Freedom of Information request on the Risk Management Plan (RMP) for PL 36301/0018 - Isoniazid Tablets 100mg- (FOI 21/1185)
Published 26 May 2022
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FOI 21/1185
9th November 2021
Dear,
Thank you for your email, dated 1st November 2021, in which you requested the Risk Management Plan (RMP) for PL 36301/0018 - Isoniazid Tablets 100mg.
I can confirm that we do not hold the requested information. As the original Marketing Authorisation application for Isoniazid Tablets 100mg (ISONIAZID) 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.
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