Regulatory Open Forum

Hello RAPS community,

We have been approached by a distributor that supplies Ukraine with donations of medical devices. We would like to help in whatever way we can but our product is currently only cleared in the US.
My question you are aware of any changes or exeptions made in Ukraine, given the current extreme situation, that allows the donation and use of medical devices even though they are currently not approved in Ukraine? 

Thanks in advance!

/Jonas

------------------------------
Jonas Aberg
PhD
Gamboa
Panama
------------------------------

Hello Jonas

Yes, drugs and devices with other stringent approvals, such as US or EU, are being gratefully accepted during the emergency. There is some information available from the World Health Organization and the Ukraine Ministry of Health on what is currently needed and how the supply is being coordinated.

https://www.who.int/emergencies/situations/ukraine-emergency/medical-supply-donations

https://en.moz.gov.ua/


------------------------------
Anne LeBlanc
United States
------------------------------

Original Message:
Sent: 01-May-2022 09:32
From: Jonas Aberg
Subject: Rules for donations to Ukraine

Hello RAPS community,

We have been approached by a distributor that supplies Ukraine with donations of medical devices. We would like to help in whatever way we can but our product is currently only cleared in the US.
My question you are aware of any changes or exeptions made in Ukraine, given the current extreme situation, that allows the donation and use of medical devices even though they are currently not approved in Ukraine?

Thanks in advance!

/Jonas

------------------------------
Jonas Aberg
PhD
Gamboa
Panama
------------------------------

Hello Anne,

Great thank you very much!

/Jonas

------------------------------
Jonas Aberg
PhD
Gamboa
Panama
------------------------------

Original Message:
Sent: 01-May-2022 12:34
From: Anne LeBlanc
Subject: Rules for donations to Ukraine

Hello Jonas

Yes, drugs and devices with other stringent approvals, such as US or EU, are being gratefully accepted during the emergency. There is some information available from the World Health Organization and the Ukraine Ministry of Health on what is currently needed and how the supply is being coordinated.

https://www.who.int/emergencies/situations/ukraine-emergency/medical-supply-donations

https://en.moz.gov.ua/


------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 01-May-2022 09:32
From: Jonas Aberg
Subject: Rules for donations to Ukraine

Hello RAPS community,

We have been approached by a distributor that supplies Ukraine with donations of medical devices. We would like to help in whatever way we can but our product is currently only cleared in the US.
My question you are aware of any changes or exeptions made in Ukraine, given the current extreme situation, that allows the donation and use of medical devices even though they are currently not approved in Ukraine?

Thanks in advance!

/Jonas

------------------------------
Jonas Aberg
PhD
Gamboa
Panama
------------------------------