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The summary of product characteristics is a synopsis of the marketing authorisation file forming one of its three appendices validated during the procedure. Drawn up in accordance with regulatory standards, it can be considered as an “identity card” providing a reference framework for health professionals prescribing and dispensing medicines.
From secret remedies to proprietary medicines, regulations concerning drugs have increased over time in order to guarantee patients maximum safety. The marketing authorisation procedure now stipulates the conditions and precautions of use of all available medicines.
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