Freedom of Information request on the EPAR and RMP for AZD7442 and Ronapreve/REGEN-COV (FOI 21/1072)
Published 25 February 2022
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25th September 2021
FOI 21/1072
Dear Thank you for your emails, dated 20th September 2021, in which you requested the EPAR and RMP for AZD7442 and Ronapreve/REGEN-COV.
The Risk Management Plans for both products are pending approval, and therefore are exempt from release under Section 43 (Commercial Interests) of the Freedom of Information (FOI) Act. We have concluded that disclosing this information would not be appropriate because providing information subject to Section 43 would be an infringement of commercial interests. Furthermore, we do not believe that there is an overriding public interest in disclosing this information in this instance.
In regard to the EPARs, the MHRA does not hold the EPAR for either product, as this is prepared by the EMA, who will publish this in the next 60 working days.
I hope the information provided is helpful; however, 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 of this response; and can be addressed to this email address.
Please remember to quote the reference number above in any future communications.
Yours sincerely,
FOI Team,
Vigilance and Risk Management of Medicines Division