欢迎阅读MHRA电子烟团队八月资讯。本月我们将介绍MHRA提交平台的技术改进。
Welcome tothe August newsletter of the MHRA E-cigarette Team. This month wewill cover Technical Enhancements to the MHRA SubmissionsPlatform
TechnicalEnhancements to the MHRA Submissions Platform
MHRA提交平台的技术改进
在2021年8月20日星期五至21日星期六,MHRA将对MHRA提交平台(MHRA提交)上的每个门户进行技术改进和发布服务。
Over theweekend of Friday 20 to Saturday 21 August 2021 the MHRA will bemaking technical enhancements to each of the portals on the MHRASubmissions platform (MHRA Submissions) and publishingservices.
可能对您有影响的更改描述如下。这些更改是根据提交给我们团队和MHRA客户服务中心的用户反馈制定的。我们要感谢所有自2021年1月1日上线以来向我们提供反馈的人。的发展将持续到2021/22年。
Thechanges that may impact you are described below. These changes havebeen developed based on user feedback submitted to our team and tothe MHRA Customer Service Centre. We’d like to thank everyone whohas fed back to us since we went live on 1 January2021. Furtherdevelopment will continue through 2021/22.
在更新指南发布之前,我们将提供新功能的概述。自2021年8月20日起,这将在我们的网页和MHRA提交的电子烟指南板块中找到。
We are providing an overview ofthe new functionality prior to the publication of updatedguidance.This willbe available on our webpageand in thee-cigarettes guidance tile in MHRA Submissions from 20 August2021.
通过MHRA提交支付通告费用
Paying for Notifications via MHRASubmissions
从8月21日起,提交者可以使用作为MHRA提交的一部分提供的集成系统来支付通告费用。成功提交后,您将能够下载发票并使用Gov.Pay支付通告费用。
From 21 August submitters will beable to pay for notifications using the integrated systemprovidedas part of MHRA Submissions. Upon completion of asuccessful submission you will be able download your invoice andpay for notifications using Gov.Pay.
如果您不想提交评估通告,您可以保存草稿并在以后完成提交和付款。
If you do not want to submit thenotification for assessment you will be able to save the draft andcomplete the submission and payment at a later time.
使用该系统将明显地缩短提交和合规性审查之间的时间,为英国 (GB) 和北爱尔兰 (NI) 的电子烟产品提供更快的公布途径,因为您将不再需要等待手动发票和付款的生成。
Use of this system willsignificantly reduce the time between submission and compliancechecking, providing a faster route to publication for e-cigaretteproducts in Great Britain (GB) and NorthernIreland (NI), as youwill no longer need to wait for the production of manual invoicesand payment.
请注意,在付款完成之前,我们的团队将无法对您提交的内容进行审查。我们建议所有的提交者在5天内通过EUCEG和MHRA提交通告产品,并在MHRA提交中通过GovPay付款。这笔费用将适用于您GB和NI的产品通告。
Please be aware that our teamwill not have access to your submissions for checking until paymenthas been completed. We recommend that all submitters notifyproducts via EUCEG and MHRA Submissions within 5 days of each otherand make the payments via Gov Pay within MHRA Submissions. Thispayment will apply to both your GB and NI notifications for theproduct.
我们的目标是将以这种方式通过MHRA提交和支付费用的合规产品的公布时间从当前的30-60天缩短到15-20天。请注意,这个时间表是我们的目标,但我们将无法从第一天开始履行,因为我们将在短时间内运行双重发票系统,以完成未付款的GB提交。
We are aiming to reduce thecurrent publication timescale from 30-60 days to 15 to 20 days forcompliant products submitted and paid in this way via MHRASubmissions. Please be aware that while this timescale is our goal,we will not be able to deliver it from day one as we will beoperating dual invoicing systems for a short period of time tocomplete outstanding GB submission payments.
如果您已经为提交到EUCEG但尚未提交到MHRA提交的产品支付了发票,您将可以选择输入要验证的发票信息。验证产品发票后,通告将继续进行审查。
If you have already paid aninvoice for products submitted via EUCEG that have yet to besubmitted via MHRA Submissions, you will be provided an option toinput the invoice information to be verified. Upon verification theproduct invoice the notification will proceed forchecking.
如果您打算只在NI销售您的产品,您可以继续使用当前的服务,并将收到可以使用借记卡或信用卡在线支付的发票。我们接受所有主要的借记卡和信用卡,包括Visa、Mastercard、Maestro和AmericanExpress。付款只能以英镑支付。
If you only intend to market yourproduct in NI you can continue to use the current service and willreceive invoices which can be paid online using a debit or creditcard. We accept all major debit and credit cards including Visa,Mastercard, Maestro and American Express. Payments can be made inBritish Pounds Sterling only
已通告产品的综合公布
Integrated publication ofnotified products for Great Britain
从8月21日起,通过MHRA提交成功通告的产品,一旦评估团队完成数据审查,将直接公布在MHRA出版物主页上。由于这一改进,我们将能够为通告GB的产品提供每周公布更新。公开的数据不会有任何变化。
From21 August,products which have been successfully notified via MHRASubmissions will be published directly on theMHRA publicationhome page asthe assessment team complete each data review. As a result of thisenhancement we will be able to provide weekly publication updatesfor GB products. There will be no changes to the data that is madepublicly available.
选择”ECIG”可直接进入到自2021年1月1日起发布的GB通告产品列表,您可以使用以下搜索查看此信息:
ECID
提交者名称
品牌名称
子品牌类型
产品类型
Selecting the “ECIG” tile willprovide direct access to the GB notified products list, publishedsince 1 January 2021. You will be able to view this informationusing the following searches:
ECID
Submitter Name
Brand Name
Brand Sub Type
Product Type
此页面的搜索框下方的链接将提供对以下内容的访问:
2020年12月31日之前公布的英国产品
自2021年1月1日北爱尔兰公布的产品
撤回的产品
A link below the search boxes onthis page will provide access to:
UK Products published up to 31December 2020
Products published for NorthernIreland from 1 January 2021
Withdrawn Products
正如我们在7月的资讯中所述,通告在英国 (GB) 和/或北爱尔兰 (NI) 的相关清单上公布之前,产品不符合供应要求。
As stated in our July newsletter,products are not compliant for supply until the notification hasbeen published on the relevant list for Great Britain (GB) and/orNorthern Ireland (NI).
的技术改进
Further TechnicalEnhancements
我们会继续开发一系列改进来帮助提交者,提供增强的自动化,与EUCEG更新保持一致并改进我们评估员的工具。这些包括:
字段长度增加
下拉选择
验证和禁用物质检查的改进
改进了“其他”成分的成分展示
警告消息弹出窗口
根据撤回日期自动从公布列表上撤销产品和子品牌
We have continued to develop aseries of improvements to assist submitters, provide enhancedautomation, maintain alignment with EUCEG updates and improve toolsfor our assessors. These include:
Field length increases
Drop down selections
Improvements to validation andbanned substance checks
Improved ingredientspresentations for “other” ingredients
Warning message popups
Automated withdrawals frompublication for product and sub brands based on withdrawaldates
更新指引和支持
Updated GuidanceandSupport
自2021年8月20日起,我们将在我们的网页和MHRA提交的电子烟指南板块中发布一系列指南更新。这包括我们的提交视频,演示如何使用新的支付系统。
We will publish a series ofupdates to our guidance which will be available on our webpage andin the e-cigarettes guidance tile in MHRA Submissions from 20August 2021. This includes our submission videos which will beupdated with a demonstration of how to use the new paymentsystem.
请确保您的提交团队查看我们的GB和NI指南,其概述了通告的内容要求和我们的用户参考指南,因为这将减少您的通告被延误的机会。
Pleaseensure your submission team review our GB and NI Guidanceoutlining the content requirements for notifications andour UserReference Guide, asthis will reduce the chance of your notification being heldup.
如果您遇到技术困难,请使用MHRA提交平台中的支持板块或联系submissions@mhra.gov.uk,(在您的消息中包括出现问题的窗口的“屏幕截图”)
Shouldyou encounter technical difficulties, please use the support tilein the MHRA Submissions Platform orcontact submissions@mhra.gov.uk (including in your message a‘print screen’ of the window where theproblem appears)
何时MHRA提交将不可用
When MHRA Submissions will beunavailable
为实施这些更改,MHRA提交将于2021年8月20日星期五下午6:00不可用。
To implement these changes MHRASubmissions will be taken down at 6:00pm on Friday 20 August2021.
预计该系统将于8月21日星期六下午5:00恢复运行
It is anticipated that the systemwill be back live by 5:00pm on Saturday 21 August
注册用户将在整个部署过程中收到通知,通知他们何时可以使用系统。平台上将出现一个停机时间窗口
Registered users will receiveannouncements throughout the deployment informing them when thesystem is ready to use again.In the meantime, a downtime windowwill be present on the platform.