Vastuskiri

Dear Rachael Perrio,

Does your question concern the notification of a heated tobacco product device for the Estonian market?

Best regards,

Mikaela Pakosta

Senior Specialist

Department of Chemical Safety

Republic of Estonia

Health Board

+372 794 3500

[email protected]

www.terviseamet.ee

Paldiski mnt 81, 10614 Tallinn

Estonia

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Dear Estonian Health Board (Terviseamet),

I am emailing to understand the submission process for a study we are looking to conduct in your country. This research study does not have an investigational medicinal product (IMP) or medical device. The investigated product is a consumer device with tobacco product. The study is evaluating cigarettes against this tobacco heating system in patients with COPD.

Can I confirm if this type of study would require submission to you? If yes, please can you provide details on how this type of submission would occur?

Many thanks for your input and support

Best wishes,

Rachael

Rachael Perrio

Senior Regulatory Executive

Upcoming Leave: 28th February

www.dlrc.co.uk

Tel:  +44 (0)1462 372472

Mobile: +44 (0)7563 028913

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