When can a CEP be withdrawn?

清歌一曲月如霜

CEP证书，其最终退出，或为CEP正在进行的应用程序的关闭而临时停牌遵循EDQM定义严格的规则和最近发表的题为“暂停或撤销证书的适用性，应用程序关闭“。除了关键概念的定义，该文件包含了哪些导致暂停或CEP证书的退出，和/或一个应用程序关闭的情况下一个精确的描述。此外，该文件提出了规范的决策，沟通渠道和所涉及的委员会。
术语“暂停”和“退出”往往是经常被混淆。本文档中包含的定义应澄清含糊。根据该定义：
CEP证书的“暂停”被限制在一个为期2年。它可以通过CEP的持有者被要求或应采取的EDQM决定的结果。如果CEP的持有者主动申请并提交相应信息的暂停CEP可能会恢复。如果没有，或者，如果他/她不提交所需的文件，在CEP将被自动取消。
A“提款”是一个明确的取消CEP证书的。已被撤回的CEP无法恢复。
原因临时停牌，彻底撤出，或为CEP正在进行的应用程序的关闭是相似的;然而，在案件的一个“提款”他们是更严重的 - 如下所述：
悬挂
由EDQM或监管当局（GMP认证）进行了检查发现重大GMP缺陷。有可能对公众健康的潜在风险。
由EDQM的检查表明，生产过程不符合在CEP的卷宗中的条款。
CEP的卷宗不符合再与认证程序的要求。该持有人没有提交任何信息来维护它。
CEP的人请求暂停;例如，由于生产或整修在生产现场暂时停止。另一个原因是：CEP的持有者需要时间的API，以满足经修订欧洲药典的要求制造。专着。
提款
由EDQM的检查显示，因为风险对公众健康或广泛和系统性弄虚作假行为的需要采取紧急行动中发现的文件和数据。
该公司拒绝检查，要求中止或延迟，即限制进入某些地区或文件。
CEP的持有者不会主动提起CEP暂停。
CEP的卷宗不符合再与认证程序的要求，而持有人没有提交任何信息来维护它。
CEP的持有者不存在任何更长的时间，或原料药的生产已经停止，而不通知EDQM。
CEP的持有者请求CEP撤出，如由于停止生产，或网站的关闭。
封闭一个CEP应用
由EDQM或监管当局（GMP认证）进行了检查发现重大GMP缺陷。有可能对公众健康的潜在风险。
该公司拒绝进行检查。
由CEP持有人向EDQM的不足信的答复是不足或不及时提供。
CEP的人请求应用程序的关闭。
EDQM的所谓特设委员会接管描述的过程的最终决定。这两个星期后的CEP持有人的提款要求的检查或收据呈现其决定。该委员会随后传达其决定CEP持有人及/或相关许可机关或者监察机关。特设委员会由内部决定董事会的支持。这个内部决策委员会审核所有的文件和意见，并提交提案建议应采取的决定广告hocCommittee。
“CEP悬浮液，提取和修复体”的定期更新列表可以在EDQM的网站上找到。
在新文档的连接，下面的论文演讲建议：
决议AP-CSP（07）1“的适用性欧洲药典专论证书”。自2007年该政策文件（中英双语，英语，中国）介绍了认证过程的主要特点。
PA / PH/ CEP（01）1，10R“职权范围”。本文档提供了关于参与认证过程的委员会，其组成和工作方法的信息。


The temporary suspension of a CEP, its definitive withdrawal, or the closure of an ongoing application procedure for a CEP follow strict rules defined by the EDQM and recently published in a document entitled "Suspension or withdrawal of a Certificate of Suitability, closure of an application". In addition to the definitions of the key notions, the document contains a precise description of the scenarios which lead to the suspension or the withdrawal of a CEP, and/ or to the closure of an application procedure. Moreover, the document presents the specifications for decision-making, the communication channels and the committees involved.
The terms "Suspension" and "Withdrawal" tend to be frequently confused. The definitions contained in the document should clarify ambiguities. According to the definitions:
The "Suspension" of a CEP is limited to a period of 2 years. It may be requested by the holder of a CEP or be the result of a decision taken by the EDQM. A suspended CEP may be restored if the holder of the CEP actively applies for it and submits the corresponding information. If not, or if he/ she doesn't submit the documents required, the CEP will be automatically withdrawn.
A "Withdrawal" is a definitive cancellation of a CEP. A CEP that has been withdrawn cannot be restored.
The reasons for temporary suspension, definitive withdrawal, or the closure of an ongoing application procedure for a CEP are similar; yet, in case of a "Withdrawal" they are more serious - as described below:
Suspension
An inspection carried out by the EDQM or by a supervisory authority (GMP inspection) reveals major GMP deficiencies. There may be a potential risk for public health.
An inspection by the EDQM shows that the manufacturing process doesn't comply with the provisions laid down in the CEP dossier.
The CEP dossier isn't in compliance anymore with the requirements of the certification procedure. The holder hasn't submitted any information to maintain it.
The CEP holder requests a suspension; for example because of temporary cessation of production or renovations at the production site. Another reason is: the CEP holder needs time for the manufacture of an API to meet the requirements of a revised Ph.Eur. monograph.
Withdrawal
An inspection by the EDQM shows urgent action needed because of risk for public health or extensive and systemic falsifications were found in documents and data.
The company refuses the inspection, requests the discontinuation, or delays, i.e. restricts the access to certain areas or documents.
The CEP holder doesn't actively lift the suspension of the CEP.
The CEP dossier isn't in compliance anymore with the requirements of the certification procedure, and the holder hasn't submitted any information to maintain it.
The CEP holder doesn't exist any longer, or the production of the API has ceased without informing the EDQM.
The CEP holder requests the withdrawal of a CEP, e.g. because of cessation of production, or closure of the site.
Closure of a CEP application
An inspection carried out by the EDQM or by a supervisory authority (GMP inspection) reveals major GMP deficiencies. There may be a potential risk for public health.
The company refuses to be inspected.
The reply to the EDQM's deficiency letter by the CEP holder is insufficient or not provided in time.
The CEP holder requests the closure of the application procedure.
EDQM's so-called Ad hoc Committee takes the final decision over the procedures described. It renders its decision two weeks after an inspection or receipt of the withdrawal request by the CEP holder. The committee then communicates its decision to the CEP holder and/ or to the relevant licensing or supervisory authorities. The Ad hoc Committee is supported by an internal decision board. This Internal Decision Board reviews all the documents and opinions and submits proposals to the Ad hocCommittee on the decision to be taken.
A regularly updated list of "CEP Suspensions, Withdrawals & Restorations" can be found on the EDQM website.
In connection with the new document, the lecture of the following papers is recommended:
Resolution AP-CSP (07) 1 "Certification of suitability to the monographs of the European Pharmacopoeia". This policy paper from 2007 (bilingual, english-chinese) describes the main features of the certification process.
PA/PH/CEP (01) 1, 10R "Terms of Reference".This document gives information about the committees involved in the certification process, their composition and method of working.