Example of an invitation for expression of interest SIXTH INVITATION FOR EXPRESSION OF INTEREST (EOI)
In the context of dramatically increasing the access to, and affordability of, HIV/AIDS-related care and treatment, WHO, together with UNICEF, UN- AIDS and UNFPA are inviting expressions of interest from manufacturers of pharmaceutical products in respect to the provision of drugs for the manage- ment of HIV-related diseases. The World Bank is in support of this effort.
This sixth 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 fi rst, second, third, fourth and fi fth invitations published in 2000, 2001, 2002, 2003 and 2004.
Manufacturers should be committed to providing the above-mentioned products at preferential prices to developing countries. Interested manu- facturers are encouraged to submit documentation and samples as specifi ed below for various dosage forms and strengths of the products in the follow- ing categories: Antiretrovirals as single-ingredient formulations for use in adults and adolescents:
• Nucleoside/Nucleotide Reverse Transcriptase Inhibitors, including Abacavir Didanosine Lamivudine Stavudine Tenofovir Zidovudine
• Non-Nucleoside Reverse Transcriptase Inhibitors, including Efavirenz Nevirapine
• Protease Inhibitors, including Indinavir Nelfi navir Ritonavir Saquinavir
Applications are also encouraged for single-ingredient formulations suitable for use in paediatric populations, that support existing international and or national treatment guidelines for paediatric antiretroviral therapy (ART).
As solid dosage formulations are the preferred formulations for treating children except for in the very young infant, manufacturers should also ap-ply for reduced and/or scored solid dosage formulations of: Zidovudine Abacavir Lamivudine Nevirapine Efavirenz
Also sought are syrups, solutions or dissolvable nucleoside/nucleotide and non-nucleoside formulations of the following products: Zidovudine Abacavir Lamivudine Nevirapine
For further information on paediatric formulations please consult:http://www.who.int/3by5/paediatric/en/
II) Antiretrovirals as fi xed-dose combinations (FDC):
Applications are also encouraged for fi xed-dose combinations of any fi rst-line ARV regimens as described in the WHO Guidelines for Scaling Up Antiretroviral Therapy in Resource Limited Settings – 2003 Revision. For further information please consult:http://webitpreview.who.int/entity/3by5/publicatons/documents/arv_guidelines/en/
For use in adults and adolescents: • Reverse Transcriptase Inhibitors Lamivudine + Stavudine Lamivudine + Zidovudine Lamivudine + Stavudine + Efavirenz Lamivudine + Stavudine + Nevirapine Lamivudine + Zidovudine + Efavirenz Lamivudine + Zidovudine + Nevirapine Lamivudine + Zidovudine + Abacavir Tenofovir + Emtricitabine
• Protease Inhibitors Lopinavir + Ritonavir
For paediatric use, reduced and/or scored solid dosage formulations of: • Reverse Transcriptase Inhibitors Lamivudine + Stavudine Lamivudine + Zidovudine
Lamivudine + Stavudine + Nevirapine Lamivudine + Zidovudine + Nevirapine Lamivudine + Zidovudine + Abacavir
• Protease Inhibitors Lopinavir + Ritonavir Co-packaged preparations of the standard ARV combinations, for adult, adolescent and paediatric use are also sought. for further information on paediatric fi xed dose and/or co-packaged formulations please consult: http://www.who.int/3by5/paediatric/en/
• Anti-infective drugs listed below: Antibacterial and antimycobacterial agents (other than MTB)
Azithromycin Ceftriaxone Cefi xime Ciprofl oxacin Clarithromycin Clindamycin Rifabutin Spectinomycin
Antiprotozoal and Antifungal agents Amphotericin
Fluconazole Itraconazole Pentamidine Pyrimethamine Sulfadiazine Trimethoprim/Sulphamethoxazole
Antiviral • Anti-cancer drugs Bleomycin Etoposide Vinblastine Vincristine
• Palliative care drugs Amitriptyline Codeine
Chlorpheniramine Ibuprophen Loperamide Morphine (oral formulation)
The medicines listed in this Invitation for Expression of Interest are those for which a need has been identifi ed by the HIV/AIDS department, WHO. The submitted products should be of assured pharmaceutical quality and relevant data to support effi cacy should be provided. Procedure for submission of EOI
1. Submit a covering letter expressing the interest in participating in the
project, confi rming that the information submitted in the product dos-siers is correct.
2. Submit a product dossier in the recommended format* as specifi ed in
the Guideline for submission of a product fi le which can be obtained by electronic mail from [email protected], also available on the the web page http://mednet3.who.int/prequal. The dossier should be accompanied by a sample of the product to enable analyses (e.g. 1 × 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 March, May, July, September and November 2005. Documentation should be provided in English.
Interested manufacturers should submit the above-mentioned information to: UNICEF Supply Division Reference: Accelerated Access to HIV/AIDS Care UNICEF Plads - Freeport Copenhagen Denmark E-mail: [email protected] Tel: (45) 35 27 35 27 Fax: (45) 35 26 50 48
3. Submit a site master fi le for each manufacturing site as listed in the
product dossier, in the recommended format, also available by elec- tronic mail and on the web page http://mednet3.who.int/prequal/ to The Secretary WHO/HTP/PSM/QSM 20 Ave Appia 1211 Geneva 27 Switzerland
Products and manufacturing sites assessed for acceptability and meet-ing the specifi ed standards will be added to the list published on the project web page (http://mednet3.who.int/prequal/). Products and man-ufacturers included in this list may be invited to bid for the supply of products, individually or collectively, directly by member governments, by the aforesaid United Nations agencies and/or by associated NGOs.
The following criteria will be taken into account in the quality assessment process. • Valid manufacturer’s licence for production. • Product registered or licensed in accordance with national requirements. • Products manufactured in compliance with GMP as certifi ed by the
national regulatory authority and/or certifi ed GMP inspectors.
• Product certifi cates exist in accordance with the WHO Certifi cation
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 prequalifi cation procedure.
• Outcome of the inspection performed by or on behalf of the above-
• Manufacturer demonstrates sound fi nancial standing.
Only manufacturers THAT CAN SUPPLY APPROPRIATE PRODUCTS OF ACCEPTABLE QUALITY COMPLIANT WITH APPLICABLE REGULATORY REQUIREMENTS, WHO GUIDELINES AND LEGIS-LATION will be considered.
The United Nations procurement agencies reserve the right to determine specifi c conditions, as for example the exclusion of companies using child labour, or engaged in the manufacture of land mines or parts thereof. Further references
For background information on drugs for the treatment of opportunistic infections in HIV/AIDS, please refer to www.aidsinfo.nih.gov/guidelines
For background information on palliative care drugs, please refer to http://www.who.int/3by5/publications/documents/en/genericpalliativecare082004.pdf
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