Manufacturers of medicinal products, as well as healthcare professionals, are obliged to submit information on identified adverse reactions, including adverse drug reactions, according to the applicable guidelines approved by the Ministry of Health of the Republic of Belarus.

Marketing Authorization Holders of registration certificates for medicinal products are obliged to establish and maintain pharmacovigilance system in accordance with the requirements of the Good Pharmacovigilance Practices, approved by the Ministry of Health of the Republic of Belarus. The guidelines (technical code of the established practice) for pharmacovigilance are based on the EU Directive 2012/26/EU, Regulation of the European Parliament and the Council of Europe No. 1027/2012 and European Commission Regulation No. 520/2012.

The competent state authority for the Belarus pharmacovigilance system is the Ministry of Health on the basis of the Unitary Enterprise “Center for Expert Evaluation and Testing in Health Care” (website: http://www.rceth.by/).

MAH designates Local Contact Person (LCP) responsible for pharmacovigilance in Belarus. The pharmacovigilance system of the manufacturer is subject to control by the competent authority.

Cratia provides professional services of establishment and maintenance of the pharmacovigilance system in Belarus. We have an excellent knowledge of national legislation, necessary experience and resources. 

To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: info@cratia.ua, or visit our office.