of September 6, 2016 No. 683
About introduction of amendments to the Order of the Ministry of Health No. 1400 of December 9, 2014. "About approval of rules of proper distributor practice (GDP) of medicines for the person"
According to the Resolution of Parliament of the Republic of Moldova No. 1352-XV of October 3, 2002 about approval of state policy in the field of drugs, the Order of the Government No. 1471 of December 24, 2007. "About approval of the Strategy of development for health care system during 2008-2017", Item 9 of the Regulations on the organization and functioning of the Ministry of Health approved by the Order of the Government No. 397 of May 31, 2011 and also for the purpose of quality assurance, to efficiency and safety of drugs, throughout all legal chain of distribution of drugs in the Republic of Moldova I ORDER:
1. In the Order of the Ministry of Health No. 1400 of December 9, 2014 "About approval of rules of proper distributor practice (GDP) of medicines for the person" (MO RM, 2015, No. 1-10, of the Art. 7), with subsequent changes, to make the following changes:
The phrase "June 1, 2016" to replace 1) in Item 2 with the phrase "till December 31, 2016".
2) after Item 2 it is supplemented with Item 2-1 with the following content:
"2-1. Inspections of GDP will be made based on statements of economic agents, but no later than December 31, 2016. For economic agents, distributors of medicines for the person who will not manage to implement the mentioned requirements of GDP in time specified in Item 2, but will receive positive qualification during evaluating, implementation of the mentioned regulations will be prolonged till December 31, 2017, and prolongation will be established based on decisions of the ad hoc commission created by ALMI with the assistance of representatives of MZ RM".
2. The order becomes effective from the date of publication in the Official monitor of the Republic of Moldova.
3. To impose control of execution of this order on Mrs. Liliana Jaschan, the deputy minister.
Minister of Health
Ruksanda Glavan
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