of September 14, 2005 No. 902
About approval of the Procedure of the state quality control of medicines which are imported into Ukraine
The Cabinet of Ministers of Ukraine decides:
1. Approve the Procedure of the state quality control of medicines which are imported into Ukraine it (is applied).
Acting as Prime Minister of Ukraine
Approved by the Resolution of the Cabinet of Ministers of Ukraine of September 14, 2005, No. 902
1. This Procedure determines the mechanism of the state quality control of medicines which are imported into Ukraine which is performed for the purpose of non-admission of the address of the counterfeited, low-quality and unregistered medicines.
2. Action of this Procedure extends to all subjects of managing who import medicines into Ukraine.
Action of this Procedure does not extend to the relations in the field of the state quality control of medical immunobiological supplies which are used, made or offered to application in medical practice in Ukraine.
3. On the territory of Ukraine the medicines registered in Ukraine in the presence of the quality certificate issued by their producer - the certificate of the analysis or the certificate of series (further - the quality certificate) which certifies compliance of medicines of the specification of quality of methods of quality control of medicines are imported.
The unregistered medicines can be imported into Ukraine according to the procedure, certain MZ, for carrying out preclinical researches, pharmaceutical development and clinical testing, state registration of medicines in Ukraine (samples of medicines in dosage forms); exhibiting at exhibitions, fairs, conferences without sales right; individual use by citizens; medical support (without sales right) divisions of armed forces of other states which according to the law are allowed on the territory of Ukraine, and also import of such means in case of natural disaster, catastrophic crashes, epidemic disease in the presence of the documents confirming their registration and use in foreign states.
For ensuring proper implementation of the state quality control of medicines the State Customs Service submits to Gosleksluzhbe information on the medicines imported on the territory of Ukraine.
5. For the purpose of further realization (trade) of medicines which are imported on the territory of Ukraine or uses them in production the subject of managing within five working days after the termination of customs clearance of load with medicines submits to state control body at the venue of economic activity the statement for issue of the conclusion about quality of the imported medicines (further - the conclusion) in the form established by Gosleksluzhboy.
Such documents are enclosed to the application:
the list of the imported medicines constituted in the form established by Gosleksluzhboy;
the copy of the quality certificate issued by the producer on each series of medicines, and its transfer certified by the signature of the head or authorized person of the subject of managing, sealed it, in case of its availability. Requirements to contents of the quality certificate of series of medicine are given in appendix (variations on form of presentation of information in the certificate are allowed if they do not change it to essence);
the copy of the customs declaration with mark of customs certified by the signature of the head or authorized person of the subject of managing, sealed it in case of its availability;
copy of the invoice (invoice);
copies of registration certificates on the imported medicines;
the copy of the document issued by Gosleksluzhboy confirming compliance of conditions of production of medicines to requirements to production of medicines in Ukraine except active pharmaceutical ingredients (substances).
The specified documents are filed to state control body in paper or electronic type.
The documents filed to state control body do not return.
6. Action of Item 5 of this Procedure does not extend to subjects of managing who import active pharmaceutical ingredients (substances) and products of "in bulk". Such subjects perform sampling for carrying out the laboratory analysis and control of their quality on compliance to requirements of the specification of quality of methods of quality control of medicine of the registration certificate (or to requirements of the State pharmacopeia of Ukraine - for active pharmaceutical ingredients) independently and bear responsibility for quality of the specified medicines according to the legislation.
The laboratory analysis is carried out in laboratories of quality control and safety of the medicines certified in the procedure established by the Ministry of Health.
Subjects of managing inform monthly to the 15th state control body in the place of implementation of economic activity on date of import of medicines, their name, number of series, quantity, producers, availability of registration and results of carrying out the laboratory analysis received during calendar month in the form approved by Gosleksluzhboy.
In case of identification by results of the laboratory analysis of low-quality active pharmaceutical ingredients (substances) and products of "in bulk", subjects of managing not later than within three working days inform state control bodies in the place of implementation of economic activity on the measures taken in connection with identification of low-quality active pharmaceutical ingredients (substances) and products of "in bulk".
7. For the period of implementation of the state control the subject of managing shall place load with medicines separately from other products in specially allotted zone (room) in warehouse at the venue of economic activity, make on such load text "Quarantine" and create proper conditions for its storage.
The paragraph two is excluded according to the Resolution of the Cabinet of Ministers of Ukraine of 07.10.2015 No. 804
8. The state control is exercised by carrying out by state control bodies:
examinations of the documents filed by the subject of managing;
checks of load in the place of its arrangement on compliance of the customs declaration concerning amount of medicines of each series and implementation of visual inspection of each series of medicines;
the laboratory analysis in the cases determined by this Procedure on compliance of indicators of quality of medicines to requirements of the specification of quality of methods of quality control of medicines or to general requirements to the medicines established by the State pharmacopeia of Ukraine in the laboratories certified in the procedure established by MZ.
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