TALLINN – The Ministry of Social Affairs conducted an internal audit to identify those responsible for the Health Board's cold store incident and found that the Health Board may lose its pharmaceutical wholesaler license, the Estonian daily Postimees writes.
During the inspection, it was highlighted that the activities of the management and competent person of the Health Board as the holder of the activity license for the wholesale distribution of medicinal products have been deficient, the requirements arising from legislation and the internal procedures of the Health Board have not been complied with.
Inadequate activities of the Health Board as a holder of an activity license for the wholesale distribution of medicinal products may lead to the partial or complete revocation of the activity license, the audit stated.
On a positive note, it was said that the Health Board has already started work to correct errors and bring its activities into line with the requirements. For example, a quality specialist has been appointed for the warehouse of medicines, and as of Sept. 1, a new structural unit, the warehouse of medicines, was established under the director general to fulfill the obligations set out in the wholesale license. A competition for the recruitment of a new head of unit has already taken place.
The findings of the Ministry of Social Affairs revealed that the management of the Health Board has not complied with the quality system for the wholesale of medicines or the requirement of due diligence. The director general of the Health Board has also not ensured the implementation of the internal control system in the pharmaceutical wholesale activities of the Health Board.
"The competent person of wholesale has not performed their duties in a way that ensures that the wholesaler meets the requirements of good distribution practice and with due diligence resulting from the nature of the work," the audit found.
The audit emphasized that shortcomings in the activities of the Health Board as a wholesaler of medicines have caused economic and reputational damage.