northern Ireland Protocol

The request was partially successful.

Dear Medicines and Healthcare products Regulatory Agency,

Can you publish any planning or policy documents you have as in 01/01/2022 Northern Ireland will come under the EMA?

Yours faithfully,

Abdul Hai

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

 

 

Our Ref: FOI 21/316

       

Dear Abdul Hai

       

RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

        

Thank you for your enquiry which we received on 30^th March 2021.

       

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,

 

 

MHRA Customer Service Centre

 

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

Telephone 0203 080 6000

 

 

 

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

FOI 21/316

 

Dear Abdul Hai

 

Thank you for your information request, dated 30 March 2021, where you
asked, ‘Can you publish any planning or policy documents you have as in
01/01/2022 Northern Ireland will come under the EMA?’

 

I am pleased to provide you with some of the information requested. The
Medicines and Healthcare products Regulatory Agency (MHRA) is the UK’s
standalone medicines and medical devices regulator. Guidance on the
regulatory environment in Northern Ireland from 1 January 2021 has been
published and is available here -
[1]https://www.gov.uk/government/collection...

 

Unfortunately, some of the information is exempt from release under
sections 35.

 

The information you have requested is being withheld under section 35 of
the FOI Act. Section 35 protects the internal deliberative process as it
relates to Government policy making. In other words, the exemption is
intended to ensure that the possibility of public exposure does not deter
from full, candid and proper deliberation of policy formulation and
development, including the exploration of all options, the keeping of
detailed records and the taking of difficult decisions. Section 35 is a
qualified exemption, which means that we have considered whether the
public interest in releasing the information is outweighed by the public
interest in not giving the information. We consider that the public
interest will be better served by not releasing the information as
premature disclosure of this sort of information could prejudice good
working relationship and, ultimately, the quality of Government.

 

The Freedom of Information Act only entitles you access to information –
the information supplied is subject to Crown copyright, and there are some
restrictions on its re-use. For information on the reproduction or re-use
of MHRA information, please visit
[2]https://www.gov.uk/government/publicatio....

 

If you disagree with how we have interpreted the Freedom of Information
Act 2000 with regards to your request, you can ask for the decision to be
reviewed. The review will be carried out by a senior member of the Agency
who was not involved with the original decision.

 

If you have a query about the information provided, please reply to this
email.

 

Yours sincerely

 

 

 

MHRA Customer Service Centre

 

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

 

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