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Published Report on Audit of the Annual Financial Statement of the Agency for medicines and medical devices of Montenegro for 2017

Podgorica, 2nd August 2018 – The State audit institution has carried out financial audit of the Annual Financial Statement of the Agency for medicines and medical devices of Montenegro for 2017. The audit of the Information system of the Agency has been also conducted as a separate segment of this audit.

Based on the conducted audit and determined facts, the competent Auditing Board comprised of a member of the Senate Radule Žurić, Head of the Auditing Board and president of the Senate, Milan Dabović, PhD, a member of the Auditing Board, has expressed unqualified opinion on Annual Financial Statement of the Agency for 2017 and unqualified opinion with emphasis of matter on regularity audit.

Financial audit has found that the Annual Financial Statement of the Agency for 2017 was in all material aspects prepared in accordance with the applicable financial reporting framework and it does not contain, in all material aspects significant errors. The regularity audit has found that the business activities related to the procedures and rules for adoption of the acts are not completely aligned with the legal, general and sub-legal acts, which regulate adoption of the legal acts and public spending.

Taking into account the achieved level of adopted legal acts, based on which the Agency regulates the rules and procedures for making financial decisions and its stated obligation to fully harmonize the legal norms which were not be applied according to given audit recommendations, the competent Auditing Board has given the following recommendations:

-         The Agency should harmonize the Collective Agreement with the general and branch collective agreement in the re-enactment procedure. Remuneration of the employees on the basis and from the work should be specified according to the applicable regulations for the public sector or the collective agreement and concluded in a legally prescribed manner.

-         It is recommended to the Agency to allocate funds for solving the housing needs of the employees, after passing the appropriate act on the housing needs of the employees in the Agency.

-         It is recommended that the Ministry of Health should intensify the activities to establish a special unit of internal audit at the Ministry in order to conduct internal audits of the Agency for medicines and medical devices and other entities under its supervision based on the agreement.

-         It is recommended to the Agency for Medicines and Medical Devices to request the opinion of the Ministry of Finance on possible disposition of excess revenues over expenditures – retained earnings.

-         It is necessary for the Ministry of Finance to consider regulating the establishment and operation of public regulatory agencies in a uniform manner, as well as the issue of their right to dispose the excess revenues over expenditures – retained earnings and possible sources of financing the agencies in cases of under-realization of income for performing basic activities.

The SAI has carried out audit of the Agency's information system as part of the financial and regularity audit of the Agency for medicines and medical devices. In the process of conducting the audit, the State Audit Institution has found that the Agency's information system is sufficiently harmonized with the legal norms and standards. In order to improve the information system, the Agency is recommended to undertake activities in the development of IT strategy and continue the activities on strengthening IT capacities at the IT and Quality Sector.

The final Audit Report on Annual Financial Statement of the Agency for medicines and medical devices of Montenegro for 2017 has been officially published at the web site of the SAI of Montenegro.