ORDER OF THE MINISTRY OF HEALTH REPUBLIC OF MOLDOVA

of April 26, 2024 No. 396

About introduction of amendments to the Order No. 739/2012 on regulation of authorization of medicines for application by the person and introduction of post-authorization amendments

For the purpose of reduction 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 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) 2) and the subitem 3) to exclude Item 11 of the subitem;

b) add with Item 11-1 of the following content:

"11-1. After issue of the positive conclusion by results of examination concerning quality the applicant upon the demand of ALMI shall provide:

1) product samples in the quantity sufficient for carrying out 3 complete analyses according to the quality parameters provided in the specification of finished goods by the methods provided in the analitiko-regulating documentation (DAN);

2) reference substances, impurity and products of decomposition according to DAN in the quantity sufficient for carrying out 3 complete analyses.";

c) 7) to state Item 19 of the subitem in the following edition:

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