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[e-drug] Shortage of ACT therapies against malaria (Addendum)

E-DRUG: Shortage of ACT therapies against malaria (Addendum)
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Dear e-druggers, 

>From the comments by Wilbert Bannenberg to our posting
of yesterday we noticed that the regulatory status of
Dafra's products needs to be clarified. 

As a comment to our posting about the shortage of
artemisinin therapy Wilbert added the following lines:

"Please note that DAFRA products have not been
pre-qualified by WHO or registered in Europe as far as
we know. Non-registered drugs can be exported from
Europe without regulatory controls. Apparently some of
its products are registered in developing countries." 

The suggestion that Dafra products are non-registered
and are exported without any regulatory control is 
not true. 

In reality, the procedure Dafra uses to obtain
marketing authorisations in African countries is the
following: 

1. We have to submit a pharmaceutical technical file
including GMP status of the manufacturer, the product
formula, the manufacturing process and stability and
validation data concerning the product to the Belgium
Ministry of Health, Department medicinal products. 

2. Furthermore, the file contains clinical,
pharmacological and safety data concerning the
product. The proposed patient leaflet and SPC are also
included in this file. 

3. After evaluation and approval of the file by the
examiner(s), the pharmaceutical inspection in Belgium
grants us the right to export the product. They do so
in a special document, called an export declaration
for a medicinal product. 

4. With the export declaration in hand, we then apply
for CPPs (certificate of pharmaceutical product) and
specific GMP certificates for each approved product. 

5. After obtaining all of these, we then submit the
registration file to the appropriate regulatory bodies
in Africa. In each country, the complete registration
procedure is followed, including audits of the
manufacturing sites in Belgium, the Netherlands and
Germany. Only after obtaining approval and a marketing
authorisation from the National Medicines Board the
product is put on the market in a specific country. By
following this procedure our products are registered
in approximately 35 countries in Africa. 

We hope that this makes clear that all our products
are approved by national drug authorities in Belgium
and Africa. 

We did not register our products for marketing(!) in
Europe, since the main need for artemisinin based
products to cure malaria is in Africa, not Europe. 

with regards, 

Marnix Slachmuylders
Industrial Pharmacist
Dafra Pharma
Belgium
hansplatteeuw@yahoo.com

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