即将在今年7月1日正式实施的欧盟62号令，是否将成为原料药企业的拦路虎？记者昨日从国家药监部门和药企了解到，进入今年1月以来，无论是相关部门还是企业都在采取措施积极应对，尽最大可能降低欧盟政策的不利影响。不过，原料药企业洗牌局面不可避免。

Will be in July 1, formally implementing eu 62 order,Whether the drug will become enterprise a lion in the way?Reporters yesterday from the state also departments and medicine enterprises to know,Since January this year into,Whether related departments or enterprises are taking active measures,To the maximum extent possible to reduce the harmful effects of eu policy.but,API enterprise shuffle situation inevitably.

　　2011年6月，欧盟议会和欧盟委员会颁布了2011/62/EU号新指令（即“62号令”），要求从2013年7月起，提高药品进口门槛，旨在防止假药流入正规销售渠道。该指令要求，所有出口到欧盟的药品均需出具出口国监管部门的书面声明，并保证符合以下要求：一是出口国GMP法规相当于欧盟标准；二是对生产企业实施定期而严格的GMP检查。

In June 2011,The European parliament and the European commission has issued a new directive 2011/62 / EU number(namely"62 order"),Requirements from July 2013,Improve the drug import threshold,Designed to prevent counterfeit drugs into the normal sales channel.This directive requirements,All export to the eu's drug all needs to issue exporter regulatory written statement,And to ensure that meet the following requirements:One is the exporter GMP regulations is equivalent to the eu standards;The second is to production enterprises to implement regular and strict GMP inspection.

　　业内人士分析，62号令提高了药品进口门槛，特别是“所有出口到欧盟的药品均需出具出口国监管部门的书面声明”，这一条属于难点。

Analysis of the personage inside course of,62 order to improve the threshold of imported drugs,especially"All export to the eu's drug all needs to issue exporter regulatory written statement",This one belongs to the difficulties.

　　业内人士告诉记者，国家食品药品监督管理局对该指令十分重视，近日已奔赴浙江台州等地，摸底原料药企业。同时要求企业完善在该局英文网站的原料药中英文数据库相关信息。该人士告诉记者，“实际上，欧盟此举是要求我国的药监部门为企业的境外销售提供担保，相当于要为企业承担责任，我国药监部门正在研究方法，并采取实际行动来应对此事，并积极配合企业，在企业面临新困境时给予援手。”

The personage inside course of study tells a reporter,State food and drug supervision and administration of the instruction attached great importance to,Zhejiang taizhou has recently to etc,A baseline API enterprise.At the same time, requests the enterprise in the perfect English website information database API in both Chinese and English.The source told reporters,"In fact,The European Union the move is also requires our department for enterprise's overseas sales to provide security,For enterprise is equivalent to assume responsibility,Our country also departments are research methods,And take practical action to deal with this matter,And actively cooperate with the enterprise,In the enterprise face the new trouble to give a helping hand."

　　记者昨日致电华海药业(600521,股吧)证券事务部。该部门人士表示，对已经在国内获得新版GMP认证以及符合欧洲出口标准的企业来说，获得监管部门出具证明的可能性很大。就公司来说，华海药业人士表示，62号令不会对公司今年欧洲市场业务造成不利影响。

Reporters yesterday at huahai pharmaceutical(600521,guba)Securities department.The department said people,To have been in China for new GMP certification and compliance with European export standards for the enterprise,Gaining regulatory issue a certificate of possibility is very large.It is the company,Huahai pharmaceutical say,62 order not to the company this year the European market adversely affect business.

　　与此同时，记者采访浙江台州另外一家原料药企海翔药业(002099,股吧)时获悉，公司的法规部正在就此事开展积极工作，并与国家药监部门开展配合，以期尽早拿到证明。据介绍，公司目前出口欧盟的产品均已获得欧盟的GMP认证，不需要走新的认证程序，62号令不影响公司现有产品出口。

meanwhile,Reporters zhejiang taizhou another API to sea xiang pharmaceutical(002099,guba)When we,The company's rules and regulations of the work is active,And the state department and also carry out cooperation,In order to get that as soon as possible.According to introducing,The company exports the eu's products have won the European Union GMP authentication,Don't have to go the new certification program,62 order does not affect the company existing products export.

　　事实上，62号令对原料药的质量提出了更高的要求，对相当一部分小企业特别是连国内新GMP认证都未通过的企业来说，出口欧盟市场的大门已经逐渐关闭。浙江永宁药业海外销售负责人金雄熊告诉记者，原料药小企业面临被兼并收购的命运，行业也将重新洗牌，这对于已经符合欧洲出口标准的企业来说则意味着新的机遇。

In fact,62 order to API quality put forward higher request,For quite a number of small businesses especially even domestic new GMP authentication failed the enterprise speaking,Export the eu market has gradually closed the door.Zhejiang yongning pharmaceutical overseas sales person in charge JinXiong bear told reporters,API small business face the fate of the merger and acquisition,Industry will also reshuffle,It has to conform to the European export standard enterprise is means that new opportunities.

　　事实上，从记者采访到的企业信息来看，欧盟的市场需求是刚性的，并且处于上升趋势，目前华海药业和海翔药业的海外出口业务已经回暖，2012年四季度的短单已经转变成了目前的长单，这些企业的原料药和制剂销量有望继续保持高增长。

In fact,Reporters from the enterprise information to see,The eu's market demand is rigid,And rising,At present huahai pharmaceutical and sea xiang pharmaceutical overseas export business has warmed,In the fourth quarter of 2012 short single has turned to the long list,The enterprise of drug substances and drug products sales is expected to continue to maintain high growth.