Before a medicine is granted a marketing authorisation and placed on the market, it is assessed against strict quality standards covering clinical trials, manufacturing and subsequent distribution.

Defective medicines and recalls

Before a medicine is granted a marketing authorisation and placed on the market, it is assessed against strict quality standards covering clinical trials, manufacturing and subsequent distribution. Nevertheless, manufacturing faults or other defects are sometimes discovered in medicines. The medicine then fails to work as intended and may even cause harm.

It is essential to report defective medicines to the Icelandic Medicines Agency, which assesses the nature of the defect. If the defect is considered serious, the medicine may be recalled and withdrawn from the market.

Definition of a defective medicine

A defective medicine does not have the characteristics specified in its marketing authorisation. The defect may be in the medicine itself, for example if something has gone wrong during manufacturing due to inadequate compliance with good manufacturing practice (GMP). This may result in effects that differ from those specified in the marketing authorisation, or the medicine’s appearance or texture may not be as expected. A defect may also involve incorrect labelling or damage to the packaging or dosing device. Such deviations can cause harm to the person using the medicine or lead to incorrect use.

Depending on the nature of the defect, it may be necessary to suspend sales of the medicine while an investigation is underway, or even recall it from pharmacies. When considering such measures, medicines regulatory authorities must weigh the risks against the benefits. In some cases, recalling a defective medicine or suspending its sale may pose a greater risk, for example if no comparable medicine is available and the defect is not expected to lead to serious incidents.

Falsified medicines

A falsified medicine is an imitation usually designed to resemble a genuine medicine as closely as possible. Examples include medicines that have been illegally repackaged, stolen medicines subsequently sold illegally through legitimate distribution and retail channels, and medicines containing poor-quality ingredients, ingredients in incorrect quantities, the wrong ingredients or an insufficient concentration of the active substance.

Falsified medicines can cause serious harm to people who use them, so reporting them is essential. Anyone who believes they have encountered a falsified medicine must report this to the Icelandic Medicines Agency without delay.

Healthcare professionals and people who use medicines, as well as manufacturers, marketing authorisation holders and wholesalers, can report suspected defective or falsified medicines.