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MHRA7月资讯-产品注册、英国代表及发票支付

作者:admin 发布时间:2021-07-22 21:12:01点击:
July newsletter of the MHRA E-cigarette Team.
This newsletter will cover Supply of Products Prior to Publication, Responsible Person Requirements, Payment of MHRA invoices
MHRA电子烟团队7月资讯
这份资讯涵盖了产品发布前的注册、英国代表要求、MHRA发票支付
Supply of New Products from 1 January 2021  2021年1月1日起在英国销售新产品
To supply new E-cigarette products in Great Britain (England, Scotland and Wales) and Northern Ireland you must notify your products via the appropriate notification system for each region. To supply a product to Great Britain you are required to notify using the MHRA submission portal. To supply a product to Northern Ireland you will continue to use EU-CEG. 要在英国(英格兰、苏格兰和威尔士)和北爱尔兰销售新的电子烟产品,您必须通过每个地区的相应的通告系统注册您的产品。要向英国供应产品,您需要使用 MHRA提交门户进行注册。要向北爱尔兰供应产品,您将继续使用 EU-CEG。
Once you have successfully submitted your notifications, they will be reviewed for compliance by the MHRA. If the notification meets the required standards it will be published here. Once your product notification has been published you will be able to legally supply the goods in the region for which they have been notified. 一旦您成功注册产品,MHRA将对其进行审查以确保其合规。如果提交资料符合标准的要求,则将在此处发布。一旦您的产品发布,您就可以在注册的地区合法销售商品。
Please note that it is an offence to supply any notifiable product until the notification has been completed and published on the MHRA website. Unnotified products that have not been included on the published lists may be subject to seizure by enforcement authorities. 请注意,在注册完成并在 MHRA 网站上发布之前,销售任何应注册的产品是违法的。未列入公布清单并且未注册产品可能会被执法当局扣押。
If you are currently supplying a product that has not been notified and published, you should complete a notification immediately, following the guidance below. All affected products must be withdrawn from supply until publication has been achieved.  如果您当前供应的产品尚未注册并发布在MHRA网站,您应立即按照以下指南完成注册。所有受影响的产品必须从市场中撤回,直到MHRA发布您的产品为止。
What you (as a submitter) need to do to notify products in Great Britain? 您(作为提交者)需要做什么才能在英国注册您的产品呢?
You need to have signed up for an account with the MHRA submission portal. if you have not already, we would recommend doing this as soon as possible. 您需要在 MHRA 提交门户上注册一个帐户。如果您还没有这样做,我们建议您尽快这样做。
Further guidance on the new process can be found here. You can also watch our recent webinar video for more information. 可以在此处找到有关新流程的进一步指导。您还可以观看我们最近的网络研讨会视频以了解更多信息。
More detailed information on this process can be found on our webpage
Guidance on the content of notifications
可以在我们的网页上找到有关此过程的更多详细信息。
注册内容指引
The guidance for Northern Ireland is unchanged.  对北爱尔兰的指导没有变化。
Appointing an authorised or responsible person in Great Britain (England, Scotland and Wales) 在英国(英格兰、苏格兰和威尔士)任命授权或负责人
Great Britain no longer recognises authorised representatives and responsible persons based in the EU.  英国不再承认位于欧盟的授权代表和负责人。
If the company making a notification does not have a base in the UK, you will need to appoint an authorised representative or responsible person based in the UK for products being placed on the GB market. As a submitter you are required to provide this information to the MHRA via the GB Submission Portal. This information should be added to the “Affiliate Company” field in Submitter Information for each product notification. Failure to provide this information may constitute an offence under the Regulations and will significantly delay the publication of affected product notifications.   如果注册电子烟产品的公司不在英国,您需要为在英国市场上投放的产品指定一名在英国的授权代表或负责人。作为提交者,您需要通过MHRA提交门户向 GB提供此信息。应将此信息添加到每个产品注册的提交者信息中的“附属公司”字段中。未能提供此信息可能构成条例下的违法行为,并将延迟受影响产品的公布。
If you are notifying a product for supply to Northern Ireland and have already provided details of an EU or NI based responsible person via EUCEG then no further action is required for NI notifications.  如果您正在北爱尔兰注册或销售产品,并且已经通过 EU-CEG 提供了欧盟或北爱尔兰负责人的详细信息,则无需对北爱尔兰的产品注册采取进一步行动。
Check your legal responsibilities  检查您的法律责任
Manufacturers 
You are responsible for: 
•ensuring your product complies with the relevant UK rules 
•drawing up documentation 
•submitting a notification for the product  
•You can delegate some of the duties to an authorised representative or an importer if you are based outside the UK  
制造商
您将负责:
•确保您的产品符合相关UK规则 
•起草文件
•注册产品
•如果您在英国境外,您可以将部分职责委托给授权代表或进口商
UK distributors and suppliers 
Where a product is not manufactured in the UK, you’ll need to confirm whether you or your supplier will act as an ‘importer’.
英国分销商和供应商
如果产品不在英国制造,您需要确认您或您的供应商是否将充当“进口商”。
You are an importer if you’re the first one bringing goods from outside the UK and placing them on the market in Great Britain and/or Northern Ireland. If someone has already placed a product on the UK market before you sell it in Great Britain and Northern Ireland - or if the manufacturer has appointed another UK-based person to carry out importer duties - you will remain a distributor and will not have any additional responsibilities.  如果您是第一个从英国境外带来货物并将其投放到英国和/或北爱尔兰市场的人,那么您就是进口商。如果在您在大不列颠和北爱尔兰销售产品之前,已经有人将产品投放到英国市场或者,如果制造商已任命另一位英国人来履行进口商职责,您将仍然是分销商,不会有任何额外的责任。
As an importer, you’ll need to make sure that: 
•goods are labelled with your company’s details, including your company’s name and a contact address.  
•the correct conformity assessment procedures have been carried out and that goods have the correct conformity markings 
•the manufacturer has drawn up the correct technical documentation and you or they have complied with the product labelling requirements 
•goods conform with the relevant essential requirements 
•goods have been appropriately notified to MHRA and the notifications published
作为进口商,您需要确保:
•商品标有贵公司的详细信息,包括贵公司的名称和联系地址。 
•已执行正确的合格评定程序并且货物具有正确的合格标志 
•制造商制定了正确的技术文件,并且您或他们已遵守产品标签要求 
•货物符合相关基本要求 
•产品已经在MHRA注册并公布在MHRA网站上
For detailed requirements regarding the importation and supply of manufactured products please review the current UK Government guidance for Great Britain and Northern Ireland 有关产品的进口和供应的详细要求,请查看当前英国政府针对大不列颠北爱尔兰的指南。
Payment of MHRA invoices MHRA发票支付
The MHRA now provides an online service for the payment of E-cigarette notifications. Invoices can be paid using a debit or credit card and your invoice number which is located below your address on the invoice. We accept all major debit and credit cards including Visa, Mastercard, Maestro and American Express. Payment of invoices is due immediately upon receipt. Payments can be made in British Pounds Sterling only. MHRA现在提供用于电子烟注册的在线支付服务。 可以使用借记卡或信用卡,按照位于发票上地址下方的发票编号支付发票。我们接受所有主流的借记卡和信用卡,包括 Visa、Mastercard、Maestro 和 American Express。收到发票后应立即付款。只能以英镑付款。
If you have not received an invoice, or have any queries please contact the MHRA Accounts Receivable team at sales.invoices@mhra.gov.uk 如果您没有收到发票或有任何疑问,请通过 sales.invoices@mhra.gov.uk 联系MHRA应收账款团队
Please note that assessments and publication of your notifications can not proceed until invoices are paid in full. 请注意,在全额支付发票之前,无法进行评估和公布产品。