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Home > Health Products Regulatory Authority annual report 2014.

Health Products Regulatory Authority. (2015) Health Products Regulatory Authority annual report 2014. Dublin: Health Products Regulatory Authority.

PDF (HPRA annual report 2014) - Published Version

The HPRA’s objective is to safeguard public and animal health by regulating specific health product sectors in line with applicable legislation.


PDF p.55 Enforcement cases and medicines detained:

A total of 3,703 enforcement cases were initiated, compared with 3,932 for 2013. There were a total of 730,056 dosage units were detained, down from 919,965 in the previous year. Sedative products again accounted for over half (56%) of all detentions (51% in 2013).


Inter-Agency Co-operation and Pangea VII:

The HPRA continues to liaise and work closely with other enforcement agencies both nationally and internationally, in combating, detecting and preventing the unauthorised flow of medicines and medical devices. In Ireland, co-operation between the HPRA, the Revenue’s Customs Service and An Garda Síochána continued and included Operation Pangea VII. During this operation in May, the inter-agency approach resulted in the detention of 101,182 tablets and capsules, with an estimated value of €297,557. Pangea VII was a global initiative which involved 200 agencies drawn from health product regulatory authorities, police and customs across 110 countries. The operation, which was co-ordinated by INTERPOL, targeted criminal networks behind the sale of falsified and illegal medicines via illicit websites.


District court prosecutions:

The policy of the HPRA is to prosecute where it is considered necessary in order to protect public health and where a compliance based approach is not considered appropriate. Ten prosecutions were initiated that included offences in relation to:

  • Procurement and importation of medicines without manufacturing authorisations;
  • Supply of prescription only medicines without prescriptions;
  • Wholesale of medicines without a wholesaler’s authorisation;
  • Advertising of prescription only and unauthorised medicinal products. 

The products in question contained active substances indicated for mood stabilisation, performance enhancement, erectile dysfunction and weight loss. Nine prosecutions were initiated annually during the three year period from 2011 to 2013.

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