E-drug: Pre-qualification suppliers of Artemisinin based antimalarials
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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
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