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Inspections - Product Defects and Recalls


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.

For centrally authorised products Marketing Authorisation Holders are reminded, in accordance with Regulation 726/2004, Articles 16(2) and 41(4), to inform the EMEA 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.

Competent Authorites should ensure that information concerning the recall of medicinal products is notified rapidly to other Member States, if the nature of the defect presents a serious risk to public health. This information is communicated using the Rapid Alert Procedure.

The aim of the Rapid Alert Procedure is to transmit only those alerts whose urgency and seriousness cannot permit any delay in transmission. In each case a professional assessment must be made of the seriousness of the defect, its potential for causing harm to the patient or (in the case of a veterinary product) harm to animals, consumers, operators and the environment, and the likely distribution of the affected batch(es).

Every holder of a Manufacturing Authorisation in accordance wtith Article 40 of Directive 2001/83/EC and Article 44 of Directive 2001/82/EC is required under Article 13(1) of Directive 2003/94 and Article 13 of Directive 91/412/EC to report to the Competent Authorities (EMEA and/or Supervisory Authority) any defect in a medicinal product under their authorisation that could result in a recall or abnormal restriction on supply.

Procedure for dealing with Reports of Defective Medicinal Products effective 1 April 2007.

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 EMEA 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

A report on quality defects of centrally authorised products in 2005 was completed. A total of 65 product defects were reported to the EMEA of which 20 resulted in product recalls.

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