Registered by the
Ministry of Justice of Ukraine
February 5, 2002
of October 30, 2001 No. 436
About approval of the Instruction about procedure for quality control of medicines during wholesale and retail trade
In pursuance of the Law of Ukraine "About medicines", for the purpose of strengthening of control of quality of medicines
1. Approve the Instruction about procedure for quality control of medicines during wholesale and retail trade (further - the Instruction) which is applied.
2. To provide to the First Deputy Chief state inspector of Ukraine on quality control of medicines Varchenko V. G. provision of this order on state registration in the Ministry of Justice of Ukraine and the publication in mass media.
3. Determine that the Instruction becomes effective from 01.03.2002.
4. The state inspectorate for quality control of MZ medicines of Ukraine (Varchenko V. G.), to the state inspectorates for quality control of medicines in the Autonomous Republic of Crimea, areas, the cities of Kiev and Sevastopol to provide control of fulfillment of requirements of the Instruction by the business entities having licenses for the right of wholesale and retail trade by medicines.
5. Consider invalid the order of Goskommedbioprom of 28.01.98 No. 11 "About quality assurance of medicines".
6. To impose control of execution of this order on the Deputy State secretary A. P. Kartysh.
Approved by the Order of the Ministry of Health of Ukraine on October 30, 2001 No. 436
1.1. This Instruction is developed in pursuance of the Law of Ukraine "About medicines" and the Presidential decree of Ukraine of 11.06.98 No. 615/98 "About approval of Strategy of integration of Ukraine into the European Union".
1.2. The instruction regulates procedure for carrying out incoming inspection of quality of medicines by the business entities having licenses for the right of wholesale and retail trade by medicines and the state quality control of medicines during wholesale and retail trade.
1.3. Incoming inspection of quality of medicines during wholesale and retail trade is performed by means of visual methods by the authorized persons of business entities having licenses for the right of wholesale and retail trade by medicines.
1.4. The state quality control of medicines during their wholesale and retail trade is performed Public service of Ukraine on medicines (further - Gosleksluzhba of Ukraine), the state inspectorates for quality control of medicines in the Autonomous Republic of Crimea, areas, the cities of Kiev and Sevastopol (daleeterritorialny inspections) subordinated to them by laboratories (daleelaboratoriya), and also the laboratories accredited by the State inspection (further - authorized laboratories).
1.5. The state quality control of medicines during their wholesale and retail trade is performed by inspection of business entities of all patterns of ownership by territorial inspectorates and subordination which are engaged in wholesale or retail trade of medicines (daleesubjekta), for check of observance of requirements of the legislation by them concerning quality assurance of medicines.
1.6. Trade in low-quality and counterfeited medicines is forbidden; without quality certificates which are issued by producers; not registered in Ukraine; which expiration date passed.
1.7. The main terms which are used in this Instruction:
the analitiko-regulating documentation (ARD) - the regulating documents determining quality and quantity characteristics of medicine, their admissible borders and techniques of carrying out testing establish requirements to packaging, marking, storage conditions, the transportations, medicine expiration date approved during registration of medicine in Ukraine;
the analysis of medicine - carrying out laboratory research of quality of medicine and excipients on indicators by the analysis methods stated in this AND operating in Ukraine with AND and creation of the conclusions about compliance of the checked samples to requirements of AND;
incoming inspection - quality control of medicines in case of their receipt of housekeeping by the subject who is performed by visual check or the analysis of medicine;
the low-quality (substandard) medicinal sredstvapreparata made by the legal producer with the correct marking, but which due to the lack of proper conditions of production, transportations and storages do not meet the established requirements of regulating documents;
the conclusion concerning quality - the document with information on the checked medicine sample with results of laboratory research and the conclusion concerning compliance to requirements of AND operating in Ukraine issued by laboratory according to the analysis of quality of medicines, subordinate or authorized Gosleksluzhboy of Ukraine;
the quality certificate of the producer - the document issued by the producer on medicine series compliance to the requirements established during its registration in Ukraine;
the authorized person - person appointed by the head of business entity to the corresponding position of pharmaceutical institution to which according to the order implementation of incoming inspection of quality of the medicines which are subject to wholesale and retail trade is assigned;
counterfeited medicines - medicines which are purposely incorrectly marked concerning identity and the name of the producer. Both the original, and reproduced medicines can be counterfeited; they may contain ingredients in the corresponding or inappropriate structure, can be without active ingredients, with their insufficient quantity or in deceptive package.
Contents of other terms which are applied in this Instruction are determined by the Laws of Ukraine "About medicines", "Bases of the legislation of Ukraine about health care", the resolution of the Cabinet of Ministers of Ukraine of 12.05.97 No. 447 "About ordering of activities of pharmaceutical institutions and approval of Rules of retail sale of medicines".
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