# \[e-drug\] Pre-qualification suppliers of Artemisinin based antimalarials **URL:** \ **Category:** e-drug\ **Created:** [April 4, 2003, 10:26am UTC](https://talk.edrugplus.org/t/e-drug-pre-qualification-suppliers-of-artemisinin-based-antimalarials/16513 "2003-04-04T10:26:37Z")\ **Posts on this page:** 1\ **Page:** 1
**Author:** ![Clive\_Ondari](https://avatars.discourse-cdn.com/v4/letter/c/b2d939/32.png) [@Clive\_Ondari](https://talk.edrugplus.org/u/Clive_Ondari)\ **Post date:** [April 4, 2003, 10:26am UTC](https://talk.edrugplus.org/t/e-drug-pre-qualification-suppliers-of-artemisinin-based-antimalarials/16513/1 "2003-04-04T10:26:37Z")
E-drug: Pre-qualification suppliers of Artemisinin based antimalarials ------------------------------------------------------------------------- Dear E-druggers, We wish to draw your attention to this second call for expression of interest (EOI) for the pre-qualification of manufacturers of artemisinin-based antimalarial drug products. This call for EOI issued in the context of facilitating access to artemisinin based combination antimalarial drug products by Roll Back Malaria (RBM) Project of the World Health Organization, UNICEF and UNDP invites Expressions of Interest from manufacturers of pharmaceutical products in respect to the provision of drugs for the management of malaria. The World Bank is in support of this effort. This second invitation is published in order to increase the range of possible products and sources as a follow up to the interest that was expressed as a result of the first invitation published in 2002. Interested manufacturers are encouraged to submit documentation and samples as specified below for various dosage forms and strengths of the products in the following categories: \* Artesunate (oral preparations) \* Dihydroartemisinin (tablets, capsules, paediatric granules,      suppositories) \* Artemether (oral preparations) \* Artemether (intramuscular preparations) \* Artemether + lumefantrine (oral preparations) \* Artesunate (injection for IV and IM) \* Artemotil (injectable forms) \* Artesunate + mefloquine (oral preparations) \* Artesunate + amodiaquine (oral preparations) \* Artesunate + sulphadoxine/pyrimethamine (oral preparations) Procedure for submission of EOI: 1. Submit a covering letter expressing the interest to participate in      the project, confirming that the information submitted in the      product dossiers is true and correct; 2. Submit a product dossier in the recommended format\* as      specified in the Guideline for submission of a product file which      can be obtained by electronic mail from robinsonl@who.int or      lbalslev@unicef.dk , and is also available on the web page      www.who.int/medicines/documents. The dossier should be      accompanied by a sample of the product to enable analyses (e.g.      1 x 100 Tablets).   \*If the dossier is compiled in a different format (e.g. EU), then   such a dossier can be submitted with a covering letter   cross-referencing the pages where the relevant data can be found   in accordance with the above mentioned Guideline.   Submitted documentation reaching UNICEF Supply Division will   be evaluated during May 2003, July 2003, September 2003 and   November 2003. Documentation should be provided in English.   Interested manufacturers should submit the above-mentioned to:      UNICEF Supply Division      Reference: Access to Antimalarial Combination Therapy      UNICEF Plads - Freeport      DK-2100 Copenhagen      Denmark      E-mail: supply@unicef.org      Tel: (45) 35 27 35 27      Fax: (45) 35 26 50 48 3. Submit a Site Master File for each manufacturing site as listed in      the product dossier, in the recommended format, also available by      electronic mail and on the web page www.who.int/medicines, to      Miss Lesley Robinson, WHO/HTP/EDM/QSM, 20 Ave Appia, 1211      Geneva, 27 Switzerland. Products submitted will be assessed by WHO for compliance with WHO recommended standards, and manufacturing sites will be assessed for compliance with GMP. Products and manufacturing sites which will be found to meet the aforesaid standards will be included in a list of suppliers whose products are considered acceptable in principle for procurement by UN Agencies. Products and manufacturers included in this list may be invited to bid for the supply of products, individually or collectively, directly by the aforesaid UN agencies. The following criteria will be taken into account in the quality assessment process: \* Valid manufacturer's license for production \* Product registered or licensed in accordance with national      requirements \* Products manufactured in compliance with GMP as certified by the      national regulatory authority and/or certified GMP inspectors \* Product certificates exist in accordance with the WHO certification      scheme on the quality of pharmaceutical products moving in      international commerce \* Product dossiers of acceptable quality submitted and outcome of      the assessment in respect of the pre-qualification procedure \* Outcome of the inspection performed by or on behalf of the      above-mentioned agencies \* Manufacturer demonstrates sound financial standing \* Existing/appropriate collaboration/agreements for manufacturing      and/or packaging in accordance with GMP guidelines By submitting an expression of interest for participation in the quality assessment process, a manufacturer represents that it can supply appropriate products compliant with national laws and regulations, including but not limited to regulatory requirements. WHO reserves the right to exclude a manufacturer from participation in the quality assessment process, or to remove a manufacturer from the above mentioned list, in the event that this condition is not, or no longer, complied with. The UN agencies reserve the right to require compliance with additional conditions, as and when they invite manufacturers included in the list to bid for the supply of products. Dr Clive Ondari Technical Officer Policy, Access and Rational Use (PAR) Essential Drugs and Medicines Policy (EDM) World Health Organization 20, Avenue Appia CH-1211 Geneva 27 Switzerland Tel. +41 22 791 3676 Fax. +41 22 791 4167 e-mail: ondaric@who.int -- To send a message to E-Drug, write to: e-drug@usa.healthnet.org To subscribe or unsubscribe, write to: majordomo@usa.healthnet.org in the body of the message type: subscribe e-drug OR unsubscribe e-drug To contact a person, send a message to: e-drug-help@usa.healthnet.org Information and archives: [http://www.essentialdrugs.org/edrug](http://www.essentialdrugs.org/edrug)