of July 24, 2024 No. 635
O introduction of amendments to the Order No. 739/2012
For the purpose of enhancement of the regulatory base on authorization of medicines for application by the person in compliance with the European requirements, based on article 11 of the Law No. 1456/1993 on pharmaceutical activities, article 4 of the Law No. 1409/1997 on drugs, and also according to the 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 on regulation of authorization of medicines for application by the person and introduction of post-authorization amendments, (The official monitor of the Republic of Moldova No. 254-262, of Art. 1555 of 14:12. 2012) to make the following changes:
1) in appendix No. 1:
a) in Items 92, 93 litas. g), 96 after words of "the procedure of mutual recognition" to add 94, with the text", the national procedure of authorization";
b) in Items 98, 104 after the words "the decentralized procedure" to add with the text", the procedure of mutual recognition, the national procedure of authorization".
2. This order becomes effective from the date of its publication in the Official monitor of the Republic of Moldova.
3. To impose control of execution of this order on the state secretary Mr. Alexander Gasnash.
Minister
Alla Nemerenko
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