Importing Medicinal Products for re-export

The request was successful.

Dear Medicines and Healthcare products Regulatory Agency,

Please advise if a UK based freight forwarding company can import medicinal products from a supplier in a country outside EEA and re-export to a buyer in another country outside EEA . The freight forwarding company would be acting on instructions received from either supplier or the buyer. Please confirm that the freight forwarding company can rely on exemption from requirement of wholesale dealers licence under section 19 4(a) of Human Medicines Regulation 2012.

Yours faithfully,
S. Patel

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 requests within the Department of Health’s target response time
of 18 working days, or 20 working days if your request is a Freedom of
Information request.
 
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
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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.
 
 

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Mr Patel,

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-00106371 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

Ronke Omotayo (Mrs)
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

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear S Patel,
       
Thank you for your email.

Whether the site will be exempt from holding a wholesale dealer's licence in accordance with Regulation 19(4)(a) will depend on the activities being carried out.

The EU GDP Guidelines define wholesale distribution as;

“…all activities consisting of procuring, holding, supplying or exporting medicinal products…” The annexed Glossary of Terms defines holding as “storing medicinal products”.

Medicinal products should therefore only be stored on premises that are covered by a wholesale dealer’s licence.

However, there are certain cases where medicinal products are held for short periods of time during transportation and prior to onward shipment e.g. in the transportation vehicle at motorway service stations or in overnight freight depots.

In such instances it has been determined that, as a matter of policy, a site does not have to be named on a licence where ambient products are stored for less than 36 hours.

Sites holding ambient products in excess of 36 hours must be licensed. This policy applies only where ownership of the products has not been transferred to the person carrying out the storage activities. Where ownership has been transferred, this is supply and as such the receiving site must be licensed.

It is also important to note that, where wholesaling activities other than storage are being carried out, the site should be named on the relevant licence. This includes the handling of returned goods and where decisions are made regarding suitability for resale, as well as the usual activities of picking against orders.

Sites where refrigerated products are held, even when this is for less than 36 hours, must be licensed.

The exception will be where these products are transported and stored overnight in continuously refrigerated vehicles.

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...

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Dear MHRA Customer Services,
Enquiry ref GCEP-oo106371 13th October 2015

Dear Sir/Madam

Thank you for your reply of 18 Sept 2015.

Your reply whilst giving some relevant information, did not answer fully the activity I have enquired of.

Based on your reply, it appears that under regulation 19 (4)a a person such as a Shipping & Forwarding Agent can import medicinal product and re-export outside EEA, provided there is no unjustifiable storage period of time. In this circumstance, the person will be exempted from the requirement of holding WDL

Please confirm if above view is correct.

There is the question of storage period. By way of example of storage during transportation on motorway,
you are informing that storage period of time must not exceed 36 hours. However, the logistics of import-export activity, which includes custom clearance for incoming and outgoing goods, involves a number storage and transit locations. It is impossible to maintain storage at these transit locations to the limit of 36 hours

Please advise what is the situation if storage period inadvertently exceeds 36hours. Will this be deemed illegal? It will be helpful to know what are the current MHRA guidelines given to UK WDL holders who are exporting and importing medicinal products, particularly on the question of storage limit of 36hours.

Kind regards
S.Patel

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 requests within the Department of Health’s target response time
of 18 working days, or 20 working days if your request is a Freedom of
Information request.
 
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.
 
 

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear S Patel,

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-00107188 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

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Subhash Patel,

We apologise that you have not yet received a response.

Please accept this email as confirmation that we are chasing this matter up for you and we will respond as soon as possible.

Kind Regards,

Peter Onen (Mr)
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

Your views matter. Tell us what you think of the service you have received from us by following the link below:
https://www.surveymonkey.com/s/MHRACusto...

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear S Patel,

Thank you for your email.

Our Inspection, Enforcement and Standards division experts advise 'Yes' your understanding of the first point is correct.

The exemption under 19(4)(a) is becoming increasingly redundant as more freight forwarders/logistics providers are asked to store cold-chain medicines or store ambient temperature medicines for more than 36 hours. With regards to the 36 hours storage limit, the MHRA advises that where there is a chance that the limit will be exceeded, it would be prudent for the site to apply for a WDL.

Kind Regards

Peter Onen (Mr)
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

Your views matter. Tell us what you think of the service you have received from us by following the link below:
https://www.surveymonkey.com/s/MHRACusto...

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