Round 15-March Scope of the EoI: Anti-Retroviral (HIV/AIDs, Hepatitis B and C), anti-tuberculosis and anti- Malarial products

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1 Global Fund, GDF and UNITAID Invitation to manufacturers of anti-retroviral, anti-tuberculosis and anti-malarial medicines to submit an Expression of Interest (EoI) for product evaluation by Expert Review Panel (ERP) Round 15-March 2016 Scope of the EoI: Anti-Retroviral (HIV/AIDs, Hepatitis B and C), anti-tuberculosis and anti- Malarial products Date of this EoI: Closing date for Receipt of dossiers: EoI Reference No: GF/ERP/Round 15/ Background Summary of Global Fund Quality Assurance Policy The Global Fund to Fight AIDS, Tuberculosis and Malaria fund grants to support national and global efforts to increase access, care and treatment in approximately 140 countries. The Global Fund Quality Assurance Policy for Pharmaceutical Products ( QA Policy 1 ) defines uniform and stringent quality requirements applicable to antiretrovirals, antituberculosis, and antimalarial pharmaceutical products purchased with Global Fund resources. In principle, these pharmaceutical products can be funded using Global Fund resources if they are in compliance with national regulatory standards as applicable and if: - prequalified by the WHO Prequalification Programme; and/or - authorized for marketing in a country with a stringent regulatory authority (SRA) 2 (registration "for export only" is not sufficient) or approved/subject to a positive opinion under one of the following schemes: Canada S.C. 2004, c. 23 (Bill C-9) procedures, or Art. 58 of European Union Regulation (EC9 No. 726/2004) or US- FDA tentative approval; or - products of which the dossiers were reviewed and permitted for use for a time limited period by an independent panel of technical experts (ERP-Expert Review Panel). Information about the ERP mechanism and process for procurement of ERP-reviewed products is available at: In order to assist the Global Fund recipients to identify the regulatory status of the antiretrovirals, the Global Fund has developed a list of products classified according to the above QA requirements. Current list can be downloaded from:

2 Summary of Global Drug Facility (GDF) Quality Assurance Policy In July 2010, GDF revised its Quality Assurance Policy and Procedures as part of a collaborative process to ensure harmonization with the policies of major multi-lateral financing mechanisms i.e. the Global Fund and other organizations (i.e. the Union; UNICEF, Médecins Sans Frontières) involved in TB control and in particular to: - ensure global consistency on quality standards set for procurement and supply of anti-tb medicines as well as medical items, - avoid duplication of effort and optimum utilisation of resources. With the combined objectives to improve the safety, efficacy and quality of products procured by GDF, the GDF quality assurance system is based on: - recommendations by WHO / Stop TB Strategy; - authorization for use by recipient countries; - recommendations by the relevant WHO Programmes, that is, Prequalification of Medicines Programme (PQP); - authorization for marketing by a stringent national medicines regulatory authority (SRA) in the country; - positive opinion for procurement purposes by an Expert Review Panel, for a specified time period where there are few/no WHO-prequalified or SRA-approved products available; and - a quality monitoring programme for supplied products, including independent random quality control. Summary of UNITAID Quality Assurance Policy for Medicines procured under its grants UNITAID s mission is to contribute to enable scaling-up access to prevention, diagnosis and treatment of HIV/AIDS, malaria and tuberculosis, primarily for people in low-income countries, by leveraging price reductions of quality products for prevention, diagnosis and treatment in the three disease areas and accelerating the pace at which these are made available. A key goal of UNITAID is to drive the development and uptake of new medicines that are better adapted to patients needs 3. All medicines procured under the UNITAID-funded Projects are required to be in compliance with UNITAID s Quality Assurance Policy which stipulates similar standards as described above and in the relevant sections of the Global Fund Quality Assurance policy. 2. Purpose The purpose of this Expression of Interest (EoI) is to invite submissions of product dossiers for review by the ERP for which there could be supply bottlenecks, including the cases where there are 3 or less products of the same formulation available in the global market that are already WHO prequalified or approved by a SRA. This EoI may include as well some formulations even when there are more than 3 eligible products in the market, in cases where it has been determined that such products are eligible for distribution to a restricted number of countries only, or when it has been identified that the available production capacity of the qualified products cannot cover the demand. Information provided by manufacturers, and information and advice provided by the ERP in connection with this EoI will be shared with, and used by, the Global Fund, GDF and UNITAID for taking decisions in procurement. 3 GF/ERP/Round 15/ /14

3 3. Product Formulations included in this EoI The recommended active ingredients, dosage forms and strengths ("Formulations") listed in this document are included in the current WHO Model List of Essential Medicines 4 and/or in the WHO standard treatment guidelines for treatment and prevention of the three diseases 5. Anti-retroviral formulations included in this EoI are listed in Annex A Anti-tuberculosis formulations included in this EoI are listed in Annex B Anti-malarial formulations included in this EoI are listed in the Annex C WHO recommends and endorses the use of medicines in fixed dose combinations (FDC). The Global Fund QA policy strongly recommends that principal recipients implement mechanisms to encourage adherence to treatment regimens (including but not limited to providing medicines in FDCs, once-a-day formulations and/or blister packs, and providing peer education and support), to monitor and contain resistance, and to monitor adverse drug reactions according to existing international guidelines 6. FDCs are considered as the preferred option when available. 4. Eligibility for submission 7 Requirements under CRITERION-1: Following criteria must be met in order for products to be accepted for ERP review: - the manufacturer of the product has submitted an application of the product to the WHO Prequalification Programme and it has been accepted by WHO for review; OR the manufacturer of the product has submitted an application for marketing authorization to an SRA, and it has been accepted for review by the SRA, - AND the product is manufactured at a site that is compliant with all standards of Good Manufacturing Practice (GMP) that apply to the relevant product formulation, as verified after inspection by the WHO Prequalification Programme, OR an SRA, OR a regulatory authority participating to the Pharmaceutical Inspection Cooperation Scheme (PIC/S) 8. Requirements under CRITERION-2: Following criteria must be met in order for products to be accepted for ERP review: - the product is manufactured at a site that is compliant with all standards of Good Manufacturing Practice (GMP) that apply to the relevant product formulation, as verified after inspection by the WHO Prequalification Programme OR an SRA OR a regulatory authority participating to the Pharmaceutical Inspection Cooperation Scheme (PIC/S), - AND it is not listed in the WHO invitation to manufacturers to submit an expression of interest for product evaluation by the WHO Prequalification Programme. 4 WHO, April th WHO Model List of Essential medicines 5 WHO, WHO, Treatment of tuberculosis: guidelines, 4th edition. WHO/CDS/TB/ WHO, Guidelines for the treatment of malaria, 3 rd edition. 6 Global Fund, Quality Assurance Policy for Pharmaceutical Products (as amended on 14 December 2010) 7 Global Fund, Quality Assurance Policy for Pharmaceutical Products (as amended and restated on 14 December 2010), Point 13 8 Pharmaceutical Inspection Cooperation Scheme ( GF/ERP/Round 15/ /14

4 5. Submission of documents for ERP review under CRITERION-1 All manufacturers interested in submitting applications for review by the ERP, are requested to submit the following information and material for each product under consideration: For each product awaiting WHO-prequalification: 1. A covering letter expressing interest to submit the product to the ERP for review; 2. An acceptance letter from the WHO Prequalification Programme confirming that the submission for the product has been accepted for review, and stating the WHO reference number assigned by WHO to this specific product; 3. Certification, issued by WHO Prequalification Programme, confirming that the site and production line where the product is manufactured comply with all aspects of GMP, or a letter describing arrangements made to obtain such certification and stating the date when it will be supplied; 4. A completed Pharmaceutical Product Questionnaire 9 (attached); 5. In lieu of annexes, reference can be made to the dossier submitted for WHO prequalification. Annexes should be submitted in case of any changes or updates; 6. A non-returnable product sample as requested in Section VIII of the questionnaire. For each product awaiting marketing authorization by a stringent regulatory authority: 1. A covering letter expressing interest to submit the product to the ERP for review; 2. An acceptance letter from the SRA confirming that the submission for the product has been accepted for review; 3. Certification, issued by a regulatory authority which is a member, observer or associate of ICH or a member of PIC/S, confirming that the site and production line where the product is manufactured comply with all aspects of GMP, or a letter describing arrangements made to obtain such certification and stating the date when it will be supplied; 4. A completed Pharmaceutical Product Questionnaire 10 (attached), and all annexes as applicable; 5. A non-returnable product sample as requested in Section VIII of the questionnaire. 6. Submission of documents for ERP review under CRITERION-2 All manufacturers interested in submitting applications for review by the ERP under Eligibility Criterion 2 are requested to submit the following information and material for each product under consideration: 1. A covering letter expressing interest to submit the product to the ERP for review; 2. Certification, issued by WHO Prequalification Programme confirming that the site and production line where the product is manufactured comply with all aspects of GMP, or a letter describing arrangements made to obtain such certification and stating the date when it will be supplied; and/or 9 As available in Global Fund website: GF/ERP/Round 15/ /14

5 3. Certification, issued by a regulatory authority which is a member, observer or associate of ICH or a member of PIC/S, confirming that the site and production line where the product is manufactured comply with all aspects of GMP, or a letter describing arrangements made to obtain such certification and stating the date when it will be supplied; 4. A completed Pharmaceutical Product Questionnaire 10 (attached); 5. A non-returnable product sample as requested in Section VIII of the questionnaire. 7. Confidentiality The information provided with the submission will be received by the Global Fund and shared with the ERP members for the purpose of facilitating their review of the submission and provision of advice to the Global Fund. Information provided by manufacturers, review findings and advice provided by the ERP, in connection with this EoI will be shared with and used by the Global Fund, GDF, UNITAID and the following partners (Médecins sans Frontières, UNICEF, and USAID) for taking procurement decisions. 8. Eligibility of the submission Completeness of the documents submitted to Global Fund Secretariat for ERP review is screened by the Global Fund QA officer. All documents indicated in the instructions for submission (in annex) must be sent by the applicant. Incomplete submissions will not be forwarded to the ERP. The eligibility of the submissions for the ERP review will not be considered by the Global Fund Secretariat. It is under the ERP s responsibility to review and to judge the eligibility as to whether to perform or not the risk benefit assessment of the submitted dossiers. For any product not found to comply with the required standards during previous ERP review, all documentations requested should be re-submitted in full. 9. Instructions for submission to the applicant and deadline Documentation should be submitted in hard copy (on paper) and electronically, except for annexes to the Pharmaceutical Product Questionnaire 10, which should be submitted electronically only.. Electronic documentation should be submitted on a CD. Files should be named to reflect their content as mentioned in this letter (e.g. "Covering Letter.pdf"). For ease of reference, electronically submitted annexes to the questionnaire should be named corresponding to the letters on the list of annexes on page 17 of the questionnaire (e.g. "A.pdf" for information on the formulation of the product). It is highly recommended to send an undertaking with the shipment of sample that is sent along with the dossiers, indicating that the samples are sent for review purpose only, will not be used on humans or animals have no commercial value and will not be placed in the market. This would ensure smooth transit at the customs in the country of origin and in Switzerland as well. GF/ERP/Round 15/ /14

6 Submissions should be sent by surface mail to the following address: Dr.Alain Prat Quality assurance Specialist Grant Management Support The Global Fund to Fight AIDS, Tuberculosis and Malaria Chemin de Blandonnet Vernier-Geneva, Switzerland, Alain.Prat@theglobalfund.org The deadline for submission is 11 May 2016, 17:00 h Geneva time. Geneva, 11 March 2016 GF/ERP/Round 15/ /14

7 Annex A - Anti Retroviral formulations and medicines to treat hepatitis Dossiers for unlisted individual products contained in the regimens included by WHO in most recent treatment guidelines 10 might be submitted as well to the ERP until the development of the fixed-dose combinations is finalized. Anti-retrovirals as fixed-dose combinations (FDC) for paediatric use: Nucleoside/Nucleotide Reverse Transcriptase Inhibitors plus Non-nucleoside Reverse Transcriptase Inhibitors (criterion 1): - Lamivudine/Abacavir/Efavirenz, tablet 75 mg/150 mg/150 mg scored and dispersible Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (criterion 1): - Lamivudine/Abacavir, dispersible tablet (scored) 30 mg/60 mg - Lamivudine/Abacavir, dispersible tablet (scored) 60 mg/120 mg - Lamivudine/Zidovudine, tablet 30 mg/60 mg scored and preferably dispersible Nucleoside/Nucleotide Reverse Transcriptase Inhibitors plus Protease Inhibitors: (criterion 1): - Lamivudine /Abacavir mini tablets/pellets 15 mg/30 mg co-mixed with Lopinavir/Ritonavir mini tablets/pellets (heat stable) 40 mg/10 mg - Lamivudine /Zidovudine mini tablets/pellets 15 mg /30 mg co-mixed with Lopinavir/Ritonavir mini tablets/pellets (heat stable) 40mg/10mg Protease Inhibitors (criterion 1): - Atazanavir/Ritonavir, tablet (heat-stable), 100 mg/33 mg - Darunavir/Ritonavir, tablet (heat-stable), 240 mg/40 mg scored (or 120 mg/20 mg) - Lopinavir/Ritonavir, mini tablets/pellets (heat stable) 40 mg/10 mg Antiretrovirals as single-ingredient formulations for use in children(until paediatric FDCs become available) Solid formulations of Protease Inhibitors (criterion 1): - Ritonavir tablet or pellets (heat-stable) 25 mg Solid formulations of Integrase Inhibitors: - Raltegravir, chewable tablet 25 mg, 50 mg (scored) ; 100 mg (scored) (criterion 1): - Dolutegravir 50 mg dispersible tablets (criterion 2) Antiretrovirals as single-ingredient formulations for use in adults and adolescents (until FDCs become available): Integrase Inhibitors (criterion 1): - Dolutegravir, tablet 50 mg, preferably scored and dispersible - Raltegravir, tablet 400 mg 10 WHO, November Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection ; WHO, February New recommendations in the updated WHO Guidelines for the screening, care and treatment of persons with chronic hepatitis C infection GF/ERP/Round 15/ /14

8 Anti-retrovirals as fixed-dose combinations (FDC) for adults and adolescents: Nucleoside/Nucleotide Reverse Transcriptase Inhibitors plus Non-nucleoside Reverse Transcriptase Inhibitors (criterion 1): - Emtricitabine/Tenofovir/Efavirenz, tablet 200mg/300mg/400mg - Lamivudine/Tenofovir/Efavirenz, tablet 300mg/300mg/400mg Protease Inhibitors (criterion 1): - Atazanavir /Ritonavir tablet (heat stable) 300mg /100 mg - Darunavir/Ritonavir, tablet (heat stable) 300 mg/50 mg, 400mg/50 mg Nucleotide Reverse Transcriptase Inhibitors plus Non-nucleoside Reverse Transcriptase Inhibitors plus Integrase Inhibitors (criterion 1): - Emtricitabine/Tenofovir/Dolutegravir, tablet 200mg/300mg/50mg - Lamivudine/Tenofovir/Dolutegravir, tablet 300mg/300mg/50mg Medicines to treat Hepatitis B and Hepatitis C Hepatitis B single-ingredient formulations for use in adults and adolescents (criterion 1): - Entecavir tablet, 0.5 mg, 1 mg scored Hepatitis B single-ingredient paediatric formulations (criterion 1): - Entecavir oral solution, 0.05 mg/ml Hepatitis C single-ingredient formulations for use in adults and adolescents, until FDCs become available (criterion 1) 11 : - Sofosbuvir tablet, 400 mg - Daclatasvir tablet, 30 mg, 60 mg (preferably scored) - Ribavirin capsule, 200 mg, 400 mg, 600 mg Hepatitis C Fixed-dose combination for use in adults and adolescents (criterion 1): - Sofosbuvir/ Ledipasvir, tablet 400 mg/90 mg - Sofosbuvir/ Daclatasvir, tablet 400 mg/60 mg and 400 mg/30 mg Hepatitis C single-ingredient paediatric formulations (criterion 1): - Ribavirin syrup, 40mg/ml (oral) 11 Dosiers for other regimens included in the WHO updated guidelines (WHO, February New recommendations in the updated WHO Guidelines for the screening, care and treatment of persons with chronic hepatitis C infection) might also be submitted for review by ERP if requested. GF/ERP/Round 15/ /14

9 Annex B - Anti Tuberculosis Formulations The formulations included in this category are inclusive of all groups of anti-tb medicines. Preferred standard packaging specifications: for all the solid dosage products the preferred standard packaging specifications are: - Blister of 10, 14 or 28 tablets, 3, 6 or 24 blisters in a box (i.e. 672 tablets in a box) - Injections in 1/ 10 / 100 vials/amp per box However this does not preclude the manufacturer from submitting dossiers for other pack sizes. Single ingredient (criterion 1) : - Pyrazinamide caps 400mg and 500mg (only 28 s blister pack) 12 - Rifabutin 150mg caps - Rifapentine, tablets 150 mg - Ethambutol 100mg, 50mg, chewable or dispersible tablets - Isoniazid 50 mg; chewable or dispersible tablets - Cycloserine capsule 125 mg - Levofloxacin tablet 100 mg (dispersible) - Moxifloxacin tablet 100 mg (dispersible) - Linezolid tablet 150 mg (dispersible) - Ethionamide tablet 125 mg (dispersible) - Ethionamide, tablet/capsule 125 mg) - Clofazimine, capsule 50 mg and 100 mg; (scored) - Levofloxacin, tablet 750 mg, - Linezolid, coated tablet 600 mg (scored) - Linezolid, oral powder for suspension (20 mg/ml) 240 ml, bottle - Streptomycin, powder for injection 1g (vial) - Streptomycin, powder for injection 0.75g as sulphate (vial)* - Capreomycin, powder for injection 0.5 g and 1g, vial * - Kanamycin, powder for injection 500 mg and 1g vial*, (1g/3ml or 1 g/4 ml solution for injection) - Imipenem/cilastatin; Imipenem + Cilastatin: 250 mg mg (or 500 mg), powd for infusion *with/without water for injection Fixed-dose combinations (criterion 1) - Isoniazid + Rifampicin 150 mg+150mg coated tablet/caps - Isoniazid + Pyrazinamide+ Rifampicin 75mg+400mg+150mg film coated Tablet/ capsule - Rifampicin 75 mg + Isoniazid 50 mg + Pyrazinamide 150 mg; chewable or dispersible tablets - Rifampicin 75 mg + Isoniazid 50 mg; chewable or dispersible tablet -Amoxycillin+Clavulanic acid 250mg+62.5mg; 500mg/125 mg scored tablet 12 Only blister pack is requested since there is sufficient WHO PQ /SRA-authorized products available in bulk/loose packaging available in the list. GF/ERP/Round 15/ /14

10 Single ingredient (criterion 2) -Rifampicin film coated tablets 450mg -Isoniazid, film coated tablet 75mg; 150mg scored -Rifampicin film coated tablets/capsules 75mg - Pyridoxine 5mg - Thiacetazone 150mg tablet - Capreomycin, powder for injection 0.75g vial * Anti-TB medicines used solely in India-(criterion-2) The treatment of TB susceptible cases in India with first-line anti-tuberculosis medicines, in National/institutional TB guidelines in India involves procurement and the use of combipacks or blisters of several formulations or one formulation (depending on the treatment box in question). For the purpose of this EoI, Combi-pack is thus the primary packing placed in a pouch which is referred to as the secondary packing, which in turn is placed in a treatment box which is referred to as the tertiary packing. This whole pack, consisting of tertiary, secondary and primary units, is termed as. Where there is only one formulation, the refers to the blister/foil primary packing placed in the secondary pack. The S listed in this document have been recommended for funding by the Technical Review Panel. Product code 1 Product description and composition Treatment box for Cat I Patient. Each treatment box containing 24 combi-packs of Schedule-I in one pouch and 18 multi-blister calendar combi-packs of Schedule-2 in another pouch Each combi-pack of Schedule-I containing: 1 R Cap of 450mg 2 H Tabs. of 300mg each 2 E Tabs of 600mg each 2 Z Tabs. of 750mg each Each multi-blister calendar combi-pack of Schedule-2 containing: 3 R Caps of 450 mg each 6 H Tabs. of 300mg each 4 Pyridoxine Tabs of 5mg each 2 Treatment box for Cat II Patient. Each treatment box containing 36 combi-packs of Schedule-I in one pouch and 22 multi-blister calendar combi-packs of Schedule-3 in another pouch Each combi-pack of Schedule-I containing: 1 R Cap of 450mg 2 H Tabs. of 300mg each 2 E Tabs of 600mg each 2 Z Tabs. of 750mg each Each multi-blister calendar combi-pack of Schedule-3 containing: 3 R Caps of 450 mg each 6 H Tabs. of 300mg each 6 E Tabs of 600mg each 4 Pyridoxine Tabs of 5mg each 3 Treatment box for Cat III Patient. Each treatment box containing 24 combipacks of Schedule-4 in one pouch and 18 multi-blister calendar combi-packs of Schedule-2 in another pouch Each combi-pack of Schedule-4 containing: 1 R Cap of 450mg 2 H Tabs. of 300mg each 2 Z Tabs. of 750mg each Each multi-blister calendar combi-pack of Schedule-2 containing: 3 R Caps of 450 mg each 6 H Tabs. of 300mg each 4 Pyridoxine Tabs of 5mg each GF/ERP/Round 15/ /14

11 Product code Product description and composition Treatment box for prolongation of Intensive Phase of Cat-I &Cat. II. Each box containing 5 pouches and each pouch containing 12 blister combipacks of Schedule-1 Each combi-pack of Schedule 1 containing: 1 R Cap of 450mg 2 H Tabs. of 300mg each 2 E Tabs of 600mg each 2 Z Tabs. of 750mg each Injection Streptomycin Kits Streptomycin kits for injection containing Inj. Streptomycin 750 mg - Box of 24 vials Sterile water for injection IP 5 ml - Box of 24 ampoules Disposable syringe and needle - 24 each 10 capsule of Rifampicin 150mg each Tablet of INH 100mg each 10 Tablet of Pyrazinamide 500mg each 7 Blister combi-pack in one pouch containing Each combi-pack of Schedule 1 containing: 1 R Cap of 450mg 2 H Tabs. of 300mg each 2 E Tabs of 600mg each 2 Z Tabs. of 750mg each 9 Blister or Foil pack containing: 10 Tablet of Ethambutol 800mg each 10 Tablet of INH 300mg each 10 Tablet of Rifampicin 450mg each Treatment box for paediatric category (6-10 Kg). Each treatment box containing 24 combi-packs of Schedule-5 in one pouch and 18 multi-blister calendar combi-packs of Schedule-6 in another pouch 13 Each combi-pack of Schedule-5 containing: 1 R Tab of 75mg 1 H Tab of 75mg 1 E Tab of 200mg 1 Z Tab of 250mg Each multi-blister calendar combipack of Schedule-6 containing: 3 R Tabs of 75 mg each 3 H Tabs. of 75mg each 4 Pyridoxine Tabs of 5mg each GF/ERP/Round 15/ /14

12 Product code Product description and composition Treatment box for pediatric category (11-17 Kg). Each treatment box containing 24 combi-packs of Schedule-7 in one pouch and 18 multi-blister calendar combi-packs of Schedule-8 in another pouch Each combi-pack of Schedule 7 containing: 1 R Tab of 150mg 1 H Tab. of 150mg 1 E Tab of 400mg 1 Z Tab. of 500mg Each multi-blister calendar combipack of Schedule-8 containing: 3 R Tabs of 150 mg each 3 H Tabs. of 150mg each 4 Pyridoxine Tabs of 5mg each Treatment box for prolongation of Intensive Phase of Cat I & Cat II pediatric cases (weight bands 6-10 kg &18-25 kg). Each box containing 5 pouches and each pouch containing 12 blister combipack of Schedule-5 Each combi-pack of Schedule - 5 containing: 1 R Tab of 75mg 1 H Tab. of 75mg 1 E Tab of 200mg 1 Z Tab. of 250mg Treatment box for prolongation of Intensive Phase of Cat I & Cat II pediatric cases (weight bands kg, kg and kg). Each box containing 5 pouches and each pouch containing 12 blister combipack of Schedule-7 Each combi-pack of Schedule 7 containing: 1 R Tab.of 150mg 1 H Tab. of 150mg 1 E Tab of 400mg 1 Z Tab. of 500mg 10 Tablet of Ethambutol 200mg each 10 Tablet of Pyrazinamide 750mg each 10 Tablet of Pyridoxine 100mg each 10 Tablet of Pyridoxine 50mg each GF/ERP/Round 15/ /14

13 Annex C - Anti Malarial Formulations Formulations included under Eligibility (Criterion 1): Artemisinin-based fixed-dose oral combination formulations - Artemether + Lumefantrine, o tablet 20mg+120mg (dispersible tablet formulation only); o tablet 40 mg mg; o tablet 60 mg mg; o tablet 80 mg mg. - Artesunate + Mefloquine, o tablet 25/55mg; o tablet 100/220mg. - Dihydroartemisinin + Piperaquine o tablet 20 mg mg; o tablet 40 mg mg. - Artesunate + Pyronaridine, o tablet 60 mg mg. Artemisinin-based co-blistered, or preferably fixed-dose oral combination formulations - Artesunate + Amodiaquine, o tablet 25 mg mg; o tablet 50 mg mg; o tablet 100 mg mg - Artesunate + [Sulfadoxine + Pyrimethamine], o tablet 25 mg + [250 mg mg]; o tablet 50 mg + [500 mg + 25 mg]; o tablet 100 mg + [500 mg + 25 mg] o tablet 100 mg + [1000 mg + 50 mg] Paediatric formulations, preferably dispersible/fixed-dose combinations in tablets, for the following artemisinin-based combinations: -Artemether + Lumefantrine -Artesunate + Mefloquine - Artesunate + Amodiaquine -Artesunate + Sulfadoxine + Pyrimethamine Combination antimalarial medicines in co-blistered formulations, preferably dispersible - Amodiaquine + Sulfadoxine + Pyrimethamine : o tablet 75 mg mg mg; o tablet 150 mg mg + 25 mg; o tablet 76.5 mg mg mg; o tablet 153 mg mg + 25 mg. Artemisinin-based single-ingredient formulations - Artemether, oily injection o injection 20 mg/ml; o injection 40 mg/ml; GF/ERP/Round 15/ /14

14 o o injection 80 mg/ml; injection 100 mg/ml; -Artesunate o suppositories 50 mg; o suppositories 100 mg; o suppositories 200 mg; o powder for injection 30mg, 60mg, 120mg (vial) with appropriate diluents Other antimalarial medicines o mefloquin tablet 250mg o sulfadoxine + Pyrimethamine, tablet 500 mg + 25 mg Formulations included under Eligibility (Criterion 2) Single ingredient medicines - Chloroquine Tablet 100mg, 150mg, 250mg, 300mg - Chloroquine syrup 25mg/5ml, 50mg/5ml - Primaquine Tablet 7.5 mg; 15mg (as base). - Proguanil Tablet 100mg (as hydrochloride) - Quinine Tablet (Sulphate) 125mg, 300mg, 500mg - Quinine dihydrochloride Inj 300mg/ml, 600mg/2ml GF/ERP/Round 15/ /14