HRT provider censured by UK regulator for ‘systemic failures’ that put patients at risk
Summary
Theramex, a UK company that makes hormone replacement therapy (HRT) drugs, was publicly censured by the Prescription Medicines Code of Practice Authority (PMCPA) for serious failures that risked patient safety. The company failed to update important drug information and left the industry's self-regulatory body, choosing to be regulated by the UK government agency MHRA instead.Key Facts
- Theramex produces HRT drugs Evorel and Intrarosa, widely used for hormone therapy in the UK.
- The PMCPA found Theramex breached the pharmaceutical industry's code of practice 21 times.
- Failures included not updating prescribing information for years and omitting pregnancy warnings on some drugs.
- Staff at Theramex reported these issues internally before the PMCPA took action.
- Theramex left the PMCPA’s self-regulatory system in January 2026 to be regulated by the UK Medicines and Healthcare products Regulatory Agency (MHRA).
- The MHRA has legal authority to oversee drug safety and can investigate and penalize companies for breaches.
- Theramex said it is reviewing and improving its compliance and ethical standards.
- Industry and regulator officials expressed concern about Theramex’s failures and acknowledged that MHRA will ensure ongoing patient safety.
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