of November 15, 2021 No. 1041
About introduction of amendments to the Order of the Minister of Health No. 739/2012 on authorization of medicines for the person and approval of post-registration changes
According to provisions of Art. 11 of h (1) the Law No. 1456/1993 on pharmaceutical activities (it is repeatedly published in the Official monitor of the Republic of Moldova, 2005, Art. No. 59-61, 200) and Art. 4 of h (1) the Law No. 1409/1997 on drugs (The official monitor of the Republic of Moldova, 1998, No. 52-53, to the Art. 368), and also based on Regulations on the organization and functioning of the Ministry of Health approved by the Order of the Government No. 148/2021, I ORDER:
1. In the Order of the Minister of Health No. 739/2012 "About authorization of medicines for the person and approval of post-registration changes" (The official monitor of the Republic of Moldova, 2012, Art. No. 254-262, 1555) to make the following changes:
in appendix No. 1
1) in all text of the word "Ministry of Health" in any grammatical form shall be replaced with words "The agency on drugs and medical products" in the corresponding grammatical form;
Item 2 after the words "The Agency on Drugs and Medical Products" to add 2) with syntagma" (further - ALMI)";
The subitem 6) to declare 3) in Item 5 invalid;
Item 8 to add 4) with the paragraph of the following content:
"During creation of the trade name the owner shall take into account elimination of any risk for health of the population, complying with the following conditions:
a) the trade name shall not mislead rather therapeutic or pharmaceutical properties of medicine;
b) the trade name of medicine shall not mislead concerning its structure;
c) the trade name shall not cause confusion with the trade name of the medicine which is already presented at the market which contains the same active ingredient:
d) trade names of products with other structure shall differ in at least three letters.";
5) in Item 9:
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