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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ) -- Ignore unavailable to you. Want to Upgrade?

To: MisterED who wrote (2885)11/28/1997 12:59:00 PM
From: sailor  Read Replies (1) | Respond to of 23519
 
VVUS/UK/EC

The EC seems to be fairly tied together, so once UK is appoved EC should follow. However I have posted before. VVUS will have to have some sort of ISO certification very soon to ship to anyone in the EC. Does anyone know if they are working on or have ISO certification?

Sailor

PS ISO is not required today, but will be sometime next year. It is not like FDA, but a certification on plant operations, QA/QC, and manufacturing standards. Plants I have worked with recently (in the medical field) are spending inordiante amounts of time assuring that ISO is met.



To: MisterED who wrote (2885)11/29/1997
From: DR. BOND  Read Replies (3) | Respond to of 23519
 
Interesting Reflection!

imsp008.netvigator.com

DB



To: MisterED who wrote (2885)11/30/1997 5:42:00 AM
From: Whipsaw  Respond to of 23519
 
am I correct in assuming that the other European countries will follow in quick succession as a result of the UK? Or will each
country have to go through the same procedure as the UK.

Vivus IR told me that approval in several European countries is triggered by UK. They have a period of time to raise issues and ask questions, and then it is automatic. This would mean that UK approval means a great deal more than just picking up the British ED population.


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