Euro Health Group in Belarus

EHG is taking part in the 2016-2018 project “International Accreditation of Testing Laboratories for Medical Products (BELMED)”, funded by the European Union. The main beneficiary is the Ministry of Health of the Republic of Belarus (MoH), and EHG is a part of consortium led by The British Standards Institution (BSI).

The overall objective of the project is to contribute to the improvement of the health care system by ensuring the quality, effectiveness and safety of medicines through quality assurance infrastructure and control of medicines. It is aimed at the alignment of the structural units of the MoH (official medicines control laboratories and the Pharmaceutical Inspectorate) to European and international standards.

The project consists of two independent components: Component A, Laboratory and Component B, Inspection. EHG’s main role is in supporting the Component B, aimed at strengthening the capacity of the Pharmaceutical Inspectorate in the field of inspection of manufacturing processes and international integration, followed by entry into the Pharmaceutical Inspection Cooperation System (PIC/S). This goal can be achieved by:

  • Improving professional competences of GMP (Good Manufacturing Practice) inspectors by organising appropriate trainings according to the identified needs

  • Development and implementation of the Quality System of Pharmaceutical inspectorate, harmonised with standards of Pharmaceutical Inspection Cooperation System (PIC/S), and preparation for the subsequent joining with the PIC/S

  • Assistance in gradual aligning of the national legislation of  the Republic of Belarus by regulating the medicine production and quality assurance with the current international and EU requirements in this area.

 During the inception phase, the general situation in the Pharmaceutical Inspectorate was assessed concerning staff, organisation, infrastructure, quality system, training skills and legislative background. The team gave recommendations for necessary improvements and alignment with international networks’ requirements during the implementation phase.

Mobilisation of senior non-key experts started in the implementation phase, where EHG worked on developing Quality System (QS) documents, as well as observing inspection and conducting a seminar on quality system requirements for Pharmaceutical Inspection Cooperation System (PIC/S).During this phase, EHG performed a detailed analysis of the legislative background needed for PIC/S compliance, and is now working with the beneficiary in the consultation phase.

Several training programmes have been organised, including a seminar and a workshop on Pharmaceutical Inspectorate Quality System. In the next programming, strengthening the system of medicinal products authorisation and aligning with EU procedures are planned to contribute to the improvement of the health care system by ensuring the quality, effectiveness and safety of medicines.

 Health is a major national strategic priority of the government and has been identified as a key resource for social and economic development in Belarus. The EU Delegation plays a vital role in supporting the health and pharmaceutical sector in Belarus. The institutional and staff capacity building intends to further support the Belarus government in updating the medicines policy and strengthening the quality assurance of infrastructure and control of medical products produced in Belarus, as well as the quality control of imported products with the aim to ensure the quality, efficacy and safety of medicines used for prevention and treatment. We hope this project will be a significant contribution to these efforts.