Kiri
| Dokumendiregister | Terviseamet |
| Viit | 11.1-2/24/5004-1 |
| Registreeritud | 09.05.2024 |
| Sünkroonitud | 10.05.2024 |
| Liik | Sissetulev dokument |
| Funktsioon | 11.1 Turustamise järgne järelevalve (post-marketing surveillance) |
| Sari | 11.1-2 Kirjavahetus Eesti turule lastavatest/kasutusele võetavatest/levitatavatest seadmetest MSA kaudu teavitamiseks |
| Toimik | 11.1-2/2024 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | UAB Innovative Pharma Baltics |
| Saabumis/saatmisviis | UAB Innovative Pharma Baltics |
| Vastutaja | Janne Aule (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: Alisa IPB <[email protected]>
Sent: Tue, 07 May 2024 05:15:37 +0000
To: [email protected]
Cc: Aida Binkauskienė <[email protected]>; Natalija Mikalajūnė <[email protected]>
Subject: distribution of medical devices, manufactured in the EU, in Estonia
|
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Dear Sir or Madam,
--
We, Innovative Pharma Baltics, the company based and manufacturing MDs in Lithuania, wish to distribute these MDs, class I, in Estonia.
We have got acquainted with the regulations required for MD in Estonia, including, but not limited to:
The only few questions we have for today are:
1) Does Lithuanian manufacturing company need an authorised representative in Estonia?
2) If the authorised representative is not needed for the MDs manufactured in the EU, then please provide us the access to the EMDDB
so we could complete the Notification procedure through EMDBB.
Many thanks for your collaboration,
Best regards,
Alisa Palaveniene Farmacijos skyriaus vedėja | Head of Pharma Department UAB Innovative Pharma Baltics Mokslininkų g. 6a Vilnius, Lietuva Tel.: +37064500270 El. p.: alisa@innovative.lt |
