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New Revision of GDP Guidelines is Approved

It was informed earlier that in February this year the State Inspectorate for Quality Control of Medicines developed a new revision of “Medicines. Good Distribution Practice” Guidelines but the order of the Ministry of Health of Ukraine approving the Guidelines was cancelled in March sustaining “Medicines. Good Distribution Practice” Guidelines in 2008 revision.

The order of the Ministry of Health of Ukraine dated August 22, 2014 No. 593 On Amendments to the Order of the Health Ministry of Ukraine dated February 16, 2009 No. 95 approved the GDP Guidelines in new revision: СТ-Н МЗУ 42-5.0:2014.

The Guidelines is the version of EU document – Good Distribution Practice of Medicines in 2013 revision (2013/С68/01) in Ukrainian and it covers business entities distributing medicines on the Ukrainian territory including business entities producing medicines irrespective of their agency-level submission and proprietary form and brokers.

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