PROCUREMENT INFORMATION FORM - Stop TB



PROCUREMENT REQUEST FORM FOR MEDICINESINSTRUCTIONS ON HOW TO COMPLETE THIS FORMAll sections must be completed irrespective of the products being ordered.Section 5 stipulates the conditions of supply.The annexes should be completed based on the requirements:Annex 1 - Medicines to treat Drug Susceptible (DS) TB and Latent TB Infection (LTBI)Annex 2 – Medicines to treat Drug Resistant (DR) TBAnnex 3 – Adherence Support ToolsPlease ensure that all required information is provided to enable GDF to provide you with a responsive price quote.SECTION 1. CLIENT INFORMATION & FUNDING SOURCE Request fromName of InstitutionAddress(hereinafter “Client”)Submitted toGlobal Drug Facility(hereinafter “ GDF”)Funding SourceSource of funding for product requestCheck applicable option (√)The Global FundGrant Number:______________________Is this request funded through the Covid-19 Response Mechanism?: Yes FORMCHECKBOX / No FORMCHECKBOX USAIDGovernmentUNITAIDOther, please specify source: ________________________________________SECTION 2. contact DETAILS (Please provide contact details of priNcipal recIpient in case source of funding is Global Fund)Please ensure that full contact details are provided below, including full mailing address, telephone, fax, and email.Country:Organization:Address:Contact PersonPosition:Telephone:Fax:Email:Name and full contact details of Consignee (organization receiving the goods)Organization:Address:Name:Position:Telephone:Fax:e-mail:Full contact details of party to be notified (person/authority responsible for products shipment authorization)Note: Above person will be contacted via email when shipment is ready to be shipped. Authorization will be required before the shipment is dispatched.Name:Position:Organization:Address:Telephone:Fax:e-mail: Full contact details of Payer The person in charge of managing payment related to this procurement formName:Position:Organization:Address:Telephone:Fax:e-mail:Other contacts to be copied in communication related to this procurement formName:Organization:e-mail:Name:Position:Organization:e-mail:SECTION 3: DELIVERY & IMPORTATION DETAILSThe Preferred date (s) of Delivery specified by the Programme should indicate when the Programme needs products to arrive in-country to ensure sufficient stock are maintained at the central, regional and peripheral programme levels. GDF will undertake best efforts to accommodate preferred delivery date (s). GDF will provide updates on the Estimated Time of Arrival (ETA) as such information becomes available.It is recommended to place a request for products at least 6 months before the Preferred Delivery Date.Period in which products will be used Preferred delivery date (date the products are required, considering standard lead-time 4-6 months from receipt of funds for products )Note: In case split shipments are required, a preferred delivery date for each of the shipments should be indicated (please note comment above).Preferred port of delivery FORMTEXT ? ?Preferred Incoterm FORMCHECKBOX CIP/CIF FORMCHECKBOX Standard DAP: The client is responsible for customs clearance and offloading at the delivery address FORMCHECKBOX DAP + Customs clearance and offloading at delivery address: GDF/IDA will arrange customs clearance (with their customs broker) and offloading at the delivery address If DAP delivery is requested, please fill out the contact details of the contact person responsible for all (pre-)clearance documents (e.g. NOC, NOL, legalization of documents, registration documents for import purposes):Name: FORMTEXT ? ?Telephone: FORMTEXT ? ?E-mail: FORMTEXT ? ?Preferred mode of shipment FORMCHECKBOX Air FORMCHECKBOX Sea FORMCHECKBOX OverlandDocumentation needed to accompany consignment. FORMCHECKBOX Airway bill/bill of lading FORMCHECKBOX Certificate of analysis (analytical batch certificate) FORMCHECKBOX Certificate of origin FORMCHECKBOX Packing list FORMCHECKBOX Invoice FORMCHECKBOX Gift certificate FORMCHECKBOX COPP FORMCHECKBOX GMP Certificate FORMCHECKBOX Other documents or requirements (such as original documents, etc) Please specify:Please confirm that no special pre-shipment inspections are required in addition to the pre-shipment inspection that will be carried out by the GDF agent. FORMCHECKBOX NO, GDF inspections are sufficient FORMCHECKBOX YES, Special pre-shipment inspection requirements Please specify:Advance notice required by consignee before delivery FORMTEXT ? ? week(s)Special requirements concerning markings on outer cartons. FORMTEXT ? ?Details of additional requirement such as language labelling requirements FORMTEXT ? ?Can shipments arrive outside of regular working hours (09.00 - 17.00 h / Mon - Fri). If yes, please state the hours.Yes FORMCHECKBOX No FORMCHECKBOX SECTION 4: REGISTRATION DETAILS Information on products registration is critical to ensure timely delivery of products. Please ensure that the section below is complete with accurate, up-to-date information. Is medicines registration required for the products to be delivered?Time required for registration?Yes FORMCHECKBOX No FORMCHECKBOX Number of weeks required for registration: FORMTEXT ? ?Can importation of medicines into the country be made prior to or during registration (where applicable)?Before FORMCHECKBOX During FORMCHECKBOX Neither FORMCHECKBOX If registration is required: Registration dossier for the application to be sent to:Name:Title:Organization:Address:Telephone:Fax:Email:If registration is required:Is it possible to obtain a waiver for registration?Does a fast-track mechanism exist for the registration of the products: FORMCHECKBOX Prequalified by WHO; FORMCHECKBOX Authorized for marketing by a stringent regulatory authority; FORMCHECKBOX Recommended by the Expert Review Panel (ERP) Yes FORMCHECKBOX No FORMCHECKBOX Number of weeks required for waiver: FORMTEXT Yes FORMCHECKBOX No FORMCHECKBOX Number of weeks to fast-track: FORMTEXT List of documents required:for waiver:- - - for fast-track registration:- - - Other important information concerning medicines/diagnostics registration that may affect shipments. FORMTEXT ? ? SECTION 5. CONDITIONS OF SUPPLYGeneral conditionsGDF procures only quality-assured medicines through its selected procurement agent(s) (PA). All GDF medicines shall be provided to patients free of charge.All GDF medicines will only be used according to WHO treatment guidelines and national treatment guidelines For Global Fund supported procurements, GDF may provide a copy of this Form to the responsible regional Green Light Committee(s) and Global Fund for their review.For procurement of medicines, GDF clients shall provide the file showing how quantification of medicines was done (e.g. QuanTB file, GDF Drug Calculation Sheet, etc.)Procurement processGDF works with the PA to coordinate the purchasing and logistics of GDF requests(s) under this Form. The execution of this procurement request can be initiated only after signing of a pro-forma invoice and receipt of the prepayment of funds by the PA.The Client will be responsible for payment or obtaining a waiver of any applicable duties, any import requirements, as well as to facilitate product registration in cooperation with manufacturers or obtaining relevant waivers, in-country storage, distribution and monitoring of all supplies, unless otherwise agreed with the PA and/or GDFThe Client understands the importance of quality of medicines. Applicants submitting the Form for partial regimens for DR TB understand that it is their direct responsibility to ensure that other medicines provided are of assured quality and they are fully accountable for the care of their patients.Handling feeThe handling fee for executing the order is shown in the quotation provided by the PA to the Client. The current total fee of the GDF’s appointed PA for TB drugs (IDA) applies on the ex-works cost of GDF products and are indicated in the table below. For the programmatic and technical support that GDF provides under this arrangement, GDF levies a handling fee on the ex-works cost of supplies. The fee is collected by the PA on behalf of GDF.IDA DR GrantIDA DR DP*IDA DS GrantIDA DS DPIDA component3.73.72.82.8GDF component -0.5-1.15Total Procurement Fee3.74.22.83.95* DP direct procurementMonitoring and technical assistanceGDF reserves the right to conduct monitoring mission(s) by an independent technical agency or consultant on the use of medicines and related commodities delivered under this Form. The Client agrees to interact with experts which GDF may notify and from which GDF may request assessments, such as but not limited to GDF Regional Technical Advisors, Country Supply Officers, and GDF consultants. The technical report will be shared with the Client. The Parties may also consult on and mutually agree on the implementation of technical assistance when required.Special provisionsAny serious adverse effects that come to the Client’s attention and that may be related to the use of GDF medicines are to be reported to the national pharmacovigilance centre or, in the absence of a national pharmacovigilance centre, to the national medicines regulatory authority in a timely manner in accordance with local legislation or other applicable requirements (e.g. WHO aDSM).If the Client does not represent an established international NGO, publicly known to be active in TB patient treatment (e.g. PIH, MSF, International HIV/AIDS Alliance or similar), a UN organization or the government entity engaged in tuberculosis control, the Client must provide a letter of endorsement from the National TB Program or similar entity. In case this cannot be provided, the Client needs to submit a letter of explanation to allow for GDF decision on this procurement. In submitting the letter, the Client agrees that GDF may contact its Partners for additional information without further consent by the Client.In case specific off-label medicines for DR-TB treatment such as clofazimine are requested according to WHO treatment guidelines, GDF might request the Client to sign a specific liability waiver which needs to be submitted before the supply of these products can commence. In case of request for bedaquiline, delamanid and/or pretomanid, GDF clients shall submit to GDF completed and signed Annexes 1 for bedaquiline, delamanid and/or pretomanid along with the procurement request form. The medicines should be used in accordance with the most current WHO treatment guidelines.Please sign below and send it to the following email address or to your focal point in GDF:gdfprs@ FORMCHECKBOX I hereby certify that the volumes of medicines ordered are consistent with our projected needs?(please tick the box)Signature:Name:Tittle:(Authorised Official)DateLIST OF ANNEXESANNEX 1. Medicines to treat Drug Susceptible (DS) TB and Latent TB Infection (LTBI)ANNEX 2. Medicines to treat Drug Resistant (DR) TBANNEX 3. Adherence Support ToolsANNEX 1. Medicines to treat Drug Susceptible (DS) TB and Latent TB Infection (LTBI)Period drugs will be used: from (m/yr) to (m/yr) Preferred delivery date: FORMTEXT ?Date/Month/Year Table 1 FORMTEXT a : Adult TB patients currently on treatment Number of patients currently on treatmentTable 1b: Number of ADULT cases and contacts expected to be treated Treatment regimensTotal number of adult cases expected to be treated with medicines from ALL SOURCESNumber of adult cases expected to be treated with GDF medicinesBuffer stock required If YES indicate percentage here *Treatments of drug susceptible (DS) TB Treatments of latent tuberculosis infection (LTBI)* This buffer stock percentage is applied to medicines quantities calculated for supply as indicated in "products and quantities requested" table below. Table 1c: Paediatric TB patients currently on treatment Number of patients currently on treatmentTable 1d FORMTEXT : Number of PAEDIATRIC cases and contacts expected to be treated (weight 4-24 kg). Paediatric cases above 24 kg should be entered in Table 1a. Treatment regimensTotal number of paediatric cases expected to be treated with medicines from ALL SOURCESNumber of paediatric cases expected to be treated with GDF medicinesBuffer stock required If YES indicate percentage here *Treatments of drug susceptible (DS) TBTreatment of latent tuberculosis infection (LTBI) * This buffer stock percentage is applied to medicines quantities calculated for supply as indicated in "products and quantities requested" table below. PLEASE ATTACH THE FILE SHOWING HOW QUANTIFICATION OF MEDICINES WAS DONE (E.G. QUANTB FILE, GDF DRUG CALCULATION SHEET, ETC.)PRODUCTS AND QUANTITIES REQUESTEDProductQuantity of units (tablets/vials)Rifampicin 150mg/Isoniazid 75mg/ Pyrazinamide 400mg/Ethambutol 275mg(RHZE150/75/400/275) tabletRifampicin 150 mg/Isoniazid 75 mg/ Ethambutol 275mg(RHE150/75/275) tabletRifampicin 150mg/Isoniazid 75mg(RH150/75) tabletEthambutol 400mg(E400) tabletIsoniazid 300mg(H300) tabletPyrazinamide 400mg(Z400) tabletPyridoxine 50mgPyr(B6) tabletPyridoxine 100mgPyr(B6) tabletRifabutin 150 mg (Rbt150) capsule Rifampicin 150 mg (R150) capsuleRifampicin 300 mg (R300) capsuleRifapentine 150 mg(Rpt150) tabletRifapentine/Isoniazid 300mg/300mg(3-HP-300/300) tabletIsoniazid 300mg/Pyridoxine hydrochloride 25mg/Sulfamethoxazole 800mg/Trimethoprim 160mg(HPST-Q-TIB) tablet*Includes buffer stock indicated in table 1 b.Patient KitsQuantity of Kits *Category I & III Patient kits (Type A)6 blisters (168) 4-FDC tablets (R150/H75/Z400/E275)12 blisters (336) 2-FDC tablets (R150/H75)*Includes buffer stock indicated in table 1 b.Paediatric FormulationsQuantity of units (tablets/vials)*Rifampicin 75mg/Isoniazid 50mg/ Pyrazinamide 150mg(RHZ75/50/150) dispersible tablet Rifampicin 75mg/Isoniazid 50mg(RH75/50) dispersible tabletEthambutol 100 mg(E100) tabletEthambutol 100 mg(E100) dispersible tabletIsoniazid 100mg(H100) tabletIsoniazid 100mg(H100) dispersible tablet Pyrazinamide 150mg (Z150) dispersible tablet*Includes buffer stock indicated in table 1 d.ANNEX 2. Medicines to treat Drug Resistant (DR) TBPeriod drugs will be used: from (m/yr) to (m/yr) Preferred delivery date: FORMTEXT ?Date/Month/Year Table 2 FORMTEXT a : DR TB patients currently on treatment Number of patients currently on treatmentTable 2b: Number of adult DR cases to be treated Treatment regimens*Total number of cases expected to be treated with medicines from ALL SOURCESNumber of cases expected to be treated with GDF medicinesBuffer stock required If YES indicate percentage here ***EXAMPLES:4-6 Bdq(6) Cfz E H(high-dose) Lfx Eto Z / 5 Cfz E Lfx Z – bedaquiline-based shorter regimen6 Lfx Bdq Lnz Cs Cfz / 14 Lfx Cs Cfz – all-oral longer regimen** This buffer stock percentage is applied to medicines quantities calculated for supply as indicated in "products and quantities requested" table below.Table 2c: Paediatric DR TB patients currently on treatment Number of patients currently on treatmentTable 2d: Number of paediatric DR cases to be treated Treatment regimens*Total number of cases expected to be treated with medicines from ALL SOURCESNumber of cases expected to be treated with GDF medicinesBuffer stock required If YES indicate percentage here ***EXAMPLES:4-6 Bdq(6) Cfz E H(high-dose) Lfx Eto Z / 5 Cfz E Lfx Z – bedaquiline-based shorter regimen (children > 6 years)9-12 Lfx Lzd Cfz Cs – non-severe disease** This buffer stock percentage is applied to medicines quantities calculated for supply as indicated in "products and quantities requested" table below.PLEASE ATTACH THE FILE SHOWING HOW QUANTIFICATION OF MEDICINES FOR DR TB WAS DONE (E.G. QUANTB FILE, ETC.)PRODUCTS AND QUANTITIES REQUESTEDProductQuantity of tablets/vials to SUPPLY*Group ALevofloxacin 250 mg tabletLevofloxacin 500 mg tabletLevofloxacin 750 mg tabletMoxifloxacin 400 mg tabletBedaquiline 100 mg tabletLinezolid 600 mg tabletGroup BClofazimine 100 mg capsule / tabletCycloserine 250 mg capsuleTerizidone 250 mg capsuleGroup CEthambutol 400 mg tabletDelamanid 50 mg tabletPyrazinamide 400 mg tabletPyrazinamide 500 mg tabletImipenem/Cilastatin 500/500 mg powder for IV infusionMeropenem 1 g powder for IV infusionfor use only in combination with Imipenem OR Meropenem:Amoxicillin/Clavulanate 250 mg /125 mg tablet Amoxicillin/Clavulanate 500 mg/125 mg tabletAmoxicillin/Clavulanate 875 mg/125 mg tabletAmoxicillin/Clavulanic acid 125 mg/31.25 mg powder for oral suspensionAmikacin 500 mg solution for injectionStreptomycin Sulphate 1 g powder for injectionEthionamide 250 mg tabletProthionamide 250 mg tabletPAS acid sachet, equivalent to 4 g of aminosalycilic acid, enteric coated granulesPAS sodium sachet, equivalent to 4 g of aminosalycilic acid , powder for oral solutionPAS sodium sachet, equivalent to 4 g of aminosalycilic acid, enteric coated granulesOther products and Add-on agentsIsoniazid 300 mg tabletPretomanid 200 mg tabletPyridoxine (Vit. B6) 50mg tabletPyridoxine (Vit. B6) 100mg tabletMedical SuppliesHypodermic syringe 5ml (AD: auto-disabling)Please specify needle dimensions:21G / 22G / 23GHypodermic syringe 5ml & Safety box for used S&N for 100 syringes(AD: Auto Disabling, re-use prevention)Please specify needle dimensions:21G / 22G / 23GSafety box for used syringes & needles (5L)Water for injection, 5ml(WFI)*Includes buffer stock indicated in table 2 b.Paediatric FormulationsQuantity of units (tablets/capsules)*Levofloxacin 100 mg dispersible tabletMoxifloxacin 100 mg dispersible tabletBedaquiline 20 mg tabletClofazimine 50 mg capsule / tabletCycloserine 125 mg mini-capsuleEthambutol 100 mg dispersible tabletEthambutol 100 mg tabletPyrazinamide 150 mg dispersible tabletEthionamide 125 mg dispersible tabletEthionamide 125 mg tabletIsoniazid 100 mg tabletIsoniazid 100 mg dispersible tablet*Includes buffer stock indicated in table 2 c. ANNEX 3. Adherence Support ToolsAdherence support toolsQuantity of KitsMERM kit-1 (Digital medication event reminder monitor kit) ................
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