Registered by the
Ministry of Justice of Ukraine
September 7, 2005
of August 23, 2005 No. 421
About approval of the Procedure for carrying out certification of the companies which enable wholesale (distribution) of medicines
According to resolutions of the Cabinet of Ministers of Ukraine of 06.05.2005 No. 324 "About measures for accomplishment in 2005 of the Program of activities of the Cabinet of Ministers of Ukraine "Towards to people", of 28.10.2004 No. 1419 "Some actions on quality assurances of medicines" and of 02.06.2003 No. 789 "About formation of Public service of medicines and products of medical appointment", for the purpose of increase in level of quality assurance of medicines of PRIKAZYVAYU:
1. Approve the Procedure for carrying out certification of the companies which enable wholesale (distribution) of medicines it (is applied).
2. To the vice-chairman of Public service of medicines and products of medical appointment Pidpruzhnikov Yu. V. provide provision of this order in accordance with the established procedure on state registration in the Ministry of Justice of Ukraine and to its publication in mass media.
3. To impose control over the implementation of this order on the deputy minister V. O. Rybchuk.
S. M. Hanenko
Approved by the Order of the Ministry of Health of Ukraine of August 23, 2005, No. 421
1.1. This Procedure N1419 "Some Actions on Quality Assurances of Medicines" and of 06.05.2005 N324 "About measures for accomplishment in 2005 of the Program of activities of the Cabinet of Ministers of Ukraine "Towards to people" taking into account the Rules of management of medicines in the European Union including established by the directive 2001/83/EU of the European Parliament and EU Council of November 6, 2001 about compiled laws of the Commonwealth in relation to medicines for the person and in the document 94/C63/03 "Installation on proper practice of distribution of medicines for the person" and also the recommendations stated in the document of the World Health Organization "Installation on proper practice of storage of medicines" is developed according to resolutions of the Cabinet of Ministers of Ukraine of 28.10.2004 (WHO Technical Report Series, N 908, 2003).
1.2. Certification of subjects of managing (the companies, organizations, the organizations) which enable wholesale (distribution) of medicines (further - the company) on compliance to requirements of proper practice of distribution (further certification) is entered for the purpose of increase in level of quality assurance of medicines in Ukraine and performed on a voluntary basis.
1.3. Certification is carried out by Public service of Ukraine on medicines and control of drugs (further - Gosleksluzhba).
1.4. Certification can be carried out both all company, and its separate structural divisions.
1.5. Criteria of certification are solvency of the company:
provide compliance of material and technical resources, technical means and system of quality assurance of medicines during their distribution to the requirements established by the regulatory legal acts existing in Ukraine and Installation 42-01-2002 "Medicines. Proper practice of distribution", each structural division declared to certification;
provide permanent availability and oborotnost of inventories of range of medicines, in particular the main medicines and products of the medical appointment approved by the resolution of the Cabinet of Ministers of Ukraine of 25.03.2009 of N 333, deposited in the National list and the Obligatory minimum range of medicines for drugstores approved by the order of the Ministry of Health of Ukraine of 25.11.2004 of N 569, registered in the Ministry of Justice of Ukraine 03.12.2004 for N1537/10136;
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