Examination of dossiers of medicinal products submitted for state registration( confirmation of state registration), state conditional registration ( confirmation of conditional state registration), state registration in a simplified manner, amendments to the registration dossier of medicinal products, registration (confirmation of registration) of medicinal products within the EAEU and other procedures related to the registration of medicinal products within the EAEU

Name of the document	Number and date of the document	Download
RESOLUTION OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS «On the Requirements for the documents that make up the master file» (as amended on 06.10.2023 No. 163)	№ 100 18.11.2020
Resolution Ministry of Health of the Republic of Belarus «On a Complex of Preliminary Technical Works Prior to the State Registration of Medicinal Products» (as amended on 06.10.2023 No. 163)	№ 93 02.11.2020
RESOLUTION OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS "On the criteria for trade names of medicinal products"	№ 78 24.09.2020
Decision of the Council of the Eurasian Economic Commission of 03.11.2016 No. 78 «On the Rules of marketing authorization and assessment of medicinal products for medical use» (as amended by Decision of the Council of the Eurasian Economic Commission No. 55 dated 14.06.2018)	№ 78 03.11.2016
RESOLUTION OF THE COUNCIL OF MINISTERS OF THE REPUBLIC OF BELARUS «On state registration (confirmation of state registration) of medicinal products» (as amended on 06.07.2023 No. 441)	№ 254 01.04.2015
LAW OF THE REPUBLIC OF BELARUS «On Medicine Circulation» (as amended on 14.10.2022 No. 213-З)	№ 161-З 20.07.2006

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