Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what steps his Department is taking to ensure Lithyronine sold by third parties meets legal requirements and its safe sale for patients to use.

Liothyronine is a licensed medicine used for the treatment of hypothyroidism, an underactive thyroid gland. Licensed medicines must meet standards of safety, quality and efficacy. Each batch of medicine must be tested before release for sale. The manufacturer, importer and distributors must also be licensed. Medicines and Healthcare products Regulatory Agency (MHRA), the United Kingdom competent authority for medicines, license medicines, their manufacture, importation and distribution and conduct inspections of sites of operation for compliance with good practice standards.

Prescribers may, on their own personal responsibility, also prescribe an unlicensed medicine to meet the special clinical needs of their individual patient where those needs cannot be met by an available licensed medicine. Manufacturers, importers and distributors of unlicensed medicine are also licensed and inspected by MHRA. Importers must notify MHRA of the intention to import an unlicensed medicine. These notifications are assessed by MHRA for known safety or quality issues and objections to import may be raised if prohibitive issues are identified. Unlicensed Liothyronine has been manufactured and imported for UK patients.

A prescriber or patient that suspects that their medicine is defective or is causing a side effect may report this to MHRA through the Yellow Card Scheme for reporting suspected Adverse Drug Reactions from across the whole UK and includes all medicines.