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4. Directions shall require licence holders to adopt such—
(a)systems to report, investigate, register and transmit information about serious adverse events and serious adverse reactions, and
(b)accurate, rapid and verifiable procedures for recalling from distribution any product which may be related to a serious adverse event or serious adverse reaction,
as are necessary to secure compliance with the requirements of Article 11 (notification of serious adverse events and reactions) of the first Directive and Article 5 (notification of serious adverse reactions) and Article 6 (notification of serious adverse events) of the third Directive.
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