使用CESP给EDQM提交电子文件（中英文）---Julia

巴西木

Certification of Substances Division

PUBLIC DOCUMENT

(LEVEL 1)

English only/Anglais seulement

PA/PH/CEP (13) 67, 1R

Strasbourg, December 2013

Certification of suitability to Monographs of the European Pharmacopoeia

Use of CESP to submit electronic documents to EDQM

使用CESP给EDQM提交电子文件

Address: 7 Allée Kastner, CS 30026 F-67081 Strasbourg (France)

Tel: +33 (0) 3 88 41 30 30 – Fax: +33 (0) 3 88 41 27 71 - e-mail: cep@edqm.eu

Internet: http://www.edqm.eu

Use of CESP to submit electronic documents to EDQM.

使用CESP给EDQM提交电子文件

Before submitting electronic documents via the CESP, you must first create a user account. You can register from the Home page of the CESP.

在通过CESP提交电子文件之前，你必须首先创建一个用户帐号。你可以从CESP首页上登录创建。

Connect to the CESP与CESP联系: http://cesp.hma.eu/Home

Step A – Preparation of Delivery file.

第一步：准备传送文件

To submit documents to the EDQM, you should login from the home page using your account details, and create a delivery file for the submission.

要向EDQM提交文件，你应该使用你的帐号登录网页，为申报创建传送文件。

The “delivery file” is the file which the CESP system uses to route the submission to the required agencies.

“传送文件”是CESP系统用于引导申报文件至目标机构的文件。

You are required to provide information about the submission:

你会被要求提供与申报相关的信息：

For the choice “Area”, ensure to select “EDQM”.

在选项“区域”中，确认选择“EDQM”。

Below this, choose the most appropriate “Regulatory Activity” which corresponds to the type of information you are sending to the EDQM. The list of regulatory activities is as follows:

在这下面，选择最适当的“法规活动”，其对应你提交给EDQM的信息类型。法规活动清单如下：

? Request for new CEP

申请新CEP

? Notification/revision/renewal

通知/修订/更新

? Response to request for additional information

对要求额外信息进行回复

? EDQM inspection

EDQM检查

? Other (e.g. submission of information not requested by EDQM)

其它（例如，所提交信息并非是EDQM主动要求的）

Any comments or information relating to your submission should be mentioned in the “comments” box, which is a free text box.

任何与你的申报有关的信息应在“备注”栏内提到，该栏为自由文件栏。

In particular, the following information must be given at a minimum:

特别是至少必须给出以下信息

? CEP Dossier Number (if you have one)

CEP文件编号（如果你有）

? Substance Name

物质名称

? Supporting comments relating to the submission

与申报有关的支持性建议

If a file is zipped, ensure that “Zip File” is ticked “yes” and the appropriate file format is selected. Currently “Microsoft compressed folders” and “Winzip” are the only accepted zip file formats.

如果文件为压缩文件，确认“ZIP FILE”被勾中“yes”，并选择了适当的文件类型。现在压缩文件仅接受“微软压缩文件夹”和“WINZIP”。

Note: It is recommended to submit your files as zipped files. This will reduce the possibility of complications during the delivery of your file. It is also important to note that zipped file names should not contain any special characters, and the file name / path length should not exceed 240 characters.

注：推荐提交压缩文件。这样会减少在文件传递过程中可能的麻烦。还要注意压缩文件名不应包括任何特殊字符，文件名/路径长度应不多于240字符。

Please consult the HMA guide to zipping submissions correctly, which is available on the HMA website under “General Information”.

为正确压缩申报文件，请参考HMA指南，该指南在HMA网站中“一般信息”项下可以找到。

Clicking “Next” will present the following screen:

点击“下一步”，会看到以下显示

Please ensure that “EDQM” is selected. Once you have selected “EDQM”, click “Submit” which will present the “Delivery Note Download” page.

请保证选中“EDQM”，选中后，点击“提交”，会转到“传送通知下载”页面。

Click the download button to download the delivery file (xml file):

点击下载按钮下载传送文件（xml文件）

Note: This delivery file is unique for the submission and should not be reused. You should save it to an appropriate location and must not change the file name.

注：本传送文件为每次提交唯一识别的，不可以再次使用。请将它保存在适当的位置，不可以改变文件名称。

Step B –Transfer the submission documents to CESP

第二步：将申报文件传送至CESP

Once the delivery file has been created and saved in the appropriate location, the next step is to transfer the documentation using an sFTP client or via a Web Based File Transfer System.

在创建传送文件，并保存在适当位置后，下一步就是将文件采用sFTP客户端或通过网页基础文件传输系统传送文件。

The following section is relative to the Web based file transfer system only, as it is not possible to provide details of all available sFTP client software.

以下部分是关于网页基础文件传输系统的，因为无法提供所有可能的sFTP客户端软件的细节。

Note: More detailed information on creating deliver files and transferring submissions to CESP are available on the HMA website: http://cesp.hma.eu/GeneralInformation

注：关于创建传输文件和向CESP传送申报文件的更多详细信息请参见HMA网站。

Web Based File Transfer System:

网页基础文件传输系统

The web based file transfer system is accessible on the CESP home page once you have logged in.https://cesp.hma.eu/EFTClient/Account/Login.htm

在登录上述网址后，可以在CESP首页上找到网页基础文件传输系统。

For users who have Java enabled computers, please ensure to tick “Use JavaTM”.

对于采用JAVA激活电脑的用户，请保证勾选“使用JAVA”。

Once logged in, you must create a folder in the “Remote Server Files and Folders” pane to place your submission. To do this, click an empty area of the “Remote Server Files and Folders” Pane, followed by“New Folder”. Please ensure you name your folder appropriately.

登录后，必须在“远程服务器文件和文件夹”面板中创建一个文件夹，来放入申报文件。要做到这点，点击“远程服务器文件和文件夹”面板中空白位置，点击“新文件夹”。请确认将文件夹正确命名。

In the top left hand pane labelled “my files and folders”, please select the file(s) you wish to transfer.

在面板的左上端，有一个标签“我的文件和文件夹”，请选择你想要传送的文件。

Drag the file(s) over to the folder which you have created in the right pane.

将文件拖拽到你在右边面板创建的文件夹内。

Once all files for submission have been selected and dragged over to the pane on the right, the system will build the transfer queue in the pane at the bottom of the screen.

当所有要提交的文件都被选中，并拖拽到右边面板后，系统会在显示器面板底部建立一个传送序列。

Note: Before progressing to the next step, ensure that ALL files have been completely uploaded, i.e. the“progress” bar for all files shows 100%

注：在进行下一步之前，要保证所有文件均被上传完整，也就是所有文件的“进度”条均显示为“100%”。

Once all files have been uploaded fully, select the delivery file (this is the .xml file which was created in step A) and drag it into the same folder in the pane on the right. Moving the delivery file to the folder in the transfer pane on the right will trigger the sending of the submission to CESP.

在所有文件全部上传后，选择传送文件（在第一步中创建的.xml文件），拖拽到右边的面板的同一个文件夹内。移动传送文件至右边传送面板的文件则会激活向CESP发送申报文件。

As soon as you drag across the delivery file, the transfer to CESP is initiated and the files which are fully loaded in the transfer queue are transferred.

一旦你拖拽传送文件，向CESP传递文件即被启动，在传输序列中的所有文件会被全部传送。

If the files are not fully loaded in the transfer queue, the transfer will happen and a partial submission will be received by the EDQM (perhaps only the .xml file will be received) as a result.

如果文件没有全部上载至传送序列，传输开始，则EDQM只能收到一部分申报文件（可能仅只收到.xml文件）。

Attention: You must allow all the files in the transfer queue to reach 100% BEFORE you add the delivery xml file because as soon as you add this file the software will launch the transfer to CESP and only the files present in the transfer queue will be transferred. This will result in a partial transfer and will delay your submission.

注意：你必须等传输序列中的所有文件均达到100%后再加入.xml传送文件，因为一旦你将此文件加入，则软件即会启动向CESP的传输，则只有已出现在传输序列中的文件会被传送。这会导致部分文件传送，延迟你的申报。

Confirmation of submission and confirmation of delivery to the agency:

申报确认和提交官方确认

After the submission has been sent, you will receive two emails:

在申报发送后，你会收到两封邮件

? Firstly, you will receive an email to confirm that the submission has been uploaded to the CESP server.

首先，你会收到一封邮件确认申报文件已被上传至CESP服务器

? Secondly, you will receive an email to confirm that the submission has been delivered to EDQM.

其次，你会收到一封邮件确认申报已传送至EDQM

The EDQM will then proceed with the normal reception and validation of the submission before issuing the acknowledgement of receipt as appropriate.

然后EDQM会开始正常的接收，和申报验证程序，然后签署接收通知书（适当时）。

Generally you should receive the first email (confirmation of submission to CESP) within 2 hours, and the second email (confirmation of delivery to agency) within 24 hours. If you do not receive either of these emails within the timeframes specified, please do not contact the EDQM. Please contact the CESP team using the support portal on the CESP website.

一般你会在2小时内收到第一封邮件（提交CESP确认），在24小时内收到第二封邮件（传送官方确认）。如果你没有在指定的时间内收到这两封邮件，请不要与EDQM联系，请采用CESP网页上的支持端口与CESP团队联系。

幻影

感谢分享。

syhorchid

谢谢分享

一沙一叶

收藏学习。

lindaqueen

谢谢分享，谢谢

紫宸曼影

这个挺好的，谢谢楼主。