Freedom of Information request on the risk management plan for Betamethasone sodium phosphate 500mcg soluble tablets (FOI 22/585)
Published 14 June 2022
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FOI 22/585
21st April 2022
Dear
Thank you for your email, dated 30th March 2022, in which you requested the:
‘Risk Management Plan for Betamethasone sodium phosphate 500mcg soluble tablets from the following products: PL 36301/0052, PL 49578/0006’
A copy of the information, which can be disclosed, is attached.
Regarding your request for PL 49578/0006, information that has been redacted is exempt under Section 40 (Personal Information) of the Freedom of Information (FOI) Act and is therefore withheld.
Section 40 provides that personal information may be exempt from release where to do so would contravene data protection principles. Furthermore, we do not believe that there is an overriding public interest in disclosing this information in this instance.
Regarding your request for PL 36301/0052, as the original Marketing Authorisation applications for the generic products to which you refer (Betamethasone Sodium Phosphate) were made prior to the 2012 amendment in pharmacovigilance legislation, requiring an RMP for all new applications, the MHRA does not hold an RMP for this product.
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