Adverse Events

John Watts made this Freedom of Information request to Medicines and Healthcare Products Regulatory Agency

This request has been closed to new correspondence. Contact us if you think it should be reopened.

The request was successful.

Dear Medicines and Healthcare products Regulatory Agency,

Please can I have the details of any adverse events reported from the 22nd July 2019 until now.

Please can you include the cause of the adverse event, if known.

Yours faithfully,

John Watts

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; one month if you are making a request for access to
your personal data under the General Data Protection Regulation 2018.
 
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
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone: 020 3080 6000
Email: [8][MHRA request email]
Stay connected: [9]mhra.gov.uk/stayconnected
 
All emails are retained by the Agency in a secure area together with the
Agency’s response, for eight years in accordance with our Retention and
Disposal Schedule. Our privacy notice can be found [10]here.
 
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 John Watts,

Thank you for your email.

Please clarify what information you are looking for. We could provide numbers of ADRs reported. However, if you want specific details for medicines we would need you to be more specific about what you are requesting.

Kind Regards

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone: 020 3080 6000
Email: [MHRA request email]
Stay connected

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Dear MHRA Customer Services,

My original request was:

"Please can I have the details of any adverse events reported from the 22nd July 2019 until now.

Please can you include the cause of the adverse event, if known."

i'm not sure what further claririfcation is required. However, to clarify, please give me details of any (and all) adverse events reported from the 22nd july 2019 until now.

The details I require are:

The medicine involved or suspected to be involved.
The nature of the adverse event.
The cause of the adverse event (if known).

Yours sincerely,

John Watts

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; one month if you are making a request for access to
your personal data under the General Data Protection Regulation 2018.
 
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
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone: 020 3080 6000
Email: [8][MHRA request email]
Stay connected: [9]mhra.gov.uk/stayconnected
 
All emails are retained by the Agency in a secure area together with the
Agency’s response, for eight years in accordance with our Retention and
Disposal Schedule. Our privacy notice can be found [10]here.
 
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

Our Ref: FOI 20/043

Dear Mr John Watts,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 24 January 2020.

I confirm that your request is now 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.

Kind Regards,

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
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

1 Attachment

FOI 20/043

 

Dear Mr Watts,

 

Thank you for your email.

 

Please find attached the response to your FOI request.

 

Kind Regards

 

Customer Services

Communications division

Medicines and Healthcare Products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

Telephone: 020 3080 6000

Email: [MHRA request email]

Stay connected

 

 

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Dear MHRA Customer Services,

I would be happy to restrict my equiry to any adverse reactions which were caused by (or suspected to have been caused by) medicines having been exposed to high temperatures.

If possible, and if known, please identify at whoch point in the supply chain these medicines were exposed to (or suspected to have been exposed to) the high temperatures. For example, during transportation or storage in the pharmacy.

Yours sincerely,

John Watts

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; one month if you are making a request for access to
your personal data under the General Data Protection Regulation 2018.
 
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
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone: 020 3080 6000
Email: [8][MHRA request email]
Stay connected: [9]mhra.gov.uk/stayconnected
 
All emails are retained by the Agency in a secure area together with the
Agency’s response, for eight years in accordance with our Retention and
Disposal Schedule. Our privacy notice can be found [10]here.
 
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

Our Ref: FOI 20/064

Dear Mr Watts,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 6 February 2020.

I confirm that your request is now 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.

Kind Regards,

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
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

1 Attachment

FOI 20/064

Dear Mr Watts,

Thank you for your email.

Please find attached the response to your FOI request.

Kind Regards

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone: 020 3080 6000
Email: [MHRA request email]
Stay connected

show quoted sections