Procure SOP - Compressed

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
PART THREE: STANDARD OPERATING PROCEDURES............................................................................................. 13
Procurement budget preparation & approval................................................................................................................. 13
Preparation of Bid Document......................................................................................................................................... 18
Bid Advertisement. ..............................................................................................................................................................1
Bid document issuing/selling..............................................................................................................................................4
Bid clarification. .................................................................................................................................................................7
Bid offer receiving............................................................................................................................................................ 11
Bid opening....................................................................................................................................................................... 15
Bid offer analysis............................................................................................................................................................. 19
Bid offer analysis approval.............................................................................................................................................. 23
Awarding.......................................................................................................................................................................... 28
Complaint handling.......................................................................................................................................................... 31
Purchase order processing.............................................................................................................................................. 35
Contract signing.............................................................................................................................................................. 39
Special Import Permit....................................................................................................................................................... 42
Preparation of Technical Specifications for Pharmaceuticals....................................................................................... 44
Pharmaceuticals Fund and Supply Agency (PFSA)......................................................................................................... 51
Pre-qualification evaluation & maintenance of suppliers’ list. ...................................................................................... 51
Suppliers Post-contract performance appraisal............................................................................................................. 57
Documentation of the procurement process.................................................................................................................. 60
ANNEX 1: LIST OF FORMS............................................................................................................................................... 64
ANNEX 2: LIST OF WORKSHOP PARTICIPANTS FOR REVIEWING THE DRAFT PROCEDURE........................... 65
II
Forward
From pharmaceutical supply chain perspective, procurement is a structured procedure designed to
consult the market for the purchase of Pharmaceuticals and services. A procurement procedure leads
to the conclusion of a public contract. The purpose of a procurement procedure is threefold: To guaran-
tee the widest possible participation of economic operators; to ensure the transparency of operations;
and to obtain the desired quality of pharmaceuticals and services at the best possible price.
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. As part of this effort, 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.
This manual contains eighteen procurement procedure SOPs that document regularly recurring work
processes in pharmaceuticals procurement. The SOP will promote access to quality assured pharma-
ceuticals through consistent implementation of processes and procedures. The SOP can be used as
reference material for professionals working on sourcing of pharmaceuticals in the public sector. The
implementation of the SOP needs to be re-enforced by management at all levels and it should be re-
viewed regularly.
I would like to take this opportunity to thank all who participated in the development of this SOP. 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), P. O. Box 21904, Addis Ababa, Ethiopia)
Meskele Lera
Director General, Pharmaceuticals Fund and Supply Agency (PFSA)
III
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. 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. The following persons have contributed starting from idea generation to the
development this document and their advice and support are gratefully acknowledged. Mr. Yemane-
berhan Taddesse (Deputy Director General, PFSA), Mr. Yared Yiegezu Zegiorgis (Director of Forecasting
& Capacity Building Directorate, PFSA), Mr. Bekele Ashagire Yeshanew (Director of Pharmaceuticals &
Medical supplies Procurement Directorate, PFSA) Mesfin Teklehaimanot and Yared Debebe from Adroit
Consultancy and Training Service PLC. Furthermore, 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.
Recommended citation
Pharmaceuticals Fund and Supply Agency (PFSA). Standard Operating Procedure (SOP) for Pharmaceu-
ticals Procurement. October 2015, Addis Ababa, Ethiopia
IV
Procurement Procedure Pharmaceuticals Fund and Supply Agency (PFSA)
Part One: General

1 Background
Procurement is an important step for efficient drug management and supply, and has become a
routine procedure in the existing drug management system in many countries. An effective pro-
curement process ensures the availability of the right drugs in the right quantities, at reasonable
prices, and at recognizable standards of quality. Problems can often be encountered if procure-
ment is carried out without such a systematic process, for instance the needed medicines are out
of stock, overstocks and wastage of resources, and purchase of low quality products.
Adequately forecasting, financing, procuring, and delivering health commodities—the four pillars
of a logistics system—are prerequisites to achieving commodity security. Procurement is a vital
step in that system and a vital function in supply chain management, which is the array of pro-
cesses that link manufacturers, even producers of raw materials, all the way to end users of their
products.
The procurement process begins with selection and forecasting and quantification of product
requirements. It includes the development of exacting product specifications, identification of
financing, and a budget process to secure that financing.
2 Purpose
2.1 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 the Public Procurement
Directive, and is meant to promote effective and efficient performance of the procurement
process of the Agency.
2.2 This SOP manual defines and describes the functional relationships and internal controls
that promote efficiency, transparency and accountability in the procurement process of the
Agency.
3 Scope
3.1 This SOP manual is applicable to all procurements of pharmaceuticals executed using the
Agency budget or funds granted from various partner organizations.
3.2 This SOP manual covers:
• The generic and specific steps in procurement of pharmaceuticals;
• Procurement planning and its linkage to budgeting process and implementation;
1
• Administration of the complete procurement cycle up signing of contract with awardee;

and
• Supplier performance measurement.
4 Process owner
The responsibility for control of the implementation of this SOP will be that of the Procurement
Director.
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.
5 Reference
• FDRE Proclamation to provide for the establishment of the Drug Fund and Pharmaceutical
Supply Agency- No 553/2007;
• FDRE Proclamation on Procurement and Property Administration Proclamation Agency- No

649/2009;
• Federal Public Procurement Directive, MoFED June 2010.
• FDRE Proclamation on Food, Medicine & Health Care Administration and Control - No
661/2009;
• 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. Additional measures can be used as deemed relevant.
• Difference between scheduled and actual time taken to complete each cycle of procure-
ment;
• Ratio of cancelled/rebid procurements.
7 Definitions & Abbreviations
7.1 Definitions
• Pharmaceuticals - any substance or mixture of substances used in the diagnosis, treat-

ment, mitigation or prevention of a disease, and includes medical instruments and medical
supplies;
2
• Medical supplies - any Article that may be used on the inner or outer part of the human
body for diagnosis or treatment of disease, and includes suturing materials, syringes, nee-
dles, bandages, gauze, cotton and similar products, chemicals and x’-ray films;
• Medical instrument - any instrument that may be used on the inner or other part of the
human body for diagnosis or treatment of a disease, and includes various diagnostic, labo-
ratory, surgery and dental instruments.
• Agency - the Pharmaceuticals Fund and Supply Agency (PFSA).
• Technical Specification - document describing the quality, type and standard with which
the required pharmaceuticals should comply.
• Supplier - any potential legal entity or commercial firm provider of pharmacuticals to the
Agency.
7.2 Abbreviations
• DG – Director General
• EDL - Essential Drug List
• EOI – Expression of Interest
• FCB – Forecasting and Capacity Building
• FMHACA – Food, 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 - Pharmaceuticals Fund and Supply Agency
• PO – Purchase Order
• RFI - Request for Information
• SOP – Standard Opearting Procedure
• TEC– Tender Endorsement Committee
3
8 Mandates, Duties and Responsibilities
8.1 Mandates of the Agency
The Pharmaceuticals Fund and Supply Agency (PFSA), established by the Drug Fund and Phar-
maceuticals Supply Agency Establishment Proclamation No 553/2007, 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;
• to play a complementary role in developmental efforts for health service expansion and
strengthening by ensuring enhanced and sustainable supply of pharmaceuticals;
• 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.
PFSA also is mandated with the powers and duties, inter-alia, to:
• establish and implement efficient and effective procurement and distribution systems to
deliver, by using the Drug Fund and focusing on the country's major health problems, qual-
ity assured pharmaceuticals at affordable prices sustainably to public health institutions;
• provide adequate and proper pharmaceutical storage facilities to ensure uninterrupted

supply through establishment of a modern storage management system;
• expand and strengthen storage and distribution outlets based on equity and effectiveness;
• supply essential pharmaceutical of quality, safety and efficacy approved by the appropriate
body to all public health institutions; where appropriate and in accordance with directives
of the Board, supply to private and non-governmental health institutions selected pharma-
ceuticals which are not adequately available;
• deliver pharmaceutical directly to districts, hospitals and selected health centers through
establishing an effective transport network system; establish a logistics management infor-
mation system compatible with the overall pharmaceuticals logistics system;
• Prepare and implement short, medium and long-term plan for procurement, storage and
distribution, and monitor its implementation.
4
8.2 Duties and Responsibilities
8.2.1 Director General
The Director General of PFSA has the following duties and responsibilities as stipulated in the procure-
ment and property administration proclamation, 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;
• Ensure that the procurement staff and head of the procurement unit meet
high ethical standards;
• 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;
• Establish a Procurement Endorsing Committee to approve procurements of high value in

PFSA, 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, who are in high position of responsibility in PFSA,
b) Need to have a better knowledge and experience and as far as possible should com-
prise from various professions.
• Where appropriate, extend the service of members of the Procurement Endorsing Commit-
tee for one additional term.
• Ensure that members of the Procurement Endorsing Committee have adequate time and
office facility necessary to carry out their duty.
• Ensure that the service, employees of the PFSA perform as members of the Procurement
Endorsing Committee, is part of their regular duty and is as such, incorporated into their
work program and their performance in the committee accounts for their overall result.
• Make sure that the procurement staff, head of the procurement unit and members of the
Procurement Endorsing Committee have in their possession, copies of the procurement
and property administration Proclamation, and the Directive, the Standard Bidding Docu-
ment and other necessary documents, and make training available to them in ordered to
enable them acquire adequate knowledge of the public procurement system.
• 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, and where necessary, take
corrective measures.
5
• Establish ad hoc evaluation committee for procurements which are complex and require
detailed technical evaluation.
• Examine and approve the procurement plan of PFSA by ascertaining that the following re-
quirements are satisfied:-
a) That, the procurement plan is in harmony with the Agency’s work program.
b) That, items of procurement which can be consolidated in to a single procurement

package are consolidated as such.
c) That, 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.
d) That the procurement plan is inclusive of all procurement needs of the PFSA and has
secured the consent of the Procurement Endorsing Committee.
• Cause to be communicated in due time to the body responsible for framework procure-
ments, complete information on procurements of PFSA which can be executed in consolida-
tion with procurements of other Public Bodies under a framework 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.
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.
• 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.
• 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.
• Sign a contract or delegate authority to sign a contract where necessary, and monitor the
execution of any procurement as per the contract.
• Authorize the outsourcing of a procurement by reason of its complexity or for lack of capac-
ity of PFSA to handle that procurement, inconformity with the following procedures:-
6
a) Ensure that the outsourced procurement service is rendered in compliance with the
provisions of the Proclamation and Procurement Directive.
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.
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.
• Make arrangements necessary for procurement audit or inspection to be conducted by the

Agency in respect of the execution of procurements by PFSA, including the following:-
a) Make available in due time, documents necessary for procurement audit,
b) Cause the provision of office space and facilities for employees assigned to conduct
the procurement audit.
c) Assign a staff to give explanation on the conduct of procurements made by PFSA.
• 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,
• Cause information to be conveyed to the concerned tax authority regarding payments made
to suppliers in connection with procurements executed by PFSA.
8.2.2 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 Reviewing budget and specification of items in purchase requests;
o Selecting procurement method;
o Preparing budget proposal and procurement plan;
o Receiving correspondences/instructions from the Director General & ODDG;
o Preparing and submiting bidding documents to the Procurement Endorsing Com-

mittee;
7
o Making corrections to the bidding documents in conformity with the recommen-

dation of the Procurement Endorsing Committee;
o Issuing endorsed bid documents to interested suppliers;
o Keeping procurement documents and giving clarifications on procurements of

the Agency when requested by the appropriate bodies;
o Preparing and managing bid box;
o Facilitating the evaluation/ screening of technical and financial proposals;
o Disclosing result of a Bid evaluation to the successful and unsuccessful bidders;
o Receiving, reviewing, implementing corrective actions and closing complaints on

procurement processes including evaluation and award of tenders;
o Preparation of purchase orders;
o Securing purchase order approvals from regulatory bodies;
o Drafting contractual agreements and get signed by selected bidder;
o Handling bank, insurance, customs and other related processes;
o Ensuring complienace with the national public procurement proclamation and

regulations;
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 Developing the capacity and competency of procurement personnel to enable

them efficiently carry out their duties and responsibilities;
o Developing good working relationship with suppliers, funding agencies, regula-

tory bodies and all departments in the agency;
o Build the capacity of suppliers on tender requirements.
8.2.3 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;
8
b) that there is no other alternative to procurement to satisfy each need;
c) that the procurement plan is prepared in such away as to enable bulk purchase;
d) That other special requirements arising from the nature of the Agency are adressed.
• Ensure legal adherence of each procurement package;
• 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;
b) That the evaluation criteria are non-discriminatory, transparent and achievable;
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.
• Reviewing and approve Bid evaluation reports of procurements reported by Procurement

Directorate for each type of procurement, 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, and the Agencies Directives and SOPs;
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.
• Ensuring any decision given by the Tender Evaluation Committee on evaluation report sub-
mitted to is reasonable;
• Advising the Director Geenral of the Agency on ways of ensuring compliance with the Proc-
lamation, the Directive and other legal documents regulating the conduct of public procure-
ment;
• Submit to the Director Geenral of the Agency reports on procurements made, problems
encountered and solutions suggested;
• 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.
9
8.2.4 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,
together with minutes of the tender opening, the results of the preliminary evaluation, and
a recommendation to award the tender.
10
Part Two: Procurement Objectives and Principles
9 Strategic objectives for good pharmaceutical procurement
9.1 General
The following four strategic objectives are relevant to any pharmaceutical procurement:
i. Procure the most cost-effective drugs in the right quantities
ii. Select reliable suppliers of high-quality products
iii. Ensure timely delivery
iv. Achieve the lowest possible total cost.
9.2 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. 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.
9.3 Select reliable suppliers of high-quality products
Reliable suppliers of quality products must be pre-selected, and that active quality assurance
programmes involving both surveillance and testing must be implemented.
9.4 Ensure timely delivery
Procurement systems must ensure timely delivery of appropriate quantities to central or re-
gional stores.
9.5 Achieve the lowest possible total cost
Procurement and distribution systems must achieve the lowest possible total cost, con-
sidering four main components:
o the actual purchase price of drugs;
o hidden costs due to poor product quality, poor supplier performance or short shelf-life;
o inventory holding costs at various levels of the supply system; and
o Operating costs and capital loss by management and administration of the procurement.
11
10 Procurement Principles
10.1 PFSA shall acquire pharmaceuticals including medical supplies at optimum by taking into
account the acquisition price, payment terms, product or service quality, availability, and
supplier support.
10.2 The suppliers with acceptable performance track record shall be given equal opportunity to
bid for supply of medical products and services.
10.3 The highest ethical and professional standards should always be observed in establishing a
mutually beneficial relationship with suppliers and customers.
10.4 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, and Fed-
eral Public Procurement Directive, or this SOP Manual.
10.5 There shall be a continuous improvement of procurement processes to ensure that the
processes are simple, efficient and cost effective.
10.6 Procurement shall be planned to enable prudent management of budgets and value opti-
mization.
10.7 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.
10.8 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.
12
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. Introduction
The procurement process begins with determining which products to order, estimating needs,
quantifying purchases, and ensuring that financing is available.
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.
2. 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.
3. Scope
This SOP is applicable to all procurement forecasts and budgets prepared at the PFSA
head office.
4. 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
Procurement Procedure Doc No: P/PRO/A Rev No: 0

5. Process map/Flowcharts
Procurement Procurement Procurement Pro request

request from requestfrom requestfrom from Int.
FCB MoH hospitals & asso. 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. complete &
correct? body forclarification
Yes
Estimate unit price for each line

item
Page 14 of 65
14
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. Procedures
6.1. The procurement directorate may receive procurement request from the Forecasting and
Capacity Building Directorate, or the Federal Ministry of Health or Hospitals, Health Centers,
Associations, or International/National partner organizations engaged in public health pro-
motion activities.
6.2. The procurement director receives the request, get it registereed, and forward to the rel-
evant team which is responsible to assign a procurement officer in charge.
6.3. The procurement officer in charge shall check the procurement request validity against ac-
ceptable essential documents like Essential Drug List (EDL).
6.4. The procurement officer in charge shall check the procurement request to ensure com-
pleteness and correctness of the documents.
6.5. The procurement officer will also check the financial package, i.e. who finances the procure-
ment and availability of fund for the purpose.
6.6. If the procurement request document is not complete or correct, the officer will communi-
cate the requesting body for clarification or adjustment. The communication will be done in
writing and be signed the procurement director.
6.7. If the procurement request document is found to be complete and correct, the officer(s) in
charge will estimate the unit price for each line item.
6.8. Taking into consideration the amont, level of urgency and other factors, the officer will pro-
pose a procurement method.
6.9. Following the unit price assignment, the officer will prepare a budget analysis proposal, and
procurement plan.
6.10. The budget analysis proposal and procurement plan will be checked by Procurement Coor-
dinator, and verified by the procurement director.
6.11. If the proposal and plan are found not acceptable, they will be returned with remark to the
officer for correction.
6.12. If the proposal and plan are accepted by the procurement director, they will be sent to the
Operation Deputy Director General of (ODDG) for approval accompanied by a memo.
6.13. The ODDG will approve the proposal and plan and forward it to the Director General (DG)
for ratification.
16
6.14. If the proposal and/or plan is not approved or ratified by the responsible authorities, it will
be sent back the procurement directorate with remark for correction, amendment or other
recommended action.
6.15. If the proposal and/or plan is approved and ratified, the documents will be signed by the
responsible authorities and be sent back to the procurement directorate accompanied with
‘no objection’ letter.
7. Forms
Form No Form Title

F/PRO/01 Budget analysis format
F/PRO/02 Procurement plan format
8. Amendment History
Revision: Effective Date: Approved By: Reason

0 Initial release
17

Document Title Preparation of Bid Document
1. Introduction
Competitive bidding is a mandatory requirement to comply with the FDRE Procurement and
Property Administration Proclamation associated and Guidelines.
2. 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.
3. Scope
This SOP is applicable to all procurement tenders prepared at the PFSA head office.
4. Responsibilities
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
Procurement Procedure
Procurement Procedure Doc No: P/PRO/A
Pharmaceuticals Rev No:(PFSA)
Fund and Supply Agency 0
5. 5.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
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
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
7. Forms
Form No Form Title

F/PRO/03 Bid document template

0 Initial release
22

Document Title Bid Advertisement
1. 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. It is also used for formal methods of solicitation and limited competition, either the
dissemination of upcoming solicitation information through a request for information
(RFI), a request for expression of interest (EOI), or notice of pre-qualification in appropri-
ate media.
2. Purpose
The purpose of this SOP is to assist PFSA procurement officers and mangers in carrying
out tender advertisement activities for procurement of pharmaceuticals.
3. Scope
This SOP is applicable to all ICB procurement tenders advertised at the PFSA head office.
4. Responsibilities
Procurement officer Drafting tender notice & follow up correctness of
publication
Procurement Procure- Verify content of tender notices, determine date for
ment Coordinator publication of notices
Procurement director Authorization of correspondences with external
bodies
Finance department Settlement of service fee
23
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. Procedures
6.1. The procurement officer shall fill the ‘invitation to bid’ document.
6. Procedures
6.1. The
6.2. The procurement
concerned officer shall
Procurement fill the ‘invitation
Coordinator, gettingto bid’document.
approval from the procurement director,
6.2. requests the Ethiopian
The concerned Press Coordinator,
Procurement Agency for quotation to put the
getting approval fromtender notice in the
the procurement official
director,
newspaper(s).
requests the Ethiopian Press Agency for quotation to put the tender notice in the official
newspaper(s).
6.3. Receiving the quotation from the Press Agency, the Procurement Coordinator shall com-
6.3. municate
Receivingthethe
Finance Department
quotation to settle
from the Press payment
Agency, for
thepublication
Procurementof the tender notice.
Coordinator shall
communicate
6.4. The ProcurementtheCoordinator
Finance Department to settle the
shall communicate payment for publication
IT Department to postofthe
theinvitation
tender
tonotice.
bid notice on the agency’s website.
6.4. The Procurement Coordinator shall communicate the IT Department to post the invitation
6.5. 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.
published is complete and accurate.
6.5. The procurement officer in charge will follow up the publication of the invitation to bid
6.6. In case the publication is found to be incomplete or in accurate, the officer will inform the
notice and ensure
Procurement the information
Coordinator, published
and request is complete
the press agencyand
to accurate.
publish corrigendum or take
6.6. other
In case the publication is found to be incomplete or in accurate, the officer will inform
action.
the Procurement Coordinator, and request the press agency to publish corrigendum or
take other action.
24 Page 2 of 65
7. Forms
Form No Form Title

F/PRO/04 Invitation to bid

0 Initial release
25

Document Title Bid document issuing/selling
1. 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.
The directive describes the procuring organization to fix the selling price of bidding documents, or
may allow candidates to obtain bidding documents free of charge, or at a price less than the cost
incurred in the preparation of such document.
2. Purpose
The purpose of this SOP is to define the process steps to be followed in issuing bid documents
during the floating period.
3. Scope
This SOP is applicable to issuance of bids.
4. Responsibilities
Procurement director- Selling/Issue bid document
ate secretary
Procurement officer Provide enough copies of bid documents for issu-
ance
26
Receive request for

collection of bid document
Check name, 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, if
required)
6. Procedures
6.1.
6. Suppliers interested to participate in the bid will forward their request to the secretary of
Procedures
the procurement directorate.
6.1. Suppliers interested to participate in the bid will forward their request to the secretary of
the procurement
6.2. The procurementdirectorate.
directorate secretary will check the name of the company on the re-
6.2. newed trade license,directorate
The procurement and ID card of the delegated
secretary personnel
will check to collect
the name of the the bid document.
company on the
renewed trade
6.3. Confirming license, supplier
the potential and ID has
carda valid
of the delegated
trade personnel
license, the to shall
secretary collect the bid
complete the
document.
bid selling form and forward to finance department for collection of bid document selling
6.3. fee.
Confirming the potential supplier has a valid trade license, the secretary shall complete
the secretary,
6.4. The bid sellingafter
formregistering
and forward to financereceipt
the payment department foron
number collection of form,
the selling bid document
shall issue
the bid document.
selling fee. If required, the secretary may issue the bid document together with the
letter of invitation.
6.4. The secretary, after registering the payment receipt number on the selling form, shall
issue the bid document. If required, the secretary may issue the bid document together
with the letter of invitation.
Page 5 of 65
27
7. Forms
Form No Form Title

F/PRO/05 Bid document selling form

0 Initial release
28

Document Title Bid clarification
1. Introduction
Suppliers are entitled to request and obtain clarification on floating bids before the of bid clarifica-
tion deadline. The objective of the clarification is to clarify to suppliers any ambiguity or contradic-
tory or anomalies found in the bid document.
2. 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.
3. Scope
This SOP is applicable to query, clarification or amendment of bid document for all types of com-
petitive bidding and restricted bidding carried out at the PFSA head office.
4. Responsibilities
Procurement directorate Receiving queries and clarifications
secretary
Procurement officer Respond to queries and clarifications
Procurement Procure- Check amendments
ment Coordinator
Procurement Director Approve/authorize amendments
29
Procurement
Procedure Doc No: P/PRO/A
5. 5.Process
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
6. Procedures
6.1. The procurement directorate secretary will receive queries or clarifications requests from
suppliers that have bought the bid document. Queries from suppliers must be handled
through written correspondence.
6.2. The secretary shall register the request and forward it to procurement director and to the
Procurement Coordinator and/or procurement officer in charge accoredingly.
6.3. The procurement officer shall review the query or clarification request.
6.4. If the request is not a valid one, the officer shall inform the requesting body non acceptance
of the request.
6.5. If the request is valid and is found to be requiring an amendment, the procurement officer
shall draft the amendment document.
6.6. The Procurement Coordinator shall check the draft amendment, and get verified/ autho-
rized by the procurement director.
6.7. If the request is valid but does not require amendment, the procurement officer shall pre-
pare clarification notice.
6.8. 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, as
appropirate.
7. Supplementary issues
7.1. 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. The procurement
officer with the authorization of the Procurement Coordinator and the procurement direc-
tor will prepare and dispatch written replies to such queries, and make all replies known,
together with the text of the queries, to all suppliers at the same time, without referencing
the source of the queries.
7.2. At any time before the deadline for submission of offers, the agency may, for any reason,
whether on its own initiative or following a request for clarification by a supplier, modify the
bid documents.
7.3. 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.
In certain cases, amendments may justify an extension of the submission deadline. This
should be assessed on a case by case basis.
31
7.4. In order to ensure that all suppliers have the same details, amendments of bid documents
must:
a. In the case of a limited competition, be sent simultaneously in writing to all invited sup-
pliers;
b. In the case of an open competition, a letter will be prepared and be uploaded to the
agency’s website.
7.5. Substantial changes to the requirements may make re-tendering necessary.
8. Forms
Form No Form Title

F/PRO/06 Bid query registration form

0 Initial release
32

Document Title Bid offer receiving
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.
2. Purpose
The purpose of this SOP is to define the process steps to be followed in receiving quotations.
3. Scope
This SOP is applicable to for all types of bidding carried out at the PFSA head office.
4. Responsibilities
Procurement director- Registration of suppliers with bid submission offers
ate secretary
Procurement officer Availing of bid box, receipt of large size bid submis-
sion packages
Procurement Procure- Signing and sealing of the bid box, and it closure at
ment Coordinator submission deadline
33
Procurement
5. 5.Process
map/Flowcharts
Prepare an empty tender

submission box
Write the bid title, number, 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, 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
6. Procedures
6.1. 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.
6.2. The procurement officer ensures the bid title, number, closing and opening dates of the bid
are posted on the bid submission box, and also make sure the box is locked and sealed with
a signature of the Procurement Director.
6.3. The procurement officer ensures the bid submission box is placed in visible and secured
location.
6.4. During submission of bid offers, the procurement directorate secretary shall check if the
envelopes are sealed, bid title, bid number and supplier’s name is written on the envelope. If
the bid offers are submitted via post office, the secretary will sign the archieve’s acceptance
note.
6.5. The secretary also checks the bid documents issuance register to confirm the supplier has
bought a bid document.
6.6. The secretary ensures that suppliers that have submitted offers shall register their company
name, contact person and other information as stipulated in the bid receipt form. For sup-
pliers whose name is not registered in the bid issuance record, the secretary shall put a
special remark in the record.
6.7. If samples are presented as part of the bid offer, the procurement officer will receive the
samples and provide/sign a confirmation note to the supplier for the receipt of the sample.
6.8. The procurement officer ensures the samples are stored in safe and conditioned environ-
ment until forwarded for visual examination or lab analysis.
6.9. The Procurement Coordinator will make sure the bid submission package is inserted in the
bid box. For sizes larger than the slot of the bid box, the packages can be submitted directly
to the procurement officer in charge.
6.10. Exactly at the deadline of bid submission, the Procurement Coordinator or his delegate will
close the bod box and strike the remaining rows of the bid submission registration record.
The Procurement Coordinator also signs and put the date and time the bid was closed on
the registration record.
35
7. Forms
Form No Form Title

F/PRO/07 Bid offer submission registration form

0 Initial release
36

Document Title Bid opening
1. 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.
2. Purpose
The purpose of this SOP is to define the process steps to be followed and responsibilities to open
bid offers.
3. Scope
4. Responsibilities
Procurement directorate sec- Maintaining of bid bonds securely
retary
Tender Evaluation Committee Opening bid offers, signing bid offer documents, an-
(TEC) nouncing bid offer prices and other information to
participating bidders
TEC secretary Calling TEC meeting, taking minutes, handover of bid
offer documents and bid bonds, maintain records of
the proceedings
Procurement Coordinator Submit bid offer submission box, communicate TET
secretary schedules of bid offer openings
37
5. 5.Process
map/Flowcharts
Call the scheduled meeting

of Tender Eval. 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. secretary
tender reading modality
The chair person reads name of

suppliers, items participated, 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, if any
38
Page 16 of 65
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
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

0 Initial release
40

Document Title Bid offer analysis
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
4. Responsibilities
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
Procurement
5. 5.Process
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, technical & financial eval.
Submit analysis report to

Tender evaluation committee
42 Page 20 of 65
6. Procedures
6.1. The procurement officer in charge shall organize original copies of the bid offer documents
for posting.
6.2. The procurement officer extracts a preliminary screening and technical evaluation formats
based on the general and technical requirements on the bid document.
6.3. The Procurement Coordinator in charge shall check and approve the formats for posting of
bid offer data.
6.4. The procurement officer will post bid offer data of each supplier in the preliminary technical
and financial evaluation formats.
6.5. In order to avoid spending resources on the evaluation of invalid offers, the procurement
officer shall review whether each supplier complies with the preliminary requirements stat-
ed in the bid document or not.
6.6. In case a supplier doesn’t comply with the general requirements for preliminary screening,
the noncomplying parameter will be highlighted with red color, and NC note will be put in
the remark column.
6.7. 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.
6.8. In case an offered item doesn’t comply with the technical requirements stated in the bid
document, the noncomplying parameter will be highlighted with red color, and NC note will
be put in the remark column.
6.9. The procurement officer shall post bid offer prices in the price schedule format.
6.10. The procurement officer shall prepare a summary report on the interim results of prelimi-
nary screening and technical evaluation. The report will also include number of suppliers
participated, how many items got suppliers, the preliminary screening and technical evalu-
ation criteria used, etc.
6.11. The Procurement Coordinator in charge shall verify the report and forward it to the Tender
Evaluation Committee for consideration.
43
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

0 Initial release
44

Document Title Bid offer analysis approval
1. 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. The aim is to deter-
mine the offer that best fits the evaluation criteria, and thus represents best value for the Agency.
An objective, fair and well-executed evaluation process is critical as it results in a recommendation
and a request for award of contract.
2. Purpose
for approval of bid offers.
3. Scope
4. Responsibilities
Deputy Director General Receive decision report of TET and write a no objec-
of Operations (ODDG) tion letter.
Tender Evaluation Com- 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, and meeting minute
45
Procurement
5. 5.Process
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
46
Page 24 of 65
Procurement Procedure Pharmaceuticals Fund
Pharmaceuticals Fundand
andSupply
SupplyAgency
Agency(PFSA)
(PFSA)
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
6. Procedures
6.1. The procurement officer submits the bid offer analysis report to the Tender evaluation com-
mittee.
6.2. The tender evaluation committee chair person shall convene the committee meeting as
prescheduled.
6.3. The procurement officer in charge or the Procurement Coordinator, as appropriate, will
present the bid analysis report to the tender evaluation committee.
6.4. The tender evaluation committee checks correctness of the posting and report. If the post-
ing or report is found to be not correct or inconsistent, it will be returned to the officer for
correction or rework.
6.5. The tender evaluation committee shall review the preliminary screening and technical anal-
ysis report against the requirements in the bid documents, procurement directives of PFSA
and government regulations.
6.6. Following the review, the tender evaluation committee shall communicate the procurement
officer the list of qualified suppliers for financial analysis.
6.7. The procurement officer shall conduct analysis of financial offers of suppliers in comparison
with budget & current market price, and present to the tender evaluation committee.
6.8. The tender evaluation committee shall review the financial analysis report in comparison
against budgeted price and current market price.
6.9. If there is significant difference of price between the suppliers’ offer and the budgeted price
or market price, the tender evaluation committee may recommend retendering or negotia-
tion or cancelation of the bid. Or if the technical or financial analysis are not correct, the
tender evaluation committee returns the document for correction.
6.10. The tender evaluation committee shall propose bid winners on a least price base for con-
tract award.
6.11. 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.
6.12. 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. The decision proposal will be prepared in four copies and include cover letter,
table of contents, winners list, minutes of meetings, preliminary screening, technical evalu-
ations, offer analysis, tender initiation letters, no objection letters, and other records gener-
48
ated in the processes.
6.13. If the decision report is accepted by the Tender Endorsement Committee, the Deputy Di-
rector General of Operation (DDGO) will write a tender approval- no objection letter to the
procurement directorate to proceed to the next level. If the report is not accepted by the
Tender Endorsement Committee, it will be forwarded to the procurement directorate to
implement the committee decision/recommedndation.
6.14. 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.
7. Forms
Form No Form Title

F/PRO/14 TEC minutes of meeting form
F/PRO/15 Decision proposal form

0 Initial release
49

Document Title Awarding
1. Introduction
Generally, contracts are awarded based on recommendations from a Tender Endorsing Commit-
tee. An award may be made subject to the prior fulfillment of conditions, and generally the Deputy
Director General of Operations or the Director General has the authority to award a contract.
2. Purpose
for awarding of contracts.
3. Scope
This SOP is applicable to for all types of procurements methods used for the supply of pharma-
ceuticals.
4. Responsibilities
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
Procurement
5. 5.Process
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. Procedures
6.1. The procurement officer in charge shall receive a no objection letter from TEC and prepares
a list of awardee and draft award notification document.
6.2. The Procurement Coordinator shall check and verify the list and draft award notification
document.
6.3. The procurement director shall approve the award notification, and enclosed it with a signed
official letter.
6.4. The procurement director shall communicate the MIS division to post the award notification
on the Agency’s website.
51
Page 29 of 65
6.5. The procurement directorate secretary informs all participating bidders to collect the award
notification documents.
6.6. The officer and/or Procurement Coordinator ensures the award notification is posted on
the website, and the documents are distributed to participating bidders.
7. Forms
Form No Form Title

F/PRO/16 Award notification form

1 Initial release
52

Document Title Complaint handling
1. 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, as stated in the bid document. Depending on the nature
of the complaints received, the Director General may conduct investigation or consider seeking
advice from the tender endorsal committee before reaching decision.
2. Purpose
for complaint handling in line with the Federal Public Procurement Directive.
3. Scope
ceuticals.
4. Responsibilities
Director General Receive and register complaints from bidders on award

notification
Procurement Director Checking whether complaintants are reported or not
53
Procurement
Procedure Pharmaceuticals Fund and Supply Agency
Doc No: P/PRO/A Rev No:(PFSA)
0
5. 5.Process
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
6. Procedures
6.1. The procurement officer in charge shall ensure the complaint submission deadline is com-
municated posted on the website.
6.2. The Director General receives complaints on the award notification from bidders, if any.
6.3. The Director General, depending on the nature of the case, conducts investigation and gives
decision on the complaint.
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.
6.5. The Procurement Director checks whether there is an appeal by complaintants on their
complaint decisions or not.
6.6. If there are no appeals, the Procurement Director triggers the procurement process to pro-
ceed.
6.7. 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), the Director General instruct to hold the
procurement process to receive the Board decision.
6.8. The Director General communicates the Board’s decision to ensure it is implemented ac-
cordingly.
7. Supplimentary issues
7.1. 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.
c) The preference given to Domestic Providers pursuant to Article 25 of the proclama-

tion and article 16.20/1 of the Procurement Directive.
d) Decisions given to reject bids, bid documents or price quotation pursuant to article
30 of the proclamation.
55
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, 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.
f) No complaint shall be accepted after a contract was signed, 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 46.3 of the proclamation and article 45.1 (a) of the
Procurement Directive.
8. Forms
Form No Form Title

F/PRO/16 Complaint registration form

0 Initial release
56

Document Title Purchase order processing
1. Introduction
A purchase order (PO) is a type of contract that documents the purchase of goods and/or ser-
vices.
2. Purpose
for preparation of purchase orders.
3. Scope
ceuticals.
4. Responsibilities
Procurement officer Prepare draft Purchase Orders

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

F/PRO/17 Purchase order form

0 Initial release
60

Document Title Contract signing
1. Introduction
A contract is a written, legally binding agreement between the Agency and a supplier, which es-
tablishes the terms and conditions, including the rights and obligations of the Agency and the
supplier.
2. Purpose
for preparation and signing of contracts.
3. Scope
ceuticals.
4. Responsibilities
Director General Signing of contract on behalf of PFSA
Procurement Director Verify correctness of draft contract document,
Send signed original contract document to supplier

Procurement Coordina- Ensuring receipt of fresh proforma invoice and per-
tor formance guarantee
Procurement officer Prepare draft contract agreement,
Check consistency of reissued proforma invoice
61
5. 5.Process
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, and

copies to all concerned functions
Issue a copy of contract & PO to

Procurement follow up team
62 Page 40 of 65
6. Procedures
6.1. The procurement officer in charge shall fill out a draft contract agreement for each supplier
awarded using the standard contract template.
6.2. The Procurement Coordinator shall check the content & correctness of the draft contract.
6.3. The Procurement Director shall verify the draft contract document for completeness and
consistency.
6.4. The Procurement Directorate Secretary shall notify and register supplier’s agent to collect
the draft contract for signing in six originals.
6.5. The Procurement Directorate Secretary shall receive the contract document signed by the
supplier, inform the Director and forward the document to concerned Procurement Coor-
dinator.
6.6. The officer or Procurement Coordinator ensures fresh proforma invoice is submitted by the
supplier.
6.7. The officer or Procurement Coordinator ensures a 10% performance guarantee is issued by
the supplier.
6.8. The officer in charge shall check the content and consistency of the freshly prepared pro-
forma against the PO.
6.9. The officer in charge & Coordinator shall sign the contract as witnesses of PFSA.
6.10. The Procurement Director shall present the contract including all relevant documents to the
Director General for approval.
6.11. The Director General signs the contract on behalf of PFSA.
6.12. The Procurement Director ensures one original copy of the contract document is sent to
the supplier, and copies to the concerned functions of PFSA.
6.13. The Procurement Director will issue a copy of contract, PO, fresh performa invoice and 10%
performance bond to Procurement follow up team for action.
63
7. Forms
Form No Form Title

F/PRO/18 Standard contract form

0 Initial release
64

Document Title Special Import Permit
1. Introduction
Regarding a presence of restricted pharmaceuticals such as narcotic or psychotropic drugs, sup-
pliers usually require special permission from FMHACA.
2. 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, Insecticide for malaria control, and radiating equipment.
3. Scope
This SOP is applicable to receipt of special import permit from the national regulatory the agen-
cies.
4. Responsibilities
Procurement Director Prepare import permit request of NPD to FMHACA

Procurement Coordinator Follow up special import permit from FMHACA
65
Identify items requiring

special import permit
Request for a special import permit

enclosing PO & other relavant docs.
Follow up to receive regulatory body’s

permit
Send permit to supplier
6. Procedures
6. Procedures
6.1. The procurement director shall identify items that required of special import permit from
6.1. Thenational
the procurement director
regulatory shall identify items that required of special import permit from
authorities.
the national regulatory authorities.
6.2. The Procurement Director shall prepare and submit a special import permit request letter
6.2. toThe
theProcurement Director shall prepare and submit a special import permit request letter
regulatory agencies.
to the regulatory agencies.
6.3. The Procurement Coordinator in charge shall follow up the import permit request from the
6.3. 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.
the regulatory agencies and facilitate in provision of information required by the
6.4. The Procurement Director shall communicate the import permit issued by the regulatory
agencies.
agencies to the suppliers.
6.4. The Procurement Director shall communicate the import permit issued by the regulatory
7. Forms
agencies to the suppliers.
Form No Form Title

7. Forms
8. Amendment
Form No History Form Title

8.0 Amendment History Initial release

0 Initial release
66 Page 43 of 65

Document Title Preparation of Technical Specifications for Pharmaceuticals
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.
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.
Failure to develop specifications that meet the need of users can result in the procurement of
unsuitable products. 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.
Specifications for products that have previously been successfully procured are generally used as
a starting point for new procurements.
2. 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.
3. Scope
This SOP is applicable to all procurements of pharmaceuticals carried out by PFSA.
4. Responsibilities
Procurement Di- • Review of request/proposal for aTechnical Specification (TS)
rector
• Formulation of Technical Committee
Procurement Di- • Approval of request/proposal for aTS
rector
• Approval of Draft TS
MIS Registration and publishing of approed TS
67
5. 5.Process
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. Procedures
6. Procedures
6.1. Any officer/expert associated with procurement activities may request/propose to the
6.1. Any officer/expert associated with procurement activities may request/propose to the Pro-
Procurement Director on preparation or revision of TS for an item.
curement Director on preparation or revision of TS for an item.
6.2. Each request/proposal shall be submitted to the Procurement Director in writing, and it
6.2. Each request/proposal shall be submitted to the Procurement Director in writing, and it
shall indicate the name of the item and give the reasons for the need of the TS.
shall indicate the name of the item and give the reasons for the need of the TS.
6.3. The Procurement Director shall review the request/proposal against a catalogue of TS or
6.3. 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.
TS.
6.4. On the basis of the review the D/Director General of Operations shall decide upon
6.4. On the basis of the review the D/Director General of Operations shall decide upon accep-
acceptance or rejection of the request/proposal.
tance or rejection of the request/proposal.
6.5. When the request/proposal is approved, the Procurement Director shall for mulate an ad
hoc technical committee(s) to prepare TS for the item(s) requested/proposed. If deemed
68 Page 45 of 65
6.5. When the request/proposal is approved, the Procurement Director shall for mulate an ad
hoc technical committee(s) to prepare TS for the item(s) requested/proposed. If deemed
relevant, the Procurement Director may request endorsement from the D/Director General
of Operations regarding the composition of technical committee members.
6.6. The technical committee shall prepare Draft TS taking into consideration availability and
effect of international, regional and other national standards and legislations, instructions,
specifications, best practices, etc.
6.7. The Procurement Director shall ensure the Draft TS is reviewed for completeness and clarity
and, as appropriate, collect feedback from experts other than technical committee mem-
bers.
6.8. Analysing the review and expert feedback, the D/Director General of Operations will ap-
prove the Draft TS or not. If not approved, the Draft TS will be sent back to the Technical
Committee for correction.
6.9. If approved, the TS will be given an identification number, be included in the TS masterlist,
and get published.
7. Supplemental Issues
7.1. 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;
o size, units, quantity, and intended use;
o product properties, such as stability, shelf life, and storage temperature;
o packaging, packing, and marking, including dosage size, dose package, labeling, and
printed materials;
o regulatory requirements; and
o applicable standards and required certifications.
7.2. General issues to consider in preparation of specifications
6.1.1 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.
69
6.1.2 Generic specifications

Specifications need to be as generic as possible to encourage adequate responses from
potential suppliers.
6.1.3 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.
ii. The specifications should be checked by the Procurement Unit to ensure clarity and
completeness.
6.1.4 Product specifications

Specifications are to address functions and performance in order to avoid elements
that restrict competition such as brand, trade names, origin, 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.
6.1.5 Use of brand names and patents

i. The FDRE Procurement and Property Administration Proclamation do not encourage
specification by trademark or name, patent, design or type, specific original producer
or service provider, brand names or patents.
ii. However, due to prevalence of identification and prescription of specific drugs for par-
ticular ailments by medical practitioners, 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.
6.1.6 Demonstration and samples

i. When it is difficult to specify consumables such as disinfectants and laboratory chemi-
cals adequately and clearly, potential suppliers may be asked to demonstrate perfor-
mance of a product. Otherwise the samples should be accompanied by a certificate
of conformance to specifications from an authorized laboratory.
ii. Where appropriate, 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.
iii. Once a sample has been approved, all the supplied products must conform to the
sample.
70
6.1.7 Medical Equipment Technical specifications

Medical equipment specifications generally include a combination of the following:
a) Physical characteristics (dimensions, strength, etc);

b) Design details;
c) Tolerances;
d) Materials used;
e) Processes/ methods involved in production; and
f) Maintenance requirements.
6.1.8 Composition specifications for pharmaceutical products

Composition specifications are generally stated in terms of physical as well as chemical
characteristics such as weight, volume, level of purity, density, ingredients, additives etc.
6.1.9 Testing and inspections

In addition to specifying performance of an equipment or product for the health sector, 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);
b) Acceptance testing at the time of receipt, installation and /or commissioning.
6.1.10 National and International Standards

Unless existing standards may not meet user’s needs, technical specifications to be pre-
pared shall be based on the relevant national or international standards to enhance testing,
inspection and suppliers responsiveness.
6.1.11 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. The list contains the names and specifica-
tions of most the essential pharmaceuticals recommended to treat most of the ailments
prevalent. The Procurement Directorate shall make reference to this list for specifications
before they start developing alternative specifications.
7.3. Specific issues to consider

6.2.1 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).
71
a) Specifications for products such as tablet, capsules, dry syrup, liquid, ointment, injectable,
emulsion, suspension, etc. should contain dosage and content (exact number of mg or in-
ternational units [IU] or % v/v, w/w or v/w acceptable range);
b) The products should conform to standards specified in the acceptable pharmacopoeia

standard;
c) In case the pharmaceutical product is not included in the specified pharmacopoeia, but is
included in the Ministry of Health’s national essential pharmaceuticals list, the acceptable
limits and supplier need to be clearly indicated, upon award of the contract, and must also
provide the reference standards and testing protocols to allow for quality control testing;
d) The packaging and labelling components (e.g., bottles, closures, and labeling) should also
meet specifications suitable for distribution, storage, and use in a climate similar to that
prevailing in Ethiopia;
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. As appropriate additional special require-
ments may be specified;
f) All labelling and packaging inserts should be in the language requested by the Purchaser or
English if not otherwise stated;
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.
6.2.2 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, where a brand name has been given;
b) Dosage form e.g. tablet, ampoule, syrup, etc.;
c) The active ingredient “per unit, dose, tablet or capsule, etc.”;
d) The applicable pharmacopoeia standard;
e) The Purchaser’s logo and code number and any specific colour coding if required;
f) Content per pack;
g) Instructions for use;
h) Special storage requirements;
i) Batch number;
j) Date of manufacture and date of expiry (in clear language, not code);
72
k) Name and address of manufacture;

l) Any additional cautionary statement;
m) The outer case or carton should also display the above information.
6.2.3 Case Identification

a) No case should contain pharmaceutical products from more than one batch.
b) All cases should prominently indicate the following:
i. Purchaser’s line and code numbers;

ii. The generic name of the product;
iii. The dosage form (tablet, ampoule, syrup);
iv. Date of manufacture and expiry (in clear language not code);
v. Batch number;
vi. Quantity per case;
vii. Special instructions for storage;
viii. Name and address of manufacturer; and
ix. Any additional cautionary statements.
6.2.4 Specifications for Vaccines

The Agency may develop additional specifications for vaccines, as deemed appropriate.

0 Initial release
73

Document Title Pre-qualification evaluation & maintenance of suppliers’ list
1. Introduction
The selection of suppliers has a profound effect on the quality and cost of pharmaceuticals ac-
quired. In adequate safeguards in supplier selection may result in the purchase of medicines
that are ineffective, unsafe, or even deadly. Hidden costs resulting from late deliveries, default on
confirmed orders, losses caused by poor packaging, or short expiration dates are some of the
common problems caused by unreliable suppliers.
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.
A prequalification is the process of developing a list of registered suppliers based on past perfor-
mance,
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.
3. Scope
This SOP is applicable to all procurement processes carried out by the Procurement Directorate
of PFSA.
4. Responsibilities
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
5. 5.Process
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.
Communicate decision to
suppliers
Page 52 of 65
75
6. Procedures
6.1. The Procurement Director initiates and requests the Bid Evaluation and Endorsement Com-
mittee to conduct the process for prequalification reqview of potential suppliers. The Di-
rector General of the Agency assigns, if it was not functional, 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, Forecasting and Capacity Building Directorate, Procurement
Directorate, and Stock and Distribution Directorate.
6.2. The committee shall prepare criteria document for pre-qualification of suppliers, and regis-
tration formats to be filled by applicant suppliers.
6.3. The D/Director General reviews the pre-qualification criteria document and associated reg-
istration formats, and gets it approved. If not approved, it will be sent back to the committee
with the comment to be considered.
6.4. 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.
6.5. The Procurement Directorate avails the application formats/documents and submits to in-
terested suppliers as requested.
6.6. The Procurement Directorate receives applications of expression of interest from potential
suppliers including supportive documents. The application documents together with the list
of applicants and accompanied with official memo will be forwarded to the Evaluation Com-
mittee Secretary.
6.7. The Secretary of the Evaluation Committee, in consultation with the Chair Person of the
Committee, will set schedule and conduct the pre-qualification evaluation.
6.8. The Evaluation Committee shall establish a draft document of approved suppliers list, and
submit together with the committee minutes to the D/DG of Operations for approval.
6.9. The D/DG of Operations shall verify the transparency of the process, check for correctness
of the report on sample basis, and get it approved. If deemed not satisfactory, the docu-
ment will be sent back to the committee with comments for consideration.
6.10. As approved, the office of the D/DG of Operations will officially circulate the list of approved
suppliers to the concerned departments.
6.11. Following the approval, the Procurement Directorate will ensure suppliers that have sub-
mitted their expression of interest are communicated on their status, i.e. whether they are
registered in the approved suppliers list or not.
76
6.12. Any complaint from a supplier shall be handled in accordance with the complaint handling
procedure.
7. Supplemental Issues
7.1. Practical aspects to consider
6.0.1 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. Drug regulatory authorities
may provide relevant information regarding new suppliers.
6.0.2 The process for evaluating new suppliers can include formal registration, formal inspection,
reference checks with past clients and international agencies, test purchases in small quan-
tities and informal local information-gathering.
6.0.3 The Procurement Directorate is expected to maintain continued good supplier performance
through a formal monitoring system which tracks lead time, compliance with contract terms,
partial shipments, quality of drugs, remaining shelf-life, compliance with packaging and la-
belling instructions, etc.
6.0.4 The Procurement Directorate shall maintain a cumulative file for each supplier that have
copies of registration papers, references, special correspondence, complaints and other
anecdotal supplier information. The information system should track chronologically the
number and value of tender contracts awarded, and the value of total purchases from the
supplier by year and performance for each tender.
7.2. As part of prequalification the following list of questions can be used, as appropriate. As
the questions are not exhaustive for the required purpose, the technical committee may
customize or add different set of questions.
A. Status
• Is the supplier a primary manufacturer or a distributor?
• If a manufacturer, does the supplier manufacture all products in-house?
• If the supplier does not manufacture all products in-house, who is the primary
manufacturer for each product offered?
B. 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
• What tests-chemical, biological, stability, accelerated stability, or others-are rou-

tinely performed during and after the manufacturing process?
• Are special tests performed for stability in tropical environments?
C. 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. 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. 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. Financial status
• Is the supplier financially stable?
• Will the supplier remain in existence for the entire contract period?
G. Corporate associations
• Is the supplier a subsidiary, a parent company, 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
with a known supplier?
• How long has the supplier been supplying the goods under consideration?
H. 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?

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79

Document Title Suppliers Post-contract performance appraisal
1. Introduction
Post contract appraisal includes observing the performance of the supplier to ensure that a qual-
ity product, in the right quantity, is delivered on time and within budget.
Post-contract appraisal is fundamental to contract and supplier relationship management – it

allows the buyer and supplier to monitor compliance, identify non-compliance and trigger correc-
tive action, quantify important performance attributes and measure change and improvement,
and assess supplier performance and compare it with its peers.
Various requirements are built into the standard contracts and, the extent to which suppliers fulfil
these requirements is used to measure the achievement of performance indicators. The latter is
instrumental in evaluating the ongoing performance of the contract (e.g. quality standards, deliv-
ery times, inspections, milestone dates, etc.). Control of performance ensures that the supplier’s
performance is in accordance with the contract.
2. 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.
3. Scope
of PFSA.
4. Responsibilities
Procurement Director • Approval of suppliers post contract assessment
Procurement officer • Conduct post contract assessment of suppliers
80
5. 5. 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. Procedures
5.1 The Procurement Director initiates and assigns procurement officers to conduct post-con-
6. Procedures
tract suppliers’ assessment.
6.1 The Procurement Director initiates and assigns procurement officers to conduct post-
5.2 The assigned procurement officer(s) will prepare post-contract evaluation criteria. The fol-
contract suppliers’ assessment.
lowing topics can be addressed in evaluating the performance:
6.2 The assigned procurement officer(s) will prepare post-contract evaluation criteria. The
• Fulfilment of delivery schedule/timely delivery;
following topics can be addressed in evaluating the performance:
• Fulfilment
• Compliance of delivery schedule/timely
with contractual delivery;
terms and conditions;
• Compliance with contractual terms and conditions;
• Adherence to warranty provisions;
• Adherence to warranty provisions;
Page 58 of 65 81
• Fulfilment of social and environmental requirements;
• Sustainability performance exceeding minimum requirements;
• Quality of goods or services provided in accordance with the contract;
• Timely response to the PFSA’s requests;
• Undue delay of the performance under the contract;
• Failure to disclose information relevant to performance (e.g. bankruptcy, ongoing litiga-

tion, etc.)
5.3 The Procurement Director reviews the assesntsme criteria and associated formats, and gets
it approved. If not approved, it will be sent back to the committee with the comment to be
considered.
5.4 The assigned procurement officer(s) will carryout the assessment of the performance of
contract awarded suppliers, and submit the report to the Procurement Director.
Depending on the nature of the procurement, the process to evaluate supplier performance
could consider the following approaches:
• Using questionnaires, which require a sound knowledge of what will be measured to

ensure relevance of result;
• Undertaking site visits;
• Using metrics and key performance indicators for contracts;
• Developing and using supplier scorecards to measure cost of poor quality, customer
social responsibility, etc;
• Measuring performance against service level agreements.
5.5 The Procurement Director verifies the completeness and correctness of the assessment
report.
5.6 If the assessment report is found to be incomplete or incorrect, it shall be sent back to the
officer(s) with comment. If the report is accepted, it will be approved and be used to update
the list of suppliers’ database.

0 Initial release
82

Document Title Documentation of the procurement process
1. 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, 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.
2. Purpose
The purpose of this SOP is to define the activities required for establishing and maintaining record
control system of the procurement processes.
3. Scope
of PFSA.
4. Responsibilities
Procurement Direc- • Ensuring establishment of a records control
tor system for procurement processes
Procurement officer • Timely filing of procurement documents
Procurement Direc- • Classification, titling and indexing of records/
tor Secretary files
83
Procurement Procedure Pharmaceuticals Fund and Supply Agency
Doc No: P/PRO/A Rev No:(PFSA)
0
5. 5.Process
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. Procedures
5.1 Receiving records shall be checked for legibility, cleanness and completeness.
6. Procedures
5.2 Incoming
6.1 Receivingand outgoing
records shalldocuments/ records
be checked for shall cleanness
legibility, be registered on documents registration
and completeness.
logbook.
6.2 Incoming and outgoing documents/ records shall be registered on documents registration
logbook.
5.3 Check availability of previous file for the record against the records index list.
6.3 Check availability of previous file for the record against the records index list.
5.4 If there is no previous file, the Procurement Director Secretary shall create a new file. Allo-
6.4 cate
If there is no previous
classification, file,indexing
titling and the Procurement Director Secretary shall create a new
to the record.
file.Allocate classification, titling and indexing to the record.
5.5 File number will be assigned and registered in the documents/records master list.
6.5 File number will be assigned and registered in the documents/records master list.
5.6 Attach
6.6 Attachdocuments/record to the
documents/record to thedesignated
designatedfile.
file.
7. 7.Supplimentary
Supplimentary issues
issues
7.1 Typically, procurement files will include the following relevant information/
6.1 Typically, procurement files will include the following relevant information/ documentation,
documentation, in original form and appropriately signed, when applicable:
in original form and appropriately signed, when applicable:
• Requisition
84
Page 61 of 65
• Requisition
• Requirement definition (notes, correspondence, communication with requisitioner,

justification if brand name is used etc.)
• Sourcing information including justification of procurement method and type of com-

petition
• Signed short list
• Signed bid document, including attachments such as specifications (copies of cover

letters, copies of emails, fax receipts, etc.)
• Amendments to bid documents, and any other clarifications and correspondence

with suppliers
• Bid opening report
• All offers received (technical, 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, 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, phone calls etc.
• Amendments to contracts/POs
• Documented decision regarding claims, 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
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.
6.2 Records retention
6.2.1 Procurement records will be retained for ten years or more, if they are required to
preserve knowledge
6.2.2 If procurement records are available in an electronic media the backups shall be prop-
erly labelled and retained.
6.3 Storage of files
6.3.1 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, de-
terioration, or loss and allow access control.
6.3.2 All records shall be physically or electronically filed by a method which enhances ac-
cessibility and retrieval by a user. If electronic files are used a back-up system or other
suitable measures shall be used to prevent record loss.

0 Initial release
86
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
Annex 2: List of workshop participants for reviewing the draft Procedure
S.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.
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

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thRough sustained

7 DEFINITIONS & 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

9.2 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

Preparation of Bid Document......................................................................................................................................... 18

Bid Advertisement. ..............................................................................................................................................................1

Bid document issuing/selling..............................................................................................................................................4

Bid clarification. .................................................................................................................................................................7

Bid offer receiving............................................................................................................................................................ 11

Bid offer analysis............................................................................................................................................................. 19

Bid offer analysis approval.............................................................................................................................................. 23

Purchase order processing.............................................................................................................................................. 35

Special Import Permit....................................................................................................................................................... 42

Preparation of Technical Specifications for Pharmaceuticals....................................................................................... 44

Pharmaceuticals Fund and Supply Agency (PFSA)......................................................................................................... 51

Pre-qualification evaluation & maintenance of suppliers’ list. ...................................................................................... 51

Pharmaceuticals Fund and Supply Agency (PFSA)......................................................................................................... 57

Suppliers Post-contract performance appraisal............................................................................................................. 57

Pharmaceuticals Fund and Supply Agency (PFSA)......................................................................................................... 60

Documentation of the procurement process.................................................................................................................. 60

ANNEX 1: LIST OF FORMS............................................................................................................................................... 64

ANNEX 2: LIST OF WORKSHOP PARTICIPANTS FOR REVIEWING THE DRAFT PROCEDURE........................... 65

Director General, Pharmaceuticals Fund and Supply Agency (PFSA)

Part One: General

3.2 This SOP manual covers:

• The generic and specific steps in procurement of pharmaceuticals;

• Procurement planning and its linkage to budgeting process and implementation;

• Administration of the complete procurement cycle up signing of contract with awardee;

• Supplier performance measurement.

• FDRE Proclamation on Procurement and Property Administration Proclamation Agency- No

• Federal Public Procurement Directive, MoFED June 2010.

• Ratio of cancelled/rebid procurements.

7 Definitions & Abbreviations

• Pharmaceuticals - any substance or mixture of substances used in the diagnosis, treat-

• Agency - the Pharmaceuticals Fund and Supply Agency (PFSA).

• EDL - Essential Drug List

• EOI – Expression of Interest

• FCB – Forecasting and Capacity Building

• FMHACA – Food, 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 - Pharmaceuticals Fund and Supply Agency

• RFI - Request for Information

• SOP – Standard Opearting Procedure

• TEC– Tender Endorsement Committee

8 Mandates, Duties and Responsibilities

8.1 Mandates of the Agency

• to enable public health institutions to supply quality assured essential pharmaceuticals at

• provide adequate and proper pharmaceutical storage facilities to ensure uninterrupted