Freedom of Information request on the SmPC, PIL and the PAR for Dioctyl 100 mg Tablets (FOI 21/1031)
Published 25 February 2022
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1st October 2021
FOI 21/1031
Dear
Thank you for your email of 08 September 2021, where you requested the Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and the Public Assessment Report (PAR) for Dioctyl 100 mg Tablets (PL 04147/5910R).
Dioctyl 100 mg Tablets were originally licensed as a Product Licence of Right (PLR 04147/5910). A Product Licence of Right (PLR) is a licence granted to medicines already on the market when the 1968 Medicines Act came into force. It was subsequently reviewed and granted as a Reviewed Licence to Medo Pharmaceuticals Limited (PL 04147/5910R) on 22 April 1994. As the date of grant of the original marketing authorisation pre-dates when the MHRA would have been required to prepare a PAR, no PAR exists for this product licence.
We have searched our records, including any archived paper records, for the PIL; however, we have been unable to obtain this information. Therefore, having exhausted all the usual avenues, we must conclude that this information is not in our systems in a retrievable form.
Please find the SmPC for Dioctyl 100 mg Tablets (PL 04147/5910R).
I now consider this request closed. If you require any further information, please respond to the FOI Licensing Team at FOILicensing@mhra.gov.uk.
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 you receive this response and addressed to: info@mhra.gov.uk.
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If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review.
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Yours sincerely,
The FOI Licensing Team