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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:
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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.
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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.
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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.
Writer:
Dr Gerhard Becker
CONCEPT HEIDELBERG
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