Vastuskiri
| Dokumendiregister | Terviseamet |
| Viit | 10.2-7/25/1389-4 |
| Registreeritud | 07.03.2025 |
| Sünkroonitud | 10.03.2025 |
| Liik | Väljaminev dokument |
| Funktsioon | 10.2 Toodete terviseohutusega seotud toimingud |
| Sari | 10.2-7 Tubakatooted |
| Toimik | 10.2-7/2025 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | DLRC Ltd |
| Saabumis/saatmisviis | DLRC Ltd |
| Vastutaja | Mikaela Pakosta (TA, Peadirektori asetäitja (1) vastutusvaldkond, Kemikaaliohutuse osakond) |
| Originaal | Ava uues aknas |
Failid
From: Mikaela Pakosta
Sent: Fri, 07 Mar 2025 08:57:22 +0000
To: '[email protected]' <[email protected]>
Cc: '[email protected]' <[email protected]>
Subject: Vs: Estonia - Tobacco Product Study
Dear Rachael Perrio,
Thank you for your inquiry regarding the approval process for conducting clinical or scientific research.
For obtaining an opinion on the coordination and approval of such studies, we kindly ask you to contact the Ethics Committee. You can find more information at the following link: https://ut.ee/en/node/113848
Please let us know if you have any further questions.
Best regards,
Mikaela Pakosta
Senior Specialist
Department of Chemical Safety
Republic of Estonia
Health Board
+372 794 3500
Paldiski mnt 81, 10614 Tallinn
Estonia
This e-mail meant for use by the person named in the letterhead. If you have got this e-mail by mistake, please notify of it the sender without delay and delete the received e-mail together with all its attachments.
Saatja: Rachael Perrio <[email protected]>
Saatmisaeg: esmaspäev, 3. märts 2025 18:19
Adressaat: TA tpd <[email protected]>
Koopia: Cecile Limousin <[email protected]>
Teema: RE: Estonia - Tobacco Product Study
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Dear Mikaela,
Not at this stage, at this stage we are planning to conduct the study outlined below in your country. Plans for market are yet to be established. Can I confirm if you would require review of this type of study? Also, if you are able to confirm the importation requirements/guidance for bringing this type of device into Estonia for the research study?
Thank you for your support!
Best wishes,
Rachael
From: TA tpd <[email protected]>
Sent: 03 March 2025 14:11
To: Rachael Perrio <[email protected]>
Cc: Cecile Limousin <[email protected]>
Subject: Vs: Estonia - Tobacco Product Study
Mõnedele selle sõnumi saanud inimestele ei saadeta aadressilt [email protected] meilisõnumeid. Lugege täpsemat teavet selle kohta, miks see on oluline |
Please be cautious
This email was sent from outside of your organisation
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
Paldiski mnt 81, 10614 Tallinn
Estonia
This e-mail meant for use by the person named in the letterhead. If you have got this e-mail by mistake, please notify of it the sender without delay and delete the received e-mail together with all its attachments.
Saatja: Rachael Perrio <[email protected]>
Saatmisaeg: reede, 21. veebruar 2025 12:57
Adressaat: [email protected]
Koopia: Cecile Limousin <[email protected]>
Teema: Estonia - Tobacco Product Study
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
Tel: +44 (0)1462 372472
Mobile: +44 (0)7563 028913
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Seosed
| Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
|---|---|---|---|---|---|---|
| Selgitustaotlus | 03.03.2025 | 1 | 10.2-7/25/1389-3 | Sissetulev dokument | ta | DLRC Ltd |