Directive 98/34/EC also for drugs?

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Joerg, people think drugs are exempt GATT/WTO -- they are not -- I've checked with the WTO (also have a masters in international business which helps with understanding)... All it would take is to get a single country to take a case to the WTO claiming a technical barrier to trade -- just remember, you are not representing the drug industry -- but the whole industry -- any victory is worthwhile -- and there would be non greater than the WTO!!! They are very heavy on evidence-based risk analysis -- given the data there is only one solution they can come too... open market -- labelling at worst as proposed by NZ...

Ron

At 20:54 10/12/2003, Dr. Joerg Gruenwald wrote:

Thanks Ron,

Sure we question things and have a lot of fights about what is a drug and a food.

In Germany Kava was 99.9% a drug market, practically no use of fresh or powdered root, so consequently it was a drug ban.

And drugs are excluded from the notification requirements as we understand.

Joerg

Von: Juderon [email protected]
Datum: Wed, 10 Dec 2003 06:50:02 +1300
An: "Dr. Joerg Gruenwald" [email protected]
Betreff: Re: Directive 98/34/EC also for drugs?

My understanding is that kava has been available in many countries as a food (not processed, no claims) and drug (extracted) in which case the food ban would be illegal without notification.

The following French court case might be worth following up...

Maine-et-Loire, FranceAfter ten years of appeals and counter-appeals, a court in the central French province of Maine-et-Loire has ruled that vitamin C should not be considered a drug even in doses many times above the existing safety limit.

The verdict, delivered by the Court of Appeal of Angers, recommended vitamin C up to 1,000mg in strength be reclassified as a food, thereby allowing it to be sold in any retail outlet.

Presently, vitamin C with a potency greater than 120mg is classified as a medicine in France and is banned from the shelves of supermarkets, health food stores and other vendors without a medicinal licence.

Jacques Karlsson, secretary general of Synadiet, a body that represents French health-food manufacturers, says the decision was encouraging because it was based on evidence presented by traditionally conservative French regulatory bodies. These same bodies presented evidence and advice to the current draft of the European Food Supplements Directive to be debated in the European Parliament in January 2002.

"This decision reflects the likelihood that the Directive will recommend upper limits of about 1,000mg for vitamin C," Karlsson says. "It is definitely a good signal for the industry. Even though the court's verdict is only a recommendation, not legislation, and does not actually affect the availability of the product within Maine-et-Loire or anywhere else within France, it sets a precedent that cannot be ignored."

He said pharmacists, who brought the original case to court a decade ago to prevent supermarkets and health food outlets from stocking vitamin C, were unlikely to take the proceedings any further because of the impending Directive debate in the European Parliament.

www.newhope.com/ffn/ffn_backs/Jan_02/news5.cfm
Shane Starling

Just because someone says something is a drug does not make it a drug. Don't simply accept bureaucrats' word... challenge the legality of what they are doing.

Regards
Ron

At 23:40 9/12/2003, Dr. Joerg Gruenwald wrote:

Dear Ralph,

Good talking to you, we will be in closer contact in the future.

We are looking deeper into 98/34 and found an original exclusion of drugs and cosmetics, food products have been added later on but are you sure that it covers also drugs?

This question is essential for the German strategy, since you are in court already you may have come over this question or your lawyer can easily answer that.

Thanks and best regards

Joerg

Dr. Joerg Gruenwald
Executive Director
International Kava Executive Committee (IKEC)
Co: Phytopharm Consulting
Waldseeweg 6, 13467 Berlin/Germany
[email protected]
Tel: +49 30 4000 8111
Fax: +49 30 4000 8500
www.analyze-realize.com

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