FOI release

Chloramphenicol 5 & 10% w/v Ear Drops / Martindale Pharma - Legal basis of approval & PAR

Case reference FOI2025/01143

Received 30 October 2025

Published 4 December 2025

Request

I am seeking information on the products Chloramphenicol 5 & 10 % w/v Ear Drops from Martindale Pharma (PL 00156/0050 & PL 00156/0051). Could you please confirm if these products have been approved with a full dossier application, so that they can be used as a reference medicinal product? In addition, is there any PAR that could be provided from MHRA's side for these products? If these are not the reference medicinal products, could please let us know which are considered as the reference products for Chloramphenicol Ear Drops in UK? Thank you very much in advance and best regards

Response

See attached

Documents

• FOI2025_01143 (redacted).pdf (642.4 KB)

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