Safety Notices

From time to time notices relating to the safety, efficacy and quality of human medicinal products are published by the Health Products Regulatory Authority.

The issues covered by these notices include medicinal product safety information, updated efficacy information on the appropriate usage of medicines and quality defect information.

Notices are categorised in accordance with their importance at time of publication.

The four notice categories are outlined as follows:

  • Advisory  -  Routine safety information            
  • Warning  -  Urgent safety information
  • Recall  -  Urgent safety information relating to a product recall
  • Publications  -  General information provided by 3rd parties as approved by the HPRA, e.g. MIMS, Direct Healthcare Professional Letter or Product Information Update

The HPRA Drug Safety Newsletter is also published on a regular basis.

Date Title Type
13/09/2023 Medicinal Product Shortages - update - 13 September 2023 Advisory
08/09/2023 Recall notice for Ketofall 0.25 mg/ml eye drops, solution in single-dose container, PA1815/002/001 Recall
06/09/2023 Medicinal Product Shortages - update - 6 September 2023 Advisory
04/09/2023 HPRA IMF Article September 2023 3rd Party Publications
04/09/2023 HPRA MIMS Article September 2023 3rd Party Publications
01/09/2023 Ozempic (Semaglutide) - Supply Update Advisory
30/08/2023 Medicinal Product Shortages - update - 30 August 2023 Advisory
23/08/2023 Medicinal Product Shortages - update - 23 August 2023 Advisory
16/08/2023 Medicinal Product Shortages - update - 16 August 2023 Advisory
10/08/2023 Reminder of serious health risks with ‘Melanotan 2’ self-tan products Advisory