Kiri
| Dokumendiregister | Terviseamet |
| Viit | 11.1-2/24/11629-1 |
| Registreeritud | 13.11.2024 |
| Sünkroonitud | 14.11.2024 |
| 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 | 11.1-2/2023 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | HAL Allergy B.V. |
| Saabumis/saatmisviis | HAL Allergy B.V. |
| Vastutaja | Karl Kalev Türk (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: "Driehuis, Ingelise" <[email protected]>
Sent: Wed, 19 Apr 2023 09:58:32 +0000
To: "'[email protected]'" <[email protected]>
Cc: "Koster; Annette" <[email protected]>; "'[email protected]'" <[email protected]>
Subject: import of prick test
Importance: High
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Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Dear Mr Türk,
I would like to ask you some questions regarding a diagnostic (prick test) which HAL Allergy would like to import in Estonia:
- HAL Allergy intends to sell a German registered and German labelled diagnostic (prick test) in Estonia. Is this allowed under Estonian law and, if so, on what legal basis? Could you please provide me with the English text of the relevant legislation?
- Also, the leaflet for this diagnostic is currently in the German language. Is it required or allowed to provide our Estonian distributor by email with a translation of the official leaflet in the Estonian language (in pdf format), which the distributor can in turn provide (by email) to all customers (pharmacies, hospitals with a pharmacy)?
I appreciate receiving your swift answer.
Kind regards,
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Ingelise Driehuis |
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Director Legal & Compliance Officer HQ |
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Phone: +31 (0) 88 1959 016 | Fax:+31 (0) 88 1959 001 | Mobile: +31 (0) 6 5798 7783 |
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HAL Allergy B.V. | J.H. Oortweg 15 | 2333 CH Leiden, The Netherlands |
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HAL Allergy Group |
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CEO: Alex Huybens, CCFO: Florian Rösch |
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