Freedom of Information request on Fludrocortisone 0.1mg/ml oral solution (FOI 21-606)
Published 13 August 2021
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25th June 2021 FOI 21/606
Dear
Thank you for your email, dated 27th May 2021, in which you requested:
‘On 30/11/2020 we had submitted our product PL 20646/0092 (Fludrocortisone 0.1mg/ml oral solution) as a 10.3 Hybrid application (PL 20646/0092), with reference product: Fludrocortisone acetate 0.1 mg tablets Aspen Pharma Trading Limited (PL 39699/0071)
May I ask to provide us with the below documents of PL 39699/0071:
1) Risk management plan (1.8.2)
2) Periodic Safety Update Reports (PSUR)’
I can confirm that we do not hold all of the information that you have requested.
Regarding your request for the Risk Management Plan (RMP), as the original Marketing Authorisation application for Florinef Tablets 0.1mg (Fludrocortisone Acetate) was made prior to the 2012 amendment in pharmacovigilance legislation, which requires an RMP for all new applications, the MHRA does not hold an RMP for this product.
A copy of the Periodic Safety Update Reports, which can be disclosed, are attached.
Information that has been redacted is exempt under Section 43 (commercially sensitive) of the Freedom of Information (FOI) Act and is therefore withheld. We have concluded that disclosing this information would not be appropriate because providing information subject to Section 43 would be an infringement of commercially sensitive data. Furthermore, we do not believe that there is an overriding public interest in disclosing this information in this instance.
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