The Rapid Alert System for the PIC/S Member Countries

GMP News No. 248

GMP News
15 October 2002

 The Rapid Alert System for the PIC/S Member Countries

On 1 July, the PIC document PI-010-1 titled "Procedure for Handling Rapid Alerts and Recalls arising from Quality Defects" came into force. The document is declared as SOP and describes the implementation of urgent measures in case of quality defects in medicinal products for human or veterinary use. The SOP is operative in all countries with which a bi- or multilateral agreement exists, i.e. all PIC/S countries and MRA partners.

The wording of the document is to a great part identical with that of a corresponding Guideline with the same title, which already came into force in the EU member states and the MRA partner countries on 1 May 2000. Only the section on the responsibility for issuing a Rapid Alert Notification contains far more details in the EU document (e.g. different kinds or sizes of packaging have to be indicated in a RAN). In contrast to this, the PIC/S SOP only reads:

"The Competent Authority of the party in which the defect was first identified should issue the Rapid Alert."

The Alert System is based on the division of the quality defects into three classes:

  • Class I defects are potentially life threatening. A Rapid Alert notification must be sent to all parties, irrespective of whether or not the batch was exported to that country.

  • Class II defects could cause illness or mistreatment, but are not Class I. A Rapid Alert notification should be sent only to those parties to which it is known, or believed, that the batch has been distributed. In the case of parallel imports where there is difficulty in establishing the traceability of batches, consideration should be given to notifying all parties by the Rapid Alert System.

  • Class III defects may not pose a significant hazard to health, but withdrawal may be initiated for other reasons. These are not notified through the Rapid Alert System.

With the introduction of this PIC/S document, the regulations of the Rapid Alert System - including the form for the Rapid Alert Notification - are in force not only within the EU and MRA partner countries, but "PIC-wide", i.e. from Canada to Singapore and from Romania to Malaysia, which joined PIC/S in January this year.

The Rapid Alert System also has to be implemented in the case of fraud and counterfeit products (see Chapter 6). One can only hope that this regulation will help to fight the product piracy and to remove the potentially dangerous counterfeit medicinal products rapidly from the market. 

The document PI 010-1 can be downloaded directly from the PIC/S website via this link.

Dr Gerhard Becker

Go back

GMP Conferences by Topics