Product Requirements: Drugs for Substitution Therapy

  1. Buprenorphine Hydrochloride

Sublingual absorption tablets, strength 2 mg

  • Dosage form: tablets; not more then 100 tablets in 1 pack
  • Quantity to be purchased: see table №1

Sublingual absorption tablets, strength 8 mg

  • Dosage form: tablets; not more then 100 tablets in 1 pack
  • Quantity to be purchased: see table №1

Table №1 – Quantity of products to be purchased.

№ / INN / Description / Total weigh in mg / Ration between total weigh of each product strengths, % / Total quantity of tablets
Drugs for substitution therapy:
1 / Buprenorphine Hydrochloride / tablets
2,0 mg / 864000 / 33,33% / 432 000
2 / Buprenorphine Hydrochloride / tablets
8,0 mg / 1728000 / 66,67% / 216 000

According to conditions of the contract to be concluded between the winner and the organizer of the Bidding process total quantity to be purchased can be changed +/- 20 % of the total quantity. In the case of making any changes in quantity the ratio between weigh of each product strength will stay the same.

  1. Raw materials

Pharmaceutical products offered under this purchase description shall be produced from validated raw materials obtained from a licensed manufacturer or its authorized distributor. This applies to both active and inactive ingredients.

  1. Registration requirements

Pharmaceutical products offered under this purchase description shall be currently registered in Ukraine and approved by the Ministry of Health of Ukraine on the date of Procurement review committee meeting holding.

  1. Certificate of licensing

Pharmaceutical products offered under this purchase description shall be licensed for marketing by the drug regulatory authority of the country of origin. Documented by a "statement of licensing status of pharmaceutical product(s)" as provided under the World Health Organization (WHO) Certification Scheme.

  1. Compliance with good manufacturing procedures (GMP).

Certification stating that the pharmaceutical products offered under this purchase description are manufactured according to WHO good manufacturing practices. Such certification can be found in the WHO Certification Scheme "Certificate of a Pharmaceutical Product". In the case of being certified following WHO good manufacturing practices the supplier must be able to provide copies of its annual GMP audit reports.

Having such certificate is not an obligation and can be considered as one of the supplier’s advantages.

  1. WHO certification

The supplier must be able to provide documentation indicating the manufacturer of the products has received confirmation from the national regulatory agency of the country of manufacture that the pharmaceutical meets the requirements in the WHO Certification Scheme

  1. Primary container

The primary container should maintain the quality, safety and stability of the product contained. All packaging must be properly sealed and tamper-proof and packaging components must meet criteria of the latest product registration certification in Ukraine and be approved for pharmaceutical packaging by the manufacturer’s national regulatory authority.

  1. Labelling and Direction for use.

The label of the primary container for each pharmaceutical product shall be in accordance with the registration dossier submitted and approved by the Ukrainian Pharmacological Committee including such elements in Ukrainian or Russian:

  1. The international non-proprietary (generic) name of the active ingredient(s).
  2. Dosage form, e.g., tablet, ampoule etc.
  3. Quantity of active ingredient(s) in the dosage form.
  4. The applicable pharmacopoeia standard.
  5. Batch/Lot number.
  6. Date of manufacture.
  7. Expiry date.
  8. Direction for storage.
  9. Name of manufacturer.

Direction for the products use must be made in Russian or Ukrainian.

  1. Lots per order

The supplier shall fill the order using the fewest number of manufacturing lots possible.

  1. Shelf life

At the time of inspection or acceptance for delivery to the country of destination, no more than 20 percent of product shelf life shall have expired since the date of manufacture shown on the batch release or Certificate of analysis (conformance).

If requested the supplier shall be able to provide to the satisfaction of the registration/national quality control authorities the manufacturer's stability test data to validate the product's stated shelf life at ambient temperature 32 degrees C or above and relative humidity of 85%. Variations must be proven scientifically as comparable by means of stability data.

  1. Workmanship

Products and packaging shall be free of defects that impair their serviceability, affect their durability, or detract from their appearance.

  1. Test Data

Chemical and physical test data for raw materials, components, in-process, and finished product testing must be on record for each lot shipped and must be available to Purchaser's representatives when requested.

  1. Documentation

Prior to award of the Contract, the successful participants are required to submit the following documentation (obligatory documentation):

  1. Copy of registration certificate issued by the State pharmacological centre of the Ministry of health of Ukraine, according to clause III of this specification.
  2. Copy of the license for marketing issued by the drug regulatory authority of the country of origin, according to clause IV of the specification.
  3. Copy of the confirmation from the national regulatory agency of the country of manufacture that the pharmaceutical meets the requirements of WHO Certification Scheme, according to clause IV of the specification.
  4. To fill in and to submit the document attached to the specification: see Annex №1 (as Bid form), Annex №1 (as company quotation) and Annex №2 (as confirmation of meeting requirements).

In the case of having such documents participants might submit following additional (non-obligatory) documentation:

  1. Copies of annual GMP audit reports.
  2. Copies of documents on products clinical trials results.
  3. Copies of documents on products bioequivalence research.

Annex №1

to the specification «Product Requirements: Drugs for Substitution Therapy».

To: ICF “The International HIV/AIDS Alliance in Ukraine”

Gentlemen and/or Ladies:

Having examined the bidding documents the receipt of which is hereby duly acknowledged, we, the undersigned, offer to supply and deliver Buprenorphine Hydrochloride sublingual absorption tablets, strength 2 mg and Buprenorphine Hydrochloride sublingual absorption tablets, strength 8 mgin conformity with the said bidding documents at the prices as mentioned in attached quotation and 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 draft-contract (as part of Bidding Documents).

If our bid is accepted, we undertake to provide 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 the Bidding announcement and it shall remain binding upon us and may be accepted at any time before the expiration of that period.

Until a formal Contract is prepared and executed, this Bid, together with your written acceptance thereof 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.

We certify/confirm that we have the legal capacity to enter into the contract.

Dated this ______day of ______2007.

[signature][in the capacity of]

Duly authorized to sign Bid for and on behalf of

Annex №2

to the specification «Product Requirements: Drugs for Substitution Therapy».

Please fill in the table below as quotations of the company.

Note: prices should be indicated on terms of delivery CIP Borispol airport, Kyiv Ukraine.

Table №2 – Quotation on buprenorphine hydrochloride.

№ / Products / Proprietary trade name of products / Country of origin / Quantity of tablets in 1 pack / Price of 1 pack in US dollarsCIP Borispol airport, Kyiv Ukraine / Price of 1 tablet in US dollars CIP Borispol airport, KyivUkraine
1 / Buprenorphine Hydrochloride, strength 2,0 mg
2 / Buprenorphine Hydrochloride, strength 8,0 mg

Dated this ______day of ______2007.

[signature][in the capacity of]

Duly authorized to sign Bid for and on behalf of

Annex №2

to the specification «Product Requirements: Drugs for Substitution Therapy».

Please fill in the table below as confirmation on meeting requirements of the Specification.

Table №2 – Confirmation on meeting requirements of the Specification.

№ / Specification criteria / Confirmation on meeting criteria or declaration of discrepancy to the criteria
1 / Products raw materials confirming clause II of the Specification
2 / Registration confirming clause III of the Specification
3 / Licensing confirming clause IV of the Specification
4 / WHO certification confirming clause VI of the Specification
5 / Primary container confirming clause VII of the Specification
6 / Labelling and Direction for use confirming clause VIII of the Specification
7 / Agree to ensure the fewest number of manufacturing lots possible confirming clause IX of the Specification
8 / Agree on products shelf-life confirming clause X of the Specification
9 / Workmanship confirming clause XI of the Specification
10 / Test data for each lot shipped confirming clause XII of the Specification
11 / Agree on the draft-contract included into bidding documents being used as the contract on products purchase.

Dated this ______day of ______2007.

[signature][in the capacity of]

Duly authorized to sign Bid for and on behalf of