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[e-drug] Invitation to manufacturers for EoI from the Asthma Drug Facility

E-DRUG: Invitation to manufacturers for EoI from the Asthma Drug Facility
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Dear E-druggers,

The Asthma Drug Facility (ADF) is qualifying anti-asthma medicines for
use in low- and middle-income countries with a high incidence of asthma.
This qualification aims at ensuring the quality of those medicines and
the reliability of the manufacturers. ADF?s qualification process is
based on WHO norms and standards. For more information, please refer to
the website: www.GlobalADF.org

For the purchase of asthma medicines, the ADF will then issue a Limited
International Competitive Bid (LICB). Only manufacturers with products
that have been qualified by the ADF will be entitled to participate in
such bids.  

Interested manufacturers, or their legal representative, are invited to
submit their expression of interest to the ADF, indicating which of the
following asthma medicines they are interested in supplying:

Inhaled HFA short-acting beta2-agonist
1. Salbutamol 100 microgram, 200 doses, HFA inhaler

Inhaled HFA corticosteroids 
2.   Beclometasone 100 microgram, 200 doses, HFA inhaler 
3.   Budesonide 200 microgram, 200 doses, HFA inhaler
4.   Fluticasone 125 microgram, 120 doses, HFA inhaler

To express their interest, new manufacturers are requested to download
the ?manufacturer questionnaire? and the ?product questionnaire? from
the ADF website 

http://www.globaladf.org/index.php?option=com_content&view=article&id=21
&Itemid=22&lang=en

Once duly completed, the questionnaires must be sent to the ADF,
accompanied by the required documents, certificates and samples. A
product questionnaire and one sample must be submitted for each product
that a manufacturer is interested in supplying. Any applicant failing to
send all the required documents, certificates and samples will be
rejected.

For manufacturers who have products that have already been qualified by
the ADF (i.e. they have a signed Product Specification Sheet), please
send to the ADF:
- An updated manufacturer questionnaire
- For each product qualified by the ADF, a declaration signed by the
quality assurance officer stating that all the specifications listed in
the Product Specification Sheet(s) are still valid
- If there is any variation in the specifications, a declaration signed
by the quality assurance officer listing the variation(s), accompanied
by the supporting documentation.

Manufacturing sites will be audited by the ADF. The costs of conducting
the audit will be borne by ADF.

Manufacturers in all countries of the world are eligible to respond to
this Invitation for Expression of Interest.

Please submit all the above-mentioned information, documents and samples
to the following address before 5.00pm Paris time on Thursday 23
December 2010:

Asthma Drug Facility (ADF)
International Union Against Tuberculosis and Lung Disease (The Union)
68 boulevard Saint-Michel
75006 Paris
France

Any enquiries should be directed to ADF@theunion.org

Cécile MACE
Asthma Drug Facility Coordinator
Quality Assurance Pharmacist 
International Union Against Tuberculosis and Lung Disease (The Union)
68, boulevard Saint-Michel
75006 Paris
France 
Tel: (+33) 1 44 32 03 75
Fax: (+33) 1 43 29 90 87
cmace@theunion.org
www.theunion.org
www.GlobalADF.org

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