State registration (renewal of registration) of medicinal preparations

Contacts

2a Tovarishesky Lane, Minsk, 220037 Belarus
rceth@rceth.by (reception)
mo-th: 8³⁰–17¹⁵
fr: 8³⁰–16⁰⁰

break: 12³⁰–13⁰⁰
sa, su: day off
+375 17 231-85-14 (reception)
+375 17 354-53-53 (office)
+375 17 252-53-58 (fax)

Online databases (russian version)

On-line application (russian version)

Appointment for consultation (russian version)

Submit an application according to the EEC rules (russian version)

Report an adverse drug reaction (russian version)

Appointment to the LFFA (russian version)

Personal account for medical devices (russian version)

Main
Documents
Department of Medicinal Preparations

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Name of the document	Number and date of the document	Download
DECREE OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS «On the complex of preliminary technical works preceding the state registration of strategically important medicinal products»	№ 126 21.12.2021
DECREE OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS «On the establishing a list of strategically important medicinal products»	№ 116 29.10.2021
RESOLUTION OF THE COUNCIL OF MINISTERS OF THE REPUBLIC OF BELARUS «On state registration of strategically important medicinal products»	№ 570 08.10.2021
RESOLUTION OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS «On the Requirements for the documents that make up the master file»	№ 100 18.11.2020
RESOLUTION OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS «On Inspection (Pharmaceutical Inspections) for Compliance with Good Pharmaceutical Practices»	№ 102 18.11.2020
RESOLUTION OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS «On approval of the Regulation on the Commission on medicinal products»	№ 97 17.11.2020
Resolution Ministry of Health of the Republic of Belarus «On a Complex of Preliminary Technical Works Prior to the State Registration of Medicinal Products»	№ 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
RESOLUTION NO. 51 OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS «On the establishment of a list of documents for a set of preliminary technical works»	№ 51 18.05.2020
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" (Amendments and additions: Resolution No. 611 of the Council of Ministers of the Republic of Belarus dated October 27, 2020)	№ 254 01.04.2015
Resolution of the Council of Ministers of the Republic of Belarus «On issues of the Ministry of Health of the Republic of Belarus»	№ 1446 28.10.2011
LAW OF THE REPUBLIC OF BELARUS No. 433-Z dated October 28, 2008 «On Principles of Administrative Procedures» (in the version of Law of the Republic of Belarus No. 17-Z dated January 9, 2017)	№ 433-З 28.10.2008
LAW OF THE REPUBLIC OF BELARUS No. 161-З dated July 20, 2006 On Circulation of Medicinal Products (as amended by Law of the Republic of Belarus No. 13-3 dated 13.05.2020)	№ 161-З 20.07.2006

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