Dear Medicines and Healthcare Products Regulatory Agency,

1. With regard to Covid-19 vaccine authorisations, please confirm your definition of "Emergency Use".

2. What is the MHRA definition of the length of a public health emergency i.e. what criteria marks the end of the current Covid-19 emergency.

Yours faithfully,

Roland Gilmore

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Thank you for your email.  This auto-response is to inform you that your
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We will respond to you as soon as possible. 
 
Please note that we may not respond if your query: 
 
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Medicines and Healthcare products Regulatory Agency
10 South Colonnade, 
Canary Wharf, 
London 
E14 4PU
gov.uk/mhra
Stay connected 
 
For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: MHRA,
CPRD and NIBSC. 
 
The UK has left the EU, and the transition period ends on 31 December
2020. Ourguidance and information can be accessed here.

________________________________________ From: Roland Gilmore
<[FOI #794765 email]> Sent: Thursday, September 23,
2021 1:32:58 PM To: MHRA Customer Services Subject: Freedom of Information
request - Definition of "Emergency Use" Dear Medicines and Healthcare
Products Regulatory Agency, 1. With regard to Covid-19 vaccine
authorisations, please confirm your definition of "Emergency Use". 2. What
is the MHRA definition of the length of a public health emergency i.e.
what criteria marks the end of the current Covid-19 emergency. Yours
faithfully, Roland Gilmore
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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Reference: CSC 68347

Dear Roland Gilmore,

Thank you for your email.

We have reviewed your enquiry and this has been passed on to our Licensing experts.

Should you have any other questions or requests please feel free to call us on 0203 080 6000 or email at [MHRA request email]

Our opening hours are Mon – Fri 9am to 5pm (excluding UK Public Holidays)

Kind regards
 
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU

show quoted sections

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

 

Dear Roland Gilmore,

 

Thank you for your email.

 

Details regarding Regulation 174 can be found at the following link:

[1]The Human Medicines Regulations 2012 (legislation.gov.uk)

 

Please note as this information is available in the public domain this has
not been treated as a Freedom of Information request.

 

Kind Regards

 

MHRA Customer Service Centre

 

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

Telephone 020 3080 6000

 

 

 

show quoted sections

Dear MHRA Customer Services,

Thank you for your response.

I have downloaded the pdf versions of The Human Medicines Regulations 2012; both the original and the latest available. I have searched both documents and found no definition of "emergency use".

Please reply to my question. It is of significant public interest that you clearly state the MHRA definition of "emergency use".

To help you, I would refer you to the USA where emergency use is described as "where no other treatment exists". In relation to the MHRA approval of Covid-19 vaccines for "emergency use", it is well known that other successful treatments do exist and I can provide evidence in the form of reference material to you if you claim that the MHRA has no records of this.

Furthermore, it is a fact that the vaccine suppliers leaflets clearly state that the "vaccine" does not prevent recipients from contracting Covid-19 or from transmitting/spreading it and therefore, the MHRA reasoning for approving Covid-19 vaccines for "emergency use" is not only obscure but appears to be irrational.

Yours sincerely,

Roland Gilmore

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Thank you for your email.  This auto-response is to inform you that your
email has been received and will be reviewed by our Customer Service Team.
We will respond to you as soon as possible. 
 
Please note that we may not respond if your query: 
 
• contains offensive language
• has already been answered in a previous reply to you
• is illegible
• is selling or promoting a product
• is for information only 
 
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, 
Canary Wharf, 
London 
E14 4PU
gov.uk/mhra
Stay connected 
 
For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: MHRA,
CPRD and NIBSC. 
 
The UK has left the EU, and the transition period ends on 31 December
2020. Ourguidance and information can be accessed here.

________________________________________ From: Roland Gilmore
<[FOI #794765 email]> Sent: Thursday, September 30,
2021 11:12:29 PM To: MHRA Customer Services Subject: Re: CSC 68347 Freedom
of Information request - Definition of "Emergency Use" Dear MHRA Customer
Services, Thank you for your response. I have downloaded the pdf versions
of The Human Medicines Regulations 2012; both the original and the latest
available. I have searched both documents and found no definition of
"emergency use". Please reply to my question. It is of significant public
interest that you clearly state the MHRA definition of "emergency use". To
help you, I would refer you to the USA where emergency use is described as
"where no other treatment exists". In relation to the MHRA approval of
Covid-19 vaccines for "emergency use", it is well known that other
successful treatments do exist and I can provide evidence in the form of
reference material to you if you claim that the MHRA has no records of
this. Furthermore, it is a fact that the vaccine suppliers leaflets
clearly state that the "vaccine" does not prevent recipients from
contracting Covid-19 or from transmitting/spreading it and therefore, the
MHRA reasoning for approving Covid-19 vaccines for "emergency use" is not
only obscure but appears to be irrational. Yours sincerely, Roland Gilmore
-----Original Message----- Dear Roland Gilmore, Thank you for your email.
Details regarding Regulation 174 can be found at the following link:
[1]The Human Medicines Regulations 2012 (legislation.gov.uk) Please note
as this information is available in the public domain this has not been
treated as a Freedom of Information request. Kind Regards MHRA Customer
Service Centre Medicines and Healthcare products Regulatory Agency 10
South Colonnade, Canary Wharf, London E14 4PU Telephone 020 3080 6000
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #794765 email] Disclaimer: This message and
any reply that you make will be published on the internet. Our privacy and
copyright policies:
https://eur01.safelinks.protection.outlo...
For more detailed guidance on safely disclosing information, read the
latest advice from the ICO:
https://eur01.safelinks.protection.outlo...
Please note that in some cases publication of requests and responses will
be delayed. If you find this service useful as an FOI officer, please ask
your web manager to link to us from your organisation's FOI page.

show quoted sections

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Reference: CSC 69447

Dear Roland Gilmore,

Thank you for your email.

We have reviewed your enquiry and this has been passed on to our Licensing experts.

Should you have any other questions or requests please feel free to call us on 0203 080 6000 or email at [MHRA request email]

Our opening hours are Mon - Fri 9am to 5pm (excluding UK Public Holidays)

Kind regards

MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU

show quoted sections

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Roland Gilmore,

 

Regulation 174 states:

The prohibitions in Regulation 46 (requirement for authorisation) do not
apply where the sale or supply of a medicinal product is authorised by the
licensing authority on a temporary basis in response to the suspected or
confirmed spread of—

(a)pathogenic agents;

(b)toxins;

(c)chemical agents; or

(d)nuclear radiation,

 

which may cause harm to human beings.

 

Please note that the vaccines have now been granted market authorisations.

[1]https://www.gov.uk/government/publicatio...

[2]https://www.gov.uk/government/publicatio...

[3]https://www.gov.uk/government/publicatio...

[4]https://www.gov.uk/government/publicatio...

 

MHRA have provided you with the Public Assessment Reports for each of the
authorised vaccines in a previous response, which clearly explains how
each of the vaccines was authorised and the benefit that each vaccine
shows.

 

Kind Regards

 

Ella

MHRA Customer Service Centre

 

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

Telephone 020 3080 6000

 

 

 

show quoted sections

Dear MHRA Customer Services,

Your response does not answer my request for information.
I therefore request an internal review.

Yours sincerely,

Roland Gilmore

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Thank you for your email.  This auto-response is to inform you that your
email has been received and will be reviewed by our Customer Service Team.
We will respond to you as soon as possible. 
 
Please note that we may not respond if your query: 
 
• contains offensive language
• has already been answered in a previous reply to you
• is illegible
• is selling or promoting a product
• is for information only 
 
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, 
Canary Wharf, 
London 
E14 4PU
gov.uk/mhra
Stay connected 
 
For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: MHRA,
CPRD and NIBSC. 
 
The UK has left the EU, and the transition period ends on 31 December
2020. Ourguidance and information can be accessed here.

________________________________________ From: Roland Gilmore
<[FOI #794765 email]> Sent: Tuesday, October 26,
2021 10:20:02 AM To: MHRA Customer Services Subject: Internal review of
Freedom of Information request - Definition of "Emergency Use" Dear MHRA
Customer Services, Your response does not answer my request for
information. I therefore request an internal review. Yours sincerely,
Roland Gilmore -----Original Message----- Dear Roland Gilmore, Regulation
174 states: The prohibitions in Regulation 46 (requirement for
authorisation) do not apply where the sale or supply of a medicinal
product is authorised by the licensing authority on a temporary basis in
response to the suspected or confirmed spread of— (a)pathogenic agents;
(b)toxins; (c)chemical agents; or (d)nuclear radiation, which may cause
harm to human beings. Please note that the vaccines have now been granted
market authorisations.
[1]https://eur01.safelinks.protection.outlo...
[2]https://eur01.safelinks.protection.outlo...
[3]https://eur01.safelinks.protection.outlo...
[4]https://eur01.safelinks.protection.outlo...
MHRA have provided you with the Public Assessment Reports for each of the
authorised vaccines in a previous response, which clearly explains how
each of the vaccines was authorised and the benefit that each vaccine
shows. Kind Regards Ella MHRA Customer Service Centre Medicines and
Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf,
London E14 4PU Telephone 020 3080 6000
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #794765 email] Disclaimer: This message and
any reply that you make will be published on the internet. Our privacy and
copyright policies:
https://eur01.safelinks.protection.outlo...
For more detailed guidance on safely disclosing information, read the
latest advice from the ICO:
https://eur01.safelinks.protection.outlo...
Please note that in some cases publication of requests and responses will
be delayed. If you find this service useful as an FOI officer, please ask
your web manager to link to us from your organisation's FOI page.

show quoted sections