E-DRUG: Asthma Drug Facility :Invitation for expressions of interest
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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 copy/paste the
following on your internet browser: 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 beta 2-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
Inhaled HFA combined long-acting beta 2-agonist & corticosteroid
5. Formoterol-Budesonide 4.5 microgram / 160 microgram, 120 doses, HFA
inhaler
Alternatively to this former combination, the ADF is also inviting
manufacturers, or their legal representative, to submit their expression of
interest for the following formulation:
Formoterol-Budesonide 6 microgram / 200 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.
Please copy/paste the following on your internet browser:
http://globaladf.org/index.php?option=com_content&view=article&id=21&Itemid=22&lang=en
[fix URL in browser if broken - moderator]
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) and who wish to
keep on supplying ADF with these products, please send to the ADF:
- Samples for each product
- 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/CET time on Friday 26 April 2013:
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(at)theunion.org
Christophe PERRIN
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
cperrin(at)theunion.org