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Health Sector Goods - Section VIII. Sample Forms

Section VIII. Sample Forms

Notes to the Purchaser on the Preparation of the Sample Forms

The Sample Forms provided in these SBD provide standard formats for a number of the key documents that the Purchaser and Bidders will exchange in the process of bidding, awarding, and implementing the Contract. Most of the Sample Forms are to be completed by the Purchaser. Except for the Bid Form and Form of Contract Agreement, the Purchaser or the Bidder may modify the forms to suit the particular procurement. The forms are included in the Bidding Documents before they are released to potential Bidders. In turn, the Bidders or winning Bidder must complete other forms, as indicated on the form, and submit them to the Purchaser. Notes providing instructions for the Purchaser, the Bidders, and the winning Bidder have been provided. To avoid confusion, the Purchaser should remove all the instructions to the Purchaser from the final version of the Bidding Documents that is released to potential Bidders.

The typographical aides used in the previous sections of the SBD continue in this section. General explanatory text that appears in this text (sans serif typeface) remains intended for the Purchaser. General instructions or explanatory text aimed at Bidders and/or the winning Bidder appear in standard roman typeface. Instructions that appear directly in the forms continue to be in italicized roman typeface, set off with square brackets and intended for the Bidders or the winning Bidder. If an instruction is meant for the Purchaser, it is identified as such. Purchasers are encouraged to provide as many of these Sample Forms as possible in revisable, electronic format in the Bidding Documents. This will expedite bid preparation, reduce the number of inadvertent mistakes made by Bidders, and, as a result, simplify the evaluation.

Bid Form and Form of Contract Agreement: Except as indicated by blanks and/or instructions to fill in information, the text of the Bid Form and the Contract Agreement should be left unaltered in the Bidding Documents from how it appears in these SBD. It would be at the time of Contract award when the Purchaser has an opportunity to add the final details needed in the Contract Agreement form, by making any necessary insertions or changes to paragraph 2.

Since the Price Schedules will form part of the final Contract, if there have been any corrections or modifications to the winning bid resulting from price corrections, pursuant to the Instructions to Bidders, these too should be reflected in the Price Schedules at the time of Contract award.

Price Schedules: The price breakdown given in the sample Price Schedules generally follows the usual breakdown requested for procurement of Goods in order for the domestic preference procedure to be applied. It is essential that Bidders submit their prices in the manner prescribed by the Price Schedules. Failure to do so, may result in loss of the preference, if applicable.

Manufacturer¬タルs Authorization Form: In accordance with ITB Sub-Clause 7.1 (b), Bidders must submit, as part of their bids, Manufacturer¬タルs Authorization Form(s) in the format provided in the SBD for all items specified in the Bid Data Sheet.

Bid Security Form: Regarding ITB Clause 19, the Purchaser should include the Bid Security form provided in the SBD in the Bidding Documents. The Purchaser must ensure that the new form substantially complies with the features of the form included here in respect to its degree of protection and clarity of conditions under which it can be made effective.

Performance Security Form: Pursuant to GCC Sub-Clause 8.1, the successful Bidder is required to provide the performance security within twenty-eight (28) days of notification of Contract award.

Advance Payment Bank Guarantee: Pursuant to GCC Sub-Clause 16.1, the successful Bidder is required to provide a bank guarantee securing the advance payment, if SCC related to GCC Sub-Clause 16.1 provides for one.

Notes to Bidders on the Preparation of Sample Forms

The Purchaser has prepared the forms in this section of the Bidding Documents to suit the specific requirements of the procurement. In its bid, the Bidder must use these forms (or forms that present in the same sequence substantially the same information). If the Bidder has a question regarding the meaning or appropriateness of the contents or format of the forms and/or the instructions contained in them, these questions should be brought to the Purchaser¬タルs attention as soon as possible during the bid clarification process, by addressing them to the Purchaser in writing pursuant to ITB Clause 11.

The Purchaser has provided explanatory text and instructions to help the Bidder prepare the forms accurately and completely. The instructions that appear directly on the forms themselves are indicated by use of typographical aides such as italicized text within square brackets.

In preparing its bid, the Bidder must ensure all such information is provided and that the typographical aides are removed.

Sample Forms

1. Bid Form
2. Price Schedule for Goods Offered from Abroad
3. Price Schedule for Domestic Goods Offered from within the Purchaser's Country
4. Bid Security Form
5. Form of Contract Agreement
6. Performance Security Bank Guarantee
7. Bank Guarantee Form for Advance Payment
8. Manufacturer's Authorization Form
9. Specimen Certificate of a Pharmaceutical Product

1. Bid Form

Date: [ insert: date of bid ]
Loan/Credit No.: [ Purchaser insert: number ]
[ Purchaser specify: "IFB No.: [ number ]" ]
[ insert: name of Contract ]
To: [ Purchaser insert: Name and address of Purchaser ]

Dear Sir or Madam:

Having examined the Bidding Documents, including Addenda Nos. [ insert numbers ], the receipt of which is hereby acknowledged, we, the undersigned, offer to supply and deliver the Goods under the above-named Contract in full conformity with the said Bidding Documents for the sum of:

 

[ insert: amount of local currency in words ]

([ insert: amount of local currency in figures ])

plus

[ insert: amount of foreign currency A in words ]

([ insert: amount of foreign currency A in figures ])

[ as appropriate, include the following ]

plus

[ insert: amount of foreign currency B in words ]

([ insert: amount of foreign currency B in figures ])

plus

[ insert: amount of foreign currency C in words ]

([ insert: amount of foreign currency C in figures ])

(hereinafter called "the Total Bid Price") or such other sums as may be determined in accordance with the terms and conditions of the Contract. The above amounts are in accordance with the Price Schedules attached herewith and are made part of this bid.

We undertake, if our bid is accepted, to deliver the Goods in accordance with the delivery schedule specified in the Schedule of Requirements.

If our bid is accepted, we undertake to provide an advance payment security and a performance security in the form, in the amounts, and within the times specified in the Bidding Documents.

We agree to abide by this bid, for the Bid Validity Period specified in Clause 18.1 of the Bid Data Sheet and it shall remain binding upon us and may be accepted by you at any time before the expiration of that period.

Until the formal final Contract is prepared and executed between us, this bid, together with your written acceptance of the bid and your notification of award, shall constitute a binding Contract between us. We understand that you are not bound to accept the lowest or any bid you may receive.

Commissions or gratuities, if any, paid or to be paid by us to agents relating to this bid, and to contract execution if we are awarded the Contract, are listed below:

Name and Address of Agent

 

Amount and Currency

 

Purpose of Commission or Gratuity

 ____________   ____________   ____________
 ____________   ____________   ____________

(if none, state "none")

 

Dated this [ insert: number ] day of [ insert: month ], [ insert: year ].

Signed: ________________________________________
Date: ________________________________________
In the capacity of [ insert: title or position ]
Duly authorized to sign this bid for and on behalf of [ insert: name of Bidder ]


2. Price Schedule for Goods Offered from Abroad

(Group C bids)

Name of Bidder ________________ IFB Number ________________ Page___ of ___

1

2

3

4

5

6

7

8

9

10

11

12

13

14

Product code

Product

Strength

Dosage form

Unit pack

Qty. offered

Unit prices

Total unit

Total price per

Local agent¬タルs

Shipment weight

Name of manufac-

Ctry. of

Pharma-copoeial

    

size

 

[a]
Unit price FOB port loading

[b]
CIF at port of entry or CIP named place of destina-tion (specify one)

[c]
Inland transp., insurance & other local costs incidental to delivery if specified

[d]
Other incidental costs as defined in the SCC

price
[a+c+d]
or
b+c+d]

item
[6 x 8]

commission as a % of FOB price included in quoted price

and volume

turer

origin

standard

                 
                 
                 
                 

Note:

(i) Column 7[c] is optional and it will be applicable only when required in accordance with ITB Sub-Clause 16.2 (b) (iv) and (v) and the related provisions in the Bid Data Sheet.

(ii) For column 9, pursuant to ITB 30.1, in the case of discrepancy between unit price and total price, the unit price shall prevail.

Total Bid Price:

Currency:

In figures:

In words:

Signed:

Dated: (in the capacitiy of [insert: title or other appropriate designation]



3. Price Schedule for Domestic Goods Offered from within the Purchaser's Country

(Group A and Group B bids)

Name of Bidder ________________ IFB Number ________________ Page___ of ___

1

2

3

4

5

6

7

8

9

10

11

12

13

Product code

Product

Strength

Dosage form

Unit pack

Qty. offered

Unit prices

Total unit

Total price

Sales and other

Name of manufacturer

Pharma-copoeial

Local input in the cost as %

    

size

 

[a]
Ex-factory
Ex-warehouse
Ex-showroom
Off the shelf

[b]
Inland transp., insurance & other local costs incidental to delivery

[c]
Other incident-al costs as defined in the SCC

price
[a+b+c]

per item
[6 x 8]

taxes payable if contract is awarded

 

standard

of ex-factory price in column 7[a]

               
               
               
               

Note:

(i) Column 7[b] is optional and it will be applicable only when required in accordance with ITB Sub-Clause 16.2 (a) (iii) and (iv) and the related provisions in the Bid Data Sheet.

(ii) For column 9, pursuant to ITB 30.1 in the case of discrepancy between unit price and total price, the unit price shall prevail.

(iii) For column 13, a breakdown of the cost of local labor, local raw materials, and local components provided from within the country should also be indicated separately as specified in ITB Sub-Clause 27.1 along with adequate proof to substantiate each of these local inputs.

Total Bid Price:

Currency:

In figures:

In words:

Signed:

Dated: (in the capacitiy of [insert: title or other appropriate designation]



4. Bid Security Form

________________________________
[insert: Bank’s Name, and Address of Issuing Branch or Office]

Beneficiary:    [insert: Name and Address of Employer]

Date:   [insert: date]

BID GUARANTEE No.:       [insert: Bid Guarantee No.]

We have been informed that [insert: name of the Bidder] (hereinafter called "the Bidder") has submitted to you its bid dated [insert: date] (hereinafter called "the Bid") for the execution of [insert: name of contract]  under Invitation for Bids No. [insert: IFB number] (“the IFB”).

Furthermore, we understand that, according to your conditions, bids must be supported by a bid guarantee.

At the request of the Bidder, we [insert: name of Bank]   hereby irrevocably undertake to pay you any sum or sums not exceeding in total an amount of [insert: amount in figures]   ([insert: amount in words])   upon receipt by us of your first demand in writing accompanied by a written statement stating that the Bidder is in breach of its obligation(s) under the bid conditions, because the Bidder:

(a)     has withdrawn its Bid during the period of bid validity specified by the Bidder in the Form of Bid; or

(b)     does not accept the correction of its Bid price in accordance with the Instructions to Bidders (hereinafter “the ITB”) of the IFB; or

(c)     having been notified of the acceptance of its Bid by the Employer during the period of bid validity, (i) fails or refuses to execute the Contract Form, if required, or (ii) fails or refuses to furnish the performance security, in accordance with the ITB.

 

This guarantee will expire:  (a) if the Bidder is the successful bidder, upon our receipt of copies of  the contract signed by the Bidder and the performance security issued to you upon the instruction of the Bidder; or (b) if the Bidder is not the successful bidder, upon the earlier of (i) our receipt of a copy of your notification to the Bidder of the name of the successful bidder; or (ii) twenty-eight days after the expiration of the Bidder’s Bid.

 

Consequently, any demand for payment under this guarantee must be received by us at the office on or before that date.

 

This guarantee is subject to the Uniform Rules for Demand Guarantees, ICC Publication No. 458.

 

_____________________________

[signature(s)]


5. Form of Contract Agreement

THIS CONTRACT AGREEMENT is made

the [ insert: number ] day of [ insert: month ], [ insert: year ].

BETWEEN

(1) [ insert: Name of Purchaser ], a [ insert: description of type of legal entity, for example, an agency of the Ministry of .... of the Government of [ insert: country of Purchaser ], or corporation incorporated under the laws of [ insert: country of Purchaser ] ] and having its principal place of business at [ insert: address of Purchaser ] (hereinafter called "the Purchaser"), and

(2) [ insert: name of Supplier ], a corporation incorporated under the laws of [ insert: country of Supplier ] and having its principal place of business at [ insert: address of Supplier ] (hereinafter called "the Supplier").

WHEREAS the Purchaser invited bids for certain goods and ancillary services, viz., [insert: brief description of goods and services] and has accepted a bid by the Supplier for the supply of those goods and services in the sum of [ insert: contract price in words and figures ] (hereinafter called "the Contract Price").

NOW THIS AGREEMENT WITNESSETH AS FOLLOWS:

1. In this Agreement words and expressions shall have the same meanings as are respectively assigned to them in the Conditions of Contract referred to.

2. The following documents shall constitute the Contract between the Purchaser and the Supplier, and each shall be read and construed as an integral part of the Contract:

  1. This Contract Agreement
  2. Special Conditions of Contract
  3. General Conditions of Contract
  4. Technical Requirements (including Technical Specifications)
  5. The Supplier's bid and original Price Schedules
  6. The Purchaser's Notification of Award
  7. [Add here: any other documents]

3. In consideration of the payments to be made by the Purchaser to the Supplier as hereinafter mentioned, the Supplier hereby covenants with the Purchaser to provide the Goods and Services and to remedy defects therein in conformity in all respects with the provisions of the Contract.

4. The Purchaser hereby covenants to pay the Supplier in consideration of the provision of the Goods and Services and the remedying of defects therein, the Contract Price or such other sum as may become payable under the provisions of the Contract at the times and in the manner prescribed by the Contract.

For and on behalf of the Purchaser

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

in the presence of ___________________________________
For and on behalf of the Supplier

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

in the presence of _______________________________________

CONTRACT AGREEMENT

dated the [ insert: number ] day of [ insert: month ], [ insert: year ]

BETWEEN

[ insert: name of Purchaser ], "the Purchaser"

and

[ insert: name of Supplier ], "the Supplier"


6. Performance Security Bank Guarantee

________________________________ [insert: Bank’s Name, and Address of Issuing Branch or Office]

Beneficiary:    ___________________ [insert: Name and Address of Purchaser]            

Date:   ________________

PERFORMANCE GUARANTEE No.:       _________________

We have been informed that [insert: name of Supplier] (hereinafter called "the Supplier") has entered into Contract No. [insert: reference number of the contract] dated ____________ with you, for the supply of [insert: description of goods] (hereinafter called "the Contract").

Furthermore, we understand that, according to the conditions of the Contract, a performance guarantee is required.

At the request of the Supplier, we [insert: name of Bank] hereby irrevocably undertake to pay you any sum or sums not exceeding in total an amount of [insert: amount in figures] (___) [insert: amount in words][1]  upon receipt by us of your first demand in writing accompanied by a written statement stating that the Supplier is in breach of its obligation(s) under the Contract, without your needing to prove or to show grounds for your demand or the sum specified therein.

This guarantee shall expire no later than the  ____ day of _________, 2_____,[2] and any demand for payment under it must be received by us at this office on or before that date.

This guarantee is subject to the Uniform Rules for Demand Guarantees, ICC Publication No. 458, except that subparagraph (ii) of Sub-article 20(a) is hereby excluded.

__________________
[signature(s)]



[1]      The Guarantor shall insert an amount representing the percentage of the Contract Price specified in the Contract and denominated either in the currency(ies) of the Contract or a freely convertible currency acceptable to the Purchaser.

[2]      Established in accordance with Clause 8.4 of the General Conditions of Contract (“GCC”), taking into account any warranty obligations of the Supplier under Clause 15.2 of the GCC intended to be secured by a partial performance guarantee. The Purchaser should note that in the event of an extension of the time to perform the Contract, the Purchaser would need to request an extension of this guarantee from the Guarantor.  Such request must be in writing and must be made prior to the expiration date established in the guarantee. In preparing this guarantee, the Purchaser might consider adding the following text to the form, at the end of the penultimate paragraph:  “The Guarantor agrees to a one-time extension of this guarantee for a period not to exceed [six months] [one year], in response to the Purchaser’s written request for such extension, such request to be presented to the Guarantor before the expiry of the guarantee.”


7. Bank Guarantee Form for Advance Payment

________________________________ [insert: Bank’s Name, and Address of Issuing Branch or Office]

Beneficiary:    ___________________ [insert: Name and Address of Purchaser]

Date:   ________________

ADVANCE PAYMENT GUARANTEE No.:          _________________

We have been informed that [insert: name of Supplier] (hereinafter called "the Supplier") has entered into Contract No. [insert: reference number of the contract] dated ____________ with you, for the supply of [insert: description of goods] (hereinafter called "the Contract").

Furthermore, we understand that, according to the conditions of the Contract, an advance payment in the sum [insert: amount in figures] (_____) [insert: amount in words] is to be made against an advance payment guarantee.

At the request of the Supplier, we [insert: name of Bank] hereby irrevocably undertake to pay you any sum or sums not exceeding in total an amount of [insert: amount in figures] (___) [insert: amount in words] upon receipt by us of your first demand in writing accompanied by a written statement stating that the Supplier is in breach of its obligation under the Contract because the Supplier used the advance payment for purposes other than toward delivery of the goods.

It is a condition for any claim and payment under this guarantee to be made that the advance payment referred to above must have been received by the Supplier on its account number ___________ at _________________ [insert: name and address of Bank].

This guarantee shall expire, at the latest, upon our receipt of copy(ies) of ________[1], or on the ___ day of ______, 2___,[2] whichever is earlier. Consequently, any demand for payment under this guarantee must be received by us at this office on or before that date.

This guarantee is subject to the Uniform Rules for Demand Guarantees, ICC Publication No. 458.

_____________________
[signature(s)]



[1]        Insert documents establishing “delivery” of the goods in accordance with the particular Incoterm selected. (See SCC 11.) 

[2]      Insert the delivery date stipulated in the original delivery schedule. The Purchaser should note that in the event of an extension of the time to perform the Contract, the Purchaser would need to request an extension of this guarantee from the Guarantor.  Such request must be in writing and must be made prior to the expiration date established in the guarantee. In preparing this guarantee, the Purchaser might consider adding the following text to the form, at the end of the penultimate paragraph:  “The Guarantor agrees to a one-time extension of this guarantee for a period not to exceed [six months][one year], in response to the Purchaser’s written request for such extension, such request to be presented to the Guarantor before the expiry of the guarantee.”

 


8. Manufacturer's Authorization Form
(Manufacturer's or Producer's letterhead)

To: [ insert: name of the Purchaser ]

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 Bidder ] (hereinafter, the "Bidder") to submit a bid, and subsequently negotiate and sign the Contract with you against IFB [ insert: title and reference number of the Invitation for Bids ] including the above Goods produced by us.

We hereby extend our full guarantee and warranty for the above specified Goods against these Bidding Documents.

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 ]


9. Specimen Certificate of a Pharmaceutical Product

Certificate of a Pharmaceutical Product1

This certificate conforms to the format recommended by the World Health Organization (general instructions and explanatory notes attached).

No. of certificate: ___________________________________________

Exporting (certifying) country: ___________________________________________

Importing (requesting) country: ___________________________________________

1. Name and dosage form of product:

1.1 Active ingredients2 and amount(s) per unit dose.3

_________________________________________________________________________
_________________________________________________________________________

For complete qualitative composition including excipients, see attached.4

1.2 Is this product licensed to be placed on the market for use in the exporting country?5 yes/no (key in as appropriate)

1.3 Is this product actually on the market in the exporting country? yes/no/unknown (key in as appropriate)

If the answer to 1.2 is yes, continue with section 2A and omit section 2B.

If the answer to 1.2 is no, omit section 2A and continue with section 2B.6

2A. 1 Number of product license7 and date of issue:

_________________________________________________________________________

2A.2 Product-license holder (name and address):

_________________________________________________________________________
_________________________________________________________________________

2A.3 Status of product-license holder:8 a/b/c (key in appropriate category as defined in note 8)

2A.3.1 For categories b and c the name and address of the manufacturer producing the dosage form are: 9

_________________________________________________________________________
_________________________________________________________________________

2A.4 Is Summary Basis of Approval appended?10 yes/no (key in as appropriate)

2A.5 Is the attached, officially approved product information complete and consonant with the license?11 yes/no/not provided (key in as appropriate)

2A.6 Applicant for certificate, if different from license holder (name and address):12

2B. 1 Applicant for certificate (name and address):

2B.2 Status of applicant: a/b/c (key in appropriate category as defined in note 8)

2B.2.1 For categories b and c the name and address of the manufacturer producing the dosage form are:9

_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________

2B.3 Why is marketing authorization lacking?

not required/not requested/under consideration/refused (key in as appropriate)

2B.4 Remarks:13

3. Does the certifying authority arrange for periodic inspection of the manufacturing plant in which the dosage form is produced?

yes/no/not applicable14 (key in as appropriate)

If no or not applicable proceed to question 4.

3.1 Periodicity of routine inspections (years): ______________________________

3.2 Has the manufacture of this type of dosage form been inspected?

yes/no (key in as appropriate)

3.3 Do the facilities and operations conform to GMP as recommended by the World Health Organization?15

yes/no/not applicable16 (key in as appropriate)

4. Does the information submitted by the applicant satisfy the certifying authority on all aspects of the manufacture of the product? 11

yes/no (key in as appropriate)

If no, explain: __________________________________________________

Address of certifying authority: ___________________________

Telephone number: __________________ Fax number: ______________________________

Name of authorized person: _____________________________________________

Signature:__________________________________________________

Stamp and date: _____________________________________________

General instructions

Please refer to the guidelines for full instructions on how to complete this form and information on the implementation of the Scheme.

The forms are suitable for generation by computer. They should always be submitted as hard copy, with responses printed in type rather than handwritten.

Additional sheets should be appended, as necessary, to accommodate remarks and explanations.

Explanatory notes

1 This certificate, which is in the format recommended by WHO, establishes the status of the pharmaceutical product and of the applicant for the certificate in the exporting country. It is for a single product only since manufacturing arrangements and approved information for different dosage forms and different strengths can vary.

2 Use, whenever possible, international nonproprietary names (INNs) or national nonproprietary names.

3 The formula (complete composition) of the dosage form should be given on the certificate or be appended.

4 Details of quantitative composition are preferred, but their provision is subject to the agreement of the product-license holder.

5 When applicable, append details of any restriction applied to the sale, distribution, or administration of the product that is specified in the product license.

6 Sections 2A and 2B are mutually exclusive.

7 Indicate, when applicable, if the license is provisional or if the product has not yet been approved.

8 Specify whether the person responsible for placing the product on the market:

(a) manufactures the dosage form;

(b) packages and/or labels a dosage form manufactured by an independent company; or

(c) is involved in none of the above.

9 This information can be provided only with the consent of the product-license holder or, in the case of non-registered products, the applicant. Noncompletion of this section indicates that the party concerned has not agreed to inclusion of this information. It should be noted that information concerning the site of production is part of the product license. If the production site is changed, the license must be updated or it will cease to be valid.

10 This refers to the document, prepared by some national regulatory authorities, that summarizes the technical basis on which the product has been licensed.

11 This refers to product information approved by the competent national regulatory authority, such as a Summary of Product Characteristics (SPC).

12 In this circumstance, permission for issuing the certificate is required from the product-license holder. This permission must be provided to the authority by the applicant.

13 Please indicate the reason that the applicant has provided for not requesting registration:

(a) The product has been developed exclusively for the treatment of conditions--particularly tropical diseases--not endemic in the country of export.

(b) The product has been reformulated with a view to improving its stability under tropical conditions.

(c) The product has been reformulated to exclude excipients not approved for use in pharmaceutical products in the country of import.

(d) The product has been reformulated to meet a different maximum dosage limit for an active ingredient.

(e) Any other reason, please specify.

14 Not applicable means that the manufacture is taking place in a country other than that issuing the product certificate and inspection is conducted under the aegis of the country of manufacture.

15 The requirements for good practices in the manufacture and quality control of drugs referred to in the certificate are those included in the thirty-second report of the Expert Committee on Specifications for Pharmaceutical Preparations (WHO Technical Report Series, No. 823, 1992, Annex 1). Recommendations specifically applicable to biological products have been formulated by the WHO Expert Committee on Biological Standardization (WHO Technical Report Series, No. 822, 1992, Annex 1).

16 This section is to be completed when the product-license holder or applicant conforms to status (b) or (c) as described in note 7 above. It is of particular importance when foreign contractors are involved in the manufacture of the product. In these circumstances the applicant should supply the certifying authority with information to identify the contracting parties responsible for each stage of manufacture of the finished dosage form, and the extent and nature of any controls exercised over each of these parties.

The layout for this Model Certificate is available on diskette in WordPerfect from the Division of Drug Management and Policies, World Health Organization, 1211 Geneva 27, Switzerland.