Sampling and analysis of human health products

The HPRA's Sampling and Analysis Programme contributes to the HPRA's role in protecting human and animal health. We monitor the quality and safety of medicines by taking samples of medicines and evaluating them.

The programme is comprised of two main parts:

  1. Laboratory testing (physiochemical, microbiological and biological analysis)
  2. Product examination

How we operate sampling activities

We have authorised officers who complete sampling activities. These officers are entitled to take samples without payment. This is provided for in legislation under the Irish Medicines Board Act.

The following medicines are included:

  • authorised human and veterinary medicines on the Irish marketplace,
  • medicines manufactured in Ireland for export,
  • clinical trial products,
  • active substances.

Our samples can be sourced from any point in the Irish supply chain, such as:

  • manufacturers,
  • wholesalers,
  • hospitals,
  • pharmacies,
  • patients.

How we operate testing and examination activities

Annually, more than 400 samples are included in the programme. About 75% are sent for laboratory analysis and the remainder are examined.

The laboratory analysis:

  • Uses the company’s registered test method. This allows us to evaluate the company's test methods and directly compare our laboratories' results with the company's results.
  • Checks that all of our laboratories' results comply with the company's registered specifications.

Samples that are not tested in a lab may be examined for:

  • Compliance with their registered product information. For example, to check that the company have included new safety warnings in the product information.
  • The readability of Braille on the product's packaging. We use a Braille Consultant to complete this.
  • Usability. We check if a product can be used as per the instructions in the package leaflet.

Who we work with

We work with our HPRA colleagues to ensure that our programme reflects current needs for surveillance.

We are an active member of an EU network of laboratories. This network is known as the Official Medicines Control Laboratory Network (OMCL). The function of this network is to:

  • Ensure EU surveillance testing activities deliver maximum, meaningful surveillance information,
  • Make best use of the available laboratory resources and capacity,
  • Ensure a collaborative approach to testing activities,
  • Encourage information sharing.

We also carry out surveillance activities which form part of the EU surveillance. This work is coordinated by the EDQM.