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Greek Pharmacovigilance Legislation

National Organization for Medicines Circular 70473 01-10-2013

Requirement to add: (a) specific text regarding ADR reporting in SmPC and PIL; (b) a black triangle in SmPC and PIL; and (c) specific text in educational material that is part of RMPs in order to promote ADR reporting by HCPs and consumers.

[Original text: GR]

 

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