Sampling and Analysis

Our Role

The sampling and analysis programme functions to support the HPRA in monitoring the quality and safety of medicinal products both on the Irish market and produced for export.  It allows us to identify unauthorised medicinal products that may be on the Irish marketplace.

We achieve this through a risk-based approach to surveillance testing and product examination.  This programme contributes to the HPRA’s role in protecting public and animal health by checking the quality of the medicines via laboratory testing and ensuring that any non-compliance issues are followed up on and addressed.  It also allows us to identify deficient analytical test methods that may be in use at pharmaceutical company laboratories. The programme also allows us to check that the product information supplied in packs of medicines is correct and up-to-date.

How We Operate

The sampling and analysis programme 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 HPRA, are analytically tested and/or examined internally. We use risk-based approaches when carrying out our sampling and analysis work, and the extent of the work carried out is dependent on the reason for sampling. 

The HPRA is legally entitled to take samples without payment. This is provided for in Section 32B(3)(F) of the Irish Medicines Board (Miscellaneous Provisions) Act, No. 3 of 2006. Wholesalers that act as primary wholesalers for certain medicinal products may be able to claim reimbursement from the concerned Marketing Authorisation Holder (MAH) companies. Please know that the authorised officer will provide wholesalers with an official HPRA receipt for all samples collected.

Who We Work With

The sampling and analysis programme operates in tandem with our 'Quality Defect and Product Recall Programme', and our surveillance activities form part of various EU-wide surveillance programmes coordinated by the European Directorate for the Quality of Medicines (EDQM).  In this regard, HPRA is an active member of an EU network known as the OMCL Network.  This is the Official Medicines Control Laboratory Network and its function is to ensure that surveillance testing activities in the EU are designed to deliver the maximum amount of meaningful surveillance information in medicines, while making the best use of the available laboratory resources and capacity.