Product Requirements:

Drugs for Substitution Therapy. Methadone Hydrochloride in tablets.

  1. Description and quantity of Methadone Hydrochloride to be purchased.

Total quantity to be purchased is 226,800,000 mg.

Bidding organizer reserves the right to change real quantity to be procured up to +/- 30%.

Options of dosage forms and strengths to be procured:

  • Tablets, strength 5 mg
  • Tablets, strength 10 mg
  • Tablets, strength 20 mg
  • Tablets, strength 25 mg
  • Tablets, strength 40 mg

Specific conditions:

  1. Pharmaceutical products offered under this purchase must be in TABLET form only. Soluble tablets can be offered.
  2. Pharmaceutical products offered under this purchase description to have current registration for marketing in Ukraine on the date of Procurement review committee (tender committee)meeting holding. Along with this tender winner to maintain products to have current registration on the date of its arrival to Ukraine and within the whole period of time up to the date of expire of shelf-life for each manufactured batch of products.
  3. Each bid must contain offer of 5 mg and / or 10 mg tablets (bidder can consider offering either any of them or both). The offer which doesn’t include quotation on any of them to be automatically disqualified.
  4. Bidders may propose 20 and/or 25 and/or 40 mg tablets along with 5 or/and 10 mg tablets.
  5. Offering 2 or more strengths of tablets is preferable.
  6. Quantity of tablets in 1 pack to be not more than 100 tablets.Offering smaller that 100 tablets per pack dosage forms is preferable (e.g. #10, #20 etc.).
  7. Approximated ratio between different strengths of tablets is as follows:

Strength, mg / Percentage, %
5 mg and/or 10 mg / 2-3%
20 and/or 25 and/or 40 mg / 82-90%
  1. Strict ratio, and hence exact quantity of packs of each strength to be defined by Procurement review committee for the winner’s bid only.
  2. Bidding organizer reserves the right to oblige the winner to supply reference standard of methadone-HCl under terms of delivery equal to those used for pharmaceutical product. Price of reference standard itself and its delivery into Ukraine to be subjects to further negotiations.
  3. Best quotation on products.

Quotations of bidders to be compared by calculating cost of monthly dose for 1 patient (equal to 3000 mg).

In majority of cases offering bigger strengths in addition to 5 and /or 10 mg leads to cheaper value of a standard monthly dose.

  1. Time needed for each particular bidder to manufacture theproduct is another very important factor for successful bid.
  2. Having bidder’s representative office in Ukraine and/or designated distributor in Ukraine is preferable.
  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 for marketing in Ukraine on the date of Procurement review committee meeting holding. Along with this tender winner to maintain products to have current registration on the date of its arrival to Ukraine and within the whole period of time up to the date of expire of shelf-life for each manufactured batch of products.

Registration certificate issued by the State pharmacological centre of the Ministry of health of Ukrainefor each strength and being submitted as constituent to official bid to be valid at least 1 (one) year after the date of Procurement review committee meeting holding.

Participants unable to submit a copy of registration certificates on all offered strengths before the date of Procurement review committee meeting holding to be automatically disqualified.

  1. Certificate of licensing

Pharmaceutical products offered under this purchase description to be licensed for marketing by the drug regulatory authority of the country of origin. The valid certificate(s) (e.g. Free sale certificate) indicating all strengths of tablets offered under this purchase to be attached to the bid.

Certificate(s) of licensing to be valid at least during 6 (six) months after the date of Procurement review committee meeting holding. If certificate(s) expire earlier,bidder to attach explanatory letter providing the current status of renewal of the certificate(s).

  1. Compliance with good manufacturing practices (GMP).

Manufacture of pharmaceutical products offered under this tender descriptions to be certified upon compliance to GMP.

Submitted certificates of GMP compliance to include all manufacture sites designated for production of products offered under this tender and to be valid during at least 6 (six) months after the date of holding Procurement review committee meeting. If certificate(s) expire earlier, bidder to attach explanatory letter providing the current status of renewal of the certificate(s).

The GMP certificate for each production site to contain the date of the most recent authorized inspection to the site(s).

  1. WHO certification

The supplier to be able to provide valid Certificates of a pharmaceutical product (CPP or WHO certificate) issued by respective national authorities in accordance to WHO certification scheme. Presented certificates should comply with the format recommended by the WHO and be indicative that:

  • offered productsare authorized to be placed on the market within its jurisdiction or, if they are not thus authorized, the reason why that authorization has not been accorded;
  • manufacture sites in which they are produced are subjects to inspections at suitable intervals to establish that the manufacturer conforms to GMP as recommended by WHO; and
  • all submitted during process of certification product information, including labelling, is currently authorized in the certifying country.

Separate CPP to be submitted for the each offered strength.

Though it isn’t required however highly recommended CPPs to contain expiration date (validity).

  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 certificate in Ukraine and be approved for pharmaceutical packaging by the manufacturer’s national regulatory authority.

  1. Labelling and Direction for use.

The label of primary container for each pharmaceutical product shall be made in accordance with the registration dossier submitted to and approved by Ukrainian Pharmacological Committee. Among other it shall contain the following elements in Ukrainian or Russian:

  1. International non-proprietary (generic) name of the active ingredient(s).
  2. Dosage form, e.g. tablet.
  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. Instruction for storage.
  9. Name of manufacturer.

Direction for the use of product to be made in Ukrainian only.

  1. Shelf life

At the time of inspection or acceptance for delivery to the country of destination, notmorethan 20 percent of product shelf life to past 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 stated shelf lifeof the product. 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. Reference standard

In case of being awarded with the contract, the successful bidder to be able to supply reference standard of methadone-HCl under terms of delivery equal to those used for pharmaceutical product. Price of reference standard itself and its delivery into Ukraine to be subjects to further negotiations.

Delivered reference standard to be used further for the purposes of obligatory quality control testing of imported pharmaceutical product after its arrival to Ukraine, prior to product distribution to health centres.

Approximate quantity of supplied reference standard is 200 mg for each 3 supplied batches of pharmaceutical product.

  1. Documentation

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

Obligatory block:

  1. Copy of registration certificates issued by the State pharmacological centre of the Ministry of health of Ukraine, according to clause III of this specification.

Bidders unable to submit certificates on all offered strengths before the date of Procurement review committee meeting holding will be automatically disqualified.

  1. Copy of the license for marketing issued by the drug regulatory authority of the country of origin, according to clause IV of the specification.
  2. Copy of Certificates of a pharmaceutical product issued by national regulatory authorities of the country of manufacture for EACH offered strength and indicating offered products compliance with requirements of WHO certification scheme, according to clause IV of the specification.
  3. Copy of valid GMP certificate according to clause V of the specification.
  4. To fill in and to submit applications attached to the specification: see Annex №1 (as Bid form), Annex №2 (as company quotation) and Annex №3 (as confirmation of meeting requirements of the specification).
  5. Documents issued by bidder and authorizing any legal Ukrainian entity to represent company interests in Ukraine. Such documents shall confirm the presence of bidder’s representative office in Ukraine and/or the availability of the bidder’s designated distributor in Ukraine (if available).

Obligatory block – only for soluble tablets:

  1. Copies of reports on dissolution profiles for methadone hydrochloride in tablets. Dissolution test profiles to be provided for EACH strength of offered tablets. (Note: only for each dosage of proposed soluble tablets).

Non-obligatory while highly recommended block:

  1. Copies of reports on post-marketing surveillance studies. (Note: if available).

Requirements to compiling the bid:

  • Each document or its copy if not originally issued in English should have a translation into English.
  • Please note that bid application should be structured in a way that single sheet of paper shall entitle the following document (set of documents on the same theme). For instance, if bidder submits the Copy of registration certificate, there should be a paper with the title “Copy of registration certificate issued by the State pharmacological centre of the Ministry of health of Ukraine” in the dossier prior to the document per se.

Annex №1 to the specification «Product Requirements: Drugs for Substitution Therapy. Methadone Hydrochloride in tablets».

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 Methadone Hydrochloride in tablets, strength 5 mg and/or strength 10 mg, and/or strength 20 mg, and/or strength 25 mg, and/or strength 40 mg, in 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. Methadone Hydrochloride in tablets».

Please fill in the table below being designated the quotations form of the company.

Note:

  • Prices should be indicated on terms of delivery CIP Borispol airport, Kyiv Ukraine including all relevant taxes and duties.
  • The participant is allowed to apply either all or any particular positions out of the list below according to clause I of the Specification.

Table №2 – Quotation on Methadone hydrochloride in tablets

№ / Products / Proprietary trade name of products / Country of origin / Quantity of tablets in 1 pack / Price of 1 pack in US dollars CIP Borispol airport, Kyiv Ukraine / Price of 1 tablet in US dollars CIP Borispol airport, Kyiv Ukraine
1 / Methadone Hydrochloride in tablets, strength 5,0 mg
2 / Methadone Hydrochloride in tablets, strength 10,0 mg
3 / Methadone Hydrochloride in tablets, strength 20,0 mg
4 / Methadone Hydrochloride in tablets, strength 25,0 mg
5 / Methadone Hydrochloride in tablets, strength 40,0 mg

Dated this ______day of ______2007.

[signature][in the capacity of]

Duly authorized to sign Bid for and on behalf of

Annex №3 to the specification «Product Requirements: Drugs for Substitution Therapy. Methadone Hydrochloride in tablets».

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

In the case of having any comments on any stateditem please note them in appropriate cell.

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

№ / Specification criteria / Confirmation of meeting criteria or declaration of discrepancy to the criteria
1 / Products raw materials in compliance with clause II of the Specification.
2 / Products registration in Ukraine in compliance with clause III of the Specification.
3 / Licensing in compliance with clause IV of the Specification.
4 / GMP certification in compliance with clause V of the Specification.
5 / WHO certification in compliance with clause VI of the Specification.
6 / Primary container requirements in compliance with clause VII of the Specification.
7 / Labelling and Direction for use in compliance with clause VIII of the Specification.
9 / Agree on products shelf-life in compliance with clause ІX of the Specification.
10 / Workmanship in compliance with clause X of the Specification.
11 / Test data for each lot shipped in compliance with clause XI of the Specification.
12 / Agree to comply with clause XII of the Specification concerning ability to supply methadone-HCl reference standard.
13 / Agree to use draft-contract included into bidding documentationas basis for the contract to be concluded in case of the company to be awarded the contract.
14 / Maximum period of time needed for the company in case of being awarded with the contract to provide purchaser with certificates of analysis for each batch of fully-manufactured and packed product, in days after the date of contract signature.

Dated this ______day of ______2007.

[signature][in the capacity of]

Duly authorized to sign Bid for and on behalf of