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Medicinal Products Regulation

Dáil Éireann Debate, Tuesday - 2 October 2018

Tuesday, 2 October 2018

Questions (393)

Peter Burke

Question:

393. Deputy Peter Burke asked the Minister for Health the steps being taken to discourage certain illegal marketing (details supplied); and if he will make a statement on the matter. [39714/18]

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Written answers

Under the Medicinal Products (Control of Placing on the Market) Regulations 2007, as amended, a medicine cannot be placed on the market in Ireland unless it has a marketing authorisation from the Health Products Regulatory Authority (HPRA) or a community marketing authorisation from the European Medicines Agency. Any product which makes a medicinal claim to treat medical conditions such as autism is considered to be a medicine, and requires an authorisation under this legislation.

The product referred to as Miracle Mineral Solution (MMS) is not authorised as a medicine for sale or supply in Ireland. Any manufacture, supply or sale of this product for the purposes of treating a medical condition is illegal.

The HPRA is the competent authority for medicines in Ireland. The Authority has an Enforcement section, which is responsible for investigating potential breaches of medicines legislation and, where necessary, taking corrective action, including legal proceedings. This can involve investigation into complaints regarding products advertised or marketed as medicinal products but which have no marketing authorisation or certificate of traditional-use registration. The HPRA's investigations are prioritised on the basis of perceived risk to public health.

The HPRA has taken enforcement actions against the supplier of MMS, resulting in the prosecution and conviction of the person responsible in Ireland for such supply. The HPRA continually monitors online platforms for the promotion and sale of unauthorised medicines, including MMS. The Authority does not, at this time, have evidence of the promotion of MMS on social media or any online website registered in Ireland.

The HPRA continues to advise consumers not to purchase or take MMS.

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