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Health Products Regulatory Authority

Dáil Éireann Debate, Wednesday - 5 April 2017

Wednesday, 5 April 2017

Questions (287)

Noel Rock


287. Deputy Noel Rock asked the Minister for Health if resources are being devoted specifically to investigate and intervene in the sale of real and counterfeit pregabalin; if the source of these substances has been discovered; and if he will make a statement on the matter. [17047/17]

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Written answers (Question to Health)

The Health Products Regulatory Authority (HPRA) is the statutory agency responsible for the regulation of human and veterinary medicines in Ireland. The HPRA has an enforcement section dedicated to investigation of instances of the illicit sale of medicines and other health products, including the illicit sale of genuine and counterfeit/falsified pregabalin containing medicines. The HPRA cooperates with An Garda Síochána and Revenue’s Customs Service in the investigation of offences under the Irish Medicines Board Acts 1995 and 2006.

Pregabalin is the active ingredient in a prescription only medicine that is indicated for treatment of generalised anxiety disorder in adults, pain due to nerve damage and as part of the treatment for epilepsy. Pregabalin is known to be subject to potential abuse. As for any prescription medicine, the HPRA advises that a pregabalin containing medicine should only be taken following a consultation with a registered medical practitioner and dispensing by a registered pharmacy. Prescription only medicines purchased from unauthorised sources cannot be relied on for their safety, effectiveness or quality. They may be falsified and may create a risk to the health of the consumer. The HPRA is continuing to work with An Garda Síochána, Revenue’s Customs Service and other agencies abroad in order to curtail and, where possible, halt the illicit sale and supply of prescription medicines, including those containing pregabalin.

The HPRA has informed me that during 2016, a total of 1,174 tablets of Pregabalin containing medicines were detained by the Authority. These were supplied from the following countries:

- 940 from India

- 180 from China

- 50 from Hong Kong

- 4 from Singapore.