MHRA updates and advice英國(guó)MHRA的更新和建議

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

歡迎閱讀電子煙團(tuán)隊(duì)八月資訊。這個(gè)月我們提供有關(guān)以下幾個(gè)方面的更新和建議。

Current Notification Processing Times

當(dāng)前處理通告的時(shí)間

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日期間在EU-CEG上提交的產(chǎn)品發(fā)票已于7月30日發(fā)出。8月7日MHRA網(wǎng)站上發(fā)布的產(chǎn)品清單包括MHRA在8月3日之前收到付款的所有產(chǎn)品。

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

最近產(chǎn)品從提交到發(fā)布的周期為21天。

Updating Producer Contact Details

更新生廠商聯(lián)系人詳細(xì)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收到了生產(chǎn)商的一些要求，要求他們重新發(fā)送他們無(wú)法找到的發(fā)票或資訊。然而MHRA也無(wú)法聯(lián)系某些生產(chǎn)商，以通知他們通告的問(wèn)題。這通常是由于電子郵件地址的更改，電子郵件地址錯(cuò)誤或生產(chǎn)商無(wú)法訪問(wèn)已離開(kāi)公司的員工在系統(tǒng)網(wǎng)站上注冊(cè)的電子郵件地址。

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.

所有發(fā)票都將發(fā)送到EU-CEG系統(tǒng)網(wǎng)站上注冊(cè)的電子郵件地址。請(qǐng)查看系統(tǒng)網(wǎng)站上的提交者詳細(xì)信息，以確保提供的聯(lián)系詳細(xì)信息是最新且正確的。此外，如果您自首次注冊(cè)以來(lái)已更改過(guò)聯(lián)系方式，請(qǐng)發(fā)送電子郵件至Reference.Data@mhra.gov.uk以更新您的公司詳細(xì)信息。

Revised Invoices

修改發(fā)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.

一些生產(chǎn)商要求MHRA修改發(fā)票，他們決定取消一些通告并保留其他通告。這不可能。相反，您應(yīng)該在原始發(fā)票上對(duì)您打算通告的產(chǎn)品進(jìn)行部分付款，并發(fā)送您打算保留和取消的產(chǎn)品列表到sales.invoices@mhra.gov.uk。然后，MHRA將處理付費(fèi)產(chǎn)品提交，并針對(duì)已取消提交產(chǎn)品的現(xiàn)有發(fā)票發(fā)進(jìn)行備注。

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.

一些生產(chǎn)商最近遇到了問(wèn)題，即使重新提交“更正的”xml文件后，通告中的信息也會(huì)丟失。已經(jīng)發(fā)現(xiàn)原因是使用舊版本的XML創(chuàng)建工具。為避免這種情況，請(qǐng)確保您使用最新版本的XML Creator工具（2018年6月）修改xml文件，然后再在門(mén)戶上重新提交。請(qǐng)定期檢查鏈接，以獲取與門(mén)戶功能相關(guān)的技術(shù)文檔的任何更新。

Notification and Health Warnings on Replacement Coils

可更換的霧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.

只有當(dāng)包含霧化芯的產(chǎn)品（霧化器/套裝）未做通告的情況下，可替換的霧化芯單獨(dú)銷(xiāo)售時(shí)，霧化芯才需要單獨(dú)做通告。如果套裝或者霧化器已經(jīng)通告，而可替換的霧化芯跟套裝或者霧化器里面的霧化芯是一模一樣的，那么單獨(dú)銷(xiāo)售這個(gè)霧化芯不需要再另外做通告。但是需要再標(biāo)簽上面注明這個(gè)霧化芯跟哪個(gè)已經(jīng)通告的產(chǎn)品里面的霧化芯是一樣的。

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.

已經(jīng)通告的霧化芯需要標(biāo)注健康警告語(yǔ)，一些公司可能希望考慮對(duì)所有更換線圈采用一致的方法，盡管MHRA不要求這樣做。

Substances Not Permitted as Ingredients in E-liquids

不允許作為電子煙油成分的物質(zhì)

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.

不應(yīng)包括在電子香煙和補(bǔ)充容器中作為成分的物質(zhì)清單如下。此列表并非詳盡無(wú)遺，可能會(huì)在將來(lái)添加更多信息時(shí)添加。為避免疑義，該清單中未出現(xiàn)成分的事實(shí)并不意味著它可安全用于電子煙油。發(fā)出通告者應(yīng)自行評(píng)估其產(chǎn)品中每種成分的安全性，以及控制不存在作為成分的甲醛等物質(zhì)含量的需要。

From the TPD:

來(lái)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.

?任何以加熱或未加熱形式對(duì)人類健康構(gòu)成威脅的成分

?維生素或其他添加劑，使人們產(chǎn)生煙草制品具有健康益處或降低健康風(fēng)險(xiǎn)的印象;

?咖啡因或牛磺酸或其他與能量和活力相關(guān)的添加劑和興奮劑化合物;

?具有排放著色性能的添加劑;

?添加劑具有未燃燒形式的致癌，誘變或生殖毒性（CMR）特性。

From national standards:

從英國(guó)國(guó)家標(biāo)準(zhǔn)：

? 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.

?歸類為致癌，致突變或生殖毒性的物質(zhì)（CMR類別3 1和2）

?分類為呼吸道特定目標(biāo)器官毒性的物質(zhì)（STOT類別3 1）

?呼吸道致敏物

?維生素用作食品補(bǔ)充劑

?興奮劑添加劑，如咖啡因或?；撬?/span>

?二乙酰

?戊烷-2,3-二酮

?二甘醇

? 乙二醇

?甲醛*

?乙醛*

?丙烯醛*

?金屬，包括鎘，鉻，鐵，鉛，汞和鎳

?易于釋放甲醛的防腐劑

*另見(jiàn)排放指南中測(cè)試這些物質(zhì)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會(huì)不斷審核通告，任何包含所列成分的產(chǎn)品都將經(jīng)過(guò)審核和刪除。請(qǐng)檢查您的產(chǎn)品并對(duì)已提交錯(cuò)誤的通告數(shù)據(jù)進(jìn)行適當(dāng)更正，或重新制定并修改您的通告。

Get in touch聯(lián)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).

如需一般咨詢，請(qǐng)聯(lián)系MHRA的客戶服務(wù)團(tuán)隊(duì)info@mhra.gov.uk。

如果您對(duì)產(chǎn)品的通知狀態(tài)有任何疑問(wèn)，請(qǐng)直接發(fā)送至TPD郵箱TPDnotifications@mhra.gov.uk。

要更新公司聯(lián)系方式，請(qǐng)發(fā)送電子郵件至Reference.Data@mhra.gov.uk。

有關(guān)發(fā)票和付款的查詢，請(qǐng)發(fā)送電子郵件至sales.invoices@mhra.gov.uk。

如有任何安全問(wèn)題，請(qǐng)聯(lián)系MHRA的Vigilance團(tuán)隊(duì)TPDsafety@mhra.gov.uk。

如果您在使用EU-CEG門(mén)戶時(shí)遇到任何技術(shù)問(wèn)題，請(qǐng)通過(guò)SANTE-EUCEG-ITSUPPORT@ec.europa.eu聯(lián)系歐盟委員會(huì)IT服務(wù)臺(tái)。

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

感謝您抽出時(shí)間閱讀并與同事分享此資訊。