Kiri
| Dokumendiregister | Terviseamet |
| Viit | 11.2-4/24/5778-2 |
| Registreeritud | 05.06.2024 |
| Sünkroonitud | 06.06.2024 |
| Liik | Sissetulev dokument |
| Funktsioon | 11.2 Turustamise eelne järelevalve (pre-marketing surveillance) |
| Sari | 11.2-4 Erandid vastavushindamismenetlusest, taotlused ja kirjavahetus |
| Toimik | 11.2-4/2024 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | AFMPS-FAGG |
| Saabumis/saatmisviis | AFMPS-FAGG |
| Vastutaja | Maarika Ojala (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: "Derogation.Meddev (AFMPS - FAGG)" <[email protected]>
Sent: Tue, 04 Jun 2024 14:37:03 +0000
To: "Meditsiiniseadmed (Medical Devices)" <[email protected]>
Cc: "Damien Lambot (AFMPS - FAGG)" <[email protected]>
Subject: RE: Derogation process
|
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Dear colleagues,
We have well received your question.
A few years ago, we used to ask for the patient’s initials on the compassionate use application form. As we sometimes receive different CU applications from the same doctor, for the same device, this allowed us to distinguish between two very similar applications.
As this is no longer possible, due to the GDPR legislation, we no longer ask for the patient’s initials (we now work with a unique reference number), but we still ask for the patient’s gender and age.
In addition, this information is also very important in determining whether or not, we can authorise a CU. Before we can approve a CU application, we need to know whether the device will be used on/for children, adults or elderly, as this may have an impact on our decision. It is also important to find relevant literature to support our decision.
Hoping this will be of service to you,
Kind regards,
Lotte Vansteelant
|
|
Lotte Vansteelant Wetenschappelijk dossierbeheerder DG POST Autorisation / Division Produits de santé / Cellule Dispositifs médicaux DG POST Vergunning / Afdeling Gezondheidsproducten / Cel Medische Hulpmiddelen DG POST Genehmigung / Abteilung Gesundheitsprodukte / Stelle für Medizinprodukte DG POST Authorisation / Health Products Division / Medical Devices Entity |
|
|
|
agence fédérale des médicaments et des produits de santé federaal agentschap voor geneesmiddelen en gezondheidsproducten föderale agentur für arzneimittel und gesundheitsprodukte federal agency for medicines and health products |
|
|
Galileelaan 5/03 1210 BRUXELLES - BRUSSEL - BRÜSSEL - BRUSSELS T + 32 2 528 40 00
|
||
|
|
||
Van: Meditsiiniseadmed (Medical Devices) <[email protected]>
Verzonden: maandag 3 juni 2024 9:49
Aan: Derogation.Meddev (AFMPS - FAGG) <[email protected]>
Onderwerp: Derogation process
Dear colleagues,
We are currently working on a national (single use patsient) derogation procedure and derogation form.
Looking at the derogation forms of other Member States, we noticed that on your derogation form for a specific device(s) for a specific patient, you ask about the age category.
We would like to know, why you have decided to ask this and how it affects your decision to grant a derogation?
We would be grateful for a reply.
Yours sincerely,
Maarika Ojala
Chief Specialist
Department of Medical Devices
+372 5400 4028
Republic of Estonia
Health Board
+372 794 3500
Paldiski mnt 81, 10614 Tallinn
Estonia
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.
Deze e-mail kan vertrouwelijke informatie bevatten die uitsluitend is gericht aan de bestemmeling(en). Verwittig onmiddellijk de afzender als u deze e-mail per vergissing ontvangt. Gebruik deze e-mail dan niet en vernietig deze. Voor de inhoud van deze e-mail is enkel de afzender verantwoordelijk. De afzender kan niet verantwoordelijk worden gesteld voor enige wijziging van het bericht.
Ce message peut contenir des informations confidentielles à l’attention exclusive du (des) destinataire(s). Si vous avez reçu cet e-mail par erreur, veuillez en avertir immédiatement l’expéditeur. Ne l’utilisez pas et détruisez-le. L’ expéditeur est seul responsable du contenu de ce message et ne peut être tenu responsable d’une quelconque modification de son message.
Diese E-Mail kann vertrauliche Informationen enthalten, die nur für den Adressaten bestimmt sind. Sollten Sie diese E-Mail versehentlich erhalten haben, bitten wir Sie um sofortige Mitteilung an den Absender die E-Mail nicht zu verwenden und sie zu zerstören. Für den Inhalt dieser E-Mail haftet nur der Absender, der nicht für irgendwelche Änderung seiner Nachricht verantwortlich gemacht werden kann.
This e-mail may contain confidential information solely intended for the recipient(s). Notify the sender immediately if you have received this e-mail by mistake. Do not use this e-mail and delete it then. Only the sender is responsible for the content of this e-mail and cannot accept liability for any change to the message.
