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RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of January 15, 1996 No. 73

About approval of the Regulations on control of compliance of the immunobiological medicines applied in medical practice, to requirements of the state and international standards

(as amended on 15-04-2022)

According to the Law of Ukraine "About ensuring sanitary and epidemiological wellbeing of the population" and for the purpose of enhancement of system of testing and acceleration of implementation of new immunobiological medicines in medical practice the Cabinet of Ministers of Ukraine DECIDES:

1. Medical immunobiological supplies (further immunobiological products) are vaccines, anatoksina, immunoglobulins, serums, bacteriophages, other medicines, held for use in medical practice for the purpose of treatment, specific prevention, diagnostics of condition of immunity (in vivo).

Immunobiological products can be made as ready dosage forms, biological agents (active ingredients), bulk immunobiological medicines and medicines in krupnoobjemny packaging (in bulk), standard samples (the international sample, the state (industry) standard sample, standard sample of the company).

2. Determine that state registration of medical immunobiological supplies of national and foreign production is performed by the Ministry of Health, and examination of materials on medical immunobiological supplies which move for state registration (re-registration), and also examination of materials about modification of registration materials during action of the registration certificate on medicine (medical immunobiological supply), is carried out by the state company "State MZ Expert Centre".

3. To the ministries and departments, the Government of the Autonomous Republic of Crimea, local authorities of the state executive authority, the companies, organizations and the organizations irrespective of subordination and patterns of ownership to provide to Public service on medicines and
to control of drugs information on immunobiological medicines for control of their compliance to requirements of the state and international standards.

4. To the Ministry of Health to perform state registration, re-registration of medical immunobiological supplies according to the procedure, determined for medicines.

5. Determine that for action of warlike situation for the purpose of uninterrupted providing healthcare institutions and citizens with medical immunobiological supplies, for control of compliance of the immunobiological medicines applied in medical practice, to requirements of the state and international standards according to the procedure determined by the order of the Ministry of Health, filing of applications on issue of the conclusions about compliance of medical immunobiological supplies to requirements of the state and international standards and issue of the conclusions about compliance of medical immunobiological supplies to requirements of the state and international standards is performed in electronic form.

Due to the introduction of warlike situation to the separate decision of Public service on medicines and control of drugs the conclusion about compliance of medical immunobiological supplies to requirements of the state and international standards, including the medical immunobiological supplies in foreign packaging made for needs of the markets of other countries is issued without carrying out laboratory control, the bases for which are determined by the order of the Ministry of Health. In that case responsibility for control of quality of series of medical immunobiological supplies is born by authorized persons of subjects of managing which according to licensed conditions of implementation of economic activity on production of medicines, wholesale and retail trade by the medicines, import of medicines (except active pharmaceutical ingredients) approved by the resolution of the Cabinet of Ministers of Ukraine of November 30, 2016 No. 929 (The Official Bulletin of Ukraine, 2016, No. 99, stations 3217), bear responsibility for quality and safety of the medicines imported by them.

Prime Minister of Ukraine

E.Marchuk

Minister

Cabinet of Ministers of Ukraine

 

V. Pustovoytenko

Approved by the resolution of the Cabinet of Ministers of Ukraine of January 15, 1996 No. 73

Regulations on control of compliance of the immunobiological medicines applied in medical practice, to requirements of the state and international standards

1. Medical immunobiological supplies (immunobiological products are farther) - allergens, anti-genes, vaccines (anatoksina), tsitokina, immunomodulators of bacterial origin, and also created on the basis of bodies and fabrics medicines which receive from blood and plasma of the person, immune serums, immunoglobulins (including monoclonal antibodies), probiotics, interferona, other medicines, held for use in medical practice for the purpose of treatment, specific prevention, diagnostics of condition of immunity (in vivo).

Immunobiological products receive by cultivation of strains of microorganisms and cages of eukariot, extraction of substances from biological fabrics, including tissues of the person, animals and plants (allergens), application of methods of genetic engineering, gibridomny technology, reproduction of living agents in embryos or animals.

Immunobiological products can be made as ready dosage forms, biological agents (active ingredients), bulk immunobiological medicines and medicines in high-capacity packaging (in bulk).

New immunobiological products - immunobiological products which for the first time are registered in Ukraine and are created with use of new biological agents (active ingredients) or which are new high-quality or quantitative combination of the famous biological agents (active ingredients).

2. In the territory of Ukraine only immunobiological products which meet the requirements of the state and international standards can be applied in medical practice and diagnostics, are registered in Ukraine, included in the State register of medicines and underwent in certain MZ procedure quality control.

3. Institutions of health care are provided with immunobiological products which underwent the corresponding control according to the procedure, established by this Provision, meet the requirements of the state and international standards.

4. Control of compliance of immunobiological products to requirements of the state and international standards (further quality control of immunobiological products) is exercised by Gosleksluzhboy according to this Provision.

5. Quality control of immunobiological products is exercised on conditions and in terms that certain MZ.

6. Continuous and selective control of quality of immunobiological products which are made in Ukraine and also incoming inspection of quality of immunobiological products of foreign production is exercised by Gosleksluzhboy and Laboratory.

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