Quality Information

How We Monitor Quality

The HPRA monitors the quality of medicines using both proactive and reactive surveillance programmes.

We proactively monitor the quality of medicines through our Sampling and Analysis programme. This uses a risk-based approach to co-ordinate our independent surveillance testing and examination of medicinal products on the marketplace.

Through our Quality Defects and Recall programme, we react to actual or suspected quality defects in medicines that are reported to us, and we investigate those issues. (A quality defect is defined as an attribute of a medicinal product or component which may affect the quality, safety and/or efficacy of the product and/or is not in line with the marketing authorisation/product registration file for that product or component.) Examples of the type of action that may result from a quality defect investigation are a product recall or the issuance of cautionary advice for the continued use of the product until replacement stock is available.

Other Areas of Market Compliance

The HPRA also carries out Regulatory Compliance inspections at the offices of Marketing Authorisation Holder companies. This is a risk-based inspection programme designed to assess the level of compliance at the company against the requirements in national legislation pertaining to the placing on the market and the advertising of medicinal products.

We also perform surveillance work on the advertising of medicinal products by pharmaceutical companies in Ireland. This is carried out within the Advertising Compliance programme within Market Compliance. Via this work we ensure that advertisements for human medicinal products are accurate, not-misleading and are in-line with approved product information.

The HPRA also operates an Exempt Medicinal Products notification scheme. This scheme allows us to monitor the importation and supply of unauthorised medicinal products on our marketplace.