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Report of the Auditor General on the Financial Statements of National Drug Authority for Year Ended 30Th June, 2016

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Report of the Auditor General on the Financial Statements of National Drug Authority for Year Ended 30Th June, 2016 THE REPUBLIC OF UGANDA REPORT OF THE AUDITOR GENERAL ON THE FINANCIAL STATEMENTS OF NATIONAL DRUG AUTHORITY FOR THE YEAR ENDED 30TH JUNE 2016 OFFICE OF THE AUDITOR GENERAL UGANDA TABLE OF CONTENTS ACRONYMS ................................................................................................... ii REPORT OF THE AUDITOR GENERAL ON THE FINANCIAL STATEMENTS OF NATIONAL DRUG AUTHORITY FOR YEAR ENDED 30TH JUNE, 2016 .................... 3 DETAILED REPORT OF THE AUDITOR GENERAL FOR THE FINANCIAL YEAR ENDED 2016 ................................................................................................. 6 1.0 INTRODUCTION ................................................................................... 6 2.0 BACKGROUND INFORMATION ............................................................... 6 3.0 FINANCING OF THE AUTHORITY ........................................................... 6 4.0 MANDATE OF NDA ............................................................................... 6 5.0 AUDIT SCOPE ...................................................................................... 7 6.0 PROCEDURES PERFORMED ................................................................... 8 7.0 AUDIT FINDINGS ................................................................................. 9 8.0 DETAILED FINDINGS ............................................................................ 9 i ACRONYMS CNF Committee on National Formulary DADI’s District Assistant Drug Inspectors DAR Drug Assessment and Registration GMP Good Manufacturing Practices MoU Memorandum of Understanding NDA National Drug Authority NDPA National Drug Policy and Authority PAYE Pay As You Earn PPDA Public Procurement and Disposal of Public Assets QMS Quality Management Systems UGX Uganda Shillings WHO World Health Organisation ii REPORT OF THE AUDITOR GENERAL ON THE FINANCIAL STATEMENTS OF NATIONAL DRUG AUTHORITY FOR YEAR ENDED 30TH JUNE, 2016 THE RT. HON. SPEAKER OF PARLIAMENT I have audited the financial statements of the National Drug Authority (NDA) for the year ended 30th June 2016. These financial statements comprise of the Statement of Financial Position, Statement of Comprehensive Income, Statement of Changes in Equity, and Statement of Cash Flows together with other accompanying statements, notes and accounting policies. Management Responsibility for the Financial Statements In accordance with the National Drug Policy and Authority Act (Cap.206), the Authority is required to maintain such books of account and related records to enable the preparation of Financial Statements that present fairly the state of the Authority’s affairs. The directors are responsible for the preparation and fair presentation of these financial statements in accordance with International Financial Reporting Standards and the requirements of the Companies Act (Cap 110). This responsibility includes designing, implementing and maintaining internal controls relevant to the preparation and fair presentation of financial statements that are free from material misstatement, whether due to fraud or error; selecting and applying appropriate accounting policies; and making accounting estimates that are reasonable in the circumstances. Auditor’s Responsibility My responsibility as required by Article 163 of the Constitution of the Republic of Uganda, 1995 (as amended) and Sections 13 and 19 of the National Audit Act, 2008 is to express an opinion on the financial statements based on my audit. I conducted my audit in accordance with the International Standards on Auditing. Those standards require that I comply with ethical requirements and plan and perform the audit to obtain reasonable assurance about whether the financial statements are free from material misstatement. An audit involves performing audit procedures to obtain audit evidence about the amounts and disclosures in the financial statements as well as evidence supporting compliance with relevant laws and regulations. The procedures selected depend on the Auditor’s judgment, including the assessment of risks of material misstatement of the financial statements whether due to fraud 3 or error. In making those risk assessments, the Auditor considers internal controls relevant to the entity’s preparation and fair presentation of financial statements in order to design audit procedures that are appropriate in the circumstances, but not for purpose of expressing an opinion on the effectiveness of the entity’s internal controls. An audit also includes evaluating the appropriateness of accounting policies used and the reasonableness of accounting estimates made by management, as well as evaluating the overall presentation of the financial statements. I believe that the audit evidence I have obtained is sufficient and appropriate to provide a basis for my audit opinion. Part “A” of my report sets out my opinion on the financial statements. Part “B” which forms an integral part of this report presents in detail all the significant audit findings made during the audit which have been brought to the attention of management. PART "A" Opinion In my opinion the financial statements present fairly in all material respects the financial position of the National Drug Authority as at 30th June 2016 and of its financial performance and cash flows for the year then ended in accordance with the International Financial Reporting Standards and the National Drug Policy and Authority Act (Cap 206). Emphasis of Matter Without qualifying my opinion, I wish to draw your attention to Note 11 to the financial statements; Pending Legal Cases National Drug Authority is involved in several pending law suits with claims amounting to UGX.113,599,025,876. Though the cases are still pending before courts of law, their determination against National Drug Authority and hence payment of the estimated significant claims and damages could have a material impact on the ability of the Authority to continue as a going concern. 4 Report on Other Legal and Regulatory Requirements As required by the National Drug Policy and Authority Act I report to you, based on my audit that, the business administration of the Authority has been conducted efficiently; In accordance with Authority principles, and the auditing and accounting provisions of the Act, In accordance with its objectives, regulations and any other decision made by the Authority members. John F. S. Muwanga AUDITOR GENERAL 18th December, 2016 5 PART “B” DETAILED REPORT OF THE AUDITOR GENERAL FOR THE FINANCIAL YEAR ENDED 2016 This section outlines in detail the audit scope, audit findings, my recommendations and management responses in respect thereof. 1.0 INTRODUCTION I am mandated by Article 163 (3) of the Constitution of the Republic of Uganda, 1995 (as amended), to audit and report on the public accounts of Uganda and of all public offices including the courts, the central and local government administrations, universities and public institutions of the like nature and any public corporation or other bodies or organizations established by an Act of Parliament. Accordingly, I appointed Shore Partners, Certified Public Accountants to audit the Authority on my behalf and report to me so that I report to Parliament. 2.0 BACKGROUND INFORMATION The NDA was set up by an Act of Parliament (Cap 206) in 1993 and is a corporate body fully owned by the Government of Uganda. NDA is charged with ensuring availability and promote use of safe, efficacious and good quality medicines for human and animal use. 3.0 FINANCING OF THE AUTHORITY The authority’s funds were mainly derived from the following sources; Internally Generated Funds of UGX.41,180,272,921; Rent from properties UGX.185,332,549; Donor Funds UGX.683,851,375 and income from investments UGX.323,841,200. Total entity financing for the year was therefore UGX 323,841,200. 4.0 MANDATE OF NDA NDA is mandated to carry out:- a) Assessment and registration of medicines for quality, safety and efficacy. b) Inspection, approval and/or licensing of local and foreign manufacturing sites for compliance with current Good Manufacturing Practices (GMP). c) Inspection and licensing of premises (drug outlets: Pharmacies and Drug Shops) in and through which medicines are stored or distributed to the public. 6 d) Licensing of medicines importers and processing applications for importation of medicines. e) Inspection of medicines at gazetted ports of entry. f) Testing of drugs for compliance to approved quality standards. g) Regulation of drug promotion and advertising through screening and monitoring medicines advertisements. h) Pharmacovilance (monitoring and assessing adverse drug reactions and taking appropriate regulatory action). i) Post marketing surveillance (surveillance of the formal and informal markets for compliance with drug regulations and guidelines and ensuring absence of substandard, expired and counterfeit medicines. j) Supervision of safe and environment friendly disposal of condemned, substandard, expired and counterfeit medicines. k) Regulation of drug related clinical trials. 5.0 AUDIT SCOPE I carried out the audit in accordance with International Standards on Auditing (ISA) and accordingly included a review of the accounting records and agreed procedures as was considered necessary. In conducting my reviews, special attention was paid to the following:- a) The financial statements have been prepared in accordance with International Financial Reporting Standards and the requirements of the Companies Act (Cap 110) and fairly present the Authority’s revenue
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