FOI release

Freedom of Information request (FOI 22/770)

Published 17 January 2024

2nd November 2022

FOI 22/770

Dear

Firstly, I’d like to apologise for the delay in responding. Thank you for your request on 12th June 2022 where you requested the following:

I attach “Summary of Product Characteristics for Spikevax” downloaded from Gov.UK.

I note the document was updated 10 June 2022 and acknowledges - inter alia - an increased risk for myocarditis and pericarditis following inoculation with Spikevax, with the condition developing within a few days after inoculation.

Publication of this information raises concerns regarding how important MHRA documentation {Public Assessment Reports [PAR] and Summary of Product Characteristics [SPC]} regarding the safety and efficacy of new therapeutics is managed by MHRA, and how amendments to the documents are recorded to provide an audit trail.

Accordingly, I would be grateful if you could arrange to provide me with a copy of MHRA document control policy and procedure.

The explanatory note provided in Annex 1 below should provide further clarification. An examination of the document, now requested, will enable me to establish:

1. how change to important documents [PAR, SPC] is managed

2. who is the designated document controller

3. what document control log [audit log] is available to record when amendments are made

4. how metadata is managed

5. who has authority to make changes to important documents: what is the approval process.

I look forward to receiving a copy of MHRA document control policy and procedure at your earliest convenience.

On 10th October, we asked to you clarify the specific information you were seeking. The same day you responded with the following:

I requested a copy of MHRA document control policy and procedure. This is a single document that explains in general terms how information is managed by MHRA. The link below should provide you with general information regarding the document control process. I would normally expect all public bodies to hold such a document.

https://theecmconsultant.com/document-control/

I can confirm that we do not hold the information you have requested as a single overarching document. The Agency Quality Manual is structured around the requirements of ISO 9001. I have provided an extract from Version 11, which was published in January 2022.

You specifically referenced PARs and SPCs. With regards to PARs, these public assessment reports provide a summary of the assessment that led to our approving a specific product. PARs are published and edited in accordance with a specific EC Directive, 2004/27/EC.

Once the PAR is published, it is not expected to go through any major revisions. Our website states the following:

Subsequent non-safety changes (variations) of clinical significance for each marketing authorisation are provided at the end of each PAR as separate annexes.

Minor changes to a marketing authorisation, for example, changes in pack sizes and minor updates to the product literature, may not be represented in the PAR.

We also publish Safety Public Assessment Reports, which provide details of significant safety changes to a marketing authorisation.

With regards to SPCs, these are not documents owned by the agency. Our website provides the following information:

Summaries of Product Characteristics (SPCs) are descriptions of a medicinal product’s properties and the conditions attached to its use.

The SPCs are made up of individual fragments which are individually approved. These can be amended by way of variation where the Marketing Authorisation Holder (MAH) makes an application to us which is supported by relevant evidence and/or data. Variations can update a single SPC fragment or multiple fragments. Once we are satisfied that the variation is approvable, the application is granted which updates the relevant SPC fragments. Our system then automatically creates a new SPC, joining up all the individually approved fragments into the single document you are able to download from our website.

If you have a query 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: [email protected]

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 FOI Team