有关英国电子烟资讯认证解读

欢迎阅读MHRA电子烟团队七月资讯。本月我们将介绍电子烟产品公布之前的产品供应、责任人要求、MHRA发票的支付、数据冲突问题的解决等内容。

Welcome to the July newsletter of the MHRA E-cigarette Team. This month we will cover Supply of Products Prior to Publication, Responsible Person Requirements, Payment of MHRA invoices, Troubleshooting Data Conflict Issues.

从2021年1月1日起新产品的供应

Supply of New Productsfrom 1 January 2021

要在英国(英格兰、苏格兰和威尔士)和北爱尔兰供应新的电子烟产品，您必须通过每个地区相应的通告系统来通告您的产品。如果向大不列颠供应产品，您需要通过MHRA提交门户进行通告。如果向北爱尔兰供应产品，您将继续使用EU-CEG进行通告。

To supply new E-cigaretteproducts in Great Britain (England, Scotland and Wales) and Northern Irelandyou must notify your products via the appropriate notification system for eachregion. To supply a product to Great Britain you are required to notify usingthe MHRA submission portal. To supply a product to Northern Ireland you willcontinue to use EU-CEG.

一旦您成功地提交了通告，MHRA将审查其合规性。如果通告符合要求的标准，将在这里公布。一旦您的产品通告被公布，您将能够合法地在产品通告地区供应产品。

Once you havesuccessfully submitted your notifications, they will be reviewed for complianceby the MHRA. If the notification meets the required standards it will be published here. Once your productnotification has been published you will be able to legally supply the goods inthe region for which they have been notified.

请注意，在通告完成并在MHRA网站上公布之前，供应任何需要通告的产品都是违法的。未列入公布清单的未通告产品可能会被执法当局扣押。

Please note that it isan offence to supply any notifiable product until the notification has beencompleted and published on the MHRA website. Unnotified products that have notbeen included on the published lists may be subject to seizure by enforcementauthorities.

如果您当前供应的产品尚未通告并公布，您应该按照以下指引立即完成通告。所有未通告的产品必须撤回供应，直到被公布为止。

If you are currentlysupplying a product that has not been notified and published, you shouldcomplete a notification immediately, following the guidance below. All affectedproducts must be withdrawn from supply until publication has been achieved.

在大不列颠通告产品，您(作为提交者)需要做什么

What you (as asubmitter) need to do to notify products in Great Britain

您需要在 MHR提交门户网站注册一个账户。如果您还没有注册账户，我们建议您尽快去注册。

You need to havesigned up for an account with the MHRA submission portal. If you have not already, we would recommend doing this as soon aspossible.

可在此处here找到关于新流程的更多指引。您还可以观看我们*近的网络研讨会视频以获取更多信息。

Further guidance onthe new process can be found here. You can also watchour recent webinar video for more information.

更多关于这个流程的详细信息可以在我们的网页上找到。

More detailed information on this process canbe found on our webpage. 

通告内容的指引

Guidance on the content of notifications 

对于北爱尔兰的指引没有变化。

The guidance forNorthern Ireland is unchanged.

在大不列颠(英格兰、苏格兰和威尔士)指定一个授权或责任人

Appointing anauthorised or responsible person in Great Britain (England, Scotland and Wales)

英国不再承认位于欧盟的授权代表和责任人。

Great Britain no longerrecognises authorised representatives and responsible persons based in the EU.

如果提交通告的公司在英国没有场地，您将需要为在英国市场上投放的产品指定一个在英国的授权代表或责任人。作为提交者，您需要通过英国提交门户向MHRA提交此信息。此信息应被添加到每个产品通告的提交者信息中的“附属公司”字段。根据法规，未提供此信息可能构成违法行为，并将明显地延迟受影响产品通告的发布。

If the company makinga notification does not have a base in the UK, you will need to appoint anauthorised representative or responsible person based in the UK for productsbeing placed on the GB market. As a submitter you are required to provide thisinformation to the MHRA via the GB Submission Portal. This information shouldbe added to the “Affiliate Company” field in Submitter Information for eachproduct notification. Failure to provide this information may constitute anoffence under the Regulations and will significantly delay the publication ofaffected product notifications. 

如果您正在通告供应到北爱尔兰的产品，并且已经通过EUCEG提供了欧盟或北爱尔兰责任人的详细信息，则无需对北爱尔兰的通告采取进一步行动。

If you are notifying aproduct for supply to Northern Ireland and have already provided details of anEU or NI based responsible person via EUCEG then no further action is requiredfor NI notifications.

明确您的法律责任

Check your legal responsibilities

制造商

Manufacturers

您负责:

（1）确保您的产品符合相关的英国法规

（2）编写文件

（3）提交产品通告

（4）如果您在英国境外，您可以将部分责任委托给授权代表或进口商

You are responsiblefor: 

（1）ensuring your productcomplies with the relevant UK rules 

（2）drawing updocumentation 

（3）submitting anotification for the product  

（4）You can delegate someof the duties to an authorised representative or an importer if you are basedoutside the UK  

英国经销商和供应商

UK distributors and supplier

如果产品不是在英国生产的，您需要确认您或者您的供应商是否充当“进口商”。

Where a product is notmanufactured in the UK, you’ll need to confirm whether you or your supplierwill act as an ‘importer’.

如果您是第一个将商品从英国境外带入并投放到大不列颠和/或北爱尔兰市场的人，那么您就是进口商。如果在您向大不列颠及北爱尔兰销售此产品之前，已经有人将产品投放在英国市场—或者如果制造商已经委托另一个英国责任人来实行进口商关税—则您将是一个经销商，不会有任何额外的责任。

You are an importer ifyou’re the first one bringing goods from outside the UK and placing them on themarket in Great Britain and/or Northern Ireland. If someone has already placeda product on the UK market before you sell it in Great Britain and NorthernIreland - or if the manufacturer has appointed another UK-based person to carryout importer duties - you will remain a distributor and will not have anyadditional responsibilities.

作为进口商，您需要确保:

（1）商品上有您公司的详细信息，包括公司名称和联系地址

（2）已实行正确的合格评定程序，货物有正确的合格标志

（3）生产商已经编写了正确的技术文件，并且您或他们已遵守产品标签的要求

（4）货物符合有关基本要求

（5）货物已经正确地通告MHRA并且已经被公布

As an importer, you’llneed to make sure that:

（1） goods are labelledwith your company’s details, including your company’s name and a contactaddress

（2） the correctconformity assessment procedures have been carried out and that goods have thecorrect conformity markings

（3） the manufacturer hasdrawn up the correct technical documentation and you or they have complied withthe product labelling requirements

（4）goods conform with therelevant essential requirements

（5）goods have been appropriatelynotified to MHRA and the notifications published

关于产品的进口和供应的详细要求，请参阅当前英国政府对大不列颠和北爱尔兰的指导。

For detailedrequirements regarding the importation and supply of manufactured productsplease review the current UK Government guidance for GreatBritain and NorthernIreland. 

MHRA发票的支付

Payment of MHRA invoices

MHRA现在提供电子烟通告费用的在线服务。可以使用借记卡或信用卡支付，发票上的发票号码位于地址下方。我们接受所有主要的借记卡和信用卡，包括Visa, Mastercard, Maestro和美国运通卡。收到发票后应立即付款。

付款只能用英镑。

The MHRA now provides online service for the payment ofE-cigarette notifications. Invoices can be paid using a debit or credit cardand your invoice number which is located below your address on the invoice. Weaccept all major debit and credit cards including Visa, Mastercard, Maestro andAmerican Express. Payment of invoices is due immediately upon receipt.

Payments can be made in British Pounds Sterling only.

如果您还没有收到发票，或者有任何疑问，请联系MHRA应收账款团队sales.invoices@mhra.gov.uk。

请注意，在全额支付发票之前，您的通告无法进行评估和公布。

If you have notreceived an invoice, or have any queries please contact the MHRA AccountsReceivable team at sales.invoices@mhra.gov.uk .

Please note that assessments and publication of your notificationscan not proceed until invoices are paid in full.

数据冲突问题的解决

Troubleshooting Data Conflict issues 

 我们一直与提交者保持联系，发现了问题并且解决问题。在这种情况下，我们尽快收到回复是*重要的。

如果您遇到任何所列出的问题，请遵循以下解决问题的步骤:

We have been in touchwith submitters where we have identified conflicts and are working with them toresolve conflicts. It is of upmost importance that we receive a response assoon as possible in these instances.

Below are some troubleshootingsteps to follow should you encounter any of the listed issues:

1.在欧盟系统中已经有提交者ID的申请人

1. Applicants that already have a submitter ID in EU system

在MHRA提交门户上提交时，如果您发现门户上提供了一个用来生成新的提交者ID的选项，而不是预先填写了您的欧盟提交者ID，则不要继续提交，请通过MHRA提交门户上的“帮助和支持”互动程序向MHRA报告。

Whilst making asubmission on MHRA submission portal if you find the portal is providing anoption to generate new submitter ID instead of pre-populating your EU submitter IDthen instead of progressing with the submission please report this to MHRA viathe ‘Help and Support’ tile on MHRA submission portal.

2.申请人不认同MHRA提交门户上的公司名称

2. Applicants do not agree with the company name on MHRA submissionportal

一旦您验证了MHRA提交门户分配的提交者ID，并且它与您的欧盟提交者ID一致，那么您可以选择提出更新公司显示名称的请求。可以通过“帮助和支持”互动程序提出。

Once you havevalidated the submitter ID assigned by MHRA submission portal and it is in linewith your EU submitter ID then you will have an option to raise a request toupdate your company display name. A request can be raised via the ‘Help andSupport’ tile.  

注：MHRA提交门户上显示的公司名称也用于MHRA政府网站上公布的摘录

NOTE – The companyname displayed on the MHRA submission portal is also used in the extractpublished on our MHRA gov website.

3.所有权的变更

3. Change of ownership 

如果您的公司所有权发生了变化，而且您需要一个新的5位数的MHRA公司编号用于MHRA提交门户，请通过Reference Data Team提出请求。

If your companyownership has changed and you require a new 5-digit MHRA company number for theMHRA Submissions Portal please raise a request via the Reference Data Team.

请确保在您的电子邮件中尽可能多的包含以下信息: 

Please be sure toinclude as much of the information below as possible in your email:

（1）完整的法人实体/公司名称(请不要使用缩写、交易风格或简称) 

（2）总部地址

（3）收票人/开票地址(如与总部地址不同) 

（4）发票电子邮件地址

（1）Fulllegal entity/company name (no abbreviations, trading styles or short namesplease)

（2）Headquartersaddress

（3）BillTo/Invoicing address (If different from the Headquarters address.)

（4）Invoicingemail address

联系方式

如需一般咨询，请联系MHRA的客户服务团队 info@mhra.gov.uk.

如果您对产品的通告状态有任何疑问，请直接发送至TPD邮@mhra.gov.uk.

要更新公司联系方式，请发送电子邮件至Reference.Data@mhra.gov.uk.

有关发票和付款的查询，请发送电子邮件至sales.invoices@mhra.gov.uk.

如有任何安全问题，请联系MHRA的Vigilance团队TPDsafety@mhra.gov.uk.

如果您在使用EU-CEG门户时遇到任何技术问题，请联系欧盟委员会IT服务台SANTE-EUCEG-ITSUPPORT@ec.europa.eu(在您的消息中包括出现问题的窗口的“屏幕截图”)

感谢您抽出时间阅读并与同事分享此资讯。

通过信用卡或借记卡支付MHRA发票:https://www.gov.uk/payments/mhra/online-payments

Get in touch

For general enquiriesplease contact our Customer Services team at info@mhra.gov.uk.

If you have anyquestions about the notification status of your products, please send themdirectly to our TPDnotifications@mhra.gov.uk.

To update companycontact details email Reference.Data@mhra.gov.uk.

For queries regardinginvoices and payments email our Finance team at sales.invoices@mhra.gov.uk.

For any safetyconcerns contact our Vigilance team at TPDsafety@mhra.gov.uk.

If you encounter anytechnical difficulties while using the EU-CEG portal, please contact the EUcommission IT helpdesk at SANTE-EUCEG-ITSUPPORT@ec.europa.eu (including in yourmessage a ‘print screen’ of the window where the problem appears).

Thank you for yourtime in reading and sharing this newsletter with your colleagues.  

Pay MHRA invoices by Credit or Debit Card:https://www.gov.uk/payments/mhra/online-payments