Vastuskiri
| Dokumendiregister | Terviseamet |
| Viit | 11.2-1/24/4923-2 |
| Registreeritud | 07.05.2024 |
| Sünkroonitud | 08.05.2024 |
| Liik | Väljaminev dokument |
| Funktsioon | 11.2 Turustamise eelne järelevalve (pre-marketing surveillance) |
| Sari | 11.2-1 Meditsiiniseadmete kliiniliste uuringute ja toimivusuuringute dokumendid (taotlused, load, muud teavitused ja kirjavahetus) |
| Toimik | 11.2-1/2024 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | Amgen AB |
| Saabumis/saatmisviis | Amgen AB |
| Vastutaja | Merili Saar-Abroi (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: "Meditsiiniseadmed (Medical Devices)" <[email protected]>
Sent: Mon, 06 May 2024 13:18:27 +0000
To: "Bjorling; Johanna" <[email protected]>
Cc: "Carlens; Eva" <[email protected]>; EU-Nordic Baltic Regulatory <[email protected]>
Subject: Vs: Question regarding performance study application in Estonia
Dear Ms. Björling,
Thank you for your inquiry.
The Public Information Act of Estonia provides that any contents of the information you submit whose disclosure may violate a busniess secret, is classified as internal use within the Health Board. Your submission (e-mail with the documents) is registered in the Health Board’s public document register, but only metadata of this register entry is seen publicly; the contents of the e-mail and the dossier is only for the internal use of the Health Board. Therefore, the public can not access your performance study submission.
In case of any further questions, please do not hesitate to contact us again.
All the best,
Merili Saar-Abroi
Chief Specialist
Department of Medical Devices
Phone +372 554 3041
[email protected] | [email protected]
| Terviseamet | Health Board +372 794 3500 [email protected] Paldiski mnt 81, 10614 Tallinn |
This e-mail is confidential and meant for use by the person named in the letterhead. Any use in any way or copying of it by a person not marked as the addressee thereof is prohibited. 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: Bjorling, Johanna <[email protected]>
Saatmisaeg: esmaspäev, 6. mai 2024 15:38
Adressaat: Meditsiiniseadmed (Medical Devices) <[email protected]>
Koopia: Carlens, Eva <[email protected]>; EU-Nordic Baltic Regulatory <[email protected]>
Teema: Question regarding performance study application in Estonia
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Dear Madam/Sir,
I have a general question regarding applications for performance studies. Once a performance study application has been submitted, will any of this information be made publicly available? We have noted that for example in the Netherlands certain information become accessible through registers and databases to potential study participants as well as other healthcare professionals.
Thank you in advance for your clarification.
Kind regards,
Johanna
Johanna Björling (she/her/hers)
CW Regulatory Affairs Associate
Local Regulatory Representative
mobile: +46 701 40 30 53
Amgen AB
Gustav III:s Boulevard 54
169 27 Solna, Sweden
Seosed
| Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
|---|---|---|---|---|---|---|
| Kiri | 07.05.2024 | 1 | 11.2-1/24/4923-1 | Sissetulev dokument | ta | Amgen AB |