ORDER OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF MOLDOVA

of November 19, 2015 No. 969

About change of the Order No. 739 of 23.07.2012.

According to provisions of Art. 11 of the Law on pharmaceutical activities No. 1456-XII of May 25 1993, with subsequent changes and amendments, to Art. 4 of the Law on drugs No. 1409-XIII for December 17 1997, with subsequent changes and amendments, for the purpose of harmonization of regulatory framework for registration of medicines for the person according to the European requirements, and also according to 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 with subsequent changes and amendments, I ORDER:

The order No. 739 of 23.07.2012 "About authorization of medicines for the person and approval of post-registration changes" (The official monitor of the Republic of Moldova, 2012, No. 254-262, of the Art. 1555), with changes and amendments, according to the Order No. 58 from 29.01.2015, to change and add as follows:

1. In all text of appendices 1 and 3 to the order of syntagma "or parts of 1-2 files in format ne-OTD/CTD", "or parts 3-4 ne-OTD/CTD", "and parts 1-4 formats ne-OTD/ne-CTD", "also speak rapidly 1-4 formats ne-OTD/ne-CTD", "or 2-3 formats ne-OTD/CTD", "or parts 1-2 ne-OTD/CTD", in the corresponding case, are excluded.

2. In appendix No. 1 to the order:

1) in Item 11 of the subitem 1) after the words "on paper" it is supplemented with syntagma" (only the Module 1)";

2) Item 16 changes as follows:

"16. In that case when the owner of the registration certificate of medicine is not his producer, the notarized copy of the agreement between these two parties apostilled or legalized, if necessary in addition is submitted. In case (whether) the owner of the registration certificate of medicine and its producer are members of the same group of companies, the letter certified notarially confirming belonging of the owner and producer to the same group of companies apostilled or legalized if necessary "is provided

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