Countries where you should (absolutely?) avoid appointing a distributor ...

[supadrai]

... as your regulatory liaison (for lack of a better general term).

So far, I'm finding the below:

1. Brazil (Brasilian Holder of Registration)
2. Saudi Arabia (Authorized Representative)
3. Costa Rica
4. U.S.A. (U.S. Agent, but multiple initial importers)
5. Canada (Regulatory Correspondent)

Places where multiple regulatory liaisons are not a problem:

1. Japan (multiple Marketing Authorization Holders)
2. Australia (multiple sponsors)
3. E.U. (multiple legal manufacturers)

But this is not easy to figure out alone ...

Any thoughts?

Thanks!

 

[Mark Meer]

Curious: what is your basis for this? Personal experience, or are there other data/sources you are referencing?

Unless regulations prohibit otherwise, I would think this would be case-by-case, and difficult to make any sweeping (thread title: "absolutely") generalisations.

There are certainly advantages to maintaining distributor-representative independence, but these usually come at a significant financial cost. If your distributor has all the qualifications, is trustworthy, and otherwise meets your needs, I don't see any reason to rule out such relationships strictly by country they are from...

 

[supadrai]

Your uncharitable strawmanning of my position aside ...

We manufacture medical gloves on an own-brand and private-label basis. Which means we need to have more than one distributor in just about every country (85 at last count). Some countries, such as Saudi Arabia and Brazil, from my understanding, only allow a single representative. In those countries, if your representative is a distributor - unsurprisingly - they don't tend to support other distributors coming into competition with them as they have a de facto exclusive distribution arrangement based upon the regulatory regime. In these countries it absolutely (no question mark) does make sense to "rule out such relationships strictly by what country they are from".

Other countries may not have a legal prohibition on more than one representative but there could be practical barriers. This is what I'm hoping to suss out and would hope for constructive replies.

So maybe this only affects we lowly Class I manufacturers who survive on volume due to poor margins for our commodity-like products.

 

[Miner]

Your uncharitable strawmanning of my position aside ...
...and would hope for constructive replies.

So maybe this only affects we lowly Class I manufacturers who survive on volume due to poor margins for our commodity-like products.

No need for sarcasm. Mark asked a very reasonable question asking for clarification. There was nothing uncharitable about it, nor did it reduce your question to a strawman. Your original post was vague and did not offer much detail.

 

[pkost]

I'm inclined to agree with Mark, there is no one size fits all situation here, what may be bad for you could be good for another and vice versa

For clarity, you mention the EU as good, however the scenario you present is where your distributor is a manufacturer, in situations where they do not want to be a manufacturer you will need an EC-rep and you can only have one EC-per product, it can therefore be problematic if you use a distributor.

 

[pkost]

So maybe this only affects we lowly Class I manufacturers who survive on volume due to poor margins for our commodity-like products.

In the EU it's worth noting the gloves (depending on the claims) can also be simultaneously classified as Class III PPE.

 

[Access2hc]

license holding decisions are a function of
1. geography - size of country, distribution
2. specificity of the market segment (general or a niche product)
3. volume and cost of product

there are certain situations where having an exclusive distributor would be helpful
there are also situations where you can start with an exclusive then gravitate to a license holder that manages your sub-distributors
there are situations where you would find a license holder right away

in all cases with distributors, in the agreement, there has to be a get-out clause to allow the license to be transferred out to another distributor or license holder. same applies for license holder

this is what we advise folks on license holding, as this is a big deal in Asia Pacific.

Cheers,
Ee Bin
Access2hc