On July 1st 2014, the Irish national regulator for medicines, medical devices, cosmetics and other health products will be named HPRA (Health Products Regulatory Authority) instead of its former name – IMB (Irish Medicines Board)

Visit HPRA’s Website

Why now?

According to the HPRA, the new name more clearly reflects the wider scope of functions and responsibilities assigned to the regulatory authority in reference to its initial status established in 1996, towards regulating only human & veterinary medicines.

As such, the HPRA is officially responsible to regulate the following range of sectors on the Irish market, including: cosmetics, medical devices, controlled drugs, clinical investigations and more.

Principle activities of HPRA towards Cosmetics

Under the competencies/services of the HPRA:

  • Operating an effective and broad reaching market surveillance program
  • Investigation of safety concerns arising during cosmetic product use.
  • Inspection of manufacturers and distributors of cosmetic products.
  • Participation in international activities, including relevant EU working groups.
  • Generation of Certificates of Free Sale.

How will HPRA monitor Cosmetics?

Under its market surveillance activities, the HPRA shall conduct annual programs for products being sampled for analytical testing and review. HPRA market surveillance activities will focus on products which were reported to lead to serious undesirable effects (SUEs) or products reported through the EU rapid alert network (RAPEX) to all EU Member states.

Cooperation with Responsible Persons

The HPRA will work closely with Responsible Persons towards the key requirements of which may include but are not limited to:

  • Labeling
  • Notification
  • Product information file (PIF)
  • Good Manufacturing Practices (GMP)
  • Communication of serious undesirable effects
  • Sampling, analysis and Traceability within the supply chainCorrective actions in the event of cosmetic product non-compliance

The HPRA will work closely with Responsible Persons towards corrective and/or preventative measures to ensure consumer safety – such as:

  • A change in usage instructions;
  • Updates to product labeling;
  • Additional precautions for use;
  • Re-formulation;
  • Product recall or withdrawal;

Future Expectations

The HPRA will continue to operate under the regulatory framework of the European Cosmetic Regulation EC 1223/2009 towards enforcing it by monitoring the safety and compliance of cosmetic products. The HPRA will rely on effective and pro-active post market surveillance activities which will focus on sampling and analysis alongside a close work with Responsible Persons.

If you would like to know more on the Irish Health Products Regulatory Authority, please contact us.

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