Regulatory Open Forum

Are authorized representative agreement in Saudi Arabia Expires at the end of August. We are not considering renewal but have product on the market. I’m trying to understand two things.
How much time do I have to notify the KFDA?
Do I need to remove my product from the market as we probably won’t have an AR agreement in place by the time our existing one expires?

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Fred Cowdery


Collegeville PA
United States
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Hi,

@Alaa El Kazak can give insights as an expert.​

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Youmna Abboud
Beirut
Lebanon
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Original Message:
Sent: 16-Jul-2021 05:34
From: Fred Cowdery
Subject: KSA A/R

Are authorized representative agreement in Saudi Arabia Expires at the end of August. We are not considering renewal but have product on the market. I'm trying to understand two things.
How much time do I have to notify the KFDA?
Do I need to remove my product from the market as we probably won't have an AR agreement in place by the time our existing one expires?

---------------------------------
Fred Cowdery


Collegeville PA
United States
---------------------------------

Dear @Youmna Abboud, thanks for mentioning me. Could you please refer to me the SFDA related decision? so that I can ask a colleague who has experience in MDs. I think I don't know a similar decision in the drug sector.​

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Alaa El Kazak Msc., RAC
Jeddah
Saudi Arabia
https://www.linkedin.com/in/alaaelkazak/
http://bcert.me/snztdjygk
------------------------------

Original Message:
Sent: 21-Jul-2021 07:54
From: Youmna Abboud
Subject: KSA A/R

Hi,

@Alaa El Kazak can give insights as an expert.​

------------------------------
Youmna Abboud
Beirut
Lebanon

Original Message:
Sent: 16-Jul-2021 05:34
From: Fred Cowdery
Subject: KSA A/R

Are authorized representative agreement in Saudi Arabia Expires at the end of August. We are not considering renewal but have product on the market. I'm trying to understand two things.
How much time do I have to notify the KFDA?
Do I need to remove my product from the market as we probably won't have an AR agreement in place by the time our existing one expires?

---------------------------------
Fred Cowdery


Collegeville PA
United States
---------------------------------

Hi Fred

Under the interim regulations, having an authorized representative is mandatory.​ I don't think you can get access to the adverse event reporting system if you're overseas. Here's the guidance:
https://www.sfda.gov.sa/sites/default/files/2021-06/%28MDS-G3%29.pdf

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Anne LeBlanc
United States
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Original Message:
Sent: 22-Jul-2021 05:21
From: Alaa El Kazak
Subject: KSA A/R

Dear @Youmna Abboud, thanks for mentioning me. Could you please refer to me the SFDA related decision? so that I can ask a colleague who has experience in MDs. I think I don't know a similar decision in the drug sector.​

------------------------------
Alaa El Kazak Msc., RAC
Jeddah
Saudi Arabia
https://www.linkedin.com/in/alaaelkazak/
http://bcert.me/snztdjygk

Original Message:
Sent: 21-Jul-2021 07:54
From: Youmna Abboud
Subject: KSA A/R

Hi,

@Alaa El Kazak can give insights as an expert.​

------------------------------
Youmna Abboud
Beirut
Lebanon

Original Message:
Sent: 16-Jul-2021 05:34
From: Fred Cowdery
Subject: KSA A/R

Are authorized representative agreement in Saudi Arabia Expires at the end of August. We are not considering renewal but have product on the market. I'm trying to understand two things.
How much time do I have to notify the KFDA?
Do I need to remove my product from the market as we probably won't have an AR agreement in place by the time our existing one expires?

---------------------------------
Fred Cowdery


Collegeville PA
United States
---------------------------------

Hi Fred , i can help if you want , please send me more details on my email and we can arrange a call 

Mona Al Moussli 
m.almoussli@gmail.com 
00971507569968 
www.pra-me.com

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Mona Al Moussli
CEO
Dubai
United Arab Emirates
------------------------------

Original Message:
Sent: 16-Jul-2021 05:34
From: Fred Cowdery
Subject: KSA A/R

Are authorized representative agreement in Saudi Arabia Expires at the end of August. We are not considering renewal but have product on the market. I'm trying to understand two things.
How much time do I have to notify the KFDA?
Do I need to remove my product from the market as we probably won't have an AR agreement in place by the time our existing one expires?

---------------------------------
Fred Cowdery


Collegeville PA
United States
---------------------------------