TRIAL EDITION

STANDARD PREQUALIFICATION
DOCUMENT

Procurement of Health
Sector Goods

World Bank
Washington, D.C.
April 2002
 1

SPECIFIC PROCUREMENT NOTICE

Invitation for Prequalification
[insert country]
[insert project name]
Loan No. [insert loan no.]
This invitation for prequalification follows the general procurement notice for this project that
appeared in Development Business No. [insert number] of [insert date].
The Government of [insert country] has received a loan from the International Bank for
Reconstruction and Development (IBRD) toward the cost of the [insert name of project], and it
intends to apply part of the proceeds of this loan to payments under the contracts for supply of
the following Goods:
Lot Ref. Lot Description Dosage/Form
No.

Note: applications may be made for prequalification for one or more of the contracts.
The [insert implementing agency name], 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 [insert month and year].
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 eligible bidders may obtain further information from and inspect the prequalification
documents at the [insert name of agency] (address below) from [insert office hours]. A
complete set of prequalification documents in [insert language] may be purchased by interested
bidders on the submission of a written application to the address below and upon payment of a
nonrefundable fee of [insert amount in local currency] or in [insert amount in specified
convertible currency]. The method of payment will be [insert payment method]. The
document will be sent by [insert delivery procedure]. All banking costs shall be borne by the
bidder.
Applications for prequalification should be submitted in sealed envelopes, delivered to the
address below by [insert date], and be clearly marked “Application to Prequalify for the [insert
number(s) and name(s) of Lots].”
The Purchasers Implementing Agency:
General Instructions to Applicants - GITA 3

GENERAL INSTRUCTIONS TO APPLICANTS (GITA)

General Instructions to Applicants - GITA 4

1. Source of Funds and Scope of Works

Source of 1.1 The Borrower named in the Particular Instructions to Applicants
Funds (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
contract(s) for which this prequalification is issued.

Goods to be 1.2 The Purchaser, as named in the PITA, intends to prequalify

supplied suppliers for supply of Goods described in the PITA.

Lot and 1.3 If so indicated in the PITA, bids will be invited for one or more
Package 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 1.4 It is expected that prequalified applicants will be invited to submit

Invitation bids during the month and year indicated in the PITA.

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

General 1.6 General information on the delivery terms, frequency of shipments,

Information 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 Corruption

2.1 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 influence
the action of a public official in the procurement
process or in contract execution; and
General Instructions to Applicants - GITA 5

(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 Bidders

Eligible 3.1 Except as provided in Sub-Clauses 3.2 and 3.3, this Invitation for
Countries 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

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.
6 General Instructions to Applicants - GITA

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

Particular 4.3 The Applicant shall provide evidence that it has the financial,
Experience 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.
Manufacturi 4.4 The applicant should have manufactured and marketed
ng
Experience (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
General Instructions to Applicants - GITA 7

for and on behalf of the primary manufacturer.

Experience 4.5 The Applicant should provide proof of experience with and knowledge
on of modes of packing, distribution, and transportation of
Packaging, pharmaceuticals similar to those subject to bidding under logistical
Distribution and climatic conditions similar to the ones in the purchaser’s
and country. It should provide names of countries to which the
Transportati Applicant has supplied (including packaged, distributed, and
on transported) products worth at least the amount specified in the
PITA within the past three years.
Registration 4.6 Unless PITA stipulates otherwise, the Goods to be supplied under
Requiremen the Contract shall be registered with the relevant authority in the
ts 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 4.7 When applying for prequalification on more than one contract under
Package the lot and package arrangements, the Applicant must provide
evidence that it meets or exceeds the sum of all the individual
8 General Instructions to Applicants - GITA

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

5. Domestic Preference
Eligibility 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 Clarification
Notificatio 6.1 Applicants are responsible for requesting any clarification of the
n prequalification documents. A request for clarification shall be made
and in writing to the Purchaser’s address indicated in the PITA. The
Response 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 Applications
Delivery 7.1 Submission of applications for prequalification must be received in
General Instructions to Applicants - GITA 9

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 7.2 The Purchaser reserves the right to accept or reject late applications.
Applicatio
ns
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 7.4 Failure of an Applicant to provide comprehensive and accurate
Informatio information that is essential for the Purchaser’s evaluation of the
n Applicant’s qualifications, or to provide timely clarification or
substantiation of the information supplied, may result in
disqualification of the Applicant.
Material 7.5 Applicants, and those subsequently prequalified or conditionally
Changes 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 Process

Invitation 8.1 Within the period stated in the PITA from the date for submission of
for Bid 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 8.2 An Applicant may be “conditionally prequalified”, that is, qualified
Prequalificat subject to certain specified nonmaterial deficiencies in the
ion 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
10 General Instructions to Applicants - GITA

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 8.5 The Purchaser reserves the right to take the following actions, and
Rights 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.
 11

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

1.1 Source of Funds

The Borrower: [insert name of Borrower]

Amount of Loan: US$ ______ equivalent [insert loan amount]

Name of Project: [insert project name]

1.2 The Purchaser: [insert name and complete mailing address, telephone and fax
numbers, and electronic mail address of Purchaser]

1.3 Bids are being invited for [indicate “one or more items,” or “individual
contracts (lots)”]

1.4 Bid Invitation

Expected date of Invitation for Bids: [Insert date for Invitation for Bids]

5.1 Domestic Preference: [insert domestic preference “will” or “will not” 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.
 12

6.1 Requests for Clarification:

Requests for clarification shall be addressed to:

The Purchasers Implementing Agency:
Name
Address
Tel.
Fax.
Email:
Contact person:

7.1 Submission of Applications

Address:
The Purchasers Implementing Agency:
Name
Address
Tel.
Fax.
Email:
Contact person:

Date for Submission:

[The time allowed for preparation and submission of the prequalification
document should be sufficient for applicants to gather all the information
required—preferably eight weeks, but in any case not less than six weeks after
the dates when the documents are available for distribution or the date of the
advertisement.]

Envelope Marking: [insert project name and no.]

7.3 Language:

All information requested for prequalification shall be provided in the [insert

language] language.
Particular Instructions to Applicants - PITA 13

8.1 Purchaser’s Notification

Time period from submission of applications: _____ days

[Depending on the complexity of the contract(s), and of the evaluation criteria
(e.g. slice and package), etc., a period between fifty-six to eighty-four (56 to
84) days is considered appropriate, including seeking the Bank’s “no
objection.”]
Particular Instructions to Applicants - PITA 14

PARTICULAR INSTRUCTIONS TO APPLICANTS (PITA)

Part B: Specific Contract Requirements

1.2 The goods to be supplied: [insert need for goods, i.e., 1st line
Pharmaceuticals for treatment of Tuberculosis]
1.3 [Insert details of “one or more items” or “individual contract (lots)”]

1.5 Type of Contract

Bidding Documents: [insert name of bidding document]

Method of payment: [insert payment method]

Prices: [insert “Fixed” or “Adjustable”]

1.6 Delivery terms: [insert delivery terms]

Frequency of shipments: [insert frequency of shipments]
Goods registration and packing/marking requirements: [insert registration
and packing/marking requirements]
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: [insert contract validity period]
Other relevant information: [insert other relevant information]
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
Particular Instructions to Applicants - PITA 15

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.
4.3 (a) The range should be not less than three and not more than five (normally
four), depending on the size and complexity of the subject contract within
the last five years. Similar contracts are those of approximately the same size
and that includes comparable products, e.g., capsules, tablets, vaccines.
4.3 (b) The Annual Production required should be at least three times the quantities
specified under the contract.
4.3 (c) The amount of Annual Sales Value required should be at least five 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 years.
16 Annexes to PITA

4.4 (b) An Applicant should have manufactured and marketed similar goods subject
of bidding for at least five years
4.5 Products supplied equivalent of US$ ______ or more.

4.6 By the time of Contract signing, the successful Bidder shall have complied
with the following documentary requirements in order to register the Goods
to be supplied under the Contract:
[insert documentary requirements]

For the purpose of obtaining additional information about the requirements

for registration, Applicants may contact:
Registration of pharmaceuticals:
[insert name, address, telephone, and contact persons for registration
offices, i.e., Pharmaceutical registration, Pharmacological committee of
Ministry of Health, Pharmacopoeia committee of Ministry of Health,
Department of governmental control for quality, efficiency and safety of
pharmaceuticals and medical equipment ]
Invitation for Bids (Sample form) 17

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 [insert amount in local
currency], 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.
Letter of Application 18

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.

Preferred
Contract reference* Contract title* individual contract
(1) (2) (3)
1.

2.

3.

4.
etc.

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

(a) the Applicant's legal status;

(b) the principal place of business; and

Letter of Application 19

(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

Contact 2 Address and communication facilities

Personnel inquiries
Contact 1 Address and communication facilities

Contact 2 Address and communication facilities

Technical inquiries
Contact 1 Address and communication facilities

Contact 2 Address and communication facilities

Financial inquiries
Contact 1 Address and communication facilities
20 Letter of Application

Contact 2 Address and communication facilities

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:

Letter of Application 21

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)
22 Particular Instructions to Applicants - PITA

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:

31. List product recalls linked to defects during the last 36 months. Include reason and
date of recall.
Letter of Application 23

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.

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.)

24 Particular Instructions to Applicants - PITA

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 Name of client, cause of litigation, and Dispute amount
or AGAINST matter in dispute (current value, US$
applicant 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]

Annex 1 to Letter of Application 25

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 ]