Regulatory Open Forum

Related to a recently posted topic of label overload, does anyone know of countries that do not permit labelling that is not required by their regulations.
E.G.: India, UK, Swiss, Russia, all have or will require their own labels.
Packaging size permitting would any countries have an issue with all these labels being on products together? Could these cause import issues into 3rd countries?
Thanks

------------------------------
John Gibbs
Mortsel
Belgium
------------------------------

Hello John,

I do not think those countries require their own labels, what they require is information specific to their regulations on the label.  This was in another thread concerning the In-Country Representative information needing to be contained on the product labelling, which now can be EU, UK, Swiss, etc.  Just because you have a UK RP on the label does not mean it needs to be a separate label which is sold only in UK and not anywhere else in Europe.  In fact, many regulatory agencies know content of labelling may have information related to many other regulatory jurisdictions, i.e. CE Mark on products sold in U.S.  The only points of needing separate labelling I am aware is when content is contradicting, e.g. the indications for use are different between say U.S. and EU, and the labelling has more political/import requirements, e.g. products made in a Middle East country not able to distribute in other countries.  Content of a label could certainly cause some importation issues into third countries, but you would have to look at each one - such as if the label contains a CE Mark, the importing company may require a copy of the Declaration of Conformity or even the CE Certificate.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 15-Sep-2021 09:54
From: John Gibbs
Subject: Are there countries that don't permit labelling meant for another country?

Related to a recently posted topic of label overload, does anyone know of countries that do not permit labelling that is not required by their regulations.
E.G.: India, UK, Swiss, Russia, all have or will require their own labels.
Packaging size permitting would any countries have an issue with all these labels being on products together? Could these cause import issues into 3rd countries?
Thanks

------------------------------
John Gibbs
Mortsel
Belgium
------------------------------

Thanks for your feedback Richard, and you are correct, it is about country specific information on the label. And within EU I agree it won't be an issue though I had heard that France is critical of superfluous information on the package. Outside of EU I think it is one of those  where you won't know for sure until you actually ship it. The new India regulation on medical devices does require quite extensive specific information on the package and I have information that Ukraine, Russia, Morocco would have an issue with this.

------------------------------
John Gibbs
Mortsel
Belgium
------------------------------

Original Message:
Sent: 16-Sep-2021 01:19
From: Richard Vincins
Subject: Are there countries that don't permit labelling meant for another country?

Hello John,

I do not think those countries require their own labels, what they require is information specific to their regulations on the label.  This was in another thread concerning the In-Country Representative information needing to be contained on the product labelling, which now can be EU, UK, Swiss, etc.  Just because you have a UK RP on the label does not mean it needs to be a separate label which is sold only in UK and not anywhere else in Europe.  In fact, many regulatory agencies know content of labelling may have information related to many other regulatory jurisdictions, i.e. CE Mark on products sold in U.S.  The only points of needing separate labelling I am aware is when content is contradicting, e.g. the indications for use are different between say U.S. and EU, and the labelling has more political/import requirements, e.g. products made in a Middle East country not able to distribute in other countries.  Content of a label could certainly cause some importation issues into third countries, but you would have to look at each one - such as if the label contains a CE Mark, the importing company may require a copy of the Declaration of Conformity or even the CE Certificate.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 15-Sep-2021 09:54
From: John Gibbs
Subject: Are there countries that don't permit labelling meant for another country?

Related to a recently posted topic of label overload, does anyone know of countries that do not permit labelling that is not required by their regulations.
E.G.: India, UK, Swiss, Russia, all have or will require their own labels.
Packaging size permitting would any countries have an issue with all these labels being on products together? Could these cause import issues into 3rd countries?
Thanks

------------------------------
John Gibbs
Mortsel
Belgium
------------------------------

Yep, I had heard that too.  The IMDRF is doing a great job .... sarcasm.  The world is sadly deharmonising not harmonising.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 16-Sep-2021 02:16
From: John Gibbs
Subject: Are there countries that don't permit labelling meant for another country?

Thanks for your feedback Richard, and you are correct, it is about country specific information on the label. And within EU I agree it won't be an issue though I had heard that France is critical of superfluous information on the package. Outside of EU I think it is one of those  where you won't know for sure until you actually ship it. The new India regulation on medical devices does require quite extensive specific information on the package and I have information that Ukraine, Russia, Morocco would have an issue with this.

------------------------------
John Gibbs
Mortsel
Belgium

Original Message:
Sent: 16-Sep-2021 01:19
From: Richard Vincins
Subject: Are there countries that don't permit labelling meant for another country?

Hello John,

I do not think those countries require their own labels, what they require is information specific to their regulations on the label.  This was in another thread concerning the In-Country Representative information needing to be contained on the product labelling, which now can be EU, UK, Swiss, etc.  Just because you have a UK RP on the label does not mean it needs to be a separate label which is sold only in UK and not anywhere else in Europe.  In fact, many regulatory agencies know content of labelling may have information related to many other regulatory jurisdictions, i.e. CE Mark on products sold in U.S.  The only points of needing separate labelling I am aware is when content is contradicting, e.g. the indications for use are different between say U.S. and EU, and the labelling has more political/import requirements, e.g. products made in a Middle East country not able to distribute in other countries.  Content of a label could certainly cause some importation issues into third countries, but you would have to look at each one - such as if the label contains a CE Mark, the importing company may require a copy of the Declaration of Conformity or even the CE Certificate.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 15-Sep-2021 09:54
From: John Gibbs
Subject: Are there countries that don't permit labelling meant for another country?

Related to a recently posted topic of label overload, does anyone know of countries that do not permit labelling that is not required by their regulations.
E.G.: India, UK, Swiss, Russia, all have or will require their own labels.
Packaging size permitting would any countries have an issue with all these labels being on products together? Could these cause import issues into 3rd countries?
Thanks

------------------------------
John Gibbs
Mortsel
Belgium
------------------------------

You won't have an issue in Russia if you have EU label on a package. It is just that you would have to have an additional label with information specific for Russian market next to that label. There is A LOT of information that is required to be in Russian onl lables, so it is very unlikely that you would be able to squeeze it on a EU lable in addition to other information.) Right now  (for MD) companies print up labels down here and put it on a package. The situation might be tricky if it is difficult to put on an additional label on a primary package (e.g. when it impossible/very difficult to open secondary boxes and then packing them back). For imported drugs labeling is always done at manufacturing sites.
While applying for registration we  provide a photo of a device with its original label (one you have as a finished label with all information that is there) and a draft for  local Russian label  and confirm that this label  would be put in addition to original one. 
In Ukraine you also may do it the same way. However, Ukraine requires less information to be in Ukranian, so sometimes manufacturers can manage to put it on their multiple labels.
Kazakhstan requires labels in Kazakh language as well (they also put local stickers). Belarussia accepts stickers in Russian.

------------------------------
Oksana Kolosova
Moscow
------------------------------

Original Message:
Sent: 16-Sep-2021 02:16
From: John Gibbs
Subject: Are there countries that don't permit labelling meant for another country?

Thanks for your feedback Richard, and you are correct, it is about country specific information on the label. And within EU I agree it won't be an issue though I had heard that France is critical of superfluous information on the package. Outside of EU I think it is one of those  where you won't know for sure until you actually ship it. The new India regulation on medical devices does require quite extensive specific information on the package and I have information that Ukraine, Russia, Morocco would have an issue with this.

------------------------------
John Gibbs
Mortsel
Belgium

Original Message:
Sent: 16-Sep-2021 01:19
From: Richard Vincins
Subject: Are there countries that don't permit labelling meant for another country?

Hello John,

I do not think those countries require their own labels, what they require is information specific to their regulations on the label.  This was in another thread concerning the In-Country Representative information needing to be contained on the product labelling, which now can be EU, UK, Swiss, etc.  Just because you have a UK RP on the label does not mean it needs to be a separate label which is sold only in UK and not anywhere else in Europe.  In fact, many regulatory agencies know content of labelling may have information related to many other regulatory jurisdictions, i.e. CE Mark on products sold in U.S.  The only points of needing separate labelling I am aware is when content is contradicting, e.g. the indications for use are different between say U.S. and EU, and the labelling has more political/import requirements, e.g. products made in a Middle East country not able to distribute in other countries.  Content of a label could certainly cause some importation issues into third countries, but you would have to look at each one - such as if the label contains a CE Mark, the importing company may require a copy of the Declaration of Conformity or even the CE Certificate.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 15-Sep-2021 09:54
From: John Gibbs
Subject: Are there countries that don't permit labelling meant for another country?

Related to a recently posted topic of label overload, does anyone know of countries that do not permit labelling that is not required by their regulations.
E.G.: India, UK, Swiss, Russia, all have or will require their own labels.
Packaging size permitting would any countries have an issue with all these labels being on products together? Could these cause import issues into 3rd countries?
Thanks

------------------------------
John Gibbs
Mortsel
Belgium
------------------------------

This message was posted by a user wishing to remain anonymous

Hi Oksana
Where could I find the specific Russian requirements on labelling?
Original Message:
Sent: 18-Sep-2021 17:51
From: Oksana Kolosova
Subject: Are there countries that don't permit labelling meant for another country?

You won't have an issue in Russia if you have EU label on a package. It is just that you would have to have an additional label with information specific for Russian market next to that label. There is A LOT of information that is required to be in Russian onl lables, so it is very unlikely that you would be able to squeeze it on a EU lable in addition to other information.) Right now  (for MD) companies print up labels down here and put it on a package. The situation might be tricky if it is difficult to put on an additional label on a primary package (e.g. when it impossible/very difficult to open secondary boxes and then packing them back). For imported drugs labeling is always done at manufacturing sites.
While applying for registration we  provide a photo of a device with its original label (one you have as a finished label with all information that is there) and a draft for  local Russian label  and confirm that this label  would be put in addition to original one.
In Ukraine you also may do it the same way. However, Ukraine requires less information to be in Ukranian, so sometimes manufacturers can manage to put it on their multiple labels.
Kazakhstan requires labels in Kazakh language as well (they also put local stickers). Belarussia accepts stickers in Russian.

------------------------------
Oksana Kolosova
Moscow

Original Message:
Sent: 16-Sep-2021 02:16
From: John Gibbs
Subject: Are there countries that don't permit labelling meant for another country?

Thanks for your feedback Richard, and you are correct, it is about country specific information on the label. And within EU I agree it won't be an issue though I had heard that France is critical of superfluous information on the package. Outside of EU I think it is one of those  where you won't know for sure until you actually ship it. The new India regulation on medical devices does require quite extensive specific information on the package and I have information that Ukraine, Russia, Morocco would have an issue with this.

------------------------------
John Gibbs
Mortsel
Belgium

Original Message:
Sent: 16-Sep-2021 01:19
From: Richard Vincins
Subject: Are there countries that don't permit labelling meant for another country?

Hello John,

I do not think those countries require their own labels, what they require is information specific to their regulations on the label.  This was in another thread concerning the In-Country Representative information needing to be contained on the product labelling, which now can be EU, UK, Swiss, etc.  Just because you have a UK RP on the label does not mean it needs to be a separate label which is sold only in UK and not anywhere else in Europe.  In fact, many regulatory agencies know content of labelling may have information related to many other regulatory jurisdictions, i.e. CE Mark on products sold in U.S.  The only points of needing separate labelling I am aware is when content is contradicting, e.g. the indications for use are different between say U.S. and EU, and the labelling has more political/import requirements, e.g. products made in a Middle East country not able to distribute in other countries.  Content of a label could certainly cause some importation issues into third countries, but you would have to look at each one - such as if the label contains a CE Mark, the importing company may require a copy of the Declaration of Conformity or even the CE Certificate.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 15-Sep-2021 09:54
From: John Gibbs
Subject: Are there countries that don't permit labelling meant for another country?

Related to a recently posted topic of label overload, does anyone know of countries that do not permit labelling that is not required by their regulations.
E.G.: India, UK, Swiss, Russia, all have or will require their own labels.
Packaging size permitting would any countries have an issue with all these labels being on products together? Could these cause import issues into 3rd countries?
Thanks

------------------------------
John Gibbs
Mortsel
Belgium
------------------------------

Hi, 
Sorry for the delayed reply. 
From January 2022, Russia, Belarussia, Kazakhstan, Kyrgyzstan and Armenia will have common legislation on MD.
Legal documents on MD you may find here (those are only main directives, there are no standards and methodical recommedations here)
http://www.eurasiancommission.org/en/act/texnreg/deptexreg/LSMI/Pages/medical_devices.aspx
There is a site for EAEU (Eurasian Economic Union), but it is for ALL products (drugs, MD, cosmetics, chemical products etc. etc.). The site itself is not friendly; we rarely use it - mostly we use pdf and word documents that are distributed on local forums etc.
In particular you need this Directive:
Decision of the Council of the Eurasian Economic Commission No. 27 of February, 12, 2016 "On Approval of General Requirements for safety and efficacy of medical products, requirements for their marking and operational documentation on them"

However, I've realized that only main pages on this site are translated to other languages, but if you go to paricular documents there was only Russian text.( 

There are also local requirements for RUssia right now. They are stated in "Order 11n" by Russian MoH, but I don't have English version of it. Sometimes companies translate such documents themselves and send to their collegues in foreign office if required. However, lately I've noticed that my collegues preferred just trust our local expertise as legislation is too complicated and many things are not stated directly. So that's why  I don't have this Order translated at hand.(

------------------------------
Oksana Kolosova
Moscow
------------------------------

Original Message:
Sent: 21-Sep-2021 11:53
From: Anonymous Member
Subject: Are there countries that don't permit labelling meant for another country?

This message was posted by a user wishing to remain anonymous

Hi Oksana
Where could I find the specific Russian requirements on labelling?
Original Message:
Sent: 18-Sep-2021 17:51
From: Oksana Kolosova
Subject: Are there countries that don't permit labelling meant for another country?

You won't have an issue in Russia if you have EU label on a package. It is just that you would have to have an additional label with information specific for Russian market next to that label. There is A LOT of information that is required to be in Russian onl lables, so it is very unlikely that you would be able to squeeze it on a EU lable in addition to other information.) Right now  (for MD) companies print up labels down here and put it on a package. The situation might be tricky if it is difficult to put on an additional label on a primary package (e.g. when it impossible/very difficult to open secondary boxes and then packing them back). For imported drugs labeling is always done at manufacturing sites.
While applying for registration we  provide a photo of a device with its original label (one you have as a finished label with all information that is there) and a draft for  local Russian label  and confirm that this label  would be put in addition to original one.
In Ukraine you also may do it the same way. However, Ukraine requires less information to be in Ukranian, so sometimes manufacturers can manage to put it on their multiple labels.
Kazakhstan requires labels in Kazakh language as well (they also put local stickers). Belarussia accepts stickers in Russian.

------------------------------
Oksana Kolosova
Moscow

Original Message:
Sent: 16-Sep-2021 02:16
From: John Gibbs
Subject: Are there countries that don't permit labelling meant for another country?

Thanks for your feedback Richard, and you are correct, it is about country specific information on the label. And within EU I agree it won't be an issue though I had heard that France is critical of superfluous information on the package. Outside of EU I think it is one of those  where you won't know for sure until you actually ship it. The new India regulation on medical devices does require quite extensive specific information on the package and I have information that Ukraine, Russia, Morocco would have an issue with this.

------------------------------
John Gibbs
Mortsel
Belgium

Original Message:
Sent: 16-Sep-2021 01:19
From: Richard Vincins
Subject: Are there countries that don't permit labelling meant for another country?

Hello John,

I do not think those countries require their own labels, what they require is information specific to their regulations on the label.  This was in another thread concerning the In-Country Representative information needing to be contained on the product labelling, which now can be EU, UK, Swiss, etc.  Just because you have a UK RP on the label does not mean it needs to be a separate label which is sold only in UK and not anywhere else in Europe.  In fact, many regulatory agencies know content of labelling may have information related to many other regulatory jurisdictions, i.e. CE Mark on products sold in U.S.  The only points of needing separate labelling I am aware is when content is contradicting, e.g. the indications for use are different between say U.S. and EU, and the labelling has more political/import requirements, e.g. products made in a Middle East country not able to distribute in other countries.  Content of a label could certainly cause some importation issues into third countries, but you would have to look at each one - such as if the label contains a CE Mark, the importing company may require a copy of the Declaration of Conformity or even the CE Certificate.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 15-Sep-2021 09:54
From: John Gibbs
Subject: Are there countries that don't permit labelling meant for another country?

Related to a recently posted topic of label overload, does anyone know of countries that do not permit labelling that is not required by their regulations.
E.G.: India, UK, Swiss, Russia, all have or will require their own labels.
Packaging size permitting would any countries have an issue with all these labels being on products together? Could these cause import issues into 3rd countries?
Thanks

------------------------------
John Gibbs
Mortsel
Belgium
------------------------------

Hello,

For UK from June 2023 the MHRA mark becomes mandatory, while no you can bring products on the market under the CE marking (if registering in the UK)
Some sources are also indicating that from June 2023 onwards the CE logo could not be used on the label anymore

------------------------------
Franky Dubois
QA/RA Manager
Gent
Belgium
------------------------------

Original Message:
Sent: 15-Sep-2021 09:54
From: John Gibbs
Subject: Are there countries that don't permit labelling meant for another country?

Related to a recently posted topic of label overload, does anyone know of countries that do not permit labelling that is not required by their regulations.
E.G.: India, UK, Swiss, Russia, all have or will require their own labels.
Packaging size permitting would any countries have an issue with all these labels being on products together? Could these cause import issues into 3rd countries?
Thanks

------------------------------
John Gibbs
Mortsel
Belgium
------------------------------

Oksana, you make a really good point about some regulations.  There are some additional and/or specific information which needs to be included on labelling which sometimes prohibits or does not easily allow the "standard" label to include all of the information.  We have seen that in some local regulations where our Country Office or a distributor has to complete country configurations to ensure all local requirements are being met, including translations.

Franky, yes I heard that too about possibly not having the CE Mark on UK sold products as to not be misunderstood by the public.  This would really, really be short-sighted by UK MHRA as preventing this because would mean companies would have to create individual packaging/labelling configurations just for UK.  Companies will not sell in UK because UKCA, UKRP, separate labelling, etc., for a market <4% globally (and maybe dwindling) I think they are just fooling themselves.​​

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 17-Sep-2021 02:16
From: Franky Dubois
Subject: Are there countries that don't permit labelling meant for another country?

Hello,

For UK from June 2023 the MHRA mark becomes mandatory, while no you can bring products on the market under the CE marking (if registering in the UK)
Some sources are also indicating that from June 2023 onwards the CE logo could not be used on the label anymore

------------------------------
Franky Dubois
QA/RA Manager
Gent
Belgium

Original Message:
Sent: 15-Sep-2021 09:54
From: John Gibbs
Subject: Are there countries that don't permit labelling meant for another country?

Related to a recently posted topic of label overload, does anyone know of countries that do not permit labelling that is not required by their regulations.
E.G.: India, UK, Swiss, Russia, all have or will require their own labels.
Packaging size permitting would any countries have an issue with all these labels being on products together? Could these cause import issues into 3rd countries?
Thanks

------------------------------
John Gibbs
Mortsel
Belgium
------------------------------