Defective medicines and recalls

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This section describes the obligations placed on marketing- and manufacturing-authorisation holders concerning defective centrally authorised medicines, as well as importers and parallel distributors. European Union legislation sets out these obligations, which apply to medicines for human or for veterinary use.

A defective medicine is a medicine:

  • that may prove to be harmful under normal conditions of use;
  • that is found to be lacking in therapeutic efficacy;
  • whose benefit-risk balance may not be favourable under the authorised conditions of use, due to:
    • faulty manufacture;
    • product deterioration;
    • detection of falsification;
    • non-compliance with the marketing authorisation;
    • any other serious quality problem;
  • whose qualitative or quantitative composition is not as declared;
  • whose controls (on the medicine itself or its ingredients) or whose controls at an intermediate stage of the manufacturing process have not been carried out;
  • for which some other requirement or obligation relating to the granting of the manufacturing authorisation has not been fulfilled.

According to the compilation of Community procedures, a suspected defective product is a medicine about which a report has been received suggesting that it is not of the correct quality, as defined by its marketing authorisation.

Defective medicines can include medicines that have been falsified. This means medicines with a false representation of their identity, source or history. For more information, see falsified medicines.

Classes of defect

There are three classes of defect, based on their risk to public health:

  • class I: defects that are potentially life-threatening or could cause a serious risk to health;
  • class II: defects that could cause illness or mistreatment but are not class I;
  • class III: defects that may not pose a significant hazard to health but where withdrawal of the medicine may be indicated for some other reason, but which are not class I or II.

For more information, see classification of batch recalls for product defects.

Reporting defective medicines

Marketing-authorisation holders, manufacturers, importers and parallel distributors of centrally authorised human or veterinary medicinal products should report any defective medicine to the European Medicines Agency where the defect is due to:

  • faulty manufacture;
  • product deterioration;
  • detection of falsification;
  • non-compliance with the marketing authorisation;
  • any other serious quality problem that may lead to a recall or a restriction in the supply.

This requirement applies wherever batches are distributed in the world, either within or outside of the European Economic Area.

This includes suspected product defects that could lead to a recall or an abnormal restriction in the supply of a centrally authorised medicine and its active substances for human or veterinary use, as well as a falsified centrally authorised medicine discovered in the supply chain. The Agency should be informed as soon as the marketing-authorisation holder, manufacturer, importer or parallel distributor has initiated an investigation into a defect that may lead to a batch recall or abnormal restriction in supply. If the root-cause investigation has not been completed, a preliminary report should be submitted together with a plan and timetable for its completion.

Reporting requirements can also apply to investigational medicines for which a centralised marketing authorisation has been issued. In these cases, the manufacturer of the investigational medicine should inform the marketing-authorisation holder, in cooperation with the sponsor, of any defect that could be related to the authorised medicinal product. Consequently, the marketing-authorisation holder should inform the Agency.

Marketing-authorisation holders, manufacturers, importers and parallel distributors also have an obligation to inform the medicines regulatory authority where the batches in question are distributed.

Patients with a concern about the quality of a medicine should contact their healthcare provider. Healthcare providers should contact their national medicines regulatory authority and the marketing-authorisation holder. 

For full details, see how to report a defective medicine.

Procedure for dealing with reports of defective medicines

The Agency coordinates the assessment of reports of suspected product defects and the communication of risk-reducing measures to national European regulators and international partners, where appropriate.

Depending on the urgency of the defect and the risk to public or animal health, the Agency and national regulators may implement urgent measures, such as the recall of one or more defective batches of a medicine from the market.

It does this by using rapid alerts. These are urgent notifications from one competent authority to other authorities that a batch recall has been instituted in the country originating the rapid alert. The aim of rapid alerts is to transmit only those alerts whose urgency and seriousness cannot permit any delay in transmission between the competent authorities, for instance that a batch recall has be counterfeit or fraud in active pharmaceutical ingredients or investigational medicinal products may fall in the scope of this procedure.

Report on quality defects

The Agency carried out an analysis of product defects in 2005. The analysis found that a total of 65 product defects had been reported to the European Medicines Agency, with 20 of these resulting in recalls:

Supply issues due to quality defects

The occurrence of shortages of medicines due to manufacturing and quality problems has increased over the past few years.

For more information, see good-manufacturing-practice and good-distribution-practice compliance.

In the future, the Agency plans to publish a catalogue of medicines that have experienced a shortage or recall.

More information

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