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Medicinal Products Licensing

Dáil Éireann Debate, Tuesday - 25 October 2016

Tuesday, 25 October 2016

Questions (420)

Clare Daly

Question:

420. Deputy Clare Daly asked the Minister for Health if there is a dedicated investigations unit within the Health Products Regulatory Authority, HPRA, which examines complaints regarding products advertised or marketed as medicinal products but which have no marketing authorisation from either the HPRA or the European Medicines Agency, as for example, in the case of products marketed as a cure for autism. [31641/16]

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Written answers

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

The Medicinal Products (Control of Advertising) Regulations 2007 prohibit the advertising of medicinal products which are not the subject of a marketing authorisation or certificate of traditional-use registration.

The HPRA is responsible for the implementation and oversight of this legislation. The Authority has an Enforcement section, of which one of its roles is, to investigate potential breaches of this legislation and, where necessary, to take corrective action including legal proceedings. This can include 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.

I understand the Deputy to be referring to the product known as “Mineral Miracle Solution” (MMS), otherwise known as Chlorine Dioxide or “the CD Protocol”. This product is not authorised as a medicinal product 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 continues to advise consumers not to seek to purchase or take this product and I reiterate this advice.

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