Country of Origin or Made In Tags - Where a country is a principality

[fialor]

Here is a fun dilemma for all:

Where a country is a principality, like Monaco is of France, does one reference France as the country in the "Made In" tag on the product, or does one reference Monaco itself?

Fialor

 

[RoxaneB]

Re: Country of Origin or Made In Tags

Fialor, does this question pertain to medical devices made in Monaco or is this more of a general water cooler question?

 

[shimonv]

Re: Country of Origin or Made In Tags

I say the country of origin needs to be consistent with the address of the manufacturer. In the case on Monaco there shouldn't be a problem commercializing the product in the EU after approval, but if you intend to reach out to LATAM and Asian countries - the country of manufacturing must consistent throughout your product labeling, ISO certificate, CE certificate, Quality agreements, etc. In short - don't be smart; be precise.

 

[fialor]

Re: Country of Origin or Made In Tags

Thanks Shimony.
There is an added complication in that the manufacturer's address is different to the place of manufacture.
Diana

 

[RoxaneB]

Re: Country of Origin or Made In Tags

If the manufacturer's address (Company 1) is different than the place of manufacture (Company 2), then isn't the product made in the place by Company 2 and distributed by the address of Company 1?

 

[fialor]

Re: Country of Origin or Made In Tags

Thanks Roxane.
No - Company A physically makes the device but Company B is the legal manufacturer (not distributor). Company A is in Monaco but Company B is elsewhere (not in Monaco ).

 

[shimonv]

Re: Country of Origin or Made In Tags

I see.. then use the address of the legal manufacturer (the person placing the device on the market) as your primary contact point and country of origin.

 

[fialor]

Re: Country of Origin or Made In Tags

I see.. then use the address of the legal manufacturer (the person placing the device on the market) as your primary contact point and country of origin.

Thanks for the reply Shimony.
But I think we went off topic for minute
My question was whether I can reference made in as France though product is made in Monaco which is a principality of France.

 

[Pads38]

Re: Country of Origin or Made In Tags

The country in which your device is 'made' is the country in which the legal manufacturer exists.

That it is 'bolted together' in Monaco is not relevant.

 

[RoxaneB]

Re: Country of Origin or Made In Tags

From the European Commission Health and Consumers Directorate-General for Health Systems and Products, and Medicinal Products :

VOLUME 2A
Procedures for marketing authorisation
CHAPTER 1
MARKETING AUTHORISATION
June 2013

Monaco

An agreement between the Union and the Principality of Monaco entered into force on 1 May 2004, Council Decision 2003/885/EC of 17 November 2003 concerning the conclusion of the Agreement on the application of certain Community acts on the territory of the Principality of Monaco7. On the basis of this agreement and the special arrangements agreed between France and the Principality of Monaco in an agreement of 6 January 2003, the French authorities assume the role of competent authorities as far as the application of the medicinal products legislation to products manufactured in Monaco is concerned. The French authorities are responsible for the issue of
marketing authorisations for Monaco and conduct inspections on manufacturing sites of medicinal products in Monaco. Batches from Monaco have to be considered as batches which have already undergone controls in a Member State and are therefore exempted from further controls and retesting. The batches may be regarded as released in France, though the place of manufacturing sites is in Monaco.

The bolded text has been bolded by me. Granted this particular document appears to focus on medicinal products, not sure if that applies to medical devices.