Which ‘Controlled Drug’ is Sativex?

The request was successful.

Dear Medicines and Healthcare products Regulatory Agency,

I note that in an MHRA public assessment report labelled UK/H/2462/001/DC (but apparently undated) (http://www.mhra.gov.uk/home/groups/par/d... Sativex is recognised as a ‘Controlled Drug’, presume this use of ‘Controlled Drug’ means Sativex is a controlled drug within the meaning of the Misuse of Drugs Act 1971 (MDA), and ask to be informed as to which MDA-controlled drug it is

Is it cannabis?

Yours faithfully

Laurel Bush
www.spanglefish.com/laurelbush

MHRA Central Enquiry Point, Medicines and Healthcare products Regulatory Agency

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Laurel Bush left an annotation ()

Perhaps this request is more precise and less capable of misinterpretation than was that published at http://www.whatdotheyknow.com/request/sa...

See also ‘Is Sativex cannabis?’ at http://www.spanglefish.com/laurelbush/in...

MHRA Central Enquiry Point, Medicines and Healthcare products Regulatory Agency

Dear Laurel Bush,

Thank you for your recent enquiry to the MHRA.

Please could you confirm where in the Assessment report (page number) you have seen this statement.

Please contact us again if you need further assistance with this, or any other queries.


Kind Regards,

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency
Tel: 020 3080 6000

show quoted sections

Dear MHRA Central Enquiry Point,

See page 19, under 'Foreign travel with Sativex'

Yours sincerely,

Laurel Bush

MHRA Central Enquiry Point, Medicines and Healthcare products Regulatory Agency

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[1]http://www.mhra.gov.uk/Contactus/Central...

The MHRA website contains a wealth of information which may assist with
your enquiry. Some of our popular pages are:

Clinical Trials of medicines:
[2]http://www.mhra.gov.uk/Howweregulate/Med...
       
Clinical Trials of medical devices:

[3]http://www.mhra.gov.uk/Howweregulate/Dev...

Manufacturer’s and wholesale dealer’s licences:
[4]http://www.mhra.gov.uk/Howweregulate/Med...

Registration of medical devices, opticians and dental laboratories:
[5]http://www.mhra.gov.uk/Howweregulate/Dev...

Reporting a side effect to a medicine:
[6]http://www.mhra.gov.uk/Safetyinformation...

Reporting an adverse incident involving a medical device:

[7]http://www.mhra.gov.uk/Safetyinformation...

Does my product need a licence?:
[8]http://www.mhra.gov.uk/Howweregulate/Med...

Regulation of medical devices:

[9]http://www.mhra.gov.uk/Howweregulate/Dev...

If you have not heard from us after 20 working days then please contact us
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2. http://www.mhra.gov.uk/Howweregulate/Med...
3. http://www.mhra.gov.uk/Howweregulate/Dev...
4. http://www.mhra.gov.uk/Howweregulate/Med...
5. http://www.mhra.gov.uk/Howweregulate/Dev...
6. http://www.mhra.gov.uk/Safetyinformation...
7. http://www.mhra.gov.uk/Safetyinformation...
8. http://www.mhra.gov.uk/Howweregulate/Med...
9. http://www.mhra.gov.uk/Howweregulate/Dev...

MHRA Central Enquiry Point, Medicines and Healthcare products Regulatory Agency

Our Ref: FOI 12/079

Dear Ms Laura Bush,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 17th February.


I confirm that your request is being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.

If you need to contact us again about this request, please quote the reference number above.

Yours Sincerely

Central Enquiry Point
Information Services
MHRA
Tel: 020 3080 6000

show quoted sections

Laurel Bush left an annotation ()

This annotation is just to repeat a link from up the page; http://www.spanglefish.com/laurelbush/in... (to an ‘Is sativex cannabis?' article), and to ask: Are MHRA using delaying tactics?

Dear MHRA Central Enquiry Point,

Please spell my name correctly

Also, I am not actually a ‘Ms’

Try simple 'Laurel Bush'

G W Pharma Limited’s Sativex appears to set new standards in production and packaging of tincture of cannabis (cannabis constituents dissolved in ethanol)

If this is sums up what G W have done (and all literature I have found points in this direction – including MHRA-published literature) then Sativex is legally cannabis

Tincture of cannabis is not legally distinct from cannabis

Yours sincerely,

Laurel Bush

MHRA Central Enquiry Point, Medicines and Healthcare products Regulatory Agency

Dear Enquirer,

Thank you for your enquiry to the MHRA. This automated response confirms
that we have received your email and that it will be dealt with as quickly
as possible.

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time of 20 working days. Further information on how we handle different
requests can be found on our website at the link below:

[1]http://www.mhra.gov.uk/Contactus/Central...

The MHRA website contains a wealth of information which may assist with
your enquiry. Some of our popular pages are:

Clinical Trials of medicines:
[2]http://www.mhra.gov.uk/Howweregulate/Med...
       
Clinical Trials of medical devices:

[3]http://www.mhra.gov.uk/Howweregulate/Dev...

Manufacturer’s and wholesale dealer’s licences:
[4]http://www.mhra.gov.uk/Howweregulate/Med...

Registration of medical devices, opticians and dental laboratories:
[5]http://www.mhra.gov.uk/Howweregulate/Dev...

Reporting a side effect to a medicine:
[6]http://www.mhra.gov.uk/Safetyinformation...

Reporting an adverse incident involving a medical device:

[7]http://www.mhra.gov.uk/Safetyinformation...

Does my product need a licence?:
[8]http://www.mhra.gov.uk/Howweregulate/Med...

Regulation of medical devices:

[9]http://www.mhra.gov.uk/Howweregulate/Dev...

If you have not heard from us after 20 working days then please contact us
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Kind regards

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Information Services
Medicines and Healthcare products Regulatory Agency

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Communications via the GSi may be automatically logged, monitored and/or
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References

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2. http://www.mhra.gov.uk/Howweregulate/Med...
3. http://www.mhra.gov.uk/Howweregulate/Dev...
4. http://www.mhra.gov.uk/Howweregulate/Med...
5. http://www.mhra.gov.uk/Howweregulate/Dev...
6. http://www.mhra.gov.uk/Safetyinformation...
7. http://www.mhra.gov.uk/Safetyinformation...
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9. http://www.mhra.gov.uk/Howweregulate/Dev...

Laurel Bush left an annotation ()

Just a repeat of text and link from up page:

G W Pharma Limited’s Sativex appears to set new standards in
production and packaging of tincture of cannabis (cannabis
constituents dissolved in ethanol)

If this is sums up what G W have done (and all literature I have
found points in this direction – including MHRA-published
literature) then Sativex is legally cannabis

Tincture of cannabis is not legally distinct from cannabis

See also ‘Is Sativex cannabis?’ at http://www.spanglefish.com/laurelbush/in...

MHRA Central Enquiry Point, Medicines and Healthcare products Regulatory Agency

Dear Laurel Bush,

Thank you for your recent enquiry to the MHRA.

We apologise and have noted this. Please also note your enquiry is in hand with our experts in the Licensing division.

Please contact us again if you require further assistance.

Kind Regards

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency
Tel: 020 3080 6000

show quoted sections

Dear MHRA Central Enquiry Point,

See also 'Sativex: a new tincture of cannabis' at http://www.spanglefish.com/laurelbush/in...

Yours sincerely,

Laurel Bush

MHRA Central Enquiry Point, Medicines and Healthcare products Regulatory Agency

Dear Enquirer,

Thank you for your enquiry to the MHRA. 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 20 working days. Further information on how we handle different
requests can be found on our website at the link below:

[1]http://www.mhra.gov.uk/Contactus/Central...

The MHRA website contains a wealth of information which may assist with
your enquiry. Some of our popular pages are:

Clinical Trials of medicines:
[2]http://www.mhra.gov.uk/Howweregulate/Med...
       
Clinical Trials of medical devices:

[3]http://www.mhra.gov.uk/Howweregulate/Dev...

Manufacturer’s and wholesale dealer’s licences:
[4]http://www.mhra.gov.uk/Howweregulate/Med...

Registration of medical devices, opticians and dental laboratories:
[5]http://www.mhra.gov.uk/Howweregulate/Dev...

Reporting a side effect to a medicine:
[6]http://www.mhra.gov.uk/Safetyinformation...

Reporting an adverse incident involving a medical device:

[7]http://www.mhra.gov.uk/Safetyinformation...

Does my product need a licence?:
[8]http://www.mhra.gov.uk/Howweregulate/Med...

Regulation of medical devices:

[9]http://www.mhra.gov.uk/Howweregulate/Dev...

If you have not heard from us after 20 working days then please contact us
on 020 3080 6000.

Kind regards

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency

Please note this is an automated reply; please do not respond to this
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2. http://www.mhra.gov.uk/Howweregulate/Med...
3. http://www.mhra.gov.uk/Howweregulate/Dev...
4. http://www.mhra.gov.uk/Howweregulate/Med...
5. http://www.mhra.gov.uk/Howweregulate/Dev...
6. http://www.mhra.gov.uk/Safetyinformation...
7. http://www.mhra.gov.uk/Safetyinformation...
8. http://www.mhra.gov.uk/Howweregulate/Med...
9. http://www.mhra.gov.uk/Howweregulate/Dev...

Laurel Bush left an annotation ()

Repeat of up-page link, to ‘Sativex: a new tincture of cannabis’ at http://www.spanglefish.com/laurelbush/in...

FOILicensing, Medicines and Healthcare products Regulatory Agency

1 Attachment

Dear Laurel Bush
 
Please find enclosed the final response for the above FOI request.
 
Best regards
 
The FOI Licensing Team.
 
 

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Communications via the GSi may be automatically logged, monitored and/or
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Dear FOILicensing,

I thank you for your lengthy response, 15 March, but note I am unable to find in it the information sought by my FOI request ‘Which ‘Controlled Drug’ is Sativex?’, worded thus: I note that in an MHRA public assessment report labelled UK/H/2462/001/DC (but apparently undated)
(http://www.mhra.gov.uk/home/groups/par/d... Sativex is recognised as a ‘Controlled Drug’, presume this use of ‘Controlled Drug’ means Sativex is a controlled drug within the meaning of the Misuse of Drugs Act 1971 (MDA), and ask to be informed as to which MDA-controlled drug it is

Please clarify re your response

If your response means that the MHRA does not hold the information I have requested then please say so

Yours sincerely,

Laurel Bush

Laurel Bush left an annotation ()

See also 'Sativex is not cannabis, says medicines agency' at http://www.spanglefish.com/laurelbush/in...

FOILicensing, Medicines and Healthcare products Regulatory Agency

Dear Laurel Bush

Many thanks for your email. Regarding your specific question concerning which controlled drug Sativex is, the MHRA is a government agency that assesses and licenses new medicinal products. It is not involved in the designation of controlled drugs.

The active constituents in Sativex are extracts from Cannabis sativa L, which have been found to to be safe and efficacious for use as an add-on treatment in patients with moderate to severe spasticity due to multiple sclerosis, who have not responded adequately to other anti-spasticity medication. Any designation of Sativex or the constituents of Sativex as controlled substances would be the responsibility of the Home Office, and as such the MHRA cannot comment further on this. We recommend you contact the Home Office for any questions concerning the designation of controlled substances, including Sativex.

Best regards

The FOI Licensing Team.

show quoted sections

Laurel Bush left an annotation ()

See also ‘Sativex is 25:27 cannabis (CBD:THC)’ at
http://www.spanglefish.com/laurelbush/in...

FOILicensing, Medicines and Healthcare products Regulatory Agency

1 Attachment

Dear Laurel Bush
 
Please find enclosed the final response concerning the above FOI request.
 
Best regards

The FOI Licensing Team.
 
 

This email and any files transmitted with it are confidential. If you are
not the intended recipient, any reading, printing, storage, disclosure,
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Communications via the GSi may be automatically logged, monitored and/or
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Dear Medicines and Healthcare products Regulatory Agency

Please pass this on to the person who conducts Freedom of Information reviews

I am writing to request an internal review of Medicines and Healthcare products Regulatory Agency's handling of my FOI request 'Which ‘Controlled Drug’ is Sativex?'

Responses to date to my FOI request ‘Which ‘Controlled Drug’ is Sativex?’, dating from 16 February 2012, seem to amount to information not actually sought by the request or refusal to supply information which is not actually sought by the request

My request read as follows:

“I note that in an MHRA public assessment report labelled UK/H/2462/001/DC (but apparently undated)
(http://www.mhra.gov.uk/home/groups/par/d...
Sativex is recognised as a ‘Controlled Drug’, presume this use of ‘Controlled Drug’ means Sativex is a controlled drug within the meaning of the Misuse of Drugs Act 1971 (MDA), and ask to be informed as to which MDA-controlled drug it is

“Is it cannabis?”

I am not seeing in the responses any identification of Sativex as a controlled drug under the MDA, any clear statement that the MHRA does not hold this information, or any clear refusal to supply this information

A full history of my FOI request and all correspondence is available on the Internet at this address:
http://www.whatdotheyknow.com/request/wh...

Yours faithfully,

Laurel Bush

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Dear Enquirer,

Thank you for your enquiry to the MHRA. 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
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[1]http://www.mhra.gov.uk/Contactus/Central...

The MHRA website contains a wealth of information which may assist with
your enquiry. Some of our popular pages are:

Clinical Trials of medicines:
[2]http://www.mhra.gov.uk/Howweregulate/Med...
       
Clinical Trials of medical devices:

[3]http://www.mhra.gov.uk/Howweregulate/Dev...

Manufacturer’s and wholesale dealer’s licences:
[4]http://www.mhra.gov.uk/Howweregulate/Med...

Registration of medical devices, opticians and dental laboratories:
[5]http://www.mhra.gov.uk/Howweregulate/Dev...

Reporting a side effect to a medicine:
[6]http://www.mhra.gov.uk/Safetyinformation...

Reporting an adverse incident involving a medical device:

[7]http://www.mhra.gov.uk/Safetyinformation...

Does my product need a licence?:
[8]http://www.mhra.gov.uk/Howweregulate/Med...

Reporting a counterfeit medical product:

[9]http://www.mhra.gov.uk/Safetyinformation...

Buying medicines over the internet:

[10]http://www.mhra.gov.uk/Safetyinformation...

If you have not heard from us after 20 working days then please contact us
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*** Please note that the MHRA will be closed on Friday 1 June, Monday 4
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External Relations
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Communications via the GSi may be automatically logged, monitored and/or
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References

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1. http://www.mhra.gov.uk/Contactus/Central...
2. http://www.mhra.gov.uk/Howweregulate/Med...
3. http://www.mhra.gov.uk/Howweregulate/Dev...
4. http://www.mhra.gov.uk/Howweregulate/Med...
5. http://www.mhra.gov.uk/Howweregulate/Dev...
6. http://www.mhra.gov.uk/Safetyinformation...
7. http://www.mhra.gov.uk/Safetyinformation...
8. http://www.mhra.gov.uk/Howweregulate/Med...
9. http://www.mhra.gov.uk/Safetyinformation...
10. http://www.mhra.gov.uk/Safetyinformation...

Dear MHRA Customer Services

This FOI request is hereby withdrawn

Please see ‘Internet phobia’ at
http://www.spanglefish.com/laurelbush/in...

Yours sincerely

Laurel Bush

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Dear Enquirer,
 
Thank you for your enquiry to the MHRA. 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
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respond to all requests within the Department of Health’s target response
time of 20 working days. Further information on how we handle different
requests can be found on our website at the link below:
 
[1]http://www.mhra.gov.uk/Contactus/Central...
 
The MHRA website contains a wealth of information which may assist with
your enquiry. Some of our popular pages are:
 
Clinical Trials of medicines:
 
[2]http://www.mhra.gov.uk/Howweregulate/Med...
       
Clinical Trials of medical devices:
 
[3]http://www.mhra.gov.uk/Howweregulate/Dev...
 
Manufacturer’s and wholesale dealer’s licences:

[4]http://www.mhra.gov.uk/Howweregulate/Med...
 
Registration of medical devices, opticians and dental laboratories:

[5]http://www.mhra.gov.uk/Howweregulate/Dev...
 
Reporting a side effect to a medicine:

[6]http://www.mhra.gov.uk/Safetyinformation...
 
Reporting an adverse incident involving a medical device:
 
[7]http://www.mhra.gov.uk/Safetyinformation...
 
Does my product need a licence?:

[8]http://www.mhra.gov.uk/Howweregulate/Med...
 
Reporting a counterfeit medical product:
 
[9]http://www.mhra.gov.uk/Safetyinformation...
 
Buying medicines over the internet:
 
[10]http://www.mhra.gov.uk/Safetyinformation...
 
 
If you have not heard from us after 20 working days then please contact us
on 020 3080 6000.
 
Kind regards
 
Customer Services
External Relations
Medicines and Healthcare products Regulatory Agency
 
Please note this is an automated reply; please do not respond to this
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This email and any files transmitted with it are confidential. If you are
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show quoted sections

Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

References

Visible links
1. http://www.mhra.gov.uk/Contactus/Central...
2. http://www.mhra.gov.uk/Howweregulate/Med...
3. http://www.mhra.gov.uk/Howweregulate/Dev...
4. http://www.mhra.gov.uk/Howweregulate/Med...
5. http://www.mhra.gov.uk/Howweregulate/Dev...
6. http://www.mhra.gov.uk/Safetyinformation...
7. http://www.mhra.gov.uk/Safetyinformation...
8. http://www.mhra.gov.uk/Howweregulate/Med...
9. http://www.mhra.gov.uk/Safetyinformation...
10. http://www.mhra.gov.uk/Safetyinformation...

Wesley Hayden left an annotation ()

So using there answer as a guideline, this is no different than someone covering up there can of Kestral Super on the highstreet with a brown paper bag?

ACT 1 Scene 1
It tastes like Kessy super, after a few swigs it "feels" like Kessy super, but there is no immediate visual indication of what it actually is, as hiding it conforms to the ACT!

The Script writer, the ACTor and choreographer, between them all rely on the paperbag!

Wesley Hayden left an annotation ()

Dr Geoffrey Guy
“Most people in our industry said it was impossible to turn cannabis into a prescription medicine.
We had to rewrite the rule book. We have the first approval of a plant extract drug in modern history.
It has 420 molecules, whereas every other drug has just one.” Source

Sativex is whole plant cannabis oil. It contains all the cannabinoids, terpenes, flavonoids and other compounds present in the plants from which it is made. However, the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a marketing authorisation on an inaccurate and knowingly dishonest basis. It regulates Sativex as as a two molecule medicine: THC and CBD with added propylene glycol and peppermint oil. It acknowledges that there are also “unspecified impurities”.

Consequently, the classification of Sativex in schedule 4 of the Misuse of Drugs Regulations 2001, is also inaccurate and dishonest.

Sativex is pharmacologically identical to any illicit cannabis oil with a 1:1 ratio of THC:CBD which is classified in schedule 1 as “of no medicinal value”

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