Dear Medicines and Healthcare products Regulatory Agency,

Please can you provide
1) Names of the companies that have produced the SARS-COV2 testing kits in the England/UK.
2) Copies of the instructions and/or guidelines included in one or more (preferably all) of these SARS-COV2 testing kits that are in use in the UK and any labelling or recommendations that accompany the kits.
3) Copies of pages which show what how the results of these tests are interpreted.

Yours faithfully,

Andrew Johnson

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 20/341

       
Dear Andrew Johnson,
       
RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
        
Thank you for your enquiry which we received on 25 August 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,

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000

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MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Our ref: FOI 20/341

 

Dear Andrew Johnson,

 

Thank you for your email of 25 august 2020, in which you requested the
following information under the Freedom of Information (FOI) Act 2000:

 

 1. “Names of the companies that have produced the SARS-COV2 testing kits
in the England/UK.
 2. Copies of the instructions and/or guidelines included in one or more
(preferably all) of these SARS-COV2 testing kits that are in use in
the UK and any labelling or recommendations that accompany the kits.
 3. Copies of pages which show what how the results of these tests are
interpreted.”

 

We cannot supply you with this information as it is exempt under Section
44 of the Freedom of Information Act (FOIA), as detailed below.

 

[1]FOIA Section 44 – Prohibitions on disclosure - the release of
information is exempt as its disclosure is prohibited by other
legislation:

·      Section 44(1)(b) of FOIA provides an exemption where disclosure of
information would be incompatible with an EU obligation.

·      Information provided to the MHRA in the course of its functions
under the Medical Devices Directives (93/42/EC and 98/79/EC) is required
to be treated as confidential according to the confidentiality provisions
in Article 19 of Directive 98/79/EC on in vitro diagnostic medical
devices. Disclosure of the information you have requested would breach
that obligation.

 

The MHRA deems that the information you have requested:

·      constitutes information which came to us in connection with the
exercise of the MHRA’s functions under the Medical Devices Directives
(93/42/EC and 98/79/EC), and

·      relates to the affairs of companies which have produced SARS-COV2
testing kits.

 

On that basis, section 44(1)(b) of FOIA applies and the information is
exempt from release. Section 44(1) (b) of the FOIA is an absolute
exemption and no consideration of the public interest in disclosure is
required.

 

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 any questions about the information provided, please reply to
this email.

 

If you are dissatisfied with the handling of your request, you have the
right to ask for an internal review. Internal review requests should be
submitted within two months of the date you receive this response and
addressed to: [2][MHRA request email]

 

Please remember to quote the reference number above in any future
communications.

 

If you were to remain dissatisfied with the outcome of the internal
review, you would have the right to apply directly to the Information
Commissioner for a decision. Please bear in mind that the Information
Commissioner will not normally review our handling of your request unless
you have first contacted us to conduct an internal review. The Information
Commissioner can be contacted at:

 

Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

 

Yours sincerely

 

MHRA Customer Services

 

 

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