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  • Attention! Since 04.07.2017 bank details of Centre of Examinations and Tests in Health Service Unitary Enterprise will change: BIC: till 04.07.2017 - 153001815, after - AKBBBY21511 Settlement account: till 04.07.2017 - 3012000004130, after - BY87 AKBB30120000041305200000
We arrange and carry out the work package, namely, we:
  • develop the programs and carry out the planned and topical seminars on the matters of circulation of medicinal products (MPs), medical devices (MDs) and medical equipment (ME), assurance of their safety, efficiency and quality, including at individual and corporate requests;
  • render the services for training assistance in creation of quality assurance systems in accordance with the GMP, GLP, GCP, GDP, STB ISO/МЭК 17025, STB ISO 9001, STB ISO 13485, STB EN ISO 15378 requirements;
  • render the services for individual audits of the quality systems of researchers, manufacturers, suppliers and contractors in production of MPs, MDs and ME; for development of proposals for corrective actions;
  • render the services for development or verification of the draft documents concerning researches, registration, production, quality assurance and control of MPs, MDs and ME;
  • render the services for evaluation of compliance of documentation with the GMP, GLP, GCP, GDP, STB ISO/МЭК 17025, STB ISO 9001, STB ISO 13485, STB EN ISO 15378 requirements for preparation for inspections (certification or accreditation);
  • render the services for evaluation of complete set and contents of the draft registration dossiers for MPs, MDs and ME for their compliance with the requirements of the laws of the Republic of Belarus;
  • expertize feasibility of draft production programs in the field of the manufacturing work;
  • develop draft normative legal acts and technical normative legal acts of the Republic of Belarus and international normative legal acts on the matters included in the Department competence;
  • carry out informational and training events on the matters included in the Department competence.