英国药品管理局/行业关于反假药法令会议上的问答

唐伯虎

这个信息非常重要,请关心欧盟信息的朋友仔细研究
(转自GMP论坛)
2012年11月15号白金汉宫路举行的英国药品管理局/行业关于反假药法令会议上的问答

原料药Q1问1
Are ‘atypical’ actives exempt from Falsified Medicines Directive requirements?
是否“非典型”活性成分从反假药法令要求中免除？
A1答1No they are not, the Directive will apply. An active substance is defined as any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis. If an ‘atypical’ active is used as an active ingredient it will be a substance that becomes an active ingredient and all the provisions of the Directive in relation to Active Substances will apply.
不，其没有豁免，该法令将适用。原料药定义为拟在药品制造中使用，而且，当其生产中使用，其成为一个具有药理学、免疫学或代谢作用，来恢复、纠正或改善生理机能或医学诊断产品中的任何物质或混合物。如果一个“非典型”活性物质用作原料药，它将变成为一种原料药，并且所有有关原料药法令都将适用。
Q2问2
Does an active substance that is used in the manufacture of a medicine which is for the purpose of export to a non EEA country have to comply with the requirements of the Falsified Medicines Directive?
是否生产用于出口到非欧洲国家的药品的原料药必须符合反假药法令的要求吗？
A2答2
Yes. Matters in the Falsified Directive relating to active substances will apply to those used in the manufacture of medicines intended for export. Article 2(3) of amended Directive 2001/83 provides that Title IV of the Directive shall apply to the manufacture of medicinal products intended only for export and to intermediate products, active substances and excipients. Title IV deals with manufacture/import and lays down the obligation to only use starting material that is GMP compliant. Article 40 requires an authorisation regardless of whether the medicinal product is for export and will include the obligation on GMP.
是的。在反假药法令中有关原料药的事项，都将用于目的是出口的药品生产中。已经修订的第2001/83号法令的第2(3)条规定，该法令第四章适用于仅用于出口的药品、中间产品、原料药与辅料制造。第四章涉及制造/进口内容，并规定了有义务仅仅使用符合药品生产质量管理规范要求的起始原料。第40条需要一个授权，无论是否是用于出口的药品，都包括符合药品品生产质量管理规范的义务。
Q3问3
What will be the Customs and Excise process associated with the importation of APIs?
进口原料药会有什么关联的海关程序吗？
A3答3
Currently HM Customs or Borders do not have any oversight of GMP matters. That position has not changed under the Falsified Medicines Directive.
目前英国海关或边境没有对药品生产质量管理规范物料进行监管。这一立场没有被反假药法令所改变。
Q4问4
We understand that India is to set up a ‘written confirmation’ process that is founded on only a brief site visit. Will this truly add assurance to the supply chain?
据我们了解，印度将建立一个在简短的现场审计基础上进行“书面确认”的程序。这会真正增加对供应链保证吗？
A4答4
Currently the situation with India remains unclear. Until more information is made available this position should not be relied upon.
目前印度的情况与仍不清楚。直到得到更多可用的信息，该状况并不可靠。
Q5问5
What is the EU going to do to resolve the issue of confirming a third country manufacturer of active substances complies with equivalent GMP standards?
欧盟要做些什么来解决确认第三国原料药生产企业符合等同的药品生产质量管理规范标准问题？
A5答5
The European Commission is currently considering the supply of active substances into Europe with all Member States in order that the measures in respect of GMP requirements for active substances are met.
欧盟委员会目前正考虑欧洲所有成员国的原料药供应问题，以便符合原料药药品生产管理规范方面要求的措施。
Q6问6
What are the differences between manufacture, import and distribution of active substances?
原料药的制造、进口和流通之间区别是什么？
A6答6
Manufacturers, importers (importing from a third country) and distributors of an active substance will have to register with the MHRA. Import from a third country will be seen as a distribution activity and will be the subject of a GDP certificate. The distribution of an active substance within the UK which has been sourced from a UK manufacturers or an importer will be seen as a distribution activity and will be the subject of a GDP certificate. A manufacturer of an active substance will have to comply with GMP. The Activity will be the subject of a GMP certificate.
原料药的制造企业、进口企业(从第三国进口)与流通企业必须到英国药品管理局进行注册。从第三国进口将被看作是一个流通活动，并将需要药品流通质量管理规范证书。来源于一个英国本土的制造企业或一个进口企业在英国范围内销售原料药将被看作是一个流通活动，并需要药品流通质量管理规范证书。一个原料药的制造企业将必须符合药品生产质量管理规范。所有的活动都需要药品生产质量管理规范证书。
Q7问7
How will these differences be reflected in the registration requirements?
如何将这些差异在注册的要求中反映出来？
A7答7
The registration will describe the registered activity using standardised text.
注册将使用标准文本来描述注册活动。
Q8问8
When will the forms for registration be made available?
何时有注册格式？
A8答8
Registration forms are currently being developed and will be available by the end of the year.
目前正在开发注册格式，将在今年年底得到。
Q9问9
How long will the process of obtaining registration take?
注册过程有多长时间？
A9答9
The registration process for manufacturers, importers and distributors of active substances can take up to 60 days, possibly extending to 90 day where a site inspection is required.
原料药的生产企业、进口企业与销售企业的注册过程可能需要长达60天，当需要进行现场检查时，可能延长至90日。
Q10问10
Does the MHRA have inspection resource that could be used to inspect active substance producers in third countries outside the nations that have applied to be considered acceptable to ensure the security of supply of active substances for pharmaceuticals essential for patients within the EU?
是否英国药品管理局有检查的资源，可以用来检查已经适用保证原料安全国家以外第三国的原料药生产企业，以保证欧盟范围内的患者使用药品的原料药的安全？
A10答10
Currently the MHRA does not have sufficient resource to inspect active substance producers in third countries that have applied to be considered for acceptable GMP standards.
目前英国药品管理局没有足够的检查资源来检查在第三国应用可以接受的药品生产质量管理规范标准的原料药生产企业。
Q11问11
If an active substance has been imported for an investigational medicinal product and stocks of the active substance remain, can these be used for the manufacture of early commercial batches of medicinal products without further action, or is some retrospective action required to cover their suitability for use under the Falsified Medicines Directive?
如果一原料药已进口用于药品研发并保留有原料药的库存，在没有进一步措施时，是否可以用来早期商业批次的制造中，或者采取一些回顾性活动来论述适用性以便在反假药法令下使用？
A11答11
Unless the active substance is covered by a written confirmation, the active substance cannot be used in a medicinal product for human use.
除非该原料药被书面确认涵盖，否则该原料药不能用于人用药品。
Q12问12
What discussions is the EU having with the regulators in the likes of the US, China and India to ensure the requirements can be met?
为确保符合要求，欧盟与像美国、中国和印度这些国家的药品监管机构讨论了什么？
A12答12
Regular engagement and discussions continue with the Commission and other Member States to try to resolve the issue concerning third supplies of active substances. The MHRA remains engaged with the issues.
定期约定并讨论，欧洲委员会与其他成员国继续尝试解决第三国供应的原料药问题。英国药品管理局也在商谈这些议题。
Q13问13
What does the 02-Jul-2013 date relate to in respect of active substances?
2013年7月2日与原料药方面有什么关联？
A13答13
The 02-Jul-2013 date is the date from which active substances have to be accompanied by a written confirmation from the competent authority of the exporting third country.
从2013年7月2日开始，原料药必须附有由出口第三国的主管机关的书面确认。
Brokers
掮客
Q14问14
Are “brokers” of active substances to be subject to the same requirements as brokers of medicinal products?
是否原料药的“掮客”也需要与药品的掮客有同样的要求？
A14答14
The term “brokering of medicinal products” is defined in the Falsified Medicines Directive. Whilst the activity of “brokering” is term frequently used in the supply of active substances the two are separate. A “broker” of a medicinal product is to be the subject of a different registration scheme, to a manufacturer, importer or distributor of an active substance.
术语“药品掮客”已经在反假药法令中进行了定义。同时，“掮客”活动作为一个频繁应用在原料药供应上的术语，二者是截然分开的。药品的代理人与原料药的生产商、进口商或分销商属于不同的注册体系。
Q15问15

原料药的措施适用于兽药产品吗？
A15答15

不，这措施仅适用于生产人用药的原料药。对于既可以供应人用药品也可以供应兽用药品的原料药工厂，应当保证供应人用药品的物料符合原料药反假药法令的要求。
General
通则
Q16问16

原料药与药品的运输代理公司需要符合反假药法令吗？
A16答16

原料药和药品的运输理代理公司需要审核其运营模式。如果被要求将物品存储等待进一步指示，它可能要具进行适当的注册或授权。

paddycui

感谢，但是基本上还是没有明确的说法

蒲公英

谢谢，虽然看不太懂，也不太理解，但总会有用

syhorchid

谢谢楼主分享

巴西木

先下载收藏，谢谢楼主分享

雪锋

对于原料药还是有用的。

雪锋

关键在于怎么理解。

LLL-蓬莱

学习一下！

晴兮灬love

佩服，佩服！












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晴兮灬love

能发这么好的帖子，太谢谢了












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