Regulatory Open Forum

Dear RAPS member,

I am going to submit a CTA in France and it is requested that some documents (protocol synopsis, IMP labeling) are in French.
Is it mandatory or strongly recommended to use a certified translation ?

Thank you !

------------------------------
Nathalie DELESQUE TOUCHARD
Lauzerville
France
------------------------------

Hi Nathalie,

for my undestanding the translation Agency/ House need to be qualified by you as manufacturer. Do not forget, the translation house has become a critical supplier. Hence they must have followed the approved supplier procedure. You cannot pick any old translator... For example, if this is a translation for the Bulgarian market you must use a Bulgarian translation agency…you cannot use one based in your own country.

Please see this very simply procedure...

Hope it is useful.

K

------------------------------
Katarzyna Chrusciel
Engineer
Cavezzo
Italy
------------------------------

Original Message:
Sent: 21-Apr-2021 03:02
From: Nathalie DELESQUE TOUCHARD
Subject: Certified translation for documents to be submitted in France (ANSM) ?

Dear RAPS member,

I am going to submit a CTA in France and it is requested that some documents (protocol synopsis, IMP labeling) are in French.
Is it mandatory or strongly recommended to use a certified translation ?

Thank you !

------------------------------
Nathalie DELESQUE TOUCHARD
Lauzerville
France
------------------------------

This message was posted by a user wishing to remain anonymous

Hi Katarzyna,

Could you please provide a source in a guideline or regulation who supports your statement "For example, if this is a translation for the Bulgarian market you must use a Bulgarian translation agency…you cannot use one based in your own country".

Thank you
​
Original Message:
Sent: 22-Apr-2021 01:45
From: Katarzyna Chrusciel
Subject: Certified translation for documents to be submitted in France (ANSM) ?

Hi Nathalie,

for my undestanding the translation Agency/ House need to be qualified by you as manufacturer. Do not forget, the translation house has become a critical supplier. Hence they must have followed the approved supplier procedure. You cannot pick any old translator... For example, if this is a translation for the Bulgarian market you must use a Bulgarian translation agency…you cannot use one based in your own country.

Please see this very simply procedure...

Hope it is useful.

K

------------------------------
Katarzyna Chrusciel
Engineer
Cavezzo
Italy

Original Message:
Sent: 21-Apr-2021 03:02
From: Nathalie DELESQUE TOUCHARD
Subject: Certified translation for documents to be submitted in France (ANSM) ?

Dear RAPS member,

I am going to submit a CTA in France and it is requested that some documents (protocol synopsis, IMP labeling) are in French.
Is it mandatory or strongly recommended to use a certified translation ?

Thank you !

------------------------------
Nathalie DELESQUE TOUCHARD
Lauzerville
France
------------------------------

Good morning,

as I written it is my opinion.

What I meant to said is that translator should be native to be a reliable medical text translator.

It's just common sense practice that I prefer.

K

------------------------------
Katarzyna Chrusciel
Engineer
Italy
------------------------------

Original Message:
Sent: 23-Apr-2021 01:59
From: Anonymous Member
Subject: Certified translation for documents to be submitted in France (ANSM) ?

This message was posted by a user wishing to remain anonymous

Hi Katarzyna,

Could you please provide a source in a guideline or regulation who supports your statement "For example, if this is a translation for the Bulgarian market you must use a Bulgarian translation agency…you cannot use one based in your own country".

Thank you
​
Original Message:
Sent: 22-Apr-2021 01:45
From: Katarzyna Chrusciel
Subject: Certified translation for documents to be submitted in France (ANSM) ?

Hi Nathalie,

for my undestanding the translation Agency/ House need to be qualified by you as manufacturer. Do not forget, the translation house has become a critical supplier. Hence they must have followed the approved supplier procedure. You cannot pick any old translator... For example, if this is a translation for the Bulgarian market you must use a Bulgarian translation agency…you cannot use one based in your own country.

Please see this very simply procedure...

Hope it is useful.

K

------------------------------
Katarzyna Chrusciel
Engineer
Cavezzo
Italy

Original Message:
Sent: 21-Apr-2021 03:02
From: Nathalie DELESQUE TOUCHARD
Subject: Certified translation for documents to be submitted in France (ANSM) ?

Dear RAPS member,

I am going to submit a CTA in France and it is requested that some documents (protocol synopsis, IMP labeling) are in French.
Is it mandatory or strongly recommended to use a certified translation ?

Thank you !

------------------------------
Nathalie DELESQUE TOUCHARD
Lauzerville
France
------------------------------

Dear all,
it is always better to have a certified translation body in home country.
But it is true in some countries local translator is qualitative however without real certfication.
You should control the process and perhaps in the last case let importer/distributor sign a statement that content aligns with original labelling etc.

------------------------------
Antonio Lee
EasyChinapprov
Beijing, China
info@easychinapprov.com
------------------------------

Original Message:
Sent: 24-Apr-2021 01:39
From: Katarzyna Chrusciel
Subject: Certified translation for documents to be submitted in France (ANSM) ?

Good morning,

as I written it is my opinion.

What I meant to said is that translator should be native to be a reliable medical text translator.

It's just common sense practice that I prefer.

K

------------------------------
Katarzyna Chrusciel
Engineer
Italy

Original Message:
Sent: 23-Apr-2021 01:59
From: Anonymous Member
Subject: Certified translation for documents to be submitted in France (ANSM) ?

This message was posted by a user wishing to remain anonymous

Hi Katarzyna,

Could you please provide a source in a guideline or regulation who supports your statement "For example, if this is a translation for the Bulgarian market you must use a Bulgarian translation agency…you cannot use one based in your own country".

Thank you
​
Original Message:
Sent: 22-Apr-2021 01:45
From: Katarzyna Chrusciel
Subject: Certified translation for documents to be submitted in France (ANSM) ?

Hi Nathalie,

for my undestanding the translation Agency/ House need to be qualified by you as manufacturer. Do not forget, the translation house has become a critical supplier. Hence they must have followed the approved supplier procedure. You cannot pick any old translator... For example, if this is a translation for the Bulgarian market you must use a Bulgarian translation agency…you cannot use one based in your own country.

Please see this very simply procedure...

Hope it is useful.

K

------------------------------
Katarzyna Chrusciel
Engineer
Cavezzo
Italy

Original Message:
Sent: 21-Apr-2021 03:02
From: Nathalie DELESQUE TOUCHARD
Subject: Certified translation for documents to be submitted in France (ANSM) ?

Dear RAPS member,

I am going to submit a CTA in France and it is requested that some documents (protocol synopsis, IMP labeling) are in French.
Is it mandatory or strongly recommended to use a certified translation ?

Thank you !

------------------------------
Nathalie DELESQUE TOUCHARD
Lauzerville
France
------------------------------

Thank you all for your help.
Very useful !

------------------------------
Nathalie DELESQUE TOUCHARD
Lauzerville
France
------------------------------

Original Message:
Sent: 25-Apr-2021 04:14
From: Antonio Lee
Subject: Certified translation for documents to be submitted in France (ANSM) ?

Dear all,
it is always better to have a certified translation body in home country.
But it is true in some countries local translator is qualitative however without real certfication.
You should control the process and perhaps in the last case let importer/distributor sign a statement that content aligns with original labelling etc.

------------------------------
Antonio Lee
EasyChinapprov
Beijing, China
info@easychinapprov.com

Original Message:
Sent: 24-Apr-2021 01:39
From: Katarzyna Chrusciel
Subject: Certified translation for documents to be submitted in France (ANSM) ?

Good morning,

as I written it is my opinion.

What I meant to said is that translator should be native to be a reliable medical text translator.

It's just common sense practice that I prefer.

K

------------------------------
Katarzyna Chrusciel
Engineer
Italy

Original Message:
Sent: 23-Apr-2021 01:59
From: Anonymous Member
Subject: Certified translation for documents to be submitted in France (ANSM) ?

This message was posted by a user wishing to remain anonymous

Hi Katarzyna,

Could you please provide a source in a guideline or regulation who supports your statement "For example, if this is a translation for the Bulgarian market you must use a Bulgarian translation agency…you cannot use one based in your own country".

Thank you
​
Original Message:
Sent: 22-Apr-2021 01:45
From: Katarzyna Chrusciel
Subject: Certified translation for documents to be submitted in France (ANSM) ?

Hi Nathalie,

for my undestanding the translation Agency/ House need to be qualified by you as manufacturer. Do not forget, the translation house has become a critical supplier. Hence they must have followed the approved supplier procedure. You cannot pick any old translator... For example, if this is a translation for the Bulgarian market you must use a Bulgarian translation agency…you cannot use one based in your own country.

Please see this very simply procedure...

Hope it is useful.

K

------------------------------
Katarzyna Chrusciel
Engineer
Cavezzo
Italy

Original Message:
Sent: 21-Apr-2021 03:02
From: Nathalie DELESQUE TOUCHARD
Subject: Certified translation for documents to be submitted in France (ANSM) ?

Dear RAPS member,

I am going to submit a CTA in France and it is requested that some documents (protocol synopsis, IMP labeling) are in French.
Is it mandatory or strongly recommended to use a certified translation ?

Thank you !

------------------------------
Nathalie DELESQUE TOUCHARD
Lauzerville
France
------------------------------