Market Compliance

The Market Compliance Section of the Irish Medicines Board co-ordinates and operates the IMB 'Sampling & Analysis Programme'.

The sampling and analysis programme forms part of IMB’s market compliance and surveillance activities and operates through the collection of samples of authorised medicinal products, active pharmaceutical ingredients, enforcement samples and other products (for example, borderline products and unauthorised products making medicinal claims), from the marketplace or from the site of manufacture. These products, which are sampled by authorised officers of the IMB, are analytically tested and/or assessed internally. A risk-based approach is taken when carrying out sampling and analysis work, and the extent of the work carried out is dependent on the reason for sampling.

The sampling and analysis programme operates in tandem with the 'Quality Defect and Product Recall Programme'. The IMB’s market compliance and surveillance activities also form part of an EU wide programme, and the sampling and analysis programme is linked with the activities of the European Directorate for the Quality of Medicines (EDQM). The EDQM co-ordinates the activities of member state Official Medicine Control Laboratories (OMCL).

The Irish Medicines Board - www.imb.ie

Market Compliance