ORDER OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF MOLDOVA

of April 8, 2016 No. 251

About change and amendment of appendices No. 1, 2, 3 to the Order of the Ministry of Health 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 of 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:

1. Appendices No. 1, 2, 3 to the Order No. 739 of 23.07.2012 "About authorization of medicines for the person and approval of post-registration changes" (Official monitor of the Republic of Moldova, 2012, No. 254-262, of the Art. 1555), with subsequent changes and amendments, to change and add how it is specified further:

1) in all text of appendices the word "user" is replaced with the word "consumer" in the corresponding case;

2) in appendix No. 1 to the order:

a) in item 4 of the word "c use" it is shall be replaced with words "when using";

b) in Item 5 subitem 6 changes as follows:

"6) the active agents and ingredients used as raw materials, except for made in the Republic of Moldova";

c) in Item 9:

after determination "bioequivalence" is supplemented with new determination with the following content:

"the validirovanny statement – the statement for which complete picking of the file, i.e. availability of all documents and necessary data for examination implementation was confirmed;";

determination "the certificate of GMP" changes as follows:

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