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《欧洲人体组织产品规则》的制定接近尾声 - China Medical Device Manufacturer
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Sat, January 20th, 2018

2005 秋季刊 » 行业新闻
《欧洲人体组织产品规则》的制定接近尾声

欧洲监管机构向来很少考虑产业投入的有关问题。但是,据某位顾问所述,欧盟已着手制定有关人类组织产品的相关规则,所以 2005 年的情况将有所不同。因此,想在欧洲销售组织产品的设备商们应对今年的两个法律程序加以注意。

这可能有点棘手,因为欧洲只有两种针对卫生保健行业的监管框架:一类针对医药品,另一类则针对设备。 Quintiles 公司 (Bracknell, UK; www.quintiles.com ) 的高级顾问 Phil Brown 说道,对于组织产品之类的边缘产品,有必要弄清其何时归属哪一个框架。这是他在最近举行的一个音频会议上所作的发言。 该会议由 ForeignExchange Translations Inc. (Boston, MA, USA; www.fxtrans.com ) 主办 。

首先要注意的是在贯彻执行《欧洲委员会采购指令》时起着重大作用的指示。负责一般产品安全性的 SANCO 总署正在起草该文件。 Brown 说道,组织产品制造商需要了解的是有关人类组织的捐赠、采购和测试的指示。其涉及事项包括:

组织公司的指定、授权和许可。

捐赠人的选择标准。

捐赠人的筛选测试。

采购、接受和分配步骤。

第二道规则制定程序涉及制造与营销方面的授权。负责有关货物自由流动事宜的企业总署有此权限。

据 Brown 称,该项所包含的内容有自体和异体组织产品的批准程序、欧洲医药代理处的确切职责以及是否有针对小规模制造商的鼓励措施。

生产组织产品的公司及其产品都必须获得营销授权。他还说,这大致与 3 级医疗设备的授权程序类似。对于待审公司和产品而言是很有利的,因为这将是一个规则而非指令。它意味着文件本身将会直接体现于各成员国的法律之中,而没有国家间的分歧。

Brown 说道,至于在欧洲销售组织产品,目前的机制有一个漏洞,使得公司能进入具有更多限制性规定的国家而无需遵守那些更严格的规定。一旦产品在任何一个欧盟国家获得批准并运抵该处,其将不受任何限制即可转运至欧盟的任何其他国家。这就意味着,公司可以先在限制性较低的国家获得销售许可,接着将所有产品运至该国,然后再运往其它限制性更严格的欧盟成员国,他说道。不过他补充说道,意大利正在考虑立法以堵住该漏洞,而其它国家也将纷纷效仿。


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