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thRough sustained

availability of life
saving commodities
በኢትዮጵያ ፌዴራላዊ ዴሞክራሲያዊ ሪፐብሊክ
THE FEDERAL DEMOCRATIC REPUBLIC OF ETHIOPIA
የመድኃኒት ፈንድና አቅርቦት ኤጀንሲ
PHARMACEUTICALS FUND AND SUPPLY AGENCY

Standard Operating
Procedure (SOP) for
Pharmaceuticals Procurement

December, 2016
Addis Ababa, Ethiopia

Standard Operating Procedure (SOP)
for Pharmaceuticals Procurement

TABLE OF CONTENT
FORWARD..............................................................................................................................................................................III

ACKNOWLEDGMENTS........................................................................................................................................................IV

1 BACKGROUND..........................................................................................................................................................1

2 PURPOSE....................................................................................................................................................................1

3 SCOPE..........................................................................................................................................................................2

4 PROCESS OWNER...................................................................................................................................................2

5 REFERENCE................................................................................................................................................................2

6 PERFORMANCE INDICATORS.............................................................................................................................3

7 DEFINITIONS & ABBREVIATIONS......................................................................................................................3

7.1 DEFINITIONS..............................................................................................................................................................3

7.2 ABBREVIATIONS.......................................................................................................................................................3

8 MANDATES, DUTIES AND RESPONSIBILITIES..............................................................................................4

8.1 MANDATES OF THE AGENCY..............................................................................................................................4

8.2 DUTIES AND RESPONSIBILITIES........................................................................................................................5

8.2.1 DIRECTOR GENERAL.........................................................................................................................................5

8.2.2 PHARMACEUTICALS AND MEDICAL SUPPLIES PROCUREMENT DIRECTORATE......................8

8.2.3 TENDER ENDORSING COMMITTEE (TEC).................................................................................................9

8.2.4 TENDER EVALUATION COMMITTEE......................................................................................................... 10

PART TWO: PROCUREMENT OBJECTIVES AND PRINCIPLES................................................................................... 11

9 STRATEGIC OBJECTIVES FOR GOOD PHARMACEUTICAL PROCUREMENT.................................. 11

9.1 GENERAL.................................................................................................................................................................. 11

9.2 PROCURE THE MOST COST-EFFECTIVE DRUGS IN THE RIGHT QUANTITIES.............................. 11

9.3 SELECT RELIABLE SUPPLIERS OF HIGH-QUALITY PRODUCTS.......................................................... 11

9.4 ENSURE TIMELY DELIVERY............................................................................................................................... 11

9.5 ACHIEVE THE LOWEST POSSIBLE TOTAL COST...................................................................................... 11

10 PROCUREMENT PRINCIPLES........................................................................................................................... 12

I

..... 39 Special Import Permit............................................... 31 Purchase order processing........................................................................... 44 Pharmaceuticals Fund and Supply Agency (PFSA)...................................................................................................................................... 51 Pre-qualification evaluation & maintenance of suppliers’ list..............................................................................................................................................................1 Bid document issuing/selling................................................................................................................................................................................................................................................................ 42 Preparation of Technical Specifications for Pharmaceuticals............................................................................................................ 15 Bid offer analysis........................................................................................................................................................................................................................................................................................................................... 57 Pharmaceuticals Fund and Supply Agency (PFSA)....... 64 ANNEX 2: LIST OF WORKSHOP PARTICIPANTS FOR REVIEWING THE DRAFT PROCEDURE.................................. 35 Contract signing.............................................................................................. 11 Bid opening.................. 51 Pharmaceuticals Fund and Supply Agency (PFSA)..................................... .....................................................................................................................................................................................................................................7 Bid offer receiving............................. 65 II ................................................................... 60 Documentation of the procurement process......................... 13 Preparation of Bid Document...............................................4 Bid clarification......................................................................................... 18 Bid Advertisement...........................................................PART THREE: STANDARD OPERATING PROCEDURES.... ..................................................................................................................................................... .................................................................................................................................... 28 Complaint handling........................................................................................................................................................................................... 57 Suppliers Post-contract performance appraisal.............. 19 Bid offer analysis approval................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................. 60 ANNEX 1: LIST OF FORMS.......................................................................................... 23 Awarding................................................................................................................................. 13 Procurement budget preparation & approval...

The implementation of the SOP needs to be re-enforced by management at all levels and it should be re- viewed regularly. I would also like to encourage users of the Manual to send their comments regarding the Manual to the Agency via mail (Pharmaceuticals Fund and Supply Agency (PFSA). and to obtain the desired quality of pharmaceuticals and services at the best possible price. Box 21904.Forward From pharmaceutical supply chain perspective. Ethiopia) Meskele Lera Director General. the Agency has developed standard operating procedures (SOP) for pharma- ceuticals procurement activities with a view to standardize work processes and to make the service more effective and efficient. The purpose of a procurement procedure is threefold: To guaran- tee the widest possible participation of economic operators. Addis Ababa. Pharmaceuticals Fund and Supply Agency (PFSA) is coordinating sector wide effort aimed at significantly improving sustainable availability of quality assured pharmaceuticals at an affordable price to the pub- lic. This manual contains eighteen procurement procedure SOPs that document regularly recurring work processes in pharmaceuticals procurement. to ensure the transparency of operations. A procurement procedure leads to the conclusion of a public contract. Pharmaceuticals Fund and Supply Agency (PFSA) III . The SOP can be used as reference material for professionals working on sourcing of pharmaceuticals in the public sector. O. The SOP will promote access to quality assured pharma- ceuticals through consistent implementation of processes and procedures. I would like to take this opportunity to thank all who participated in the development of this SOP. procurement is a structured procedure designed to consult the market for the purchase of Pharmaceuticals and services. As part of this effort. P.

Yared Yiegezu Zegiorgis (Director of Forecasting & Capacity Building Directorate. Yemane- berhan Taddesse (Deputy Director General. Recommended citation Pharmaceuticals Fund and Supply Agency (PFSA). The following persons have contributed starting from idea generation to the development this document and their advice and support are gratefully acknowledged. Addis Ababa. Standard Operating Procedure (SOP) for Pharmaceu- ticals Procurement. Furthermore. Mr. Mr. Bekele Ashagire Yeshanew (Director of Pharmaceuticals & Medical supplies Procurement Directorate. PFSA). We would also like to extend our gratitude to Clinton Health Access Initiative (CHAI) for its financial assistance in printing of this SOP and Adroit Consultancy and Training Service PLC for the development of the SOP. PFSA).ACKNOWLEDGMENTS Pharmaceuticals Fund and Supply Agency (PFSA) would like to acknowledge all of the contributors for their dedicated effort in developing this Standard Operating Procedure (SOP) for Pharmaceuticals Pro- curement. Ethiopia IV . PFSA) Mesfin Teklehaimanot and Yared Debebe from Adroit Consultancy and Training Service PLC. Mr. October 2015. we would like to acknowledge the individuals and their organizations (Annex I) who participated in the workshop organized to review the draft Manual for their feedbacks.

An effective pro- curement process ensures the availability of the right drugs in the right quantities. transparency and accountability in the procurement process of the Agency.1 This SOP manual serves as a guide to procurement of pharmaceutical products by the FDRE Pharmaceuticals Fund and Supply Agency (PFSA) on the basis of the FDRE Proclamation on Procurement and Property Administration No 649/2009. and is meant to promote effective and efficient performance of the procurement process of the Agency. Adequately forecasting. overstocks and wastage of resources. • Procurement planning and its linkage to budgeting process and implementation. 1 . all the way to end users of their products. which is the array of pro- cesses that link manufacturers.1 This SOP manual is applicable to all procurements of pharmaceuticals executed using the Agency budget or funds granted from various partner organizations. Problems can often be encountered if procure- ment is carried out without such a systematic process.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) Part One: General 1 Background Procurement is an important step for efficient drug management and supply.2 This SOP manual defines and describes the functional relationships and internal controls that promote efficiency. and delivering health commodities—the four pillars of a logistics system—are prerequisites to achieving commodity security. and at recognizable standards of quality. at reasonable prices. It includes the development of exacting product specifications. The procurement process begins with selection and forecasting and quantification of product requirements. and has become a routine procedure in the existing drug management system in many countries. and purchase of low quality products. financing. for instance the needed medicines are out of stock. Procurement is a vital step in that system and a vital function in supply chain management. 3 Scope 3.2 This SOP manual covers: • The generic and specific steps in procurement of pharmaceuticals. and a budget process to secure that financing. 2 Purpose 2. 3. procuring. even producers of raw materials. and the Public Procurement Directive. 2. identification of financing.

No 649/2009. • በኢፌድሪ የመድሐኒት ፈንድና አቅርቦት ኤጀንሲ የመድሃኒት እና የሕክምና መገልገያዎች ግዢ አፈፃፀም መመሪያ- የካቲት 2005 6 Performance Indicators The following indicators are identified as indicators to measure the performance of the procure- ment process. • FDRE Proclamation on Procurement and Property Administration Proclamation Agency. mitigation or prevention of a disease.any substance or mixture of substances used in the diagnosis.No 661/2009. Medicine & Health Care Administration and Control .1 Definitions • Pharmaceuticals . 5 Reference • FDRE Proclamation to provide for the establishment of the Drug Fund and Pharmaceutical Supply Agency. Additional measures can be used as deemed relevant. • Difference between scheduled and actual time taken to complete each cycle of procure- ment. 2 . • FDRE Proclamation on Food. treat- ment. The Procurement Director has the overall responsibility to monitor and evaluate procurement activities to ensure compliance with legal provisions of the Proclamations and the Regulations as well as international medical or related conventions.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) • Administration of the complete procurement cycle up signing of contract with awardee. MoFED June 2010.No 553/2007. • Federal Public Procurement Directive. 4 Process owner The responsibility for control of the implementation of this SOP will be that of the Procurement Director. • Ratio of cancelled/rebid procurements. and includes medical instruments and medical supplies. and • Supplier performance measurement. 7 Definitions & Abbreviations 7.

any potential legal entity or commercial firm provider of pharmacuticals to the Agency. • Medical instrument . bandages. • Supplier . surgery and dental instruments. • Technical Specification .Pharmaceuticals Fund and Supply Agency • PO – Purchase Order • RFI . labo- ratory. type and standard with which the required pharmaceuticals should comply. Medicine and Health Administration Control Agency • ICB – International Competitive Bidding • MIS – Management Information System • ODDG – Opearations Deputy Director General • PD – Procurement Director (Pharmaceuticals & medical supplies) • PEC– Procurement Evaluation Committee • PFSA . 7. and includes various diagnostic.2 Abbreviations • DG – Director General • EDL .Request for Information • SOP – Standard Opearting Procedure • TEC– Tender Endorsement Committee 3 .any Article that may be used on the inner or outer part of the human body for diagnosis or treatment of disease. gauze. and includes suturing materials. chemicals and x’-ray films.Essential Drug List • EOI – Expression of Interest • FCB – Forecasting and Capacity Building • FMHACA – Food.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) • Medical supplies . cotton and similar products.the Pharmaceuticals Fund and Supply Agency (PFSA). syringes. • Agency .any instrument that may be used on the inner or other part of the human body for diagnosis or treatment of a disease. nee- dles.document describing the quality.

• deliver pharmaceutical directly to districts.1 Mandates of the Agency The Pharmaceuticals Fund and Supply Agency (PFSA). and monitor its implementation. • provide adequate and proper pharmaceutical storage facilities to ensure uninterrupted supply through establishment of a modern storage management system. • supply essential pharmaceutical of quality. 4 . • Prepare and implement short. established by the Drug Fund and Phar- maceuticals Supply Agency Establishment Proclamation No 553/2007. medium and long-term plan for procurement. have the following gen- eral objectives: • to enable public health institutions to supply quality assured essential pharmaceuticals at affordable prices in a sustainable manner to the public. supply to private and non-governmental health institutions selected pharma- ceuticals which are not adequately available. hospitals and selected health centers through establishing an effective transport network system. to: • establish and implement efficient and effective procurement and distribution systems to deliver. • to create enabling conditions for enhancing the accumulation of the Fund in its revolving and cost recovery process and thereby ensure the realization of the objectives referred above. storage and distribution. Duties and Responsibilities 8. PFSA also is mandated with the powers and duties. • to play a complementary role in developmental efforts for health service expansion and strengthening by ensuring enhanced and sustainable supply of pharmaceuticals. • expand and strengthen storage and distribution outlets based on equity and effectiveness. where appropriate and in accordance with directives of the Board. inter-alia. safety and efficacy approved by the appropriate body to all public health institutions.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) 8 Mandates. qual- ity assured pharmaceuticals at affordable prices sustainably to public health institutions. by using the Drug Fund and focusing on the country's major health problems. establish a logistics management infor- mation system compatible with the overall pharmaceuticals logistics system.

employees of the PFSA perform as members of the Procurement Endorsing Committee. • Establish a Procurement Endorsing Committee to approve procurements of high value in PFSA. head of the procurement unit and members of the Procurement Endorsing Committee have in their possession. consisting of members no less than 3 persons which serves for a maximum period of 3 years in accordance with the following criteria:- a) Officials. 5 . is part of their regular duty and is as such. copies of the procurement and property administration Proclamation.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) 8. • Follow up the activities of the procurement unit and the Procurement Endorsing Commit- tee to make sure that the procurement staff and members of the Procurement Endorsing Committee give due attention in carrying out their duty properly. extend the service of members of the Procurement Endorsing Commit- tee for one additional term. and Public Procurement Directives: • Ensure that the procurement staff and head of the procurement unit of PFSA have the required educational qualification and experience in the fields relevant to public procure- ment. b) Need to have a better knowledge and experience and as far as possible should com- prise from various professions. and where necessary. and make training available to them in ordered to enable them acquire adequate knowledge of the public procurement system. the Standard Bidding Docu- ment and other necessary documents. • Where appropriate. • Ensure that the procurement staff and head of the procurement unit meet high ethical standards. and the Directive. incorporated into their work program and their performance in the committee accounts for their overall result.1 Director General The Director General of PFSA has the following duties and responsibilities as stipulated in the procure- ment and property administration proclamation. • Ensure that the service. • Ensure that the unit responsible for procurement in PFSA has the necessary authority and system in place to enable it discharges its duties as a team.2.2 Duties and Responsibilities 8. take corrective measures. • Ensure that members of the Procurement Endorsing Committee have adequate time and office facility necessary to carry out their duty. who are in high position of responsibility in PFSA. • Make sure that the procurement staff.

• Consider and give decisions on complaints lodged pursuant to article 43 of the Procure- ment Directive and against rejection by the procurement unit of request for information concerning the conduct of a particular procurement in the PFSA. c) The delegation of procurement authority by the head of PFSA may be given to per- sons with various levels of responsibility with specified limits of procurement value. • Cause to be communicated in due time to the body responsible for framework procure- ments. b) That. • Authorize the outsourcing of a procurement by reason of its complexity or for lack of capac- ity of PFSA to handle that procurement. d) That the procurement plan is inclusive of all procurement needs of the PFSA and has secured the consent of the Procurement Endorsing Committee. complete information on procurements of PFSA which can be executed in consolida- tion with procurements of other Public Bodies under a framework contract. • Examine and approve the procurement plan of PFSA by ascertaining that the following re- quirements are satisfied:- a) That. inconformity with the following procedures:- 6 . the procurement plan is in harmony with the Agency’s work program. • Sign a contract or delegate authority to sign a contract where necessary. c) That. and monitor the execution of any procurement as per the contract. • Pursuant to article 24/2 of this Directive concerning procurements of small value which do not need the approval of the Procurement Endorsing Committee:- a) Delegate authority of approval of such procurements to the procurement unit or b) Delegate authority of approval to the head that has direct relation to the procurement. items of procurement which can be consolidated in to a single procurement package are consolidated as such.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) • Establish ad hoc evaluation committee for procurements which are complex and require detailed technical evaluation. procurements of the PFSA which can be executed together with procurements of other Agencies under a frame work contract in accordance with the decision of the Public Procurement Agency are identified. • Ascertain that price adjustments made in the process of procurement is in keeping with the procedure and the requirements of price adjustment set forth in the Procurement Direc- tive.

o Preparing budget proposal and procurement plan. o Reviewing budget and specification of items in purchase requests.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) a) Ensure that the outsourced procurement service is rendered in compliance with the provisions of the Proclamation and Procurement Directive. o Preparing and submiting bidding documents to the Procurement Endorsing Com- mittee. c) Ensure that all decisions taken in respect of out sourced procurements in accordance with this sub article have secured the approval of the PFSA. • Cause reports of completed procurements of PFSA to be sent to the Agency in line with the Formats prepared and time stipulated by the Agency. 8. documents necessary for procurement audit. o Receiving correspondences/instructions from the Director General & ODDG. b) Cause the provision of office space and facilities for employees assigned to conduct the procurement audit. • Take appropriate corrective measures in accordance with the instruction given by the Agen- cy based on the findings of the procurement audit and notify the Agency of such measures. c) Assign a staff to give explanation on the conduct of procurements made by PFSA. o Selecting procurement method. including the following:- a) Make available in due time. 7 . • Make arrangements necessary for procurement audit or inspection to be conducted by the Agency in respect of the execution of procurements by PFSA.2. • Cause information to be conveyed to the concerned tax authority regarding payments made to suppliers in connection with procurements executed by PFSA. b) Ensure that there is clear demarcation of responsibility between PFSA and the entity to which the procurement is outsourced in the execution of the procurement.2 Pharmaceuticals and Medical Supplies Procurement Directorate Major activities of the directorate include: o Receiving purchase request from forecasting and capacity building directorate and others.

o Receiving. o Handling bank. 8 . o Build the capacity of suppliers on tender requirements. o Developing the capacity and competency of procurement personnel to enable them efficiently carry out their duties and responsibilities. implementing corrective actions and closing complaints on procurement processes including evaluation and award of tenders. o Disclosing result of a Bid evaluation to the successful and unsuccessful bidders. o Preparing and managing bid box. o Ensuring complienace with the national public procurement proclamation and regulations. o Facilitating the evaluation/ screening of technical and financial proposals. o Preparation of purchase orders.2. o Issuing endorsed bid documents to interested suppliers.3 Tender Endorsing Committee (TEC) • Review and approve the annual procurement plan takes into account the following points:- a) That the identified procurement needs are in harmony with its work program. reviewing. o Transfering and handover procured items to warehouse. o Evaluating the overall performance of suppliers annually and maintaining roaster of credible suppliers and those of blacklisted. o Drafting contractual agreements and get signed by selected bidder. insurance. o Securing purchase order approvals from regulatory bodies. o Developing good working relationship with suppliers.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) o Making corrections to the bidding documents in conformity with the recommen- dation of the Procurement Endorsing Committee. funding agencies. 8. customs and other related processes. o Keeping procurement documents and giving clarifications on procurements of the Agency when requested by the appropriate bodies. regula- tory bodies and all departments in the agency.

c) That it contains all the necessary forms and conditions which the Procurement Proc- lamation and Directive. and the Agencies Directives and SOPs require to be stated depending on the type of the procurement. and other matters of fundamental impor- tance. • Submit to the Director Geenral of the Agency reports on procurements made. d) That other special requirements arising from the nature of the Agency are adressed. transparent and achievable. • Ensure legal adherence of each procurement package.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) b) that there is no other alternative to procurement to satisfy each need. • Ascertain that bidding documents satisfy the following requirements:- a) That it is inconformity with the standard bidding document prepared by the Agency for each type of procurement. • Reviewing and approve Bid evaluation reports of procurements reported by Procurement Directorate for each type of procurement. 9 . • Advising the Director Geenral of the Agency on ways of ensuring compliance with the Proc- lamation. • Ensuring any decision given by the Tender Evaluation Committee on evaluation report sub- mitted to is reasonable. and the Agencies Directives and SOPs. • Give clarification concerning its decisions made on any procurement proceedings with in its Jurisdiction when required to do so by the management of the Agency and other appropri- ate body. c) That the detailed evaluation leading to the recommendation given in the evaluation re- port and the overall process of procurement would result in ensuring value for money for the Agency. b) That the evaluation criteria are non-discriminatory. the Directive and other legal documents regulating the conduct of public procure- ment. problems encountered and solutions suggested. by ascertaining that the following conditions are satisfied:- a) That the evaluation was conducted in accordance with the bidding document. b) That the evaluation was carried out in compliance with the provisions of the Procure- ment Proclamation and Directive. c) that the procurement plan is prepared in such away as to enable bulk purchase.

together with minutes of the tender opening. 10 .Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) 8. and a recommendation to award the tender.4 Tender Evaluation Committee • Participate in public opening of tenders • To review the adherence of the tender evaluation process in alignment to the requirement of the tender and other relevant laws • To evaluate the specific tender based on the officer posting of the tender evaluation forms • Propose set of decision based on the finding to tender endorsing committee • Prepare a report to the tender evaluation which includes an analysis of the tenders received.2. the results of the preliminary evaluation.

9. 9.4 Ensure timely delivery Procurement systems must ensure timely delivery of appropriate quantities to central or re- gional stores. o hidden costs due to poor product quality. Select reliable suppliers of high-quality products iii. Ensure timely delivery iv. and o Operating costs and capital loss by management and administration of the procurement. 11 .5 Achieve the lowest possible total cost Procurement and distribution systems must achieve the lowest possible total cost.3 Select reliable suppliers of high-quality products Reliable suppliers of quality products must be pre-selected. 9.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) Part Two: Procurement Objectives and Principles 9 Strategic objectives for good pharmaceutical procurement 9. o inventory holding costs at various levels of the supply system. and that active quality assurance programmes involving both surveillance and testing must be implemented.2 Procure the most cost-effective drugs in the right quantities Procurement should be based on an essential drugs list to make sure that only the most cost- effective drugs are purchased. Achieve the lowest possible total cost.1 General The following four strategic objectives are relevant to any pharmaceutical procurement: i. Procure the most cost-effective drugs in the right quantities ii. poor supplier performance or short shelf-life. 9. con- sidering four main components: o the actual purchase price of drugs. Procedures need to be in place to accurately estimate procure- ment quantities so that continuous access to the products selected without accumulating ex- cess stock is ensured.

10.8 The Procurement Directorate is to keep abreast of best practices for procurement of phar- maceutical products and services through benchmarking with similar entities to facilitate continuous improvement of the procedures. efficient and cost effective.5 There shall be a continuous improvement of procurement processes to ensure that the processes are simple. or this SOP Manual. availability. and Fed- eral Public Procurement Directive. 10. payment terms. 10. 10. 10.2 The suppliers with acceptable performance track record shall be given equal opportunity to bid for supply of medical products and services.6 Procurement shall be planned to enable prudent management of budgets and value opti- mization.7 The Procurement Directorate shall endeavour to realize benefits of economies of scale by consolidating orders and purchasing routine medical requirements through framework contracts where feasible. 10. 12 .3 The highest ethical and professional standards should always be observed in establishing a mutually beneficial relationship with suppliers and customers.4 All procurement of medical requirements shall be done through a competitive public bid- ding unless an alternative procurement method is justified in accordance with the relevant provisions in the FDRE Procurement and Property Administration Proclamation. product or service quality. 10. and supplier support.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) 10 Procurement Principles 10.1 PFSA shall acquire pharmaceuticals including medical supplies at optimum by taking into account the acquisition price.

estimating needs. and ensuring that financing is available. quantifying purchases. Purpose The purpose of this SOP is to define the process steps to be followed in preparation of procurement plan and budget for a specific procurement request raised from the Fore- casting and Capacity Building Directorate or FDRE Ministry of Health or Public Health Service Providers (Hospitals) or other funding agencies engaged in public health improve- ment programs. A procurement plan is an instrument for implementation of the budget and shall be prepared with a view to avoiding or minimizing urgent procurements that do not enable realization of value for money. 4.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) Part Three: Standard Operating Procedures Pharmaceuticals Fund and Supply Agency (PFSA) Document Title Procurement budget preparation & approval Document No SOP/PRO/A01 Revision 1 Effective on: 1. 3. Responsibilities Title Responsibility Director General (DG) Ratification of procurement budget proporal and plan DDGO Approval of procurement budget proporal and plan Procurement Director Verification of procurement budget proporal and plan Draft procurement plan and budget for a specific procure- Procurement officer ment request Procurement Coordina- Ckecking budget analysis proposal & procurement plan tor 13 . Introduction The procurement process begins with determining which products to order. Scope This SOP is applicable to all procurement forecasts and budgets prepared at the PFSA head office. 2.

Procurement Procedure Doc No: P/PRO/A Rev No: 0 Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) 5. Process map/Flowcharts 5. complete & correct? body forclarification Yes Estimate unit price for each line item 1 Page 14 of 65 14 . FCB MoH hospitals & asso. Process map/Flowcharts Procurement Procurement Procurement Pro request request from requestfrom requestfrom from Int. partners Request registration & assign to concerned team & officer Check specifications against EDLdocument & other sources Check unit & quantity for completeness & correctness Check financial package (financial source) No Communicate requesting Is Doc.

Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) Pharmaceuticals Fund and Supply Agency (PFSA) Procurement Procedure Doc No: P/PRO/A Rev No: 0 1 Prepare budget analysis proposal Propose procurement method & selection of suppliers (if required) Prepare procurement plan Check budget analysis & procurement plan for correctness Verifybudget analysis & procurement plan for correctness No OK? Yes Approval by DDG of Operations Ratification by DG No Ratified? Yes Receive no objection letter to proceed as per procurement plan 15 Page 15 of 65 .

6. The communication will be done in writing and be signed the procurement director.13. Taking into consideration the amont. 6. and verified by the procurement director. 6.9. the officer will pro- pose a procurement method. level of urgency and other factors. they will be sent to the Operation Deputy Director General of (ODDG) for approval accompanied by a memo. get it registereed. Associations. i. The budget analysis proposal and procurement plan will be checked by Procurement Coor- dinator. they will be returned with remark to the officer for correction. 6. The procurement directorate may receive procurement request from the Forecasting and Capacity Building Directorate. The procurement officer will also check the financial package.3.11.4. If the procurement request document is found to be complete and correct. 6. 6. Procedures 6. the officer(s) in charge will estimate the unit price for each line item.e. the officer will communi- cate the requesting body for clarification or adjustment.10. 6. If the proposal and plan are accepted by the procurement director.6. The procurement director receives the request.12. Following the unit price assignment. If the proposal and plan are found not acceptable. and forward to the rel- evant team which is responsible to assign a procurement officer in charge.5. 6. 6.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) 6. The ODDG will approve the proposal and plan and forward it to the Director General (DG) for ratification. Health Centers. and procurement plan. or International/National partner organizations engaged in public health pro- motion activities.2. If the procurement request document is not complete or correct. 6.8. 6. the officer will prepare a budget analysis proposal.7. The procurement officer in charge shall check the procurement request validity against ac- ceptable essential documents like Essential Drug List (EDL). The procurement officer in charge shall check the procurement request to ensure com- pleteness and correctness of the documents. 16 . 6. or the Federal Ministry of Health or Hospitals.1. who finances the procure- ment and availability of fund for the purpose.

Amendment History Revision: Effective Date: Approved By: Reason 0 Initial release 17 . If the proposal and/or plan is not approved or ratified by the responsible authorities. amendment or other recommended action. 7. Forms Form No Form Title F/PRO/01 Budget analysis format F/PRO/02 Procurement plan format 8.15.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) 6. the documents will be signed by the responsible authorities and be sent back to the procurement directorate accompanied with ‘no objection’ letter.14. 6. If the proposal and/or plan is approved and ratified. it will be sent back the procurement directorate with remark for correction.

Scope This SOP is applicable to all procurement tenders prepared at the PFSA head office. Purpose The purpose of this SOP is to assist PFSA procurement officers and mangers in their preparation of documents required to issue a Request for bid for procurement of pharmaceuticals.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) Pharmaceuticals Fund and Supply Agency (PFSA) Document Title Preparation of Bid Document Document No SOP/PRO/A02 Revision 1 Effective on: 1. Introduction Competitive bidding is a mandatory requirement to comply with the FDRE Procurement and Property Administration Proclamation associated and Guidelines. 3. 4. Responsibilities Title Responsibility Procurement officer Draft bid document Procurement director Verify drat bid document Tender Endorsement Review and approve draft bid document Committee (TEC) Deputy Director General Communicate decision of the TEC to procurement of Operations (ODDG) directorate 18 . 2.

Process Process map/Flowcharts map/Flowcharts Receive copy of no objection letter Populate the bid document template with relevant data Check draft bid document for correctness Check draft bid document for completeness & approve No Approved? Yes Submit bid document for endorsement by Tender Endorsing Committee Evaluate bid document compliance No Bid document accepted? Yes Receive no objection letter from DDGO Communicate to case team leader/ officer Page 19 of 65 19 . Pharmaceuticals Fund and Supply Agency (PFSA) Procurement Procedure Procurement Procedure Doc No: P/PRO/A Pharmaceuticals Rev No:(PFSA) Fund and Supply Agency 0 5. 5.

Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA)

6. Procedures

6.1. The procurement officer assigned shall receive a copy of the ‘no objection letter’.

6.2. The procurement officer shall populate the standard bid document format with the relevant
data based on the endorsed procurement plan and budget proposal documents.

Editable parts of the bid document that one procurement officer shall focus to edit for each
tender include, inter-alia, the following:

 Section one: Instruction to bidders

o Tender reference number, Tender title, Date of the bid document

o Indicative timetables on: Tender Issue Date, Last Date For Inquiries, Tender Closing
Date, Tender Opening Date, Completion of Tender Evaluation, Completion of Approval
Process, Notification of Award, Contract Commencement Date, Letter of Credit opening

o Authorized contact person(s) and address

 Secton two: Bid data sheet

o Name of Purchaser

o Name of authorized Purchasing Agent

o Type of goods

o Tender No

o The finance source

o Name of project/Purchase

o Documentation requirements for eligibility

o Purchaser’s authorized purchasing agent’s address (for clarification purpose)

o Documents to be included with the bid

o Place of destination

o Date of the expiration of the bid validity period

o Date of the expiration of the bid security

o The procuring entity’s address (for bid submission purpose)

20

Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA)

o Bid submission deadline

o Time, date, and place for bid opening

o A margin of domestic preference, if applicable

o Delivery schedule, if applicable

 Section Three: Technical specifications

6.3. The Procurement Coordinator shall check the draft bid document and submit to the pro-
curement director for approval.

6.4. The procurement director verifying the completeness and correctness of the draft bid doc-
ument submit it as a Final Draft accompanied by a memo to the Operation Deputy Director
General of (DDGO) for endorsement by the Tender Endorsing Committee (TEC).

6.5. If the draft document is found not complete or correct, it shall be returned to the officer in
charge with comment/feedback for correction.

6.6. The TEC will review the final draft bid document for compliance. The review will include, but
not limited to, the following:

o Completeness of the document,

o Consistency,

o Compliance with the procurement regulation and directives,

o Compliance with procedural requirements of funding partners,

o Check on product category,

o Check on financial source,

o Check on the timeline,

o Check on prequalification requirements.

6.7. If the final draft is found acceptable by the TEC, a ‘Bid-document no objection memo’ will
be written to the procurement directorate for processing to the next step. However, if the
final draft does not pass the review criteria of the TEC, it shall be returned with comment/
feedback for correction.

6.8. The procurement director will communicate to the Procurement Coordinator and officer in
charge approval of the bid document to move to the next process.

21

Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA)

7. Forms

Form No Form Title
F/PRO/03 Bid document template

8. Amendment History

Revision: Effective Date: Approved By: Reason
0 Initial release

22

Purpose The purpose of this SOP is to assist PFSA procurement officers and mangers in carrying out tender advertisement activities for procurement of pharmaceuticals.Verify content of tender notices. 2. either the dissemination of upcoming solicitation information through a request for information (RFI). 4. Introduction Advertisement is used for international competitive bidding and invitation for the rest of tender types for better communication and transparency of the procurement proce- dure.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) Pharmaceuticals Fund and Supply Agency (PFSA) Document Title Bid Advertisement Document No SOP/PRO/A03 Revision 1 Effective on: 1. or notice of pre-qualification in appropri- ate media. a request for expression of interest (EOI). determine date for ment Coordinator publication of notices Procurement director Authorization of correspondences with external bodies Finance department Settlement of service fee 23 . 3. It is also used for formal methods of solicitation and limited competition. Scope This SOP is applicable to all ICB procurement tenders advertised at the PFSA head office. Responsibilities Title Responsibility Procurement officer Drafting tender notice & follow up correctness of publication Procurement Procure.

the officer will inform action. The ProcurementtheCoordinator Finance Department to settle the shall communicate payment for publication IT Department to postofthe theinvitation tender tonotice. for thepublication Procurementof the tender notice. 6. Pharmaceuticals Fund and Supply Agency (PFSA) Procurement Procedure Doc No: P/PRO/A Rev No: 0 Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) 5. published is complete and accurate. The procurement concerned officer shall Procurement fill the ‘invitation Coordinator. Coordinator shall communicate 6. and request the press agency to publish corrigendum or take other action.5. gettingto bid’document.2.2. Receiving the quotation from the Press Agency. The Procurement Coordinator shall communicate the IT Department to post the invitation 6. The procurement officer shall fill the ‘invitation to bid’ document. The 6. The procurement officer in charge will follow up the publication of the invitation to bid 6.1. Procedures 6. The procurement officer in charge will follow up the publication of the invitation to bid no- to and tice bid notice ensureonthe theinformation agency’s website. the Procurement Coordinator. 6. published and request is complete the press agencyand to accurate.6.4. the officer will inform the notice and ensure Procurement the information Coordinator. Process map/Flowcharts Fill ‘invitation to bid’ document Request quotation from Press Agency to put tender notice Communicate Finance to settle tender notice fee Communicate IT department to post the invitation to bid on website Follow up & ensure correctness of the publication 6. other In case the publication is found to be incomplete or in accurate.4. 24 Page 2 of 65 . publish corrigendum or take 6. Process map/Flowcharts 5. In case the publication is found to be incomplete or in accurate. municate Receivingthethe Finance Department quotation to settle from the Press payment Agency. bid notice on the agency’s website. the Procurement Coordinator shall com- 6. Procurement Agency for quotation to put the getting approval fromtender notice in the the procurement official director. 6.5. 6. newspaper(s).3.6. requests the Ethiopian Press Agency for quotation to put the tender notice in the official newspaper(s).3. approval from the procurement director. Procedures 6.1. 6. requests the Ethiopian The concerned Press Coordinator.

Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) 7. Forms Form No Form Title F/PRO/04 Invitation to bid 8. Amendment History Revision: Effective Date: Approved By: Reason 0 Initial release 25 .

or may allow candidates to obtain bidding documents free of charge.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) Pharmaceuticals Fund and Supply Agency (PFSA) Document Title Bid document issuing/selling Document No SOP/PRO/A04 Revision 1 Effective on: 1. Responsibilities Title Responsibility Procurement director. Purpose The purpose of this SOP is to define the process steps to be followed in issuing bid documents during the floating period. Introduction The national procurement directive requires the bidding document to be available to candidates desiring to participate in the bid on working days during the floating period of the bid in the man- ner stated in the advertisement. 4. or at a price less than the cost incurred in the preparation of such document. 2. Scope This SOP is applicable to issuance of bids. 3. The directive describes the procuring organization to fix the selling price of bidding documents.Selling/Issue bid document ate secretary Procurement officer Provide enough copies of bid documents for issu- ance 26 .

6. If required. Process map/Flowcharts Receive request for collection of bid document Check name.2. Page 5 of 65 27 .3. the to shall secretary collect the bid complete the document. company on the renewed trade 6.4. directorate secretary will check the name of the company on the re- 6.2.1. selling fee. Process map/Flowcharts 5. The procurementdirectorate. Suppliers interested to participate in the bid will forward their request to the secretary of the procurement 6. fee. supplier the potential and ID has carda valid of the delegated trade personnel license. the selling bid document shall issue the bid document. The secretary.3. 6. trade license & ID of the delegated personnel Fill bid selling form Register receipt number on the selling form Issue bid document (and letter of invitation. the secretary shall complete the secretary.directorate The procurement and ID card of the delegated secretary personnel will check to collect the name of the the bid document. If required. newed trade license. Pharmaceuticals Fund and Supply Agency (PFSA) Procurement Procedure Doc No: P/PRO/A Rev No: 0 Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) 5. 6. the secretary may issue the bid document together with the letter of invitation. Confirming the potential supplier has a valid trade license. the secretary may issue the bid document together with the letter of invitation. 6. Procedures 6. Suppliers interested to participate in the bid will forward their request to the secretary of Procedures the procurement directorate. if required) 6.4. The bid sellingafter formregistering and forward to financereceipt the payment department foron number collection of form.1. Confirming license. bid selling form and forward to finance department for collection of bid document selling 6. after registering the payment receipt number on the selling form. shall issue the bid document.

Forms Form No Form Title F/PRO/05 Bid document selling form 8. Amendment History Revision: Effective Date: Approved By: Reason 0 Initial release 28 .Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) 7.

clarification or amendment of bid document for all types of com- petitive bidding and restricted bidding carried out at the PFSA head office. Check amendments ment Coordinator Procurement Director Approve/authorize amendments 29 . Introduction Suppliers are entitled to request and obtain clarification on floating bids before the of bid clarifica- tion deadline. 4. 3. 2. The objective of the clarification is to clarify to suppliers any ambiguity or contradic- tory or anomalies found in the bid document. Responsibilities Title Responsibility Procurement directorate Receiving queries and clarifications secretary Procurement officer Respond to queries and clarifications Procurement Procure. Scope This SOP is applicable to query. Purpose The purpose of this SOP is to define the process steps to be followed in clarifying or amending bid documents during the floating period.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) Pharmaceuticals Fund and Supply Agency (PFSA) Document Title Bid clarification Document No SOP/PRO/A05 Revision 1 Effective on: 1.

Process Process map/Flowcharts map/Flowcharts Detect anomalies Receive query or in floating bid clarification request document in bid document Register the request and forward it to Procurement Director & case team leader Review the query/clarification No Is the request valid? Yes Yes Is amendment required? No Draft amendment document Prepare clarification notice Check amendment document Verify amendment document Communicate to all suppliers Inform body non who bought bid documents by acceptance of the official letter and website request 30 Page 8 of 65 . 5. Pharmaceuticals Fund and Supply Agency (PFSA) Procurement Procurement Procedure Procedure Doc No: P/PRO/A Pharmaceuticals Rev No:(PFSA) Fund and Supply Agency 0 5.

the procurement officer shall draft the amendment document. The procurement officer shall review the query or clarification request.2. Supplementary issues 7. Queries from suppliers must be handled through written correspondence.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) 6.1. The procurement directorate secretary will receive queries or clarifications requests from suppliers that have bought the bid document. amendments may justify an extension of the submission deadline. Suppliers requiring clarifications to the tender documents must submit their queries in writ- ing to the agency before the days stipulated in the bidding document. If the request is valid but does not require amendment. 6. The secretary shall register the request and forward it to procurement director and to the Procurement Coordinator and/or procurement officer in charge accoredingly. the agency may. The procurement officer with the authorization of the Procurement Coordinator and the procurement direc- tor will prepare and dispatch written replies to such queries. 6. At any time before the deadline for submission of offers. 6. modify the bid documents. and get verified/ autho- rized by the procurement director. for any reason. as appropirate. 6. In certain cases. Amendments to solicitation documents must be made within a reasonable time before the deadline for submission of offers in order for suppliers to address changes in their offers. 7.7. to all suppliers at the same time. The procurement officer shall ensure all suppliers who bought bid documents have re- ceived the amendments or are communicated by an official letter and ail and website. 7. 7.5. together with the text of the queries.1. 6.3. The Procurement Coordinator shall check the draft amendment. 6. the procurement officer shall pre- pare clarification notice. 6.4. Procedures 6. If the request is valid and is found to be requiring an amendment. whether on its own initiative or following a request for clarification by a supplier.3. the officer shall inform the requesting body non acceptance of the request.2. If the request is not a valid one. without referencing the source of the queries. and make all replies known.8. This should be assessed on a case by case basis. 31 .6.

7.4. Amendment History Revision: Effective Date: Approved By: Reason 0 Initial release 32 . a letter will be prepared and be uploaded to the agency’s website. Substantial changes to the requirements may make re-tendering necessary.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) 7. In the case of a limited competition. be sent simultaneously in writing to all invited sup- pliers. Forms Form No Form Title F/PRO/06 Bid query registration form 9. In order to ensure that all suppliers have the same details. b. In the case of an open competition.5. 8. amendments of bid documents must: a.

receipt of large size bid submis- sion packages Procurement Procure. 3. and it closure at ment Coordinator submission deadline 33 . 2. 4. Purpose The purpose of this SOP is to define the process steps to be followed in receiving quotations.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) Pharmaceuticals Fund and Supply Agency (PFSA) Document Title Bid offer receiving Document No SOP/PRO/A06 Revision 1 Effective on: 1. Introduction It is the responsibility of suppliers to ensure that bid offers are submitted to the agency’s procure- ment directorate in accordance with the stipulations in the bid documents.Signing and sealing of the bid box.Registration of suppliers with bid submission offers ate secretary Procurement officer Availing of bid box. Scope This SOP is applicable to for all types of bidding carried out at the PFSA head office. Responsibilities Title Responsibility Procurement director.

number. Pharmaceuticals Fund and Supply Agency (PFSA) Procurement Procurement Procedure Procedure Doc No: P/PRO/A Pharmaceuticals Rev No:(PFSA) Fund and Supply Agency 0 5. number & name of supplier are written on the envelope Check bidder has bought a bid document Register bidder on bid receipt form Yes Are samples Submit samples to officer provided? No Ensure the bid submission package is inserted in the bid box or Store samples for evaluation submitted to officer Close bid box & registration document at exactly at deadline of submission 34 Page 12 of 65 . closing and opening date on the box Ensure the box is locked & signed by the Procurement Director Place the box in visible and secured location Check envelopes are sealed & bid title. 5.Process Process map/Flowcharts map/Flowcharts Prepare an empty tender submission box Write the bid title.

6. The secretary ensures that suppliers that have submitted offers shall register their company name. For sizes larger than the slot of the bid box. bid number and supplier’s name is written on the envelope. the packages can be submitted directly to the procurement officer in charge.10.7. The secretary also checks the bid documents issuance register to confirm the supplier has bought a bid document. 6. 6. 6. For sup- pliers whose name is not registered in the bid issuance record. The procurement officer in charge shall make sure and empty bid submission box of conve- nient size and in good working condition is readily available. 6.6. closing and opening dates of the bid are posted on the bid submission box.5. The Procurement Coordinator also signs and put the date and time the bid was closed on the registration record. The procurement officer ensures the bid title. the procurement officer will receive the samples and provide/sign a confirmation note to the supplier for the receipt of the sample.2. the secretary will sign the archieve’s acceptance note.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) 6.8. and also make sure the box is locked and sealed with a signature of the Procurement Director.9. number.3. If samples are presented as part of the bid offer. contact person and other information as stipulated in the bid receipt form. the Procurement Coordinator or his delegate will close the bod box and strike the remaining rows of the bid submission registration record. 6. During submission of bid offers. 35 . 6.1. the secretary shall put a special remark in the record. If the bid offers are submitted via post office. Procedures 6. The Procurement Coordinator will make sure the bid submission package is inserted in the bid box. the procurement directorate secretary shall check if the envelopes are sealed.4. 6. The procurement officer ensures the bid submission box is placed in visible and secured location. The procurement officer ensures the samples are stored in safe and conditioned environ- ment until forwarded for visual examination or lab analysis. bid title. Exactly at the deadline of bid submission. 6.

Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) 7. Forms Form No Form Title F/PRO/07 Bid offer submission registration form 8. Amendment History Revision: Effective Date: Approved By: Reason 0 Initial release 36 .

Responsibilities Title Responsibility Procurement directorate sec. signing bid offer documents. taking minutes. 2. 4. handover of bid offer documents and bid bonds. Purpose The purpose of this SOP is to define the process steps to be followed and responsibilities to open bid offers. 3. an- (TEC) nouncing bid offer prices and other information to participating bidders TEC secretary Calling TEC meeting. Maintaining of bid bonds securely retary Tender Evaluation Committee Opening bid offers. Introduction The opening of bid offers must be handled transparently in order to ensure that only valid offers are evaluated and that all suppliers are treated in a fair and non-discriminatory manner. communicate TET secretary schedules of bid offer openings 37 . Scope This SOP is applicable to for all types of bidding carried out at the PFSA head office. maintain records of the proceedings Procurement Coordinator Submit bid offer submission box.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) Pharmaceuticals Fund and Supply Agency (PFSA) Document Title Bid opening Document No SOP/PRO/A07 Revision 1 Effective on: 1.

Process Process map/Flowcharts map/Flowcharts Call the scheduled meeting of Tender Eval. secretary tender reading modality The chair person reads name of suppliers. if any 38 Page 16 of 65 . Committee Place tender box in the meeting room visible to attendees Committee members address comments & questions of attendees Register attendees of the tender opening The committee chair person opens the Committee members sign originals of meeting with welcome remark Suppliers’ bid offer documents The chair person requests attendees to witness bid box is closed & sealed Procurement officer collects originals & copies of bid offers The chair person opens the bid box & segregate originals & copies Procurement officer submits bid bonds The chair person requests consent on to procurement dir. bid bonds. Procurement officer in charge prepares prices and additional info minutes of meeting The committeemembers The chair person facilitates comments sign on minutes & questions of attendees. 5. items participated. Pharmaceuticals Fund and Supply Agency (PFSA) Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) Procurement Procedure Doc No: P/PRO/A Rev No: 0 5.

Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA)

6. Procedures

6.1. The procurement Procurement Coordinator in charge shall communicate the Tender Evalu-
ation Committee chair person to call the scheduled meeting.

6.2. The procurement Procurement Coordinator or his/her representative shall place the ten-
der box in the meeting room in a location visible to meeting attendees.

6.3. The procurement officer shall circulate attendance form and get registered and signed all
attendees of the bid opening meeting including representatives of suppliers.

6.4. The committee chair person will open the meeting with a welcome remark and reads the
title of the bid, its bid number and other general information of the bid.

6.5. The committee chair person requests attendees to witness the bid box is closed intact and
sealed.

6.6. The committee chair person or a member shall open the bid box, sort originals and copies
of the bid offer documents for each supplier.

6.7. The committee chair person will request consent of representatives of suppliers attending
the meeting on tender reading modality.

6.8. The committee members read name of supplier, items participated, amount of bid bond,
bid guarantee, quoted prices and other information such as name of manufacturer & coun-
try of origin. Late bids and modifications that are not considered must be held unopened
– unless opened for identification – until after award and then retained with other unsuc-
cessful bids.

6.9. The committee chair person facilitates comments and questions from representatives of
suppliers attending.

6.10. The committee chair person and members address comments and questions rose by rep-
resentatives of suppliers, and ensure these are captured in the minutes of the meeting.

6.11. The committee members sign originals of the bid offer documents including quotations,
registion certificates, GMP certificates, COPP certificates, etc. The signatures will be put on
the free space at the bottom of every page of the main document. If found necessary,
accompanying documents such as product catalogue, company brochre, etc may also be
signed.

6.12. The procurement officer shall collect originals and copies of the bid offer documents using
the bid offer documents handover form

6.13. The procurement officer shall submit bid bonds of suppliers to the Procurement Director-
ate Secretary using the bid bonds handover form.

39

Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA)

6.14. The officer shall prepare minutes of the meeting including comments and questions from
representatives of suppliers attending the meeting, and decision points of the TET. Addi-
tional records such as signed attendance sheet, correspondence memo to call the meeting,
notice to participants, etc. will be attached to the minute as evidence.

6.15. The committee members who have attended the meeting will check the minute to ensure
discussion and decision points are captured in the minute of the meeting and sign the
document.

7. Forms

Form No Form Title
F/PRO/08 Meeting attendance registry form
F/PRO/09 Bid offer documents handover form
F/PRO/10 Bid bonds handover form

8. Amendment History

Revision: Effective Date: Approved By: Reason
0 Initial release

40

Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA)

Pharmaceuticals Fund and Supply Agency (PFSA)
Document Title Bid offer analysis
Document No SOP/PRO/A08
Revision 1 Effective on:

1. Introduction
As per the criteria indicated in the bid document evaluation will be conducted to confirm compli-
ance/non-compliance of the bid offers against the requirements.

2. Purpose

The purpose of this SOP is to define the process steps to be followed and define responsibilities
for evaluation of bid offers.

3. Scope
This SOP is applicable to for all types of bidding carried out at the PFSA head office.

4. Responsibilities

Title Responsibility
Procurement Procurement Verify and approve bid analysis templates; verify
Coordinator bid offer analysis reports
Procurement officer Prepare bid offer analysis; prepare bid offer analy-
sis summary report
Procurement Coordinator Verify offer analysis reports

41

Pharmaceuticals Fund and Supply Agency (PFSA) Procurement Procurement Procedure Procedure Doc No: P/PRO/A Pharmaceuticals Rev No:(PFSA) Fund and Supply Agency 0 5. Submit analysis report to Tender evaluation committee 42 Page 20 of 65 . technical & financial eval.Process Process map/Flowcharts map/Flowcharts Organize originals of bid offers for posting Extract preliminary screening & technical evaluation formats on the basis of bid documents Get approval on the format from the case team leader Post bid offer data of each supplier in the evaluation format Review bid offers against the bid preliminary requirements No Supplier meets general requirements? Yes Review bid offers against technical requirements No Offer meets technical requirements? Mark red & put remark on nonconforming (NC) suppliers and/or items Yes Post bid offer prices in the price schedule format Prepare summary report on preliminary screening. 5.

7. 6. 6.1. 6. how many items got suppliers.10. In case a supplier doesn’t comply with the general requirements for preliminary screening. The procurement officer will post bid offer data of each supplier in the preliminary technical and financial evaluation formats.5. The procurement officer shall prepare a summary report on the interim results of prelimi- nary screening and technical evaluation. the procurement officer shall review whether each supplier complies with the preliminary requirements stat- ed in the bid document or not. the noncomplying parameter will be highlighted with red color.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) 6.8.4. 6. 6. 43 . The procurement officer shall post bid offer prices in the price schedule format.9. 6. the preliminary screening and technical evalu- ation criteria used. The procurement officer shall review bid offer of each supplier item by item only for those suppliers that have complied with the general requirements and pass preliminary screen- ing. the noncomplying parameter will be highlighted with red color. and NC note will be put in the remark column.2. 6. The Procurement Coordinator in charge shall verify the report and forward it to the Tender Evaluation Committee for consideration.3.11. 6. The report will also include number of suppliers participated. etc. In case an offered item doesn’t comply with the technical requirements stated in the bid document. The Procurement Coordinator in charge shall check and approve the formats for posting of bid offer data. The procurement officer in charge shall organize original copies of the bid offer documents for posting. 6. and NC note will be put in the remark column. In order to avoid spending resources on the evaluation of invalid offers. 6. The procurement officer extracts a preliminary screening and technical evaluation formats based on the general and technical requirements on the bid document. Procedures 6.6.

Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) 7. Forms Form No Form Title F/PRO/11 Bid offer preliminary screening form F/PRO/12 Bid offer technical evaluation form F/PRO/13 Price schedule evaluation evaluation form 8. Amendment History Revision: Effective Date: Approved By: Reason 0 Initial release 44 .

Introduction Bid offer analysis approval is the process of assessing and comparing submissions in accordance with the evaluation methodology and criteria stated in the bid documents.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) Pharmaceuticals Fund and Supply Agency (PFSA) Document Title Bid offer analysis approval Document No SOP/PRO/A09 Revision 1 Effective on: 1. 4. Responsibilities Title Responsibility Deputy Director General Receive decision report of TET and write a no objec- of Operations (ODDG) tion letter. and thus represents best value for the Agency. Tender Evaluation Com. 3. Purpose The purpose of this SOP is to define the process steps to be followed and define responsibilities for approval of bid offers. Scope This SOP is applicable to for all types of bidding carried out at the PFSA head office. The aim is to deter- mine the offer that best fits the evaluation criteria. An objective.Reviewing suppliers technical and financial offers mittee Reject non complying suppliers Tender Endorsement Endorsing of technical and financial analysis reports Committee Procurement officer Prepare draft decision report. fair and well-executed evaluation process is critical as it results in a recommendation and a request for award of contract. and meeting minute 45 . 2.

5. Pharmaceuticals Fund and Supply Agency (PFSA) Procurement Procurement Procedure Procedure Doc No: P/PRO/A Pharmaceuticals Rev No:(PFSA) Fund and Supply Agency 0 5.Process Process map/Flowcharts map/Flowcharts Procurement officer submit bid offer analysis report The chair person calls scheduled meeting of the tender evaluation committee Present bid analysis report to the evaluation committee No Is the report & posting correct? Yes Review the preliminary screening and Forward to procurement technical analysis reports officer for correction/ rework Communicate the list of qualified suppliers for financial analysis Post suppliers financial offers against market price & proposed budget & submit report to the committee Analyze financial offers of suppliers in comparison with budget & current market price Yes Is there significant price difference? No Recommend to retender/ cancel/ negotiate Propose winners based on least bid price for contract award 1 46 Page 24 of 65 .

Procurement Procedure Pharmaceuticals Fund Pharmaceuticals Fundand andSupply SupplyAgency Agency(PFSA) (PFSA) Procurement Procedure Doc No: P/PRO/A Rev No: 0 1 Prepare the committee’s minutes of meeting Draft decision proposal report & documents Get checked by colleagues. case team leader and procurement director Tender evaluation committee reviews draft decision report & documents No Is the report accepted? Yes Get the reports & minutes signed Procurement Director submits evaluation reports to Tender Endorsement Committee No Is the report accepted? Yes Communicate procurement Implement decision officer to prepare for award notification 47 Page 25 of 65 .

Following the review. Or if the technical or financial analysis are not correct. The tender evaluation committee shall review the preliminary screening and technical anal- ysis report against the requirements in the bid documents. 6. The tender evaluation committee chair person shall convene the committee meeting as prescheduled.12. The tender evaluation committee checks correctness of the posting and report.6. will present the bid analysis report to the tender evaluation committee. The procurement officer shall prepare draft decision proposal report and associated docu- ments and submit to procurement director to enclose with a letter to the Tender Endorsing Committee. and present to the tender evaluation committee. preliminary screening. The decision proposal will be prepared in four copies and include cover letter.8. the tender evaluation committee returns the document for correction. 6. The tender evaluation committee shall review the financial analysis report in comparison against budgeted price and current market price.2. table of contents. If the post- ing or report is found to be not correct or inconsistent. The procurement officer or the Procurement Coordinator who has attended the tender evaluation committee meeting shall prepare the minutes of the meeting and circulate to all attendees.1. Procedures 6. no objection letters. winners list. as appropriate.9. If there is significant difference of price between the suppliers’ offer and the budgeted price or market price. The procurement officer in charge or the Procurement Coordinator. procurement directives of PFSA and government regulations.5.7. 6. minutes of meetings. it will be returned to the officer for correction or rework. offer analysis. 6. The procurement officer shall conduct analysis of financial offers of suppliers in comparison with budget & current market price.3.10. the tender evaluation committee may recommend retendering or negotia- tion or cancelation of the bid.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) 6. and other records gener- 48 . 6.4. The procurement officer submits the bid offer analysis report to the Tender evaluation com- mittee. 6. 6. The tender evaluation committee shall propose bid winners on a least price base for con- tract award. tender initiation letters. 6. 6. the tender evaluation committee shall communicate the procurement officer the list of qualified suppliers for financial analysis.11. 6. 6. technical evalu- ations.

6. Forms Form No Form Title F/PRO/14 TEC minutes of meeting form F/PRO/15 Decision proposal form 8. If the decision report is accepted by the Tender Endorsement Committee.14. If the report is not accepted by the Tender Endorsement Committee.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) ated in the processes. it will be forwarded to the procurement directorate to implement the committee decision/recommedndation.no objection letter to the procurement directorate to proceed to the next level. The procurement director communicates the Procurement Coordinator and/or procure- ment officer to prepare award notification for those accepted once and prepare to next level of evaluation as per the decision given by the Tender Endorsement Committee. 6. the Deputy Di- rector General of Operation (DDGO) will write a tender approval. 7. Amendment History Revision: Effective Date: Approved By: Reason 0 Initial release 49 .13.

4. and generally the Deputy Director General of Operations or the Director General has the authority to award a contract. Scope This SOP is applicable to for all types of procurements methods used for the supply of pharma- ceuticals. contracts are awarded based on recommendations from a Tender Endorsing Commit- tee. Introduction Generally. Responsibilities Title Responsibility Procurement Director Approve award notification document Procurement officer Preparation of list of awardee and award notifica- tion Procurement Secretary Distribute award notification to bidders MIS Post award notification on website 50 . 2. An award may be made subject to the prior fulfillment of conditions.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) Pharmaceuticals Fund and Supply Agency (PFSA) Document Title Awarding Document No SOP/PRO/A10 Revision 1 Effective on: 1. Purpose The purpose of this SOP is to define the process steps to be followed and define responsibilities for awarding of contracts. 3.

The procurement director shall approve the award notification. Pharmaceuticals Fund and Supply Agency (PFSA) Procurement Procurement Procedure Procedure Doc No: P/PRO/A Pharmaceuticals Rev No:(PFSA) Fund and Supply Agency 0 5.1. Procedures 6.4.3. The procurement officer in charge shall receive a no objection letter from TEC and prepares a list of awardee and draft award notification document. 6. and enclosed it with a signed official letter. 5. The procurement director shall communicate the MIS division to post the award notification on the Agency’s website.2. 6.Process Process map/Flowcharts map/Flowcharts Recevie no objection letter from TEC & prepare list of awardee and award notificatin Check and verify list of awardee and award notification Approve draft award notification enclosing it with an official letter Distribute award notification to all bidders participated Communicate award notification document to MIS to be posted on the website Ensure award notification is posted on website & distributed to bidders 6. The Procurement Coordinator shall check and verify the list and draft award notification document. 51 Page 29 of 65 . 6.

7. 6.5. The procurement directorate secretary informs all participating bidders to collect the award notification documents. and the documents are distributed to participating bidders. Forms Form No Form Title F/PRO/16 Award notification form 8.6. The officer and/or Procurement Coordinator ensures the award notification is posted on the website. Amendment History Revision: Effective Date: Approved By: Reason 1 Initial release 52 .Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) 6.

2. Responsibilities Title Responsibility Director General Receive and register complaints from bidders on award notification Procurement Director Checking whether complaintants are reported or not 53 . Introduction Replies to complaints made by bidders during (and after) the evaluation process must be in line with what may or may not be disclosed. the Director General may conduct investigation or consider seeking advice from the tender endorsal committee before reaching decision. as stated in the bid document. Purpose The purpose of this SOP is to define the process steps to be followed and define responsibilities for complaint handling in line with the Federal Public Procurement Directive. 3. Scope This SOP is applicable to for all types of procurements methods used for the supply of pharma- ceuticals. 4.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) Pharmaceuticals Fund and Supply Agency (PFSA) Document Title Complaint handling Document No SOP/PRO/A11 Revision 1 Effective on: 1. Depending on the nature of the complaints received.

Pharmaceuticals Fund and Supply Agency (PFSA) Procurement Procurement Procedure Procedure Pharmaceuticals Fund and Supply Agency Doc No: P/PRO/A Rev No:(PFSA) 0 5.Process Process map/Flowcharts map/Flowcharts Ensure complaint deadline is communicated to bidders No Is complaint raised? Yes DG receives complaint Investigates the case and take decision Communicate decision to complainant Are there appeals to the board? No Yes Wait for the board’s decision Implementboard’s decision Proceed procurement process 54 Page 32 of 65 . 5.

Supplimentary issues 7.20/1 of the Procurement Directive. d) Decisions given to reject bids. 6. if any.5. bid documents or price quotation pursuant to article 30 of the proclamation.7. The FDRE Public Procurement Directive (Article XI) stipulates complaint may not be lodged on the following matters a) The selection of procurement method carried out in accordance with the conditions established in the proclamation (Procurement and Property Administration Procla- mation 649/2009). b) The selection of bidders for procurement to be made by means of restricted tender- ing or request for quotation or on the evaluation criteria set forth in the bidding docu- ment beforehand. The Director General. the Director General instruct to hold the procurement process to receive the Board decision. If there are no appeals. 6.2. conducts investigation and gives decision on the complaint. 55 . 6.4. The Director General ensures the decision is communicated to the complaintant in writing within ten working days from the date of submission of the complaint. c) The preference given to Domestic Providers pursuant to Article 25 of the proclama- tion and article 16.1.3. 6. The Procurement Director checks whether there is an appeal by complaintants on their complaint decisions or not. If there are appeals to the Board (the entity established under this Proclamation to review and decide on complaints from candidates in regard to the conduct of procurements and disposal of property of the Federal Government).8.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) 6. the Procurement Director triggers the procurement process to pro- ceed. 7.1. Procedures 6. The procurement officer in charge shall ensure the complaint submission deadline is com- municated posted on the website.6. depending on the nature of the case. The Director General receives complaints on the award notification from bidders. 6. 6. The Director General communicates the Board’s decision to ensure it is implemented ac- cordingly. 6.

provided that such con- tract was signed after seven working days from the result of the bid evaluation being disclosed as provided in sub article 46. Forms Form No Form Title F/PRO/16 Complaint registration form 9. 8.3 of the proclamation and article 45.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) e) No complaint presented to the head of a Public Body after 5 working days have elapsed from the date on which the Public Body (PFSA) disclosed the result of a bid evaluation. f) No complaint shall be accepted after a contract was signed. or no complaint presented to the board after 5 working days have elapsed from the date on which the Public Body responded to the complaint shall be ac- cepted. Amendment History Revision: Effective Date: Approved By: Reason 0 Initial release 56 .1 (a) of the Procurement Directive.

4. Scope This SOP is applicable to for all types of procurements methods used for the supply of pharma- ceuticals. Introduction A purchase order (PO) is a type of contract that documents the purchase of goods and/or ser- vices. Sign letter of request to FMHACA Send original PO to awarded suppliers Deputy Director General Endorse draft PO and approve original PO of Operations (ODDG) 57 . 3. Responsibilities Title Responsibility Procurement officer Prepare draft Purchase Orders Procurement Director Verify draft PO and original PO.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) Pharmaceuticals Fund and Supply Agency (PFSA) Document Title Purchase order processing Document No SOP/PRO/A12 Revision 1 Effective on: 1. Purpose The purpose of this SOP is to define the process steps to be followed and define responsibilities for preparation of purchase orders. 2.

5.Process Process map/Flowcharts map/Flowcharts Ensure there are no outstanding complaints Draft PO for each awarded supplier Request PO approval from Enclose offer analysis & quotation of FMHACA supplier with the PO Check PO & enclosed documents for Follow up approval of PO by completeness and correctness FMHACA Verify PO & enclosed documents for completeness. correctness & clarity Issue FMHACA endorsed original PO to supplier No Is draft PO ok? Distribute copies of PO to concerned functions of PFSA Yes Endorse and sign PO File copies of PO & all supporting documents Prepare original PO Check original PO Verify original PO Is original PO ok? Approve original PO 58 Page 36 of 65 . Pharmaceuticals Fund and Supply Agency (PFSA) Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) Procurement Procedure Doc No: P/PRO/A Rev No: 0 5.

The Procurement Director will send the FMHACA approved original PO to the awarded sup- pliers. The Procurement Coordinator shall follow up for receipt of approved PO by FMHACA. unclear. etc.2. Procedures 6. That is. 6.7. 6. The procurement officer in charge shall ensure there is no outstanding complaint. 6.17. incorrect.15. The procurement director shall verify clarity. 6.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) 6. ensure all complaints (if any) are closed before preparing a PO.13. 6. unclear. the procurement director shall forward it to Deputy Director General of Operations (ODDG) for approval. ensuring the procurement process is conducted as per the rules and proce- dures of the Agency. The procurement officer will enclose offer analysis and suppliers bid documents with the PO.6.4. The ODDG. it shall be returned to the secretary for correction. 6.10. 6. The procurement directorate secretary will prepare an original PO. If the original PO is found to be correct. 6.1. etc. The Procurement Directorate Secretary shall file copies of PO and all supporting docu- ments. If the draft PO is found to be incom- plete. it shall be returned to the procurement officer for correction. If the draft PO is found to be acceptable. 6.8. The Procurement Director shall submit a formal request to FMHACA for endorsement of the PO.11.3. If the draft PO is found to be incomplete. 6. In parallel the Procurement Director will send the PO and supporting documents to all con- cerned functions of PFSA. incorrect.12. 6. The Procurement Coordinator shall check the PO against enclosed documents to make sure it is correct and complete. The procurement director verify the original PO 6.14. completeness and correctness of the PO. 6.5. 6. 59 .16. The procurement officer will prepare draft PO for each supplier awarded. 6. The ODDG shall sign on the original PO. the procurement director shall forward it to Deputy Director General of Operations (ODDG). will endorse the draft PO. The original PO will be checked by the Procurement Coordinator to ensure it is prepared in accordance with the approved draft PO. 6.9.

Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) 7. Forms Form No Form Title F/PRO/17 Purchase order form 8. Amendment History Revision: Effective Date: Approved By: Reason 0 Initial release 60 .

2. 3. which es- tablishes the terms and conditions.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) Pharmaceuticals Fund and Supply Agency (PFSA) Document Title Contract signing Document No SOP/PRO/A13 Revision 1 Effective on: 1. 4. Purpose The purpose of this SOP is to define the process steps to be followed and define responsibilities for preparation and signing of contracts. Responsibilities Title Responsibility Director General Signing of contract on behalf of PFSA Procurement Director Verify correctness of draft contract document. Introduction A contract is a written.Ensuring receipt of fresh proforma invoice and per- tor formance guarantee Procurement officer Prepare draft contract agreement. Send signed original contract document to supplier Procurement Coordina. including the rights and obligations of the Agency and the supplier. Check consistency of reissued proforma invoice 61 . Scope This SOP is applicable to for all types of procurements methods used for the supply of pharma- ceuticals. legally binding agreement between the Agency and a supplier.

5. and copies to all concerned functions Issue a copy of contract & PO to Procurement follow up team 62 Page 40 of 65 .Process Process map/Flowcharts map/Flowcharts Prepare draft contract agreement Check& verify draft contract agreement for correctness Inform supplier’s agent to collect draft contract agreement Receive suppliers signed contract agreement in six copies Receive suppliers freshly prepared proforma Receive a 10% performance guarantees Check the fresh proforma against the PO for consistency Sign as witness on behalf of PFSA Send contract to DG attaching the PO & all relevant documents DG sign contract on behalf of PFSA Send original contract to supplier. Pharmaceuticals Fund and Supply Agency (PFSA) Procurement Procedure Doc No: P/PRO/A Rev No: 0 Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) 5.

6. The Procurement Director shall verify the draft contract document for completeness and consistency. 6.7.12.1. 6.10. The Procurement Directorate Secretary shall receive the contract document signed by the supplier. 6. The officer or Procurement Coordinator ensures fresh proforma invoice is submitted by the supplier. inform the Director and forward the document to concerned Procurement Coor- dinator. Procedures 6.4.6. The Procurement Director shall present the contract including all relevant documents to the Director General for approval. 6.9.13. 6. The officer in charge & Coordinator shall sign the contract as witnesses of PFSA.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) 6. 6. The Procurement Coordinator shall check the content & correctness of the draft contract. The Procurement Director will issue a copy of contract. 63 .11. 6. The officer or Procurement Coordinator ensures a 10% performance guarantee is issued by the supplier. The Director General signs the contract on behalf of PFSA.3. 6. PO. The officer in charge shall check the content and consistency of the freshly prepared pro- forma against the PO. 6. The Procurement Directorate Secretary shall notify and register supplier’s agent to collect the draft contract for signing in six originals.5. and copies to the concerned functions of PFSA. The procurement officer in charge shall fill out a draft contract agreement for each supplier awarded using the standard contract template. fresh performa invoice and 10% performance bond to Procurement follow up team for action. The Procurement Director ensures one original copy of the contract document is sent to the supplier. 6. 6.8.2.

Forms Form No Form Title F/PRO/18 Standard contract form 8.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) 7. Amendment History Revision: Effective Date: Approved By: Reason 0 Initial release 64 .

3. and radiating equipment. Introduction Regarding a presence of restricted pharmaceuticals such as narcotic or psychotropic drugs. Insecticide for malaria control. 4. Purpose The purpose of this SOP is to define the process steps to be followed to obtain permit from the regulatory authorities regarding procurement of special items and controlled substances such as NPS. sup- pliers usually require special permission from FMHACA. Scope This SOP is applicable to receipt of special import permit from the national regulatory the agen- cies.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) Pharmaceuticals Fund and Supply Agency (PFSA) Document Title Special Import Permit Document No SOP/PRO/A14 Revision 1 Effective on: 1. Responsibilities Title Responsibility Procurement Director Prepare import permit request of NPD to FMHACA Procurement Coordinator Follow up special import permit from FMHACA 65 . 2.

4.1. 6. Forms agencies to the suppliers. The Procurement Director shall communicate the import permit issued by the regulatory agencies. Procedures 6. 6. to the regulatory agencies.2. toThe theProcurement Director shall prepare and submit a special import permit request letter regulatory agencies.2.1. agencies to the suppliers. The Procurement Coordinator in charge shall follow up the import permit request from regulatory agencies and facilitate in provision of information required by the agencies.4. The Procurement Coordinator in charge shall follow up the import permit request from the 6. the regulatory agencies and facilitate in provision of information required by the 6. the national regulatory authorities. Forms 8. The Procurement Director shall communicate the import permit issued by the regulatory 7. Follow up to receive regulatory body’s permit Send permit to supplier 6.3. Procedures 6. Thenational the procurement director regulatory shall identify items that required of special import permit from authorities. Pharmaceuticals Fund and Supply Agency (PFSA) Procurement Procedure Doc No: P/PRO/A Rev No: 0 Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) 5. 6.3. Process map/Flowcharts 5. Process map/Flowcharts Identify items requiring special import permit Request for a special import permit enclosing PO & other relavant docs. The Procurement Director shall prepare and submit a special import permit request letter 6.0 Amendment History Initial release Revision: Effective Date: Approved By: Reason 0 Initial release 66 Page 43 of 65 . Amendment Form No History Form Title Revision: Effective Date: Approved By: Reason 8. The procurement director shall identify items that required of special import permit from 6. Form No Form Title 7.

Scope This SOP is applicable to all procurements of pharmaceuticals carried out by PFSA. 2. 3. Technical specifications (TS) and descriptions laying down the characteristics of the goods and ac- companying services to be procured shall be prepared for the purpose of providing a correct and complete description of the object of procurement and for the purpose of creating conditions of fair and open competition between all candidates. Purpose The purpose of this SOP is to define the general guideline to be followed in preparation of techni- cal specifications (TS) of pharmaceuticals so that correct and complete descriptions of the object of procurement are provided.• Review of request/proposal for aTechnical Specification (TS) rector • Formulation of Technical Committee Procurement Di. 4.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) Pharmaceuticals Fund and Supply Agency (PFSA) Document Title Preparation of Technical Specifications for Pharmaceuticals Document No SOP/PRO/A15 Revision 1 Effective on: 1. Introduction Preparing technical specifications for pharmaceutical product can a challenging activity where the product is outside the Essential Pharmaceuticals (Drugs) List and will require specialized knowl- edge and expertise in pharmaceuticals. Specifications for products that have previously been successfully procured are generally used as a starting point for new procurements. A set of precise and clear specifications is a prerequisite for tenderers or bidders to respond realistically and competitively to the requirements of the purchaser.• Approval of request/proposal for aTS rector • Approval of Draft TS MIS Registration and publishing of approed TS 67 . Failure to develop specifications that meet the need of users can result in the procurement of unsuitable products. Responsibilities Title Responsibility Procurement Di.

6.4. Procedures 6.4. Each request/proposal shall be submitted to the Procurement Director in writing.2. Any officer/expert associated with procurement activities may request/propose to the 6.1. On the basis of the review the D/Director General of Operations shall decide upon 6. The Procurement Director shall review the request/proposal against a catalogue of TS or 6. If deemed 68 Page 45 of 65 . the Procurement Director shall for mulate an ad hoc technical committee(s) to prepare TS for the item(s) requested/proposed. Procedures 6.1. When the request/proposal is approved. 6. and it shall indicate the name of the item and give the reasons for the need of the TS. Each request/proposal shall be submitted to the Procurement Director in writing.2.3. tance or rejection of the request/proposal.5. Pharmaceuticals Fund and Supply Agency (PFSA) Procurement Procedure Procurement Procedure Doc No: P/PRO/A Pharmaceuticals Rev No:(PFSA) Fund and Supply Agency 0 5. 6. The Procurement a master Directornature list of similar shall review the request/proposal to prevent against relevance redendency and confirm a catalogue ofofhaving TS or a master list of similar nature to prevent redendency and confirm relevance of having such such TS. On the basis of the review the D/Director General of Operations shall decide upon accep- acceptance or rejection of the request/proposal. Any officer/expert associated with procurement activities may request/propose to the Pro- Procurement Director on preparation or revision of TS for an item. 5. 6.3. curement Director on preparation or revision of TS for an item. shall indicate the name of the item and give the reasons for the need of the TS.Process Process map/Flowcharts map/Flowcharts TS request registration Review request Accepted? Form Technical Committee Reject & notify Prepare Draft Technical Specification Review & approve No Approved? Yes Register & publish TS 6. and it 6. TS.

regional and other national standards and legislations. and get published. best practices.1 A committee of specialists Specifications of pharmaceuticals should be specified by ad hoc technical committees of at least two specialists in a committee that may include a representative of the Procurement Directorate who will provide commercial information. including dosage size. and storage temperature. the TS will be given an identification number. specifications. 69 . and printed materials. 6. If not approved. dose package. the D/Director General of Operations will ap- prove the Draft TS or not.8. such as stability. the Procurement Director shall for mulate an ad hoc technical committee(s) to prepare TS for the item(s) requested/proposed. 7. o size. instructions. Analysing the review and expert feedback. the Draft TS will be sent back to the Technical Committee for correction. o regulatory requirements. The Procurement Director shall ensure the Draft TS is reviewed for completeness and clarity and. etc. and intended use. 6.7. If approved. packing.6. 6. 6. o product properties. The technical committee shall prepare Draft TS taking into consideration availability and effect of international. the Procurement Director may request endorsement from the D/Director General of Operations regarding the composition of technical committee members.5.9.2. quantity. labeling. be included in the TS masterlist. collect feedback from experts other than technical committee mem- bers. General issues to consider in preparation of specifications 6. shelf life. o packaging. 7. units.1. as appropriate. Supplemental Issues 7. Factors to consider include in preparation of technical specification o using the generic version of the product name to ensure that a wide range of suppliers can compete.1. and marking. When the request/proposal is approved.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) 6. If deemed relevant. and o applicable standards and required certifications.

When it is difficult to specify consumables such as disinfectants and laboratory chemi- cals adequately and clearly. items like hospital disinfectants may be subjected to testing by bidders demonstrate effectiveness or appropriate method of use at premises select- ed by the Procurement Directorate.3 Scope of specifications i. The specification setting can be initiated by user functions and be prepared in a clear and unambiguous manner covering product descriptions and supporting ser- vices such as delivery requirements and service responsiveness required of a supplier where necessary. patent. design or type and producer or service provider except where such items are must-fit or are cov- ered by requirements under warranty term.1. brand names or patents. iii.1. The FDRE Procurement and Property Administration Proclamation do not encourage specification by trademark or name. 6. Where appropriate.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) 6.1. However. ii.6 Demonstration and samples i. 70 . 6. design or type. trade names. such special references may be used when procuring the drugs from potential suppliers provided the words “and/or” equivalent are used in order to avoid restriction of competition. potential suppliers may be asked to demonstrate perfor- mance of a product. ii. patent. 6. Otherwise the samples should be accompanied by a certificate of conformance to specifications from an authorized laboratory. Once a sample has been approved. 6. all the supplied products must conform to the sample. due to prevalence of identification and prescription of specific drugs for par- ticular ailments by medical practitioners. The specifications should be checked by the Procurement Unit to ensure clarity and completeness.4 Product specifications Specifications are to address functions and performance in order to avoid elements that restrict competition such as brand.5 Use of brand names and patents i.1. specific original producer or service provider.2 Generic specifications Specifications need to be as generic as possible to encourage adequate responses from potential suppliers. origin.1. ii.

Specific issues to consider 6. inspection and suppliers responsiveness. level of purity. 6.1 Product Package The required packaging standards and labelling must meet the requirements of the “Good Practices in the Manufacture and Quality Control of Drugs” compiled by the World Health Organization (WHO). e) Processes/ methods involved in production.1.7 Medical Equipment Technical specifications Medical equipment specifications generally include a combination of the following: a) Physical characteristics (dimensions. The Procurement Directorate shall make reference to this list for specifications before they start developing alternative specifications. 6. 7. additives etc. installation and /or commissioning. etc).3. density.11 Essential Drugs (Pharmaceuticals) List (EDL) All pharmaceuticals specified for procurement need to be checked against the EDL issued by the FMHACA and the FDRE Ministry of Health.9 Testing and inspections In addition to specifying performance of an equipment or product for the health sector. volume.1.1. c) Tolerances.8 Composition specifications for pharmaceutical products Composition specifications are generally stated in terms of physical as well as chemical characteristics such as weight. b) Acceptance testing at the time of receipt.10 National and International Standards Unless existing standards may not meet user’s needs. The list contains the names and specifica- tions of most the essential pharmaceuticals recommended to treat most of the ailments prevalent. 71 . 6. ingredients.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) 6. technical specifications to be pre- pared shall be based on the relevant national or international standards to enhance testing. d) Materials used. 6.1.1. b) Design details. and f) Maintenance requirements. it is practical to specify testing and inspection requirements in order to derive confidence in the delivered item by applying the following testing and inspection options: a) In-process testing and inspection at the manufacturing stage including assessment of quality assurance documentation (quality plan) in place at the end of production or pre-shipment inspection (PSI).2. strength.

liquid.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) a) Specifications for products such as tablet. syrup. g) Instructions for use. i) Batch number. injectable. but is included in the Ministry of Health’s national essential pharmaceuticals list.g. c) The active ingredient “per unit. and must also provide the reference standards and testing protocols to allow for quality control testing. ointment. b) The products should conform to standards specified in the acceptable pharmacopoeia standard. capsules. bottles. should contain dosage and content (exact number of mg or in- ternational units [IU] or % v/v. j) Date of manufacture and date of expiry (in clear language.. emulsion. h) Special storage requirements. e) The Purchaser’s logo and code number and any specific colour coding if required. suspension. w/w or v/w acceptable range). 72 . etc. dry syrup. the acceptable limits and supplier need to be clearly indicated. storage. where a brand name has been given. etc. dose. f) All labelling and packaging inserts should be in the language requested by the Purchaser or English if not otherwise stated.2 Labelling Instructions The label of the primary container for each pharmaceutical and vaccine products shall meet the latest standard and include: a) The international non-proprietary name (INN) or generic name prominently displayed and above the brand name. As appropriate additional special require- ments may be specified. d) The packaging and labelling components (e. upon award of the contract. g) Goods requiring refrigeration or freezing or those that should not fall below a certain mini- mum temperature for stability must specifically indicate storage requirements on labels and containers and be shipped in special containers to ensure stability in transit from point of shipment to port of entry. etc. b) Dosage form e.”. 6. c) In case the pharmaceutical product is not included in the specified pharmacopoeia. tablet. and labeling) should also meet specifications suitable for distribution.. not code). e) All packaging must be properly sealed and tamper-proof and packaging components must meet the latest compendium standards and be approved for pharmaceutical packaging by the manufacturer’s national regulatory authority. d) The applicable pharmacopoeia standard. and use in a climate similar to that prevailing in Ethiopia. closures.g. f) Content per pack. tablet or capsule. ampoule.2.

b) All cases should prominently indicate the following: i. vii. ii. vi. Any additional cautionary statements. iv. Batch number. syrup). The generic name of the product. as deemed appropriate.2. 6.4 Specifications for Vaccines The Agency may develop additional specifications for vaccines. Name and address of manufacturer.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) k) Name and address of manufacture. Date of manufacture and expiry (in clear language not code). Purchaser’s line and code numbers. m) The outer case or carton should also display the above information. iii. l) Any additional cautionary statement. ampoule. viii.3 Case Identification a) No case should contain pharmaceutical products from more than one batch. v. Quantity per case. and ix. Amendment History Revision: Effective Date: Approved By: Reason 0 Initial release 73 . Special instructions for storage. The dosage form (tablet.2. 6. 8.

or short expiration dates are some of the common problems caused by unreliable suppliers. unsafe. 4. Hidden costs resulting from late deliveries. In adequate safeguards in supplier selection may result in the purchase of medicines that are ineffective. 2. Purpose The purpose of this SOP is to define the processes to follow in pre-qualification evaluation of sup- pliers and maintenance of the suppliers’ list database. or even deadly. default on confirmed orders. Introduction The selection of suppliers has a profound effect on the quality and cost of pharmaceuticals ac- quired.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) Pharmaceuticals Fund and Supply Agency (PFSA) Document Title Pre-qualification evaluation & maintenance of suppliers’ list Document No SOP/PRO/A16 Revision 1 Effective on: 1. losses caused by poor packaging. A prequalification is the process of developing a list of registered suppliers based on past perfor- mance. Responsibilities Title Responsibility Operations D/ • Assign task force for preparation of criteria docu- DG ment • Approval of suppliers list & communicating to con- cerned departments Task force • Preparation of selection criteria and registration for- mats • Review of applications and associated documents • Preparation of draft list of suppliers 74 . Scope This SOP is applicable to all procurement processes carried out by the Procurement Directorate of PFSA. Hence it is a requirement for an efficient procurement process to closely monitor supplier perfor- mance and consider the relevant information during both prequalification and post qualification. 3.

5. Pharmaceuticals Fund and Supply Agency (PFSA) Procurement Procedure Doc No: P/PRO/A Rev No: 0 Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) 5. Communicate decision to suppliers Page 52 of 65 75 .Process Process map/Flowcharts map/Flowcharts Initiate pre-qualification assessment Prepare pre-qualification criteria & submission formats Review criteria & formats No Approved? Yes Invite suppliers & provide pre- qualification forms Receive pre-qualification applications & documents Review applications & prepare draft list of selected suppliers Verify correctness of selection process & list of suppliers No Approved? Yes Distribute approved list of suppliers to concerned Depts.

5.9.10. 6. 6. 6. The Secretary of the Evaluation Committee. a cross functional Evaluation Committee to prepare suppliers pre-qualification criteria document and registration/ap- plication formats. The composition of members of the committee includes representatives from Quality Assurance Unit. 6. If deemed not satisfactory.2.7. Procurement Directorate. The D/Director General reviews the pre-qualification criteria document and associated reg- istration formats.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) 6. The D/DG of Operations shall verify the transparency of the process.1. check for correctness of the report on sample basis. i.e. The Procurement Directorate avails the application formats/documents and submits to in- terested suppliers as requested. 6. 6. As approved. 6.4. The Di- rector General of the Agency assigns. and get it approved. Following the approval. Forecasting and Capacity Building Directorate. will set schedule and conduct the pre-qualification evaluation. the docu- ment will be sent back to the committee with comments for consideration. the office of the D/DG of Operations will officially circulate the list of approved suppliers to the concerned departments. whether they are registered in the approved suppliers list or not. the Procurement Directorate will ensure suppliers that have sub- mitted their expression of interest are communicated on their status. 76 . it will be sent back to the committee with the comment to be considered. The application documents together with the list of applicants and accompanied with official memo will be forwarded to the Evaluation Com- mittee Secretary. If not approved. in consultation with the Chair Person of the Committee. if it was not functional.11. and gets it approved. and submit together with the committee minutes to the D/DG of Operations for approval.6. The Evaluation Committee shall establish a draft document of approved suppliers list. The Procurement Director initiates and requests the Bid Evaluation and Endorsement Com- mittee to conduct the process for prequalification reqview of potential suppliers. 6. 6.3. The Procurement Directorate shall invite/announce on general public notice for submission of expression of interest to supply pharmaceuticals to be purchased in the budget year. Procedures 6. and regis- tration formats to be filled by applicant suppliers. The Procurement Directorate receives applications of expression of interest from potential suppliers including supportive documents.8. The committee shall prepare criteria document for pre-qualification of suppliers. 6. and Stock and Distribution Directorate.

the technical committee may customize or add different set of questions.1 Procurement systems using restricted tenders with pre-qualification should make continu- ous efforts to seek out potential new suppliers in order to maintain competitive pressure on established suppliers that had been pre-qualified previously. Supplemental Issues 7. 7.0. test purchases in small quan- tities and informal local information-gathering.1. Status • Is the supplier a primary manufacturer or a distributor? • If a manufacturer. as appropriate. references. does the supplier manufacture all products in-house? • If the supplier does not manufacture all products in-house. quality of drugs.2. etc. and the value of total purchases from the supplier by year and performance for each tender.0.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) 6.4 The Procurement Directorate shall maintain a cumulative file for each supplier that have copies of registration papers. complaints and other anecdotal supplier information. Any complaint from a supplier shall be handled in accordance with the complaint handling procedure. who is the primary manufacturer for each product offered? B.12. 6. 6. formal inspection. 7. Quality Control • Does the supplier use good manufacturing practices (GMPs)? • Does the supplier have an on-site quality control laboratory or arrangements with an immediately accessible laboratory? 77 . As part of prequalification the following list of questions can be used.3 The Procurement Directorate is expected to maintain continued good supplier performance through a formal monitoring system which tracks lead time. The information system should track chronologically the number and value of tender contracts awarded.0. partial shipments. As the questions are not exhaustive for the required purpose. 6. compliance with packaging and la- belling instructions.0. compliance with contract terms. remaining shelf-life.2 The process for evaluating new suppliers can include formal registration. special correspondence. reference checks with past clients and international agencies. Drug regulatory authorities may provide relevant information regarding new suppliers. Practical aspects to consider 6. A.

Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) • What tests-chemical. Trade references • What other local or foreign public procurement programs and hospitals buy from the supplier? • How long has the supplier served the above groups? • What is the experience of these customers with regard to the supplier’s quality and service? F. Personnel and facilities • What are the key qualifications of key production and quality control personnel? • What is the capacity of the supplier’s plant(s)? • Does the supplier have the capacity to supply all the required quantities? • Will the supplier have to subcontract portions of large awards? E. Financial status • Is the supplier financially stable? • Will the supplier remain in existence for the entire contract period? G. stability. accelerated stability. biological. Corporate associations • Is the supplier a subsidiary. Inspection • What official government agencies or reputable international organizations have inspected the manufacturing facilities? • What are the results of the most recent inspections? • What certification documents are available from the regulatory agency concerning the supplier’s status and compliance with GMPs? D. or in some other way formally as- sociated with any known supplier? If so. what is the reliability of the known supplier? • Is the supplier producing certain products under a supervised licensing agreement 78 . a parent company. or others-are rou- tinely performed during and after the manufacturing process? • Are special tests performed for stability in tropical environments? C.

Local reputation • How the supplier regarded by the knowledgeable physicians and pharmacists? • How are the products of the supplier regarded by knowledgeable physicians and pharmacists? • Is any information available from public sources (such as newspapers or trade jour- nals) concerning the supplier’s performance in other countries? 8. Amendment History Revision: Effective Date: Approved By: Reason 0 Initial release 79 .Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) with a known supplier? • How long has the supplier been supplying the goods under consideration? H.

Introduction Post contract appraisal includes observing the performance of the supplier to ensure that a qual- ity product. Post-contract appraisal is fundamental to contract and supplier relationship management – it allows the buyer and supplier to monitor compliance. Scope This SOP is applicable to all procurement processes carried out by the Procurement Directorate of PFSA. quality standards. 4. deliv- ery times. is delivered on time and within budget. Various requirements are built into the standard contracts and. quantify important performance attributes and measure change and improvement.g. and assess supplier performance and compare it with its peers. 2. milestone dates. in the right quantity. Control of performance ensures that the supplier’s performance is in accordance with the contract.). Purpose The purpose of this SOP is to define the processes to follow in post-contract appraisal of suppliers to be an input to the maintenance of the suppliers’ list database. inspections.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) Pharmaceuticals Fund and Supply Agency (PFSA) Document Title Suppliers Post-contract performance appraisal Document No SOP/PRO/A17 Revision 1 Effective on: 1. 3. etc. identify non-compliance and trigger correc- tive action. The latter is instrumental in evaluating the ongoing performance of the contract (e. the extent to which suppliers fulfil these requirements is used to measure the achievement of performance indicators. Responsibilities Title Responsibility Procurement Director • Approval of suppliers post contract assessment Procurement officer • Conduct post contract assessment of suppliers 80 .

The • Fulfilment of delivery schedule/timely delivery. • Adherence to warranty provisions.2 The assigned procurement officer(s) will prepare post-contract evaluation criteria. Pharmaceuticals Fund and Supply Agency (PFSA) Procurement Procedure Procurement Procedure Doc No: P/PRO/A Pharmaceuticals Rev No:(PFSA) Fund and Supply Agency 0 5. Procedures tract suppliers’ assessment. lowing topics can be addressed in evaluating the performance: 6. • Compliance with contractual terms and conditions. Procedures 5.1 The Procurement Director initiates and assigns procurement officers to conduct post- 5. The fol- contract suppliers’ assessment.2 The assigned procurement officer(s) will prepare post-contract evaluation criteria. • Adherence to warranty provisions. 6. 5. following topics can be addressed in evaluating the performance: • Fulfilment • Compliance of delivery schedule/timely with contractual delivery.1 The Procurement Director initiates and assigns procurement officers to conduct post-con- 6. terms and conditions. Process map/Flowcharts Process map/Flowcharts Initiate post-contract suppliers assessment Prepare post-contract evaluation criteria Review criteria & formats No Approved? Yes Assess performance of contract awarded suppliers Verify correctness of selection process & list of suppliers No Approved? Yes Update suppliers list database 6. Page 58 of 65 81 .

• Undertaking site visits. 5. etc. • Failure to disclose information relevant to performance (e. 5. customer social responsibility. etc.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) • Fulfilment of social and environmental requirements. and gets it approved. If not approved. • Sustainability performance exceeding minimum requirements. • Timely response to the PFSA’s requests.5 The Procurement Director verifies the completeness and correctness of the assessment report. • Measuring performance against service level agreements. which require a sound knowledge of what will be measured to ensure relevance of result. ongoing litiga- tion. • Using metrics and key performance indicators for contracts. Depending on the nature of the procurement.4 The assigned procurement officer(s) will carryout the assessment of the performance of contract awarded suppliers. and submit the report to the Procurement Director. it shall be sent back to the officer(s) with comment. • Quality of goods or services provided in accordance with the contract. it will be sent back to the committee with the comment to be considered. it will be approved and be used to update the list of suppliers’ database. bankruptcy. • Undue delay of the performance under the contract. Amendment History Revision: Effective Date: Approved By: Reason 0 Initial release 82 . • Developing and using supplier scorecards to measure cost of poor quality.6 If the assessment report is found to be incomplete or incorrect.g.3 The Procurement Director reviews the assesntsme criteria and associated formats. the process to evaluate supplier performance could consider the following approaches: • Using questionnaires. 7. If the report is accepted. 5.) 5.

• Ensuring establishment of a records control tor system for procurement processes Procurement officer • Timely filing of procurement documents Procurement Direc. • Classification. Introduction The Procurement and Property Administration Proclamation requires records and documents regarding their public procurement to be maintained from the date of concluding any procure- ment proceeding. A standard filing system.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) Pharmaceuticals Fund and Supply Agency (PFSA) Document Title Documentation of the procurement process Document No SOP/PRO/A18 Revision 1 Effective on: 1. as well as a numbering system to enable tracking of files is a necessity to create an audit trail and to facilitate management of procurement activities. 3. 4. Responsibilities Title Responsibility Procurement Direc. 2. Purpose The purpose of this SOP is to define the activities required for establishing and maintaining record control system of the procurement processes. titling and indexing of records/ tor Secretary files 83 . Scope This SOP is applicable to all procurement processes carried out by the Procurement Directorate of PFSA.

1 Typically.1 Typically. Pharmaceuticals Fund and Supply Agency (PFSA) Procurement Procedure Procurement Procedure Pharmaceuticals Fund and Supply Agency Doc No: P/PRO/A Rev No:(PFSA) 0 5.2 Incoming and outgoing documents/ records shall be registered on documents registration logbook. 6. 6. 5. documentation. be registered on documents registration and completeness. Procedures 5.4 If there is no previous file. the Procurement Director Secretary shall create a new file. when applicable: in original form and appropriately signed.1 Receivingand outgoing records shalldocuments/ records be checked for shall cleanness legibility.6 Attachdocuments/record to the documents/record to thedesignated designatedfile. file. 5.Process Process map/Flowcharts map/Flowcharts Receive documents/ records Registration Yes Previous file exist? No Classify & title the documents/ records Allocate file number Attach document/ record to file 6. 6. 6. logbook. 7.5 File number will be assigned and registered in the documents/records master list.1 Receiving records shall be checked for legibility.3 Check availability of previous file for the record against the records index list.indexing titling and the Procurement Director Secretary shall create a new to the record.5 File number will be assigned and registered in the documents/records master list. Allo- 6.3 Check availability of previous file for the record against the records index list.Allocate classification. when applicable: • Requisition 84 Page 61 of 65 . in original form and appropriately signed.4 cate If there is no previous classification.6 Attach 6. 7. procurement files will include the following relevant information/ documentation. file.2 Incoming 6. cleanness and completeness. Procedures 5. titling and indexing to the record. 5.Supplimentary Supplimentary issues issues 7. procurement files will include the following relevant information/ 6. file. 5. 5.

Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) • Requisition • Requirement definition (notes.) • Sourcing information including justification of procurement method and type of com- petition • Signed short list • Signed bid document. or submission to contracts and property committee • Original contract/purchase order (PO) • Copies of any advance payment guarantee or performance security received from the vendor • Bid complaints • Correspondence with contractor regarding the procurement process and manage- ment of the contract • Notes from meetings. financial. compliant and non-compliant) • Copies of any bid security received from the vendor • Evaluation report • Minutes of clarifications (if any) and relevant communication with vendor • Request for award. justification if brand name is used etc. copies of emails. • Amendments to contracts/POs • Documented decision regarding claims. phone calls etc. fax receipts. including attachments such as specifications (copies of cover letters. etc. communication with requisitioner. variations and amendments for works • Copies of insurance certificates and guarantees required for works as provided for in the contract • Any required progress reports and/or other proof of delivery of milestones as pro- 85 . correspondence. and any other clarifications and correspondence with suppliers • Bid opening report • All offers received (technical.) • Amendments to bid documents.

3.1 All documents/records shall be filed and stored in an office environment unless spe- cific media and/or special environmental control are specified to prevent damage.1 Procurement records will be retained for ten years or more.3. de- terioration.2 All records shall be physically or electronically filed by a method which enhances ac- cessibility and retrieval by a user.2.2.2 Records retention 6. If electronic files are used a back-up system or other suitable measures shall be used to prevent record loss. 8. 6. 6. 6.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) vided for in the contract • Proof of receipt of goods • Receipt and inspection report • Acceptance report from requisitioner/end user • Insurance claims • Proof of payment • Supplier performance evaluation form. if they are required to preserve knowledge 6. Amendment History Revision: Effective Date: Approved By: Reason 0 Initial release 86 .2 If procurement records are available in an electronic media the backups shall be prop- erly labelled and retained. or loss and allow access control.3 Storage of files 6.

Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) Annex 1: List of Forms Form No Form Title F/PRO/001 Budget analysis format F/PRO/002 Procurement plan format F/PRO/003 Bid document template F/PRO/004 Bid notice template F/PRO/005 Bid document selling form F/PRO/006 Bid query registration form F/PRO/007 Bid offer submission registration form F/PRO/008 Meeting attendance registry form F/PRO/009 Bid offer documents handover form F/PRO/010 Bid bonds handover form F/PRO/011 Bid offer preliminary screening form F/PRO/012 Bid offer technical evaluation form F/PRO/013 Price schedule evaluation evaluation form F/PRO/014 TEC minutes of meeting form F/PRO/015 Decision proposal form F/PRO/016 Award notification form F/PRO/017 Complaint registration form F/PRO/018 Purchase order form F/PRO/019 Standard contract form 87 .

N List of participant Organization 1 Abyot Adane PFSA 2 Bayew Liknaw PFSA 3 Bekele Ashagrie PFSA 4 Berhanu Bekele PFSA 5 Fozia Mohammed PFSA 6 G/Selassie G/Yohannes PFSA 7 Meseret Adugna PFSA 8 Mesfin T/Haimanot Adroit Consultancy & Training Ser.Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA) Annex 2: List of workshop participants for reviewing the draft Procedure S. 9 Seid Ali PFSA 10 Seifu Moges PFSA 11 Tibebu Hailu PFSA 12 Wondimu Haile PFSA 13 Yared Debebe Adroit Consultancy & Training Ser. 14 Yared Yigezu PFSA 88 .