Product defects and recalls

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This content applies to human and veterinary medicines. 

In order to protect public health and animal health, it may become necessary to implement urgent measures such as the recall of one or more defective batch(es) of a medicinal product from the market.

Every holder of a Manufacturing Authorisation is required to implement an effective procedure for the recall of defective products. The authorisation holder is required to notify the relevant Competent Authority of any defect or abnormal restriction that could result in a recall. Instructions on Notifying Quality Defects or Product Recalls of centrally authorised products are provided. See the instructions page for details.

For centrally authorised products Marketing Authorisation Holders are reminded, in accordance with Regulation 726/2004, Articles 16(2) and 41(4), to inform the European Medicines Agency of any prohibition or restriction imposed by the competent authority of any country in which the medicinal product is placed on the market and of any other new information might influence the evaluation of the benefits and risks of the medicinal product concerned. This includes systematic information on warning letters issued by non-EEA regulatory authorities relating to manufacture problems.

Procedure for dealing with Reports of Defective Medicinal Products

This procedure describes the actions and responsibilities regarding product defects for the rapid and efficient handling of urgent situations involving a centrally authorised human and/or veterinary medicinal product. The SOP outlines the procedures to be followed in order to deal with any urgent situation highlighting the interactions between the European Medicines Agency staff involved in the procedure and the Supervisory Authority(ies), the (Co)Rapporteur, the CxMP members, the European Commission (EC) and the Marketing Authorisation Holder (MAH).

Report on Quality Defects

An analysis of quality product defects in the centralised procedure was completed in 2005. A total of 65 product defects were reported to the European Medicines Agency of which 20 resulted in product recalls.

Documents of interest

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Document(s) Language Status First published Last updated Effective Date
Crisis Management regarding Defects of Centrally Authorised Products - Classification of Batch Recalls for Quality Defects (English only) adopted 2008-07-03    
An analysis of quality product defects in the centralised procedure (English only) adopted 2007-01-18   2007-01-18

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Send all queries regarding this content to: qdefect@ema.europa.eu