Freedom of Information request on Guidance on the regulatory environment in Northern Ireland from 1 January 2021
Published 28 May 2021
© Crown copyright 2021
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28th April 2021 FOI 21/316
Dear
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 - https://www.gov.uk/government/collections/new-guidance-and-information-for-industry-from-the-mhra
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 https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information.
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