Sativex ingredients part 2

A. Clerk (Account suspended) made this Freedom of Information request to Medicines and Healthcare products Regulatory Agency

This request has been closed to new correspondence from the public body. Contact us if you think it ought be re-opened.

The request was partially successful.

A. Clerk (Account suspended)

Dear Medicines and Healthcare products Regulatory Agency,

Thank you for your recent response where you stated...
"As stated in the PAR and the Summary of Product Characteristics (SmPC), Sativex contains two
extracts from the leaves and flowers of the plant Cannabis sativa L., standardised to contain two main
cannabinoids, tetrahydrocannabinol (THC) and cannabidiol (CBD). "

This is in direct contradiction of what the government believes to be true that "Cannabis has no medical value".
How can this be true?
Yours faithfully,

A. Clerk

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.
 
 

show quoted sections

A. Clerk (Account suspended)

Dear MHRA Customer Services,

You are late with your response... Please respond immediately!

Yours sincerely,

A. Clerk

A. Clerk (Account suspended)

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 'Sativex ingredients part 2'.

You chose to ignore my request and are breaking the law. Please respond immediately.

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

Yours faithfully,

A. Clerk

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.
 
 

show quoted sections

FOI_Policy, Medicines and Healthcare products Regulatory Agency

2 Attachments

Dear Mr Clerk

Please find attached the reply to your FOI request, which was sent to you on 29th July.

Please let us know if you would like us to proceed with the internal review.

Yours sincerely,

FOI Policy Team

show quoted sections

A. Clerk (Account suspended)

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 'Sativex ingredients part 2'.

I acquired The statement below from a qualified pharmacist...

"Other than the addition of ethanol, peppermint oil and propylene glycol, Sativex is pharmacologically identical to the plants from which it is made. "

" The proposal to distinguish Sativex from cannabis is fundamentally dishonest."

This is in direct contradiction of what the government "believes" to be true that "Cannabis has no medical value".

Please provide the documentary "evidence" to substantiate the claims that cannabis in its raw form has no medicinal values.

Please note: This is Not a request for "opinions", "beliefs" or unsubstantiated "claims" ..

My request is for the "factual" evidence on which your claims based.
Provide me with the facts please.

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

Yours faithfully,

A. Clerk

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.
 
 

show quoted sections

A. Clerk (Account suspended) left an annotation ()

I would also like to add the following.... G W Pharma Limited’s Sativex appears to set new standards in production and packaging of tincture of cannabis (cannabis constituents dissolved in ethanol).

As tincture of cannabis is not legally distinct from cannabis.
Sativex is legally cannabis.

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

1 Attachment

Dear A. Clerk,

       

Thank you for your email.

 

Please find attached the response to your Internal review request.

       

Kind Regards,

 

Customer Services

Communications division

Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [1][MHRA request email]
Stay connected: [2]mhra.gov.uk/stayconnected

 

 

 

show quoted sections