Dear Dr Goldacre

Re: FOI 09 473

I am writing further to my letter of 30 December 2009 about your Freedom of Information Act (FOIA) request of 30 November 2009 about statins.

You asked about delays in updating statin product information referred to in the February 2008 Drug Safety Update (DSU) and specifically for `dialogue between Dutch MEB and AZ'.

I am writing to let you know that we are able to supply the information you have requested. I am, therefore enclosing letters from AstraZeneca to Dutch regulatory Agency (MEB) and relevant parts of AstraZeneca's response to the assessment of the periodic safety updated report (PSUR), in which the adverse drug reactions (ADRs) that were added to the statin SPCs, were assessed. It is important to note that these are the documents held by the MHRA and there may be other documents held by other parties, such as the Dutch regulatory Agency.

If you have a query about this letter, please contact me. If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please write to the Communications Directorate, 10th Floor, Medicines and Healthcare products Regulatory Agency, at the above address quoting the above reference.

After that, if you remain dissatisfied, you may ask the Information Commissioner at The Information Commissioner's Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF to make a decision on whether or not we have interpreted the FOIA correctly in withholding information from you.

Yours sincerely

Dr Nageen Hashmi

Scientific Assessor, Patient Information Quality, MHRA

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