Chinese medicine druggist formulate traditional Chinese medicine the intersection of army and the intersection of Korea S. and Mexico Guo auspicious / gentle still " whether European Union traditional plant medicine registered the procedure order " according to come into force before the 7 year, from May 1 this year, traditional Chinese medicine not registering can't be sold within the territory of European Union as medicines and used. The loud limit will be near soon, but still there is not a traditional Chinese medicine that succeed in registration in European Union, does this mean traditional Chinese medicine would be kept outside of the door by the European market from then on? Does traditional Chinese medicine trade come to a halt in front of this seemingly frightening threshold? European Union has " The threshold " On April 30, 2004, " registered procedure order of traditional plant medicine of European Union " came into force formally. The new order aim at, revise come into force 2001 " people used the medicines order ", original intention is to solve the awkward situation that traditional plant medicine does not have a legal medicines identity, is mostly regarded as the health product for a long time and the food is sold on European Union market, finish the confused situation that member states do things in his own way for strengthening management on the aspect of European Union at the same time. The most outstanding content of new order is to require traditional plant medicine including traditional Chinese medicine, must apply for the registration to the responsible institution of member state in the future, only after examining and approving and agreeing with, could continue selling and using on European Union market as medicines. In view of the particularity of plant medicine, especially its long application history, the new order has stipulated first is what is called simple and easy to register the procedure, namely does not need to look like chemical medicines to register to pass the heavy and complicated clinical trial like that, but must offer the literature or expert to prove, prove there is at least medical history of 30 years before the application date in relevant plant medicine, including in at least medical history of 15 years of European Union. For let the intersection of plant and the intersection of medicine and trade finish, register, new order provide transition period of 7: Up to 7 years of April 30, 2011, all kinds of traditional plant medicines including Chinese herbal medicine can still continue selling and using, but must finish registering as soon as possible, otherwise from May 1, 2011, plant medicine not registering will have to withdraw from European Union market. Transition period of 7 would expire soon, any Chinese herbal medicine will not be succeeded in registering in European Union, Chinese herbal medicine enters European Union to face a threshold different to go beyond. Traditional Chinese medicine has been weighed down with anxieties all the time in refined these days of expert's forest of reputable traditional Chinese medicine of Holland difficult to register to sojourn in, he will arrive from a batch of Chinese medicinal materials which China import soon, but because of this new order, probably stopped outside Shanhaiguan by the customs officer. Without Chinese herbal medicine, it is not good that " there are rifles that have not been played " in Chinese medicine False skill. Obscurely, in 7 -year long transition period, why does enterprise of no traditional Chinese medicine break a awkwardness registered? Bin Lin think back in that " whether European Union traditional the intersection of plant and medicine register the intersection of procedure and order " set up threshold to be too high mainly, but traditional Chinese medicine circle should review one's own efforts it is not enough. He say traditional Chinese medicine development in Europe only 10 more than year time, so most Chinese herbal medicine take out the medical history of European Union in 15 years, prove while being difficult; Though some Chinese herbal medicines squeezed into European markets long ago, many in the name of food, health product, meal additive,etc., it is proved so it is difficult to take out pharmaceutial use. Chinese herbal medicine with long history is blocked in the pharmaceutial use of 15 years proves to have more than one thousand years, this is all that European Union's new rules made a noise. In addition, register the too high cost, make many Chinese medicine enterprises hang back too. Take Chinese medicine as examples, it is estimated that the single registered cost is about 1 million yuan, even if succeed in registration, enterprises still need to pass European Union GMP (the standardard management of quality of production of medicines) Authorize, it is a sum of big expenses, it is almost unable to bear for smaller enterprise. And seeing that export the scale to European Union market limitedly, the strong big medicine enterprise lacks enough motive force and furnishes funds of registration. The enterprise of Europe also perplexes in fact, the too high problem of the threshold is perplexing European Union plant medicine manufacturing enterprise and doctor too, " traditional plant medicine of European Union registered the procedure order " has been receiving querying and criticism from inside European Union all the time too. European Union is one of the largest markets of plant medicine in the world, account for world plant's medicine market share 40%. Plant medicine including traditional Chinese medicine is not strange for European, use traditional plant medicine according to over 60% of the Europeans of statistics. Although the original idea of issuing new order is to standardize European Union plant medicine market, protect the healthy development of it, but the result may cause hundreds and thousands of kinds of plant medicines to be refused outside gate on the market, make the European patient in breaking the medicine predicament. According to the estimation by natural health alliance based in Britain, even if is European Union pharmacy enterprise, the expenses which register a plant medicine need 80,000 to 120,000 pounds too, nearly shut 860,000 to 1,300,000 yuan, Shang Ke accepts for plant medicine products of bigger sales volume, but some small enterprises should probably close. Triumphant gram thinks the Fil of natural health Robert, executive director of alliance, " traditional plant medicine of European Union registers the procedure order it is " to give non- European plant medicine and put on Europe obstinately " The close-fitting underwear " ,But the result has destroyed plant medicine, the task of top priority is to find a kind of new quality control system more suitable and affording to bear. The natural health alliance is being set about initiating the law to challenge the new order at present. Fils of triumphant gram say, they plan to bring a suit before British court on the grounds that and order opaqueness have discrimination at the end of April, and hope the lawsuit transfers European Court of Justice based in Luxembourg to try. European the intersection of parliament and the intersection of Congressman and King, Kazakhstan of Marian, of Irish say, the new order might really cause European masses to lose much plant medicines, some of medicines of these plants have already been used for more than one thousand years, how to really have a dispute to examine and approve them. The European parliament Czech Congressman Pavel wave thatch says, it is originally for ensuring traditional plant medicine to use to issue the new order safely, but there is not any kind of China or Indian traditional medicine so far and can be registered smoothly, this kind of situation makes people unable to accept. He is considering which kind of measure can be taken, in order to prevent this kind of situation from taking place. The gate has not been closed tight and has not hesitated to object to sounds, European medicine enterprise has not stopped the efforts of legalization of products. European Union has already registered plant medicine and reached more than 249 kinds at present, it's a great pity there is not a it is the traditional Chinese medicine. Lin Bin thinks, nowadays transition period will finish soon, will begin to step into the all-sided implementation, one may well say what has been done cannot be undone, what the traditional Chinese medicine circle should do now or applying to register through European Union actively, avoid losing the market with enormous this potentiality. According to the data of chamber of import and export trade of medical health product in China, China will be 193 million dollars to the volume of export of traditional Chinese medicine of EU countries in 2008, among them the volume of export of Chinese medicine is 13,240,000 dollars, only account for European market share 0.5%, and the medicine market scale of whole plant of European Union is stated to be already been up to ten billion euro. Lin Bin says, <
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