Sampling and analysis of veterinary medicines

Our role

The sampling and analysis programme contributes to the HPRA role in protecting human and animal health. This is achieved by monitoring 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

The HPRA has 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:

  • checks that all results comply with the registered pharmaceutical company specifications,
  • uses the company’s registered test method so that we can also evaluate the test methods and allow for direct comparison.

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

  • compliance with their registered product information, for example, to check new safety warnings have been included in the product information,
  • the readability of Braille on the packaging by the HPRA Braille Consultant,
  • determining if they can be used as per the instructions in the package leaflet.

Who we work with

We work alongside 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.