How to Correctly Manage Quality Defects and Recalls?

In Europe, The EMA coordinates the assessment of reports of product quality defects of centrally authorized medicines.

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

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.

Marketing and/or manufacturing authorization holders are obliged to report to EMA any product quality defect, including a suspected defect, of a centrally authorized 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 authorization holders of centrally authorized 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.

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

EMA has a coordinating role between the marketing authorization 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.

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

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 organizations.

Related EU legislation:

- Regulation 726/2004

- Regulation (EU) 2019/6

- Directive 2001/83/EC

- EU GMP guidelines

Read also: Corrective and Preventive Action (CAPA) in Pharmaceutical Industry

Resource Person: BARBARA PIROLA

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