Brokering medicines for export outside the EEA

The request was successful.

Dear Medicines and Healthcare products Regulatory Agency,

Having been reading rules and regulations on brokering medicinal products, I would like to know if a broker's licence is required if the broker is brokering between an EEA based wholesaler and third country based wholesaler - that is, acting on behalf of third country ( outside the EEA) based wholesalers wanting to buy products from the UK.

Are there any requirement to doing this type of brokering?

Yours faithfully,

Chris

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Enquirer,
 
Thank you for your enquiry to the Medicines and Healthcare products
Regulatory Agency. This automated response confirms that we have received
your email and that it will be dealt with as quickly as possible.
 
You can expect a reply from us within a few days for a straightforward
request, however where a more detailed response or contribution from a
specialist is required this is likely to take longer; we endeavour to
respond to all requests within the Department of Health’s target response
time of 18 working days.
 
Our website contains a wealth of information which may assist with your
enquiry. Some of our popular pages are:
 
Clinical trials of medicines and Clinical investigation for a medical
device:
 
[1]https://www.gov.uk/medicines-medical-dev...
       
Manufacturer’s and wholesale dealer’s licences:

[2]https://www.gov.uk/apply-for-manufacture...
 
Registration of medical devices, opticians and dental laboratories:

[3]https://www.gov.uk/register-as-a-manufac...
 
Reporting a problem with a medicine or medical device:

[4]https://www.gov.uk/report-problem-medici...
 
Deciding if your product is a medicine or a medical device:

[5]https://www.gov.uk/decide-if-your-produc...
 
Reporting a counterfeit medical product:
 
[6]https://yellowcard.mhra.gov.uk/counterfe...
 
We are continuously looking to make improvements to the service offered by
our Customer Services team, so if you have any feedback please don’t
hesitate to get in touch with us either on the number below or by
completing the form at the link below:
[7]https://www.surveymonkey.com/s/MHRACusto...
 
If you have not heard from us after 18 working days then please contact us
on 020 3080 6000.
 
 
Kind regards
 
The Customer Services Team
Communications division
Medicines and Healthcare products Regulatory Agency
 
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [8][MHRA request email]
 
Please note this is an automated reply; please do not respond to this
message.
 
 

show quoted sections

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Chris,

Thank you for your email which has been referred to our experts for consideration; we will respond to you as soon as possible.

The reference number for your enquiry is GCEP-00103984 please quote this number in any future correspondence on this matter.

Our maximum response time is 18 working days, but the vast majority of our enquiries are responded to before this time.

Kind Regards

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [MHRA request email]
Stay connected: mhra.gov.uk/stayconnected

show quoted sections

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Chris,
       
Thank you for your email.

Brokering medicines only going to a non EEA country does not require registration.

I hope you find this information useful.
       
Kind Regards,

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [MHRA request email]
Stay connected: mhra.gov.uk/stayconnected

We are continuously looking to make improvements to the service offered by our Customer Services team, so if you have any feedback please don’t hesitate to get in touch with us on the telephone number above or via the online survey at the link below:
https://www.surveymonkey.com/s/MHRACusto...

show quoted sections