Pre-qualification for Drugs for OIs STIs.doc

GOVERNMENT OF THE REPUBLIC OF ZAMBIA

ZAMBIA NATIONAL TENDER BOARD

ZAMBIA NATIONAL RESPONSE TO HIV/AIDS (ZANARA) PROJECT

TB/ORD/020/06

PRE-QUALIFICATION TENDER FOR THE SUPPLY AND DELIVERY OF DRUGS FOR OPPORTUNISTIC AND SEXUALLY TRANSMITTED INFECTIONS TO THE

MINISTRY OF HEALTH

FUNDING AGENCY:

International Development Association (IDA) The Director General

Zambia National Tender Board2nd Floor, Red Cross HousePlot 2837, Los Angeles Boulevard Longacres, LUSAKA

May 2006

STANDARD PRE-QUALIFICATION DOCUMENT

1

SPECIFIC PROCUREMENT NOTICE

Invitation for Prequalification

ZAMBIA NATIONAL RESPONSE TO HIV/AIDS (ZANARA) PROJECT

Grant No H017-ZA

TB/ORD/020/06: PRE-QUALIFICATION TENDER FOR THE SUPPLY AND DELIVERY OF DRUGS FOR OPPORTUNISTIC AND SEXUALLY TRANSMITTED INFECTIONS TO THE MINISTRY OF HEALTH – MINISTRY OF FINANCE AND NATIONAL PLANNING

This invitation for prequalification follows the general procurement notice for this project that appeared in Development Business No. issue no. 612 of 16 August 2003.

The Government of the Republic of Zambia has received a Grant from the International Bank Development Association (IDA) toward the cost of the Zambia National Response to HIV/AIDS (ZANARA) Project and it intends to apply part of the proceeds of this Grant to payments under the contracts for the supply of the following Goods:

Item No. Generic description of drug Unit Pack Size

Required Quantity (in unit packs)

1 Ciprofloxacin 250mg tablets BP/USP 100 15,0002 Ceftriaxone, powder for Inj. 250mg, vial

BP/USPEach 35,000

3 Cefuroxime 250mg tablets 100 10,0004 Azithromycin 1g +2 Secnidazole 1g +

Fluconazole 150mg tabletsEach 5,000

5 Amphontericin B, powder for injection, 50mg vial, BP/USP

Each 10,000

6 Chloramphenicol 1g, powder for Inj. Solution, BP/USP

Each 80,000

7 Clarithromycin 250 mg tablets BP/USP 14 6,0008 Cefotaxime (as Sodium salt, powder for

reconstitution) 1g, Each 20,000

9 Amitriptyline 25mg tablets, BP/USP 100 200010 Acyclovir 400mg tablets, BP/USP 100 2,00011 Acyclovir Eye Ointment, 3%, BP/USP Each 2,00012 Actinomycin D, Lyophilised powder for

solution Inj. 500mcg, vial, BP/USPEach 5,000

13 Doxorubin Hydrochloride solution for Injection 2mg/ml, BP/USP

Each 5,000

2 Specific Procurement Notice

14 Vincristine, powder for Inj. 1mg, Vial, BP/USP

Each 8,000

15 Cefixime oral suspension 100mg/5ml, BP/USP

Each 20,000

16 Cycloserine 250mg capsules, BP/USP 100 50017 Ethionamide tablets, USP 100 50018 Kanamycin Sulphate Injection 1g,

BP/USP Each 44,000

19 Ofloxacin 200mg tablets, BP 100 1,00020 Clotrimazole pessaries 500 mg, BP/USP Pkt 15 20,00021 Benzathine Penicillin 2.4 m.u. injection,

BP/USPVial 20,000

22 Erythromycin syrup 125mg/5ml, BP/USP 100ml 100,00023 Erythromycin 250mg tablets, BP/USP 1000 12,500

Note: Each item will be considered as an individual contract, applications may be made for prequalification for one or more of the contracts.

The Zambia National Response to HIV/AIDS (ZANARA), an implementation agency for the above Project, intends to prequalify suppliers and/or firms for supply of the above said Goods..

It is expected that invitations to bid will be made in August 2006.

Prequalification will be conducted through prequalification procedures specified in the current edition of the World Bank’s Guidelines: Procurement under IBRD Loans and IDA Credits, and is open to all bidders from eligible source countries, as defined in the guidelines.

Interested Interested eligible bidders may obtain further information from and inspect the pre-qualification documents at the Zambia National Tender Board, Red Cross House, Los Angeles Boulevard, Long Acres, PO Box 31009, Lusaka, Zambia from 08:00-13:00hrs and 14:00hrs-17:00hrs. A complete set of pre-qualification documents in English may be purchased by interested bidders on the submission of a written application to the address below and upon payment of a non refundable fee of ZMK 1,000,000.00 or in any freely convertible currency. The method of payment will be cash or by Bank Certified Cheque. The Bidding Documents will be sent by express courier upon request and payment of an additional US$40.00.

The telephone numbers are 260 (1) 250632 or 250642 and the telefax number is 260 1 250633. HOWEVER, TELEGRAPHIC AND/OR ELECTRONIC OFFERS WILL NOT BE ACCEPTED. The pre-qualification document can also be accessed on the Zambia National Tender Board website: www.tenderboard.gov.zm

The applications for pre-qualification must be sent clearly marked: “Pre-qualification for the supply and delivery of drugs for opportunistic and sexually transmitted infections to the Ministry of Health”, and addressed to the Director General, Zambia National Tender Board, and sent not later than Friday, 23 June 2006 at 14:00hrs.

The applications must be deposited in the Tender Box at the Zambia National Tender Board

http://www.tenderboard.gov.zm/

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Offices, on or before Friday, 23 June 2006 at 14:00 hours local time.

The closing date for the receipt of applications is Friday, 23 June 2006 at 14:00 hours local time and any applications received after the time and date stipulated above will not be accepted. The applications will be opened in the Conference Room at the Zambia National Tender Board Offices at Red Cross House, Los Angeles Boulevard, Lusaka, on the same date soon after closing, in the presence of bidders or their representatives who choose to attend.

D.KapitoloDirector GeneralZambia National Tender Board

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GENERAL INSTRUCTIONS TO APPLICANTS (GITA)

6 Particular Instructions to Applicants - PITA

1. Source of Funds and Scope of WorksSource of Funds

1.1 The Borrower named in the Particular Instructions to Applicants (PITA) has applied for or received a loan or credit (hereinafter called “loan”) from the International Bank for Reconstruction and Development or from the International Development Association (hereinafter interchangeably called “the Bank”) equivalent to the amount in U.S. dollars indicated in the PITA toward the cost of the Project named in the PITA. The Borrower intends to apply a part of the proceeds of this loan to eligible payments under the con-tract(s) for which this prequalification is issued.

Goods to be supplied

1.2 The Purchaser, as named in the PITA, intends to prequalify suppliers for supply of Goods described in the PITA.

Lot and Package

1.3 If so indicated in the PITA, bids will be invited for one or more items, or for individual Contracts (lots) each comprising at least eighty percent (80%) of the total number of items required under the lot. In both cases, each item offered must comprise the full quantity required under that item.

Bid Invitation

1.4 It is expected that prequalified applicants will be invited to submit bids during the month and year indicated in the PITA.

Type of Contract

1.5 The bidding documents, type of contract and method of payment are indicated in the PITA.

General Information

1.6 General information on the delivery terms, frequency of shipments, Goods’ registration and packaging/marking requirements, expected places of delivery and contract validity period, and other relevant data is attached as an Annex to the PITA.

2. Fraud and Corruption2.1 It is the Bank’s policy to require that Borrowers (including

beneficiaries of Bank loans), as well as bidders/Suppliers/Contractors under Bank-financed contracts, observe the highest standard of ethics during the procurement and execution of such contracts. In pursuance of this policy, the Bank:

(a) defines, for the purposes of this provision, the terms set forth below as follows:

(i) “corrupt practice” means the offering, giving, receiving, or soliciting of anything of value to

Particular Instructions to Applicants - PITA 7

influence the action of a public official in the procurement process or in contract execution; and

(ii) “fraudulent practice” means a misrepresentation of facts in order to influence a procurement process or the execution of a contract to the detriment of the Borrower, and includes collusive practices among bidders (prior to or after bid submission) designed to establish bid prices at artificial, noncompetitive levels and to deprive the Borrower of the benefits of free and open competition

(b) will not accept a Borrower’s proposal for award if it determines that the bidder recommended for award has engaged in corrupt or fraudulent practices in competing for the contract in question; and

(c) will declare a firm ineligible, either indefinitely or for a stated period of time, to be awarded a Bank-financed contract if it at any time determines that the firm has engaged in corrupt or fraudulent practices in competing for, or in executing, a Bank-financed contract.

3. Eligibility of Countries and BiddersEligible Countries

3.1 Except as provided in Sub-Clauses 3.2 and 3.3, this Invitation for Prequalification is open to all eligible firms from eligible source countries. The Bank maintains a list of countries from which bidders, goods, and services are not eligible to participate in procurement financed by the Bank. The list is regularly updated and can be obtained from the Bank’s InfoShop in Washington, D.C., and the Public Information Centers of the Bank in Paris and Tokyo. The list can also be obtained from the Bank’s Web site: http://www.worldbank.org.html/pic/PROCURE.html.

3.2 Firms of a member country may be excluded if, (i) as a matter of law or official regulation, the Borrower’s country prohibits commercial relations with that country, provided that the Bank is satisfied that such exclusion does not preclude effective competition for the supply of goods or services required, or (ii) by an act of compliance with a decision of the United Nations Security Council taken under Chapter VII of the Charter of the United Nations, the Borrower’s country prohibits any import of goods from that country or any payments to persons or entities in that country.

Eligible 3.3 Government-owned enterprises in the Borrower’s country may

http://www.worldbank.org.html/pic/PROCURE.html


Bidders participate only if they can establish that they (i) are legally and financially autonomous, and (ii) operate under commercial law. No dependent agency of the Borrower or Sub-Borrower under a Bank-financed project shall be permitted to bid or submit a proposal for the procurement of goods or works under the project.

3.4 A firm declared ineligible by the Bank in accordance with Sub-Clause 2.1 (c) above shall be ineligible to bid for a Bank-financed contract during the period of time determined by the Bank.

4. Qualification CriteriaGeneral 4.1 Prequalification will be based on Applicants meeting all of the

following minimum pass–fail criteria regarding their general and particular production and distribution experience and capacities, quality assurance, and other relevant information as demonstrated by the Applicant’s responses in the Information Forms attached to the Letter of Application.

Required Quality Assurance

4.2 The Applicant shall provide evidence that it meets the qualification criteria specified in PITA, and has a successful performance history in accordance with criteria specified in PITA

Particular Experience

4.3 The Applicant shall provide evidence that it has the financial, technical, and production capability necessary to perform the Contract,

(a) that it has successfully completed or substantially completed at least the number of similar contracts for supply of the goods and within the period stated in the PITA. The goods may have been supplied by the Applicant as a manufacturer or by its agent, with references being submitted to confirm satisfactory performance,

(b) that it has achieved an annual production rate during the above period as specified in the PITA; and

(c) that it has generated an average annual turnover during the above period as specified in PITA.

Manufacturing Experience

4.4 The applicant should have manufactured and marketed

(a) the specific goods subject of bidding specified in the PITA for at least the number of years stated in the PITA, and

(b) similar goods for at least the number of years stated in the PITA.


Applicants wishing to prequalify for products that they do not manufacture must submit the information corresponding to the primary manufacturer of the goods who shall comply with the above manufacturing requirements. In addition, the Applicant shall submit a notarized letter of authority prepared in accordance with the Manufacturer’s Authorization Form, Annex 1 to the Letter of Application, from the primary manufacturer designating the agent for and on behalf of the primary manufacturer.

Experience on Packaging, Distribution and Transportation

4.5 The Applicant should provide proof of experience with and knowledge of modes of packing, distribution, and transportation of pharmaceuticals similar to those subject to bidding under logistical and climatic conditions similar to the ones in the purchaser’s country. It should provide names of countries to which the Applicant has supplied (including packaged, distributed, and transported) products worth at least the amount specified in the PITA within the past three years.

Registration Requirements

4.6 Unless PITA stipulates otherwise, the Goods to be supplied under the Contract shall be registered with the relevant authority in the Purchaser’s country. An Applicant who has already registered its Goods by the time of prequalification should submit a copy of the Registration Certificate with its application (subject to subsequent confirmation at bid submission). An Applicant who has not registered its goods subject of bidding and wishes to commence the process of registration, should refer to the agency and contact person identified in the PITA.

If Registration is a requirement in the country of the Purchaser, the Standard Bidding Documents for the Procurement of Health Sector Goods stipulates that:

A Bidder who has already registered the goods by the time of bidding should submit a copy of the Registration Certificate with its bid.

Otherwise, the successful Bidder, by the time of Contract signing, shall submit to the Purchaser either: (a) a copy of the Registration Certificate of the Goods for use in the Purchaser’s country, or, if such Registration Certificate has not been obtained, (b) evidence establishing to the Purchaser’s satisfaction that the Bidder has complied with all the documentary requirements for registration as specified in the Bid Data Sheet.

If the Goods of the successful Bidder have not been registered in the Purchaser’s country at the time of contract signing, then the Contract shall become effective upon such date as the


Certificate of Registration is obtained.

The Purchaser shall not annul award of a Contract on the basis of a Bidder’s failure to successfully register the Goods, without first seeking and obtaining the World Bank’s no objection.

Lot and Package

4.7 When applying for prequalification on more than one contract under the lot and package arrangements, the Applicant must provide evidence that it meets or exceeds the sum of all the individual requirements for the lots or package being applied for in regard to:

(a) Average annual turnover (Sub-Clause 4.3 [c]); and

(b) Particular experience including key production rates (Sub-Clause 4.3 [b]).

In case the Applicant fails to fully meet any of these criteria, it may be qualified only for those lots for which the Applicant meets the above requirement.

Right to Waive

4.8 The Purchaser reserves the right to waive minor deviations in the qualification criteria if they do not materially affect the capability of an Applicant to perform the contract.

5. Domestic PreferenceEligibility 5.1 If so indicated in the PITA, and for the purpose of bid comparison,

the Purchaser will grant a margin of preference to goods manufactured in the Purchaser’s country. On the basis of information submitted by Applicants and available at the time of notification, the Purchaser will inform prequalified Applicants of their apparent eligibility to qualify for the domestic bidder price preference (subject to subsequent confirmation at bid evaluation). Domestic preference may be provided in the evaluation of bids for bids offering goods manufactured in the country of the Borrower if the bidder establishes to the satisfaction of the Borrower and the Bank that:

(a) labor, raw material and components from within the country of the Borrower will account for more than 30 percent of the EXW price of the product offered, and

(b) the production facility in which those goods will be manufactured or assembled has been engage in manufacturing/assembling such goods at least since the time of bid submission.

6. Requests for ClarificationNotificatio 6.1 Applicants are responsible for requesting any clarification of the


n and Response

prequalification documents. A request for clarification shall be made in writing to the Purchaser’s address indicated in the PITA. The Purchaser will respond to any request for clarification that it receives earlier than 14 days prior to the deadline for submission of applications. Copies of the Purchaser’s response, including a description of the inquiry but without identifying its source, will be forwarded to all purchasers of the prequalification documents.

7. Submission of ApplicationsDelivery 7.1 Submission of applications for prequalification must be received in

sealed envelopes either delivered by hand or by registered mail to the address, and not later than the date stated in the PITA. The name and mailing address of the Applicant shall be indicated on the envelope, which shall be clearly marked as indicated in the PITA. A receipt will be given for all applications submitted.

Late Applications

7.2 The Purchaser reserves the right to accept or reject late applications.

Language 7.3 All information requested for prequalification shall be provided by Applicants in the language indicated in the PITA. Information may be provided in another language, but it shall be accompanied by an accurate translation of its relevant passages into the language indicated in the PITA. This translation will govern and will be used for interpreting the information.

Lack of Information

7.4 Failure of an Applicant to provide comprehensive and accurate information that is essential for the Purchaser’s evaluation of the Applicant’s qualifications, or to provide timely clarification or substantiation of the information supplied, may result in disqualification of the Applicant.

Material Changes

7.5 Applicants, and those subsequently prequalified or conditionally prequalified, shall inform the Purchaser of any material change in information that might affect their qualification status. Bidders shall be required to update key prequalification information at the time of bidding. Prior to award of contract, the lowest evaluated bidder will be required to confirm its continued qualified status in a postqualification review process.

8. Purchaser’s Notification and Bidding ProcessInvitation for Bid

8.1 Within the period stated in the PITA from the date for submission of applications, the Purchaser will notify all Applicants in writing of the results of their application and of the names of all prequalified and conditionally prequalified applicants (see Sub-


Clause 8.2 below). At the same time, successful applicants will be invited to submit a bid, in the format of the Invitation for Bids annexed to the PITA.

Conditional Prequalification

8.2 An Applicant may be “conditionally prequalified”, that is, qualified subject to certain specified nonmaterial deficiencies in the prequalification requirements being met by the Applicant to the satisfaction of the Purchaser, before submitting a bid. Upon full compliance with the prequalification requirements, other prequalified applicants will be notified accordingly.

Bid Security 8.4 Bidders will be required to provide bid security in the form and amount indicated in the bidding documents. The successful bidder will be required to provide performance security in the form and amount indicated in the bidding documents.

Purchaser’s Rights

8.5 The Purchaser reserves the right to take the following actions, and shall not be liable for any such actions:

(a) amend the scope and cost of any contract to be bid under this project, in which event bids will be invited only from those applicants who meet the resulting amended prequalification requirements;

(b) reject or accept any prequalification application, and/or any late application; and

(c) cancel the prequalification process and reject all applications.

PARTICULAR INSTRUCTIONS TO APPLICANTS (PITA)Part A: General

The PITA below is formatted for prequalification related to either one or more items, or for individual contracts (lots). Part A relates to general matters that are common to


both processes. Part B relates to specific requirements for one or more items, or for individual contracts (lots).

GITA Sub-Clause Reference

These particular instructions and related Information Forms (IF) are intended to complement, amend, or supplement the provisions in the GITA. In the event of conflict or ambiguity, the provisions in the PITA shall prevail over those in the GITA.

1.1 Source of Funds: International Development Association (IDA

The Borrower: Government of the Republic of Zambia

Amount of Grant: US$ 42 Million equivalent

Name of Project: Zambia National Response to HIV/AIDS (ZANARA) Project

1.2 The Purchaser:

The Program Administrator

Zambia National Response to HIV/AIDS (ZANARA) Project

Program Administration Unit (PAU)

Ministry of Finance and National Planning

Ground Floor Kambendekela, House, LUSAKA

Tel: 260 1 227029/49 Fax: 260 1 232862

e-mail: [email protected]

1.3 Bids are being invited for: one or more items

1.4 Bid Invitation

Expected date of Invitation for Bids: 25th August, 2006


5.1 Domestic Preference: will be applied.

Note: The amount of domestic preference will be equivalent to (i) the amount of duties and other related import charges which a nonexempt importer would have to pay for the importation of the goods offered from abroad and to be directly imported or (ii) 15 percent of the CIF or CIP bid price of such goods if said duties and charges exceed 15 percent of such price.

6.1 Requests for Clarification:

Requests for clarification shall be addressed to:

The Director- Purchasing, Goods and Services

Zambia National Tender BoardGround Floor, Red Cross HousePlot 2837, Los Angeles BoulevardLongacres, Lusaka, Zambia

The Purchasers Implementing Agency:

Name: Zambia National Response to HIV/AIDS (ZANARA) Project, Ministry of Finance and National Planning.

Address: Room 32, Ground Floor, Kambendekela House, Dedan Kimathi Road. LUSAKA

Country: Zambia

Telephone: 260 1 227029/49, 232863

Facsimile number: 260 1 232862

Electronic mail address: [email protected]

Contact person: Olive C. Chiboola (Ms)

7.1 Submission of Applications

Address:Attention: The Director General, Zambia National Tender Board

mailto:[email protected]


2nd Floor, Zambia Red Cross House Plot 2837, Los Angeles Boulevard Long Acres, Red Cross House

City: LUSAKA

ZIP Code: 10101

Country: ZAMBIA

The deadline for the submission of bids is:

Date: 23 June, 2006

Time: 14:00 hrs (PM)

The applications must be deposited in the Tender Box at the Zambia National Tender Board, 2nd Floor, Red Cross House, Plot 2837, Los Angeles Boulevard Longacres, Lusaka, Zambia, on or before 16 June 2006.

Envelope Marking:

“Pre-qualification for the Supply and Delivery of Drugs for Opportunistic and Sexually Transmitted Infections to the Ministry of Health ”

Tender No. TB/ORD/020/067.2 Late applications shall not be accepted7.3 Language:

All information requested for prequalification shall be provided in the English language.

8.1 Purchaser’s Notification

Time period from submission of applications: within sixty (60) days.


PARTICULAR INSTRUCTIONS TO APPLICANTS (PITA)Part B: Specific Contract Requirements

1.2 The goods to be supplied: Drugs for the treatment of Opportunistic and Sexually Transmitted Infections in HIV/AIDS care and support Management

1.3 Details of one or more items: See annex 1

1.5 Type of Contract

Bidding Documents: “Standard Bidding Documents (SBD) for the procurement of Health Sector Goods, May 2004”

Method of payment: The method and conditions of payment to be made to the Supplier under this Contract shall be in line with the agreed staggered deliveries as follows:

Payment for Goods supplied from abroad:

Payment of foreign currency portion shall be made in the currency of the Bid in the following manner:

(i) Advance Payment: Ten (10) percent of the Contract Price shall be paid within thirty (30) days of signature of Contract and receipt of the Performance Guarantee, upon submission of an invoice (showing Purchaser’s name; the Contract number, loan number; description of payment and total amount, signed in original, stamped or sealed with the company stamp/seal) and a bank guarantee in the form provided.

(ii) On Shipment: Eighty (80) percent of the Contract Price of the Goods shipped shall be paid through irrevocable confirmed letter of credit opened in favor of the Supplier in a bank in its country, upon submission of agreed shipping documents or, alternatively, at the Supplier’s option, within thirty (30) days of submission of agreed shipping documents by direct bank transfer to the Supplier’s nominated bank account. Opening charges and charges for amendment of the letter of credit at the request of or due to a fault or default of the Purchaser are for the account of the Purchaser. Confirmation charges and charges for amendment to letters of credit at the request of or due to a fault or default on behalf of the Supplier are for the account of the Supplier.

(iii) On Acceptance: Ten (10) percent of the Contract Price of


Goods received shall be paid within thirty (30) days of receipt of the Goods upon submission of an invoice (showing Purchaser’s name; the Contract number, loan number; description of payment and total amount, signed in original, stamped or sealed with the company stamp/seal) supported by the Acceptance Certificate issued by Medical Stores Ltd, Plot No. 6446, Mukwa Road, LUSAKA on behalf of the Purchaser.

Payment of local currency portion shall be made in Zambian Kwacha within thirty (30) days of presentation of an invoice (showing Purchaser’s name; the Contract number, loan number; description of payment and total amount, signed in original, stamped or sealed with the company stamp/seal) supported by the Acceptance Certificate issued by Medical Stores Ltd, Plot No. 6446, Mukwa Road, LUSAKA on behalf of the Purchaser.

Payment for Goods and Services supplied from within the Purchaser’s country:

Payment for Goods and Services supplied from within the Purchaser’s country shall be made in US Dollars or Zambian Kwacha at the option of the Supplier as follows:

(i) Advance Payment: Ten (10) percent of the Contract Price shall be paid within thirty (30) days of signature of Contract and receipt of the Performance Guarantee, upon submission of an invoice (showing Purchaser’s name; the Contract number, loan number; description of payment and total amount, signed in original, stamped or sealed with the company stamp/seal) and a bank guarantee in the form provided.

(ii) On Shipment: Eighty (80) percent of the Contract Price of the Goods shipped shall be paid within 30 days of submission of agreed shipping documents by direct bank transfer to the Supplier’s nominated bank account.

(iii) On Acceptance: Ten (10) percent of the Contract Price of Goods received shall be paid within thirty (30) days of receipt of the Goods upon submission of an invoice (showing Purchaser’s name; the Contract number, loan number; description of payment and total amount, signed in original, stamped or sealed with the company stamp/seal) supported by the Acceptance Certificate issued by Medical Stores Ltd, Plot No. 6446, Mukwa Road, LUSAKA on behalf of the Purchaser.

Prices: shall be Fixed

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1.6 Delivery terms: CIP (Medical Stores Ltd, Plot No. 6446, Mukwa Road, LUSAKA

Frequency of shipments: 50% supplied in the first three months of contract effectiveness, the balance to be called off as and when required by MoH but should be completed within six months of contract effectiveness.

Goods registration and packing/marking requirements: See Annex 2

The Borrower may wish to add specific packing/marking requirements, such as special notes on the package marking (e.g., “Not for sale”) and/or others to be advised separately.

Contract (s) validity period: 12 months

Other relevant information: See Annex 2

4.2 Qualification requirements for Applicants are:

Quantifiable qualification criteria for experience and/or financial viability:

The Applicant should provide the following documents with its application:

Documentary evidence of the Applicant’s qualifications to perform the Contract if its bid is accepted:

(i) that, in the case of an Applicant offering to supply Goods under the Contract that the Applicant manufactures or otherwise produces (using ingredients supplied by primary manufacturers) that the Applicant:

(a) is incorporated in the country of manufacture of the Goods;

(b) has been licensed by the regulatory authority in the country of manufacture to supply the Goods;

(c) has manufactured and marketed the specific goods covered by this Bidding Document, for at least two (2) years, and for similar Goods for at least five (5) years;

(d) has received a satisfactory GMP inspection certificate in line with the WHO certification scheme on pharmaceuticals moving in International Commerce from the regulatory authority (RA) in the country of manufacture of the goods or has been certified by the competent authority of a member country of the Pharmaceuticals Inspection Convention (PIC), and has demonstrated compliance with the quality standards


during the past two years prior to bid submission;

(ii) that, in the case of an Applicant offering to supply Goods under the Contract that the Applicant does not manufacture or otherwise produce,

(a) that the Applicant has been duly authorized by a manufacturer of the Goods that meets the criteria under (i) above to supply the Goods in the Purchaser’s country; and

The Applicant shall also submit the following additional information:

(a) a statement of installed manufacturing capacity;

(b) copies of its audited financial statements for the past three fiscal years;

(c) details of on-site quality control laboratory facilities and services and range of tests conducted;

(d) list of major supply contracts conducted within the last five years.

(e) evidence of manufacturing quality certification (certificates) for:

i) certification of quality of ingredients

ii) quality of manufactured goods, and

iii) the containers and packaging to required ISO or WHO, etc standard and or other equivalent international manufacturing standard for this type of goods.

4.3 (a) A least three (3) similar contracts within the last five years. Similar contracts are those of approximately the same size and that includes comparable products, e.g., capsules, tablets, suspensions.

4.3 (b) The Annual Production required should be at least three (3) times the quantities specified under the contract.

4.3 (c) The amount of Annual Sales Value required should be at least five (5) times the estimated contract value during the last five years.

4.4

4.4 (a) An Applicant should have manufactured and marketed the specific goods subject of bidding for at least two (2) years.

4.4 (b) An Applicant should have manufactured and marketed similar goods

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subject of bidding for at least five (5) years

4.5 Products supplied equivalent of US$ 2 million or more.

4.6 All drugs to be supplied to Zambia must be registered with the Pharmaceutical Regulatory Authority (PRA). It is expected that by the time of Contract signing, the successful Bidder shall have complied with the documentary requirements for the registration of Pharmaceutical Products in accordance with the provisions of the Pharmaceutical Act No. 14 of 2004 and Statutory Instrument No. 47 of 1993.

It takes on average four (4) – four (6) weeks for the PRA to complete the registration process when all required documents are submitted.

For the purpose of obtaining additional information about the requirements for registration, Applicants may contact the Director General at the following:

Name: Pharmaceutical Regulatory Authority (PRA)

Address: Old Medical Stores, P.O. Box 31890

Plot No. 6903

Tuleteka Road

LUSAKA

Telephone: 260 1 220429

Fax: 260 1 238458

Email: [email protected]

Contact Person: Mwape E. (Ms)

Invitation for Bids (Sample form) 21

SAMPLE BASIC FORM* INVITATION FOR BIDS [date]

To: [name of Supplier][address]

Reference: [Insert IBRD Loan No. or IDA Credit No.]

Contract Name, and Identification No. ________ / ________

Dear Sirs:

We hereby inform you that you are prequalified for bidding for the above cited contract. A list of prequalified and conditionally prequalified Applicants is attached to this invitation.

On the basis of information submitted in your application, you would [not] (insert if appropriate) appear eligible for application of the domestic bidder price preference in bid evaluation. Eligibility is subject to confirmation at bid evaluation.

We now invite you and other prequalified Applicants to submit sealed bids for the execution and completion of the cited contract.

You may obtain further information from, and inspect and acquire the bidding documents at, our offices at [mailing address, street address, and cable/telex/facsimile numbers].

A complete set of bidding documents may be purchased by you at the above office, on or after [time and date] and upon payment of a nonrefundable fee of …………….. on the day of payment. The method of payment will be [insert payment method].

All bids must be accompanied by a security in the form and amount specified in the bidding documents, and must be delivered to [address and exact location] at or before [time and date]. Bids will be opened immediately thereafter in the presence of bidders’ representatives who choose to attend.

Please confirm receipt of this letter immediately in writing by cable, fax, or telex. If you do not intend to bid, we would appreciate being so notified also in writing at your earliest opportunity.

Yours truly,

Authorized signature Name and title Purchaser

* This basic form may be adapted by the Purchaser to notify conditionally prequalified.

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LETTER OF APPLICATION

[letterhead paper of the Applicant including full postal address, and telephone, facsimile and telex numbers, and cable address]

Date: To:

Name of Project:

1. Being duly authorized to represent and act on behalf of __________________ (hereinafter referred to as “the Applicant”), and having reviewed and fully understood all of the prequalification requirements and information provided, the undersigned hereby applies for prequalification to bid on the contract or contracts indicated below:

*Note: If prequalification refers to only one contract, delete the following paragraph and table, and insert the single contract reference and title.

* We have indicated (by signature) in column (3) below our preference for individual contract consideration, or for any combination thereof within our prequalified capacity as assessed by you.

Contract reference*(1)

Contract title*(2)

Preferred individual contract

(3)

1.

2.

3.

4.etc.

2. Attached to this letter are copies of original documents defining:

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(a) the Applicant's legal status;

(b) the principal place of business; and

(c) the place of incorporation (for Applicants that are corporations), or the place of registration and the nationality of the owners (for Applicants that are partnerships or individually owned firms).

3. Your Agency and its authorized representatives are hereby authorized to conduct any inquiries or investigations to verify the statements, documents, and information submitted in connection with this application, and to seek clarification from our bankers and clients regarding any financial and technical aspects. This Letter of Application will also serve as authorization to any individual or authorized representative of any institution referred to in the supporting information to provide such information deemed necessary and as requested by yourselves to verify statements and information provided in this application, such as the resources, experience, and competence of the Applicant.

4. Your Agency and its authorized representatives may contact the following persons for further information:

General and managerial inquiries

Contact 1 Address and communication facilities


Personnel inquiries


Technical inquiries



Financial inquiries

24 Letter of Application



5. This application is made with the full understanding that:

(a) bids by prequalified Applicants will be subject to verification of all information submitted for prequalification at the time of bidding;

(b) your Agency reserves the right to:

amend the scope and value of any contracts to be bid under this project; in which event, bids will be invited only from those Applicants who meet the resulting amended prequalification requirements; and

reject or accept any application, cancel the prequalification process, and reject all applications.

(c) your Agency shall not be liable for any such actions under 5 (b) above.

6. The undersigned declare that the statements made and the information provided in the duly completed application are complete, true, and correct in every detail.

Signed Signed

Name Name

For and on behalf of: For and on behalf of:

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Section 1: Company Details and General Information

1. Name of Firm:2. Street Address: Postal Code: City: Country:

3. P.O. Box and Mailing Address:

4. Telephone Number:

5. Fax Number:

6. E-mail Address:

7. WWW Address:

8a. Contact Name:

8b. Contact Title:

9. Parent Company, if Any (Full Legal Name):

10. Subsidiaries, Associates, and/or Overseas Representative(s), if Any:

11. Nationality of the Firm

12. Type of Business:

12a. If Other, specify:

13. Nature of Business:

14. Year Established:

15. Key Personnel: [include name of candidate, position, professional qualifications, and experience]

Technical Production Management

16. Dates, Numbers, and Expiration Dates of Current Licenses and Permits:

17. Current health authority registration information:

18. Proof of product and facility registrations with purchaser’s country regulatory authority and international agencies (e.g., WHO Certification Scheme, GMP)

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19. Name of government agency(ies) responsible for inspecting and licensing of facilities in the country of origin of the raw material and or processing of the goods:

Date of last inspection: 20. Quality Assurance Certification (Please include a copy of your latest certificate with the PQ application):

21. Production capacity: [insert peak and average production capacity over the last three years in units/day or units/month, etc.]

22. List of names and addresses of sources of raw material and what products they will be used in:

23. Proof of raw material product and facility registrations with purchaser’s country regulatory authority and international agencies (e.g., WHO Certification Scheme, GMP):

24. Raw materials tested prior to use:

25. Presence and characteristics of in-house quality control laboratory

26. Names and addresses of external quality control laboratories used:

27. Are all finished products tested and released by quality control prior to release for sale?

Yes No If not, why?

28. List control tests done during production? If so list.

29. Procedures for dealing with rejected batches:

30. List tests conducted after production and prior to release of product on market:

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31. List product recalls linked to defects during the last 36 months. Include reason and date of recall.

32. Are technical documents available in: [Purchaser should insert language]

Yes No

33. Working languages (Language of bid and contract): [Purchaser should insert working language]

Section 2: Financial Information

34/35. Annual Sales Value for the last 3 years:

Year Total Sales (USD)

36. VAT No./Tax I.D.:

37a. Bank Name:

37b. Swift/BIC Address:

37c. Bank Address:

37a. Bank Account Number:

37b. Account Name:

38. Please mail a copy of the company’s Annual or Audited Financial Report of the last three years.

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Section 3: Current Contract Commitments / Contracts in Progress

39. Name of Contract(s)

40 Purchaser Contact Information [insert address, telephone, fax, e-mail address]

41 Value of outstanding contracts [current US$ equivalent]

42 Estimated delivery date

43 Average monthly invoices over the last six months (US$/mon.)

Section 4. Experience

44. Contracts over [insert amount] during the last three years:

Purchaser Value Year Goods/Services Supplied Country of Destination

Section 5: Other

45. Please list any disputes your company has been involved in over the last 3 years:Year Award FOR

or AGAINSTapplicant

Name of client, cause of litigation, and matter in dispute

Dispute amount (current value, US$ equivalent

46.We hereby certify that the information provided in this form is correct, and in the event of changes, details will be provided as soon as possible.

Signed: ___________________________________

Date:__________________________

in the capacity of: [insert title or other appropriate designation]

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Manufacturer’s Authorization Form(Manufacturer’s or Producer’s letterhead)

To:

WHEREAS [ insert: name of the manufacturer or producer ] (hereinafter, “we” or “us”) who are established and reputable manufacturers or producers of [ insert: name and/or description of the Goods requiring this authorization ] (hereinafter, “Goods”) having production facilities at [ insert: address of factory ] do hereby authorize [ insert: name and address of Applicant] (hereinafter, the “Applicant”) to submit a Letter of Application, and subsequently negotiate with you against IFP [ insert: title and reference number of the Invitation for Prequalification ] including the above Goods produced by us.

For and on behalf of the Manufacturer or Producer

Signed: ___________________________________________________________

Date: ______________________________________

In the capacity of [ insert: title, position, or other appropriate designation ] and duly authorize to sign this Authorization on behalf of [ insert: name of manufacturer or producer ]

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TECHNICAL SPECIFICATIONS

ANNEXES

ANNEX 1

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DRUGS FOR OPPORTUNISTIC INFECTIONS/ STIs

No. Generic description of drug Unit Pack Size

Required Quantity (in unit packs)

Delivery schedule in weeks from date of Shipment

1 Ciprofloxacin 250mg tablets BP/USP 100 15,000 6-10 weeks2 Ceftriaxone, powder for Inj. 250mg, vial

BP/USPEach 35,000 6-10 weeks

3 Cefuroxime 250mg tablets 100 10,000 6-10 weeks4 Azithromycin 1g +2 Secnidazole 1g +

Fluconazole 150mg tabletsEach 5,000 6-10 weeks

5 Amphontericin B, powder for injection, 50mg vial, BP/USP

Each 10,000 6-10 weeks

6 Chloramphenicol 1g, powder for Inj. Solution, BP/USP


7 Clarithromycin 250 mg tablets BP/USP 14 6,000 6-10 weeks8 Cefotaxime (as Sodium salt, powder for

reconstitution) 1g, Each 20,000 6-10 weeks

9 Amitriptyline 25mg tablets, BP/USP 100 2000 6-10 weeks10 Acyclovir 400mg tablets, BP/USP 100 2,000 6-10 weeks11 Acyclovir Eye Ointment, 3%, BP/USP Each 2,000 6-10 weeks12 Actinomycin D, Lyophilised powder for

solution Inj. 500mcg, vial, BP/USPEach 5,000 6-10 weeks

13 Doxorubin Hydrochloride solution for Injection 2mg/ml, BP/USP


14 Vincristine, powder for Inj. 1mg, Vial, BP/USP


15 Cefixime oral suspension 100mg/5ml, BP/USP


16 Cycloserine 250mg capsules, BP/USP 100 500 6-10 weeks17 Ethionamide tablets, USP 100 500 6-10 weeks18 Kanamycin Sulphate Injection 1g,

BP/USP Each 44,000 6-10 weeks

19 Ofloxacin 200mg tablets, BP 100 1,000 6-10 weeks20 Clotrimazole pessaries 500 mg, Pkt 15 20,000 6-10 weeks21 Benzathine Penicillin 2.4 m.u. injection Vial 20,000 6-10 weeks22 Erythromycin syrup 125mg/5ml BP 100ml 100,000 6-10 weeks23 Erythromycin 250mg tablets BP 1000 12,500 6-10 weeks

Delivery Point:

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Medical Stores LimitedPlot No. 6446, Mukwa RoadLUSAKA, ZAMBIA

Shelf Life:

All Pharmaceuticals are expected to have 80% of their Shelf life remaining at the time of delivery. Pharmaceuticals with less than 80% of the shelf life shall be rejected and a replacement shall be called at the supplier’s expense.

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ANNEX 2

Technical SpecificationsPHARMACEUTICALS

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1. Product and Package Specifications

1.1 The Goods to be purchased by the Purchaser under this Invitation for Bids are included in Zambia’s current national essential drugs list and Zambia National Formulary 1999-2001. The required packing standards and labeling must meet the latest requirements of the World Health Organization (WHO) good manufacturing practices (GMP) standards in all respects. (These standards are contained in “Good Practices in the Manufacture and Quality Control of Drugs.”)

1.2 Product specifications indicate dosage form (e.g., tablet, capsules, dry syrup, liquid, ointment, injectable, emulsion, suspension, etc.) and the drug content (exact number of mg or international units [IU] or % v/v, w/w or v/w acceptable range). The Goods should conform to standards specified in the following compendia: the British Pharmacopoeia, the United States Pharmacopoeia, the International Pharmacopoeia, or the European Pharmacopoeia, the standards will be the latest. In case the pharmaceutical product is not included in the specified compendium, but included in Zambia’s Current National Essential Drug List and is included in the current requirement under this Invitation the Supplier, upon award of the Contract, must provide the reference standards and testing protocols to allow for quality control testing.

1.3 Not only the pharmaceutical item, but also the packaging and labeling 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 the country of the Purchaser. All packaging must be properly sealed and tamper-proof, and packaging components must meet the latest compendium standards as specified above and be approved for pharmaceutical packaging by the manufacturer’s national regulatory authority (RA).

1.4 All labeling and packaging inserts shall be in English.

1.5 Goods requiring refrigeration or freezing or those that should not fall below a certain minimum 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 the final destination.

1.6 Upon award, the successful Supplier shall, on demand, provide a translated version in the language of the bid of the prescriber’s information for any specific goods the Purchaser

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may request.

2. Labeling Instructions

2.1 The label of the primary container for each pharmaceutical and vaccine products shall meet the W210 GMP standard and include:

(a) The international nonproprietary name (INN) or generic name prominently displayed and above the brand name, where a brand name has been given. Brand names should not be bolder or larger than the generic name;

(b) dosage form, e.g., tablet, ampoule, syrup, etc.;

(c) the active ingredient “per unit, dose, tablet or capsule, etc.”;

(d) the applicable pharmacopoeial standard;

(e) the Purchaser’s logo and code number and any specific color 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);

(k) name and address of manufacture;

(l) any additional cautionary statement.

2.2 The outer case or carton should also display the above information.

3. Case Identification

3.1 All cases should prominently indicate the following:

(a) Purchaser’s line and code numbers;

(b) the generic name of the product;

(c) the dosage form (tablet, ampoule, syrup);

(d) date of manufacture and expiry (in clear language not code);

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(e) batch number;

(f) quantity per case;

(g) special instructions for storage;

(h) name and address of manufacture;

(i) any additional cautionary statements.

3.2 No case should contain pharmaceutical products from more than one batch.

4. Unique Identifiers

4.1 The Purchaser shall have the right to request the Supplier to imprint a logo, if the quantity so justifies it, on the labels of the containers used for packaging and in certain dosage forms, such as tablets, and ampoules and this will be in the Technical Specifications. The design and detail will be clearly indicated at the time of bidding, and confirmation of the design of such logo shall be provided to the Supplier at the time of contract award.

5. Standards of Quality Control for Supply

5.1 The successful Supplier will be required to furnish to the Purchaser:

(a) With each consignment, and for each item a WHO certificate of quality control test results concerning quantitative assay, chemical analysis, sterility, pyrogen content uniformity, microbial limit, and other tests, as applicable to the Goods being supplied and the manufacturer’s certificate of analysis.

(b) Assay methodology of any or all tests if requested.

(c) Evidence of bio-availability and/or bio-equivalence for certain critical Goods upon request.

This information would be supplied on a strictly confidential basis only.

(d) Evidence of basis for expiration dating and other stability data concerning the commercial final package upon request.

5.2 The Supplier will also be required to provide the Purchaser with access to its manufacturing facilities to inspect the compliance with the GMP requirements and quality control mechanisms.

Pre-qualification for Drugs for OIs STIs.doc

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