去年6月欧盟颁布的62号指令的具体操作至今仍是件悬而未决的事儿。但能够确定的是，我国即使获得欧盟GMP认证的企业，也不能豁免。 

In June of last year the European Union directive no. 62 issued by the specific operation is still up in the air of a thing。But the sure thing is，Our country even the European Union GMP authentication enterprise，Also can't release。 

　　变故 

misfortune 

　　今年元月，年销售额近4个亿的原料药企业A公司收到了MHRA(英国药品和健康产品管理局)颁发的EU-GMP证书，这意味着它的3个产品将以原料药的形式进入欧盟市场。 

On January this year，Sales of nearly active pharmaceutical ingredients of the enterprise A company received the MHRA(British drugs and health products administration)Issued by the EU-GMP certificate，This means that its three products in the form of active pharmaceutical ingredients (apis) will be entering the eu market。 

　　而就在此前，2011年6月，欧盟议会和欧盟委员会颁布了2011/62/EU号新指令，要求从2013年7月2日起，所有输欧的人用药活性物质(AS)必须出具出口国监管部门的书面证明。 

And before，June 2011，The European parliament and the European commission has issued a new directive 2011/62 / EU number，Request from July 2, 2013 up，All the people lose drug active material(as)Must provide written proof of the exporter supervision department。 

　　据欧洲仿制药协会估计，欧盟75%的原料药来源于欧盟以外地区，其中约20%来自中国。 

According to the European generics association estimates，The European Union (75% comes from outside the European Union，And about 20% from China。 

　　在今年7月11~12日于北京举办的中国-欧盟药品质量相关法规研讨会上，作为议题之一的欧盟62号指令也得以清晰化。 

In July this year 11 to 12 days in Beijing by Chinese-the European Union drug quality related laws and regulations for the workshop，As one of the issues of the European Union to prioritize the no. 62 instructions。 

　　按照欧盟关于新指令的阐释，即使是已经获得欧盟GMP认证的原料药企业，诸如A公司，也需要SFDA(国家食品药品监督管理局)出具书面证明。 

According to the European Union on new directive interpretation，Even the European Union has been the GMP certification API enterprise，Such as A company，Also need SFDA(The state food and drug administration)Written certificate issued by。 

　　而在研讨会之前，由于双方对此没有非常透彻的沟通，使得中方包括许多原料药企业对于这一指令的理解有些偏差——认为获得欧盟GMP认证的原料药产品不会受此指令的影响。 

And before the workshop，Because the two sides have no very clear communication，Make China including many apis to the instruction of the enterprise to understand that there are some errors-the European Union (GMP authentication products will not be the influence of the order。 

　　即便是7月25日，新金融记者在与A公司负责外贸的经理向飞(化名)交谈时，发现这一理解上的偏差仍旧存在。他甚至笃定，欧盟的GMP认证，是欧洲官员到中国来做审计和认证，通过后才给企业发GMP认证证书，这说明欧洲官方对企业是认可的，这时候出口到欧盟的原料药，“我觉得是没有必要通过出口国监管部门来出证明的。” 

Even if is July 25，The new financial reporter and A company shall be responsible for the foreign trade in the manager to fly(aliases)When talking to，Find the understanding of the deviation is still there。He even with，The eu's GMP authentication，Is the European officials to China to do the audit and authentication，Through to the enterprise to send GMP authentication certificate，It shows that the European official for enterprise is a recognized，This time the eu exports to the API，“I think is not necessary to through the exporter to the proof of the supervision department。” 

　　向飞的推断源于一个小插曲。几个月前，A公司的一个产品要以原料药的身份进入法国市场。法国药监部门决定到A公司进行该产品的GMP审计，并发函通知。向飞等人收到通知函后，做出回复。回复函中说明，MHRA已经对A公司的这个产品进行了审计，并颁发了GMP认证证书。了解到情况后的法国药监部门便表示他们不需要过来审计了。 

The inference to fly from a little episode。A few months ago，A company's A product to the identity of the active entry into the French market。France the drug agency decided to A company for the product of the GMP，Notice and sent a letter。To fly people receive notification, etc，respond。In reply to that，For A company MHRA has this product audit，And the GMP authentication certificate issued。Understand that the French and the drug agency after said they don't need to come over to audit。 

　　基于此，向飞认为自己的理解应该是正确的，其实不然。 

Based on this，To fly think oneself understanding should be correct，Actually otherwise。 

　　当然，这种信息不对称的状态不是绝对的。今年4月与欧盟代表有过接触的李恒(化名)——原料药企业B公司负责欧盟市场的经理，对62号指令有着他自己的看法。 

Of course，This kind of information asymmetry of the state is not absolute。In April this year and the European Union have had contact with representatives of the LiHeng(aliases)-API B company responsible for the eu market enterprise of the manager，Of 62 (instruction has his views。 

　　李恒向新金融记者表示，获得欧盟GMP认证的原料药企业，也需要出具书面证明，但具体到欧盟各个成员国，是由成员国自己来定。 

LiHeng to new financial reporters，The European Union (GMP authentication enterprise，Also to need to issue a written proof，But the specific to the European Union member states，By member states to set his is。 

　　他举例说明，假设某公司的一个产品获得了欧盟GMP认证，该产品出口到法国时，法国药监部门可能会因其已经获得欧盟GMP认证，而不再要求其附上出口国监管部门的书面证明；但同样是这个产品，出口到德国时，德国药监部门可能依然会要求其出具书面证明。因成员国而异。 

He for example，Assumption of a company's a product won the European Union GMP authentication，The product export to France，France the drug agency may be due to its has won the European Union GMP authentication，And no longer ask its attach regulatory written proof exporter；But the same products，Export to Germany，Germany the drug agency may still can ask its issue written proof。For member countries and different。 

　　他还解释说，书面证明需要与否，是由客户来要求的。

He also explained that，Written proof of the need for it or not，The customer to the requirements。