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28 Oct 2014

What is the meaning of summary of product characteristics (SmPC)?

A document describing the properties and the officially approved conditions of use of a medicine. Summaries of product characteristics form the basis of information for healthcare professionals on how to use the medicine safely and effectively. Abbreviated as SmPC.

Importance SmPC

The Summary must be completed and submitted as an application to the European Medicines Agency, the European Chemicals Agency or one of the national competent authorities of the Member States before marketing is authorized. The document is thus an intrinsic part of the authorization and can only be changed after approval by means of an approved Variation.

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