Manufacturer Responsibilities and Declarations

Manufacturers Responsibilities, Declarations & Service Agreement.
1. The TPD requires the product to be child resistant, as your responsible person in Europe we can
now represent your products that are capable of meeting this requirement in one of two ways:
 No risk compliance – Products that have a child resistant feature as part of the design.
 High risk compliance – Products that do not meet the ‘no risk compliance’ standard will
need to have child resistant packaging.
By signing this document you declare that at least one of these standards have been met.
2. The products packaging needs to protect against breakage and leakage, by signing this document
you declare that this requirement has been met.
3. The products packaging needs to be tamper proof, by signing this document you declare that
this requirement has been met.
4. The product design needs a mechanism that ensures refilling without leakage, this is achieved by
making sure the entrance to the tank is wider than the nozzle of the bottle suggested in the
leaflet. By signing this document you declare that this requirement has been met.
5. The product (with an exception for its nicotine content) cannot pose a reasonably foreseeable
risk to human health under normal conditions of use. By signing this document you declare that
this requirement has been met.
6. The product needs to be designed to be safe when placed on the market and used under normal
or reasonably foreseeable conditions. By signing this document you declare that this
requirement has been met.
7. The production process needs to meet the required ISO standards, and the product design needs
to be complaint with the directives relative to the product which may include the ‘Low voltage
directive 2014/35/EU’ ‘Electromagnetic Compatibility Directive 2014/30/EU’ ‘Restriction of
Hazardous Substances Directive 2011/65/EU’. By signing this document you declare that this
requirement has been met.
8. The product needs to be designed to deliver a consistent rate of nicotine (dosing) during product
use and across batches under normal or reasonably foreseeable conditions, by signing this
document you declare that this requirement has been met.
9. The products packaging design needs to be inline with the packaging design guidance provided,
by signing this document you declare that this requirement has been met.
10. The products sales data needs to be reported on a per country level annually, by signing this
document you declare that you will work with us to achieve this.
11. The Products Technical file will need to be provided if requests by any of the regulators, usually
this has to be provided within 14 days from receiving the request, by signing this document you
declare that you will work with us to achieve this.
12. With the exception of the notification fee, service and license renewal fees need to be paid
annually (unless the notification is cancelled). Some countries will request their annual service
fee out of line with the notification date in order to bring it into line with their own financial year
or other event, by signing this document you declare that you understand and agree to this
requirement.
13. Requests for further information need to be provided quickly, and annual invoices paid promptly
to prevent service and compliance disruptions, by signing this document you declare that you
understand and agree to this requirement.
As your responsible person in Europe you acknowledge our responsibility to you includes:
1) We will check the information relevant to the notification before submission to identify any immediate
problems that could destabilize the status of a successful notification at a later date.
2) Where requested we will provide additional services including the submission of the initial notification.
3) We will answer any questions posed by the regulatory body in the event of an issue with the product.
4) We will monitor and report on new developments within the European product legislation relevant to
the products ongoing compliance.
5) We will put in place a system of vigilance to allow us to collect and monitor product feedback, and
when required (and when the manufacturer agrees) we will report adverse Incidents to Competent
Authorities.
6) We will store and update the products Technical Files (once available), and only upon request by an
appropriate regulator/surveillance/vigilance authorities will we make them available.
7) We will assist where required with Product Recalls and the issuing of Advisory Notices.
8) We will assist where required with the identification of suppliers of fake versions of the notified
product within Europe, and the reporting of those sellers to the relevant enforcement authorities.
9) We will assist with the renewal process to ensure the products legal status is consistently secure.
Signed On Behalf On the Manufacturer:_________Shenzhen Smoant Technology Co., Ltd__
Position held: ___China ___________________________________ Date: ________2017/04/10_______

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Manufacturers Responsibilities, Declarations & Service Agreement.

Signed On Behalf On the Manufacturer:_______Shenzhen Smoant Technology Co., Ltd

Position held: _China ___________________________ Date: 2017/04/10_

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