MHRA updates and advice英国MHRA的更新和建议

Welcome to August newsletter of E-cigarette Team. This month we include updates and advice on …

欢迎阅读电子烟团队八月资讯。这个月我们提供有关以下几个方面的更新和建议。

Current Notification Processing Times

当前处理通告的时间

Invoices for products submitted on the EU-CEG between 18^th
July and 22^nd
July were sent out on 30^th
July. The list published on our website on 7^th
August included all products for which we had received payment for by 3^rd
August.

7月18日至7月22日期间在EU-CEG上提交的产品发票已于7月30日发出。8月7日MHRA网站上发布的产品清单包括MHRA在8月3日之前收到付款的所有产品。

The turn-around-time from submission to publication for the most recent product is 21 days.

最近产品从提交到发布的周期为21天。

Updating Producer Contact Details

更新生厂商联系人详细信息

We have received several requests from producers to resend invoices or newsletters that they have not been able to find. We have also been unable to contact some producers to notify them of problems with their notifications. This is usually due to changes in email address, mistakes in email addresses or producers being unable to access email addresses registered on the portal for staff who have left the company.

MHRA收到了生产商的一些要求，要求他们重新发送他们无法找到的发票或资讯。然而MHRA也无法联系某些生产商，以通知他们通告的问题。这通常是由于电子邮件地址的更改，电子邮件地址错误或生产商无法访问已离开公司的员工在系统网站上注册的电子邮件地址。

All invoices are sent to the email address registered on the EU-CEG portal.
Please review your submitter details on the portal to ensure that the contact details provided are up-to-date and correct. In addition, please email Reference.Data@mhra.gov.uk
to update your company details if these have changed since you first registered.

所有发票都将发送到EU-CEG系统网站上注册的电子邮件地址。请查看系统网站上的提交者详细信息，以确保提供的联系详细信息是最新且正确的。此外，如果您自首次注册以来已更改过联系方式，请发送电子邮件至Reference.Data@mhra.gov.uk以更新您的公司详细信息。

Revised Invoices

修改发票

Several producers have asked us to revise invoices where they have decided to cancel some notifications and keep others.
This is not possible.
Instead, you should make a part-payment on the original invoice for the products you intend to notify and send a list of the products you intend to keep and those you want cancelled and credited to
sales.invoices@mhra.gov.uk.
We will then process the paid product submissions and issue a credit note against the existing invoice for cancelled submissions.

一些生产商要求MHRA修改发票，他们决定取消一些通告并保留其他通告。这不可能。相反，您应该在原始发票上对您打算通告的产品进行部分付款，并发送您打算保留和取消的产品列表到sales.invoices@mhra.gov.uk。然后，MHRA将处理付费产品提交，并针对已取消提交产品的现有发票发进行备注。

XML Creator Tool Update

XML Creator工具更新

Some producers have encountered problems recently where information in notifications is missing even after resubmission of ‘corrected’ xml files. The reason has been found to be the use of an old version of the XML creator tool.
To avoid this, please ensure you are using the latest version of the
XML Creator Tool
(June 2018) to amend your xml files before resubmitting them on the portal. Do check the link regularly for any updates to technical documents related to portal function.

一些生产商最近遇到了问题，即使重新提交“更正的”xml文件后，通告中的信息也会丢失。已经发现原因是使用旧版本的XML创建工具。为避免这种情况，请确保您使用最新版本的XML Creator工具（2018年6月）修改xml文件，然后再在门户上重新提交。请定期检查链接，以获取与门户功能相关的技术文档的任何更新。

Notification and Health Warnings on Replacement Coils

可更换的雾化芯的通告和健康警告

Replacement coils only require notification if they have not already been notified as part of a device or e-cigarette kit. Identical replacement coils that have already been notified as part of another notified e-cigarette product do not need to be separately re-notified if it is clear on the labelling what notified e-cigarette product the coil is for.

只有当包含雾化芯的产品（雾化器/套装）未做通告的情况下，可替换的雾化芯单独销售时，雾化芯才需要单独做通告。如果套装或者雾化器已经通告，而可替换的雾化芯跟套装或者雾化器里面的雾化芯是一模一样的，那么单独销售这个雾化芯不需要再另外做通告。但是需要再标签上面注明这个雾化芯跟哪个已经通告的产品里面的雾化芯是一样的。

Notified coils are required to carry the health warning and companies may wish to consider adopting a consistent approach for all replacement coils, although we do not require this.

已经通告的雾化芯需要标注健康警告语，一些公司可能希望考虑对所有更换线圈采用一致的方法，尽管MHRA不要求这样做。

Substances Not Permitted as Ingredients in E-liquids

不允许作为电子烟油成分的物质

A list of substances that should not be included as ingredients in electronic cigarettes and refill containers is set out below. This list is not exhaustive and may be added to in future as more information becomes available. For the avoidance of doubt, the fact that an ingredient does not appear in this list does not mean that it is safe for use in e-liquids. The notifier should make their own assessment of the safety of each ingredient in their product and the need to control for levels of substances such as formaldehyde that are not present as an ingredient.

不应包括在电子香烟和补充容器中作为成分的物质清单如下。此列表并非详尽无遗，可能会在将来添加更多信息时添加。为避免疑义，该清单中未出现成分的事实并不意味着它可安全用于电子烟油。发出通告者应自行评估其产品中每种成分的安全性，以及控制不存在作为成分的甲醛等物质含量的需要。

From the TPD:

来自TPD：

• any ingredient that poses a risk to human health in heated or unheated form

• vitamins or other additives that create the impression that a tobacco product has a health benefit or presents reduced health risks;

• caffeine or taurine or other additives and stimulant compounds that are associated with energy and vitality;

• additives having colouring properties for emissions;

• additives that have carcinogenic, mutagenic or reprotoxic (CMR) properties in unburnt form.

•任何以加热或未加热形式对人类健康构成威胁的成分

•维生素或其他添加剂，使人们产生烟草制品具有健康益处或降低健康风险的印象;

•咖啡因或牛磺酸或其他与能量和活力相关的添加剂和兴奋剂化合物;

•具有排放着色性能的添加剂;

•添加剂具有未燃烧形式的致癌，诱变或生殖毒性（CMR）特性。

From national standards:

从英国国家标准：

• Substances classified as carcinogenic, mutagenic or reprotoxic (CMR categories3 1 and 2)

• Substances classified with specific target organ toxicity for the respiratory tract (STOT category3 1)

• Respiratory sensitizers

• Vitamins used as food supplements

• Stimulant additives such as caffeine or taurine

• Diacetyl

• Pentane-2,3-dione

• Diethylene glycol

• Ethylene glycol

• Formaldehyde*

• Acetaldehyde*

• Acrolein*

• Metals, including cadmium, chromium, iron, lead, mercury and nickel

• Preservatives liable to release formaldehyde

*See also requirements for testing these substances in the
emissions guidance.

•归类为致癌，致突变或生殖毒性的物质（CMR类别3 1和2）

•分类为呼吸道特定目标器官毒性的物质（STOT类别3 1）

•呼吸道致敏物

•维生素用作食品补充剂

•兴奋剂添加剂，如咖啡因或牛磺酸

•二乙酰

•戊烷-2,3-二酮

•二甘醇

• 乙二醇

•甲醛*

•乙醛*

•丙烯醛*

•金属，包括镉，铬，铁，铅，汞和镍

•易于释放甲醛的防腐剂

*另见排放指南中测试这些物质的要求。

We are constantly reviewing notifications and any products containing the listed ingredients will be subject to review and removal. Please review your products and make appropriate corrections to notification data where errors in submission have been made or reformulate and amend your notifications.

MHRA会不断审核通告，任何包含所列成分的产品都将经过审核和删除。请检查您的产品并对已提交错误的通告数据进行适当更正，或重新制定并修改您的通告。

Get in touch联系方式

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

If you have any questions about the notification status of your products, please send them directly to our TPD mailbox at
TPDnotifications@mhra.gov.uk.

To update company contact details email
Reference.Data@mhra.gov.uk.

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

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

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

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

如果您对产品的通知状态有任何疑问，请直接发送至TPD邮箱TPDnotifications@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，请通过SANTE-EUCEG-ITSUPPORT@ec.europa.eu联系欧盟委员会IT服务台。

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

感谢您抽出时间阅读并与同事分享此资讯。