Küsimused

Saatja: RA MSO </O=SOTSIAALMINISTEERIUM/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=72F3C63240224E00B8EFA069E66B5C58-RA> Saaja: Gilbertson, Michael L, RA MSO Teema: Vs: Abbott Medical - Responsibility for Medical Devices in Estonia Dear Luke, Thank you for your enquiry. You don't need to resubmit your reports from 01-Jan-2025 until today [email protected], but for certainty, please submit your reports from today [email protected] <mailto:[email protected]> As far as we know, the old [email protected] <mailto:[email protected]> should be active until the end of this year. Kind regards, Maarika Ojala Specialist Department of Medical Devices State Agency of Medicines [email protected] <mailto:[email protected]> 1 Nooruse Street 50411 Tartu Estonia Phone: +372 737 4140 www.ravimiamet.ee <http://www.ravimiamet.ee/> Selles e-kirjas sisalduv teave (kaasa arvatud manused) on mõeldud ametialaseks kasutamiseks ning seda võivad kasutada vaid e-kirja adressaadid. E-kirjas sisalduvat teavet ei tohi ilma saatja selgelt väljendatud loata edasi saata ega mis tahes viisil kolmandatele isikutele avaldada. Juhul, kui Te olete saanud käesoleva e-kirja eksituse tõttu, teavitage sellest koheselt saatjat ning kustutage e-kiri. This e-mail and any attachments transmitted may contain confidential and privileged information. If you are not the intended recipient, please notify the sender immediately by returning the e-mail and permanently deleting what you have recieved. Any dissemination or use of this information by a third person without permission is prohibited and may be illegal. Saatja: Gilbertson, Michael L <[email protected]> Saatmisaeg: neljapäev, 27. märts 2025 17:57 Adressaat: Ravimiamet <[email protected]>; MSO (Arhiiv) <[email protected]>; RA MSO <[email protected]> Koopia: Jiwatrakan, Pin <[email protected]> Teema: Abbott Medical - Responsibility for Medical Devices in Estonia Dear Sir/Madam, We have recently become aware that from 01-Jan-2025 the administrative responsibilities of the Estonian Health Board related to medical devices have been transferred to the Estonian State Agency of Medicines. As a Medical Device Manufacturer, to avoid any missed responsibilities of ours. Please can we ask for your support/response to the following questions? 1. Was there a time period where both the old ([email protected] <mailto:[email protected]> ) and new ([email protected] <mailto:[email protected]> ) are active at the same time? If so, what is the timeframe? 2. Has the [email protected] <mailto:[email protected]> email been decommissioned? If so, should we resubmit reports from 01-Jan-2025 until the present day to [email protected] <mailto:[email protected]> ? I look forward to your response. Kind regards, Luke Luke Gilbertson Senior Regulatory Compliance Specialist (EMEA) Abbott, Elder House Blythe Valley Business Park Solihull, UK, B90 8AJ O: -- M: +44 (0) 7785 692 474 E: [email protected] <mailto:[email protected]> [email protected] <mailto:[email protected]>