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

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 17 252-53-58 (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
Republican Clinical and Pharmacological Laboratory

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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»	№ 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»	№ 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" (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 No. 156 OF THE COUNCIL OF MINISTERS OF THE REPUBLIC OF BELARUS dated February 17, 2012 On approval of a unified list of administrative procedures provided by government institutions and other organisations to legal entities and individual entrepreneurs, amendments to Resolution No. 193 of the Council of Ministers of the Republic of Belarus dated February 14, 2009 and revocation of several Resolutions of the Council of Ministers of the Republic of Belarus (Last amendments and addenda: Resolution No. 611 of the Council of Ministers of the Republic of Belarus dated October 27, 2020)	№ 156 17.02.2012
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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