Quality defects and recalls

The European Medicines Agency (EMA) coordinates the assessment of reports of product quality defects of centrally authorised medicines.

This content applies to human and veterinary medicines.

Medicinal products with a quality defect are not of the correct quality as defined by their marketing authorisation.

It is important to report these defects in a timely manner because sometimes it is necessary to implement urgent measures to protect public health and animal health, such as the recall of one or more defective batch(es) of a medicine from the market or prohibition of supply.

Also on this topic

• Reporting a quality defect to EMA

Reporting obligations

Marketing and/or manufacturing authorisation holders are obliged to report to EMA any product quality defect, including a suspected defect, of a centrally authorised medicine which could result in a recall or abnormal restriction on supply. This includes:

• any prohibition or restriction imposed by the competent authority of any country in which the medicinal product is placed on the market;
• any new information that might influence the evaluation of the benefits and risks of the medicine, including systematic information on warnings relating to manufacturing problems issued by competent authorities outside the European Economic Area (EEA);

In addition, marketing authorisation holders of centrally authorised medicines should notify the national competent authorities of the Member States or third country authorities where the suspected defective products are distributed or are to be supplied in the event of a restriction to supply.

EMA maintains a reporting system consisting of the 

Defective product report form

 

(Note: This 'Defective product report' form needs to be opened with a PDF reader. EMA advises to save the document first, and then open with a PDF reader, such as Acrobat Reader. To report any technical issues with the form, please use the EMA Service Desk (ServiceNow) portal.) 

Marketing and/or manufacturing authorisation holders are required to use the defective product report template to notify EMA of:

• quality defects of centrally authorised medicines;
• restrictions in supply due to a quality defect or good manufacturing practice issue impacting centrally authorised medicines.

EMA updated the defective product report template to incorporate Medical Dictionary for Regulatory Activities (MedDRA) terminology in April 2018. EMA encourages national competent authorities to use this template for national reporting.

For more information, see:

• Reporting a quality defect to EMA

For product quality defects of nationally authorised medicines, marketing and/or manufacturing authorisation holders should notify the relevant national competent authority(ies).

Assessment of reports of product quality defects

EMA has a coordinating role between the marketing authorisation holder, the rapporteur(s) responsible for the product at EMA's relevant scientific committee, the supervisory authority and the national competent authorities where the product is marketed.

The rapporteur(s) and the supervisory authority assess the report of the quality defect and provide recommendations on regulatory actions, as necessary.

The assessment takes into consideration:

• the risk to patient or animal health;
• the extent of the quality defect in term of batches and market distribution;
• the impact on the market;
• the root cause(s) of the defect;
• any immediate or long-term corrective action and preventive actions (CAPAs).

EMA informs the marketing authorisation holder of the outcome of the assessment.

Rapid alerts and recalls

If the nature of a product quality defect of a medicinal product presents a serious risk to public and animal health, national competent authorities inform each other through the rapid alert system.

EMA is responsible for maintaining a rapid alert list of contact points, which includes national competent authorities in EEA Member States, the European Commission and international partner regulatory authorities and organisations.

EMA maintains the forms included in the procedure for management of rapid alerts arising from quality defects risk assessment. These forms are agreed by all Member States and are for regulators use only. 

The forms should be downloaded and saved before being completed, using for example your browser's “Save link as” function. To report any technical issues with the forms, please use the EMA Service Desk (ServiceNow) portal.

Rapid alert notification of a quality defect / recall

Follow-up and non-urgent information for quality defects

For more details, see:

• Compilation of Union procedures on inspections and exchange of information