International Accreditation of Testing Laboratories for Medical Products

Ministry of Health

Euro Health Group, in partnership with the British Standards Institution (BSI) UK and the Agency for Medicinal products and Medical Devices (HALMED) Croatia, implemented the EU project “International Accreditation of Testing Laboratories for Medical Products”. The project aimed at improving the health care system in the Republic of Belarus and the general welfare of the Belarus people by strengthening the quality assurance infrastructure and control of medical products (medicines).

The purpose of the project was to assist with: strengthening control of medical products and QA, compliance with international standards, capacity building, training and aligning of the national legislation with international and EU standards.

The project helped the Ministry of Health with the following outputs:

- Ensured compliance of the national medicine quality control system with international standards;

- Integrated 4 testing laboratories into the Official Medicines Control Laboratory (OMCL) network of EDQM followed by the recognition of foreign regulatory authorities of the results of medicine quality control performed by accredited testing laboratories in the Republic of Belarus;

- Equipped the technical infrastructure of national quality control laboratories with the necessary hardware and software corresponding to internationally recognized standards;

- Integrated the Belarusian regulatory system in the field of circulation of medicines aligned with the EU system followed by the pharmaceutical inspectorate joining PIC/S;

- Strengthened the potential of the national competent authorities during the quality control procedures followed by the international recognition of the national GMP certificate;

- Aligned gradually the national legislation regulating medicine production and quality assurance with the current international and EU requirements.