This is a question to gain some understanding of what issues apply. I 
would like to understand how existing companies operate and what would 
stop another company doing similarly. Please take 'my company' as 
fictitious.

I want my company to import a medicine.

The medicine itself is not normally available in the UK. If it were 
available, it would be a prescription-only product.

In another country (non-EU, in case that matters) the product is readily 
available but is regarded as prescription-only there as well. It is 
fully tested and accepted in that country.

My company would import the medicine from the manufacturer or a 
distributor in the other country. We would then make it available to 
pharmacies only.

What English legal issues would I need to address?

Please ignore all issues about obtaining supplies and regulation abroad.

(Note: There is no question of doing anything on the basis of replies. 
This is purely theoretical and, if it were to change from that, suitable 
lwayer(s) would be consulted.)

-- 
Rod

On Sat, 13 Sep 2008 12:25:05 +0100, Rod  wrote:

> I want my company to import a medicine.

> What English legal issues would I need to address?

If you import the medicines from other countries within the European
Economic Area you must have a wholesale dealer's licence.  If you import
the medicines from outside the EEA you must also have a wholesale dealer's
import licence.  These licences are issued by the Licensing Section of the
Inspection and Standards Division of the Medicines and Healthcare products
Regulatory Agency (MHRA), an agency within the Department of Health.

Tony

Anthony R. Gold wrote:
> On Sat, 13 Sep 2008 12:25:05 +0100, Rod  wrote:
> 
>> I want my company to import a medicine.
> 
>> What English legal issues would I need to address?
> 
> If you import the medicines from other countries within the European
> Economic Area you must have a wholesale dealer's licence.  If you import
> the medicines from outside the EEA you must also have a wholesale dealer's
> import licence.  These licences are issued by the Licensing Section of the
> Inspection and Standards Division of the Medicines and Healthcare products
> Regulatory Agency (MHRA), an agency within the Department of Health.
> 

Thnak you - that has put me right on track. Not sure now what I terms I 
had used to search MHRA but I either got nothing relevant or too much to 
wade through.

-- 
Rod

Hypothyroidism is a seriously debilitating condition with an insidious 
onset.
Although common it frequently goes undiagnosed.
<www.thyromind.info> <www.thyroiduk.org> <www.altsupportthyroid.org>

Rod wrote:
> Anthony R. Gold wrote:
>> On Sat, 13 Sep 2008 12:25:05 +0100, Rod 
>> wrote:
>>> I want my company to import a medicine.
>>
>>> What English legal issues would I need to address?
>>
>> If you import the medicines from other countries within the European
>> Economic Area you must have a wholesale dealer's licence.  If you
>> import the medicines from outside the EEA you must also have a
>> wholesale dealer's import licence.  These licences are issued by the
>> Licensing Section of the Inspection and Standards Division of the
>> Medicines and Healthcare products Regulatory Agency (MHRA), an
>> agency within the Department of Health.
>
> Thnak you - that has put me right on track. Not sure now what I terms
> I had used to search MHRA but I either got nothing relevant or too
> much to wade through.

You also need to ensure that the product is actually licensed by MHRA to be 
sold in the UK.  After all, if you're in the business of selling potentially 
dangerous products, you and it need to be properly regulated.  It is not a 
field for the amateur which, I'm afraid to say, you seem to be in this area. 
And you shouldn't be taking advice on such a matter from a newsgroup.

Norman Wells wrote:
> Rod wrote:
>> Anthony R. Gold wrote:
>>> On Sat, 13 Sep 2008 12:25:05 +0100, Rod 
>>> wrote:
>>>> I want my company to import a medicine.
>>>
>>>> What English legal issues would I need to address?
>>>
>>> If you import the medicines from other countries within the European
>>> Economic Area you must have a wholesale dealer's licence.  If you
>>> import the medicines from outside the EEA you must also have a
>>> wholesale dealer's import licence.  These licences are issued by the
>>> Licensing Section of the Inspection and Standards Division of the
>>> Medicines and Healthcare products Regulatory Agency (MHRA), an
>>> agency within the Department of Health.
>>
>> Thnak you - that has put me right on track. Not sure now what I terms
>> I had used to search MHRA but I either got nothing relevant or too
>> much to wade through.
> 
> You also need to ensure that the product is actually licensed by MHRA to 
> be sold in the UK.  After all, if you're in the business of selling 
> potentially dangerous products, you and it need to be properly 
> regulated.  It is not a field for the amateur which, I'm afraid to say, 
> you seem to be in this area. And you shouldn't be taking advice on such 
> a matter from a newsgroup.
> 
> 
> 
Norman,

Thank you for your response.

I don't understand why the product has to be licensed in this country. I 
know the products I am thinking about are not licensed. They would have 
to be supplied under the rules regarding unlicensed medicines (e.g. 
named patient basis). One related product is already supplied on that 
basis - in some cases even on a standard NHS prescription.

I thought I had made it crystal clear by these statements:

"I would like to understand how existing companies operate and what 
would stop another company doing similarly. Please take 'my company' as 
fictitious."

and

"(Note: There is no question of doing anything on the basis of replies. 
This is purely theoretical and, if it were to change from that, suitable 
lawyer(s) would be consulted.) "

that I am at present merely trying to understand the legalities. My 
primary interest is not in setting up my own company to do so but in 
understanding how another company could do so - one with which I have 
absolutely no relationship or contact. Therefore I have no funds to pay 
a lawyer for proper advice.

Only if I found it unexpectedly straightforward would I ever consider 
anything further - and that would be very unlikely to be setting up a 
company to do this. Far more likely to be to discuss something with an 
existing importer/distribution company.

-- 
Rod

On Sat, 13 Sep 2008 23:20:05 +0100, "Anthony R. Gold"
 wrote:

>On Sat, 13 Sep 2008 12:25:05 +0100, Rod  wrote:
>
>> I want my company to import a medicine.
>
>> What English legal issues would I need to address?
>
>If you import the medicines from other countries within the European
>Economic Area you must have a wholesale dealer's licence.  If you import
>the medicines from outside the EEA you must also have a wholesale dealer's
>import licence.  These licences are issued by the Licensing Section of the
>Inspection and Standards Division of the Medicines and Healthcare products
>Regulatory Agency (MHRA), an agency within the Department of Health.
>

If on the other hand what you call a "Medicine" could be described
differently it would be different.

Stranger things have happened.

Derek

Rod wrote:
> Norman Wells wrote:
>> Rod wrote:
>>>> On Sat, 13 Sep 2008 12:25:05 +0100, Rod 
>>>> wrote:

>>>>> I want my company to import a medicine.

>> You also need to ensure that the product is actually licensed by
>> MHRA to be sold in the UK.  After all, if you're in the business of
>> selling potentially dangerous products, you and it need to be
>> properly regulated.  It is not a field for the amateur which, I'm
>> afraid to say, you seem to be in this area. And you shouldn't be
>> taking advice on such a matter from a newsgroup.
>>
> Norman,
>
> Thank you for your response.
>
> I don't understand why the product has to be licensed in this
> country. I know the products I am thinking about are not licensed.
> They would have to be supplied under the rules regarding unlicensed
> medicines (e.g. named patient basis). One related product is already
> supplied on that basis - in some cases even on a standard NHS
> prescription.

You need to comply with the Medicines Act 1968, which requires all medicines 
sold here to be appropriately licensed, or exempted.  It is too dangerous an 
area for just a free-for-all, source it anywhere, sell it here approach as 
it might be with other goods.

Derek Geldard wrote:
> On Sat, 13 Sep 2008 23:20:05 +0100, "Anthony R. Gold"
>  wrote:
> 
>> On Sat, 13 Sep 2008 12:25:05 +0100, Rod  wrote:
>>
>>> I want my company to import a medicine.
>>> What English legal issues would I need to address?
>> If you import the medicines from other countries within the European
>> Economic Area you must have a wholesale dealer's licence.  If you import
>> the medicines from outside the EEA you must also have a wholesale dealer's
>> import licence.  These licences are issued by the Licensing Section of the
>> Inspection and Standards Division of the Medicines and Healthcare products
>> Regulatory Agency (MHRA), an agency within the Department of Health.
>>
> 
> If on the other hand what you call a "Medicine" could be described
> differently it would be different.
> 
> Stranger things have happened.
> 

I am well aware of this. :-) In fact, similar products to the ones I am 
interested in are exactly the same - but with the officially-known-about 
'medicine' element(s) removed. They therefore qualify as supplements (or 
whatever precise term according to jurisdiction). But some people 
believe that it is largely the other components that are so important!

-- 
Rod

Hypothyroidism is a seriously debilitating condition with an insidious 
onset.
Although common it frequently goes undiagnosed.
<www.thyromind.info> <www.thyroiduk.org> <www.altsupportthyroid.org>

"Rod"  wrote in message 
news:6j1m68F11qg3U1@mid.individual.net...
> This is a question to gain some understanding of what issues apply. I 
> would like to understand how existing companies operate and what would 
> stop another company doing similarly. Please take 'my company' as 
> fictitious.
>
> I want my company to import a medicine.
If it is a perscription only medicine, who do you think will write the 
script?

mert1639 wrote:
> "Rod"  wrote in message 
> news:6j1m68F11qg3U1@mid.individual.net...
>> This is a question to gain some understanding of what issues apply. I 
>> would like to understand how existing companies operate and what would 
>> stop another company doing similarly. Please take 'my company' as 
>> fictitious.
>>
>> I want my company to import a medicine.
> If it is a perscription only medicine, who do you think will write the 
> script? 
> 
> 
> 
Doctors. As they already do for another, similar product with the same 
status.

-- 
Rod

"Rod"  wrote in message 
news:6j83htF1v5ckU1@mid.individual.net...
> mert1639 wrote:
>> "Rod"  wrote in message 
>> news:6j1m68F11qg3U1@mid.individual.net...
>>> This is a question to gain some understanding of what issues apply. I 
>>> would like to understand how existing companies operate and what would 
>>> stop another company doing similarly. Please take 'my company' as 
>>> fictitious.
>>>
>>> I want my company to import a medicine.
>> If it is a perscription only medicine, who do you think will write the 
>> script?
> Doctors. As they already do for another, similar product with the same 
> status.
>
I bet they won't.
Doctors are very unwilling to perscribe non-fomularly products.  I don't 
think your planning to get your item in the BNF are you? Few doctors would 
be willing to take the risk.

mert1639 wrote:
> "Rod"  wrote in message 
> news:6j83htF1v5ckU1@mid.individual.net...
>> mert1639 wrote:
>>> "Rod"  wrote in message 
>>> news:6j1m68F11qg3U1@mid.individual.net...
>>>> This is a question to gain some understanding of what issues apply. I 
>>>> would like to understand how existing companies operate and what would 
>>>> stop another company doing similarly. Please take 'my company' as 
>>>> fictitious.
>>>>
>>>> I want my company to import a medicine.
>>> If it is a perscription only medicine, who do you think will write the 
>>> script?
>> Doctors. As they already do for another, similar product with the same 
>> status.
>>
> I bet they won't.
> Doctors are very unwilling to perscribe non-fomularly products.  I don't 
> think your planning to get your item in the BNF are you? Few doctors would 
> be willing to take the risk. 
> 
Agreed, doctors are, in general, unwilling to prescribe such products.

There were of the order of 1300 NHS prescriptions last year for the 
existing, related products in England. (That was from DoH statistics 
that would not include some prescriptions for various reasons.) There 
were almost certainly many more non-NHS prescriptions.

The existing product has already got its own 'virtual' BNF entry in DoH 
statistics and is recognised by many GP computer systems.

-- 
Rod