ORDER OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF MOLDOVA

of January 29, 2015 No. 58

About modification and amendments in the Order of the Minister of Health No. 739 of 23.07.2012 "About authorization of medicines for the person and approval of post-registration changes"

According to provisions st.11 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, Art. 13 of the Law on regulations of the Government and other bodies of the central and local public authority No. 317-XV of July 18, 2003, for the purpose of harmonization of regulatory framework for authorization of medicines for the person according to the European requirements, and also according to Item 9 of 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:

1. In the Order of the Minister of Health 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, Art. No. 254-262, 1555) to make the following changes and additions:

1) in the order and its appendices of the word "The Agency on Drugs" shall be replaced with words "The agency on drugs and medical products" in the corresponding case;

Item 2 of the order to add 2) with paragraphs 3) and 4) in the following edition:

"3) to provide the advisory and methodical help to applicants;

To bring 4) into accord with this order the departmental regulations.".

2. In the order and appendices of the word "instruction on medical application of medicine" or "instruction on medical application" to exclude.

3. In appendix No. 3:

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