
10. The SAUMP is chaired by the Head, appointed and dismissed by the President of Ukraine, in accordance with the notification of the Prime-minister of Ukraine pursuant to the proposals of the Minister of Health of Ukraine.
Head of the SAUMP holds a position of the Chief State Inspector of Ukraine for quality control of medicinal products.
Head of the SAUMP:
1) chairs the SAUMP and stay in charge of its activities;
2) ensures fulfilment by the SAUMP and its territorial subdivisions of the Constitution and Laws of Ukraine, acts and assignments of the President of Ukraine, acts of the Cabinet of Ministers of Ukraine, orders of the Ministry of Health of Ukraine and assignments of the Minister of Health, as well as cancellation of decisions, made by the SAUMP territorial subdivisions;
3) submits proposals to the Minister of Health of Ukraine on the national policy-making in the area of quality control and safety of medicinal products, medical devices as well as pharmaceutical manufacturing, retail and wholesale licensing, drafts of Laws, acts of the President and the Cabinet of Ministers, legislative acts of the Ministry of Health, developed by the SAUMP pursuant to its competence;
4) approves annual work plan, actions on realization of the main directions of work and prioritized goals in accordance with defined criteria, agreed by the Minister of Health of Ukraine on collegial meeting;
5) reports to the Minister of Health of Ukraine about fulfilment of the SAUMP annual working plan and its inherent tasks, on the corrected violations and deficiencies, identified during inspections by the SAUMP and its territorial subdivisions, as well as bring officials guilty of violations to an account;
6) submits proposals to the Minister of Health about candidates on positions of his deputies;
7) approves organizational structure of the SAUMP Head Office on agreement withtheMinister of Health of Ukraine, approves regulations for the structural subdivisions of SAUMP;
8) appoints and dismiss heads and deputy heads of structural subdivisions in the SAUMP Head Office, on agreement withthe Ministerof Health of Ukraine; appoints and dismiss other officials and staff of the SAUMP Head Office;
9) submits proposals to the Minister of Health on creation of territorial SAUMP bodies limited by the applicable number of personnel and financial resources, which are legal entities, approves their regulations;
likewise proposals to liquidate, restructure the SAUMP territorial bodies by the Cabinet of Ministers of Ukraine;
10) establishes, liquidates, reorganizes on agreement withthe Minister of Health of Ukraine and the Cabinet of Ministers of Ukraine, territorial bodies of the SAUMP, likewise structural units of the SAUMP Head Office, limited by the total staff and financial resources;
11) approves structure and totalnumber of employees of the territorial bodies, as well as stafflist and cost estimates in accordance with the SAUMP total staff limits;
12) on agreement with the Minister of Health of Ukraine and heads of the relevant local state administrations appoints and dismisses heads of territorial bodies;
appoints and dismisses deputy heads of territorial bodies on agreement withtheMinister of Health of Ukraine;
13) approves separation of duties between deputies;
14) ensures interaction between the SAUMP and responsible structural unit of the Ministry of Health, defined by the Minister of Health of Ukraine;
15) ensures appropriate informational exchange and well-timed submission between the Ministry of Health of Ukraine and the SAUMP as defined by the Minister of Health of Ukraine;
16) conducts a personalreceptionof citizens;
17) calls and holds meetings devoted to the agenda within the SAUMP competence;
18) according to a set procedure represents the SAUMP in its relations with the other regulatory bodies, authorities of the Autonomous Republic of Crimea, local self-government bodies, other institutions and organizations both in Ukraine and outside;
19) within the limits of its powers issues binding instructions for public officials and SAUMP staff and its territorial subdivisions;
20) according to a set procedure raises agenda for the Minister of Health of Ukraine to discipline the SAUMP first deputy head and deputy head as well as the other SAUMP employees and employees in its territorial units, enterprises, institutionsand organizations under the SAUMP subordination in case the above mentioned fail to fulfil their duties;
21) enforces other authorities according to the Presidential decrees and acts.
11. Head of the SAUMP has two deputies, including one first deputy.
First deputy and deputy Head of SAUMP are appointed by the President of Ukraine according to Premier’s submission pursuant to the SAUMP Head’s proposals agreed by the Minister of Health of Ukraine.
First deputy head and deputy head of the SAUMP are dismissed by the President of Ukraine.
12. To ensure an approved decision-making within the SAUMP competence, and facilitate discussion of the most important SAUMP operations agenda, a committee is to be established including the SAUMP Head (chairman of the Board), the first deputy head and deputy head of the SAUMP, as well as the other officials of the Ministry of Health of Ukraine, defined by the Minister. If required, the SAUMP board may also include heads of the SAUMP territorial subdivisions, as well as the other officials according to a set procedure.
The Board decisions may be implemented by special decrees elaborated by the SAUMP.
To review academic recommendations and to conduct professional consultations on general activities of the SAUMP, different permanent or temporary advisory or auxiliary bodies might be established.
Decisions on creation or liquidation of the Board, permanent or temporary advisory, auxiliary and other bodies, their regulations, number and staffare to be approved by the SAUMP chairman.
13. The ultimate number of the SAUMP civil servants and employeesis to be approved by the Cabinet of Ministers of Ukraine.
The SAUMP Head Office structure is to be approved by the SAUMP Head upon agreement with the Minister of Health of Ukraine.
The SAUMP staff list and budget are to be approved by the SAUMP Head upon agreement with the Ministry of Finance of Ukraine.
The SAUMP is a legal entity, ithas its own stamp carrying the sovereign coats of arms and its own title, own header sheets and accounts in the State Treasury.
Head of Administration
of the President of Ukraine S. LYOVOCHKIN
