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Version 01/2006 CMD v ANNOTATED QRD TEMPLATE MRP/DCP adapted version based on version 7 of 8/2005 SUMMARY OF PRODUCT CHARACTERISTICS NOTE the following are those items of information required by Article 14 of Directive 2001/82/EC as amended the Guideline on Summary of the Product Characteristics SPC - Pharmaceuticals and the Guideline on Summary of the Product Characteristics SPC - Immunologicals and current practice in the Mutual Recognition and...
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What is summary of product characteristics?
Summary of product characteristics is a regulatory document that provides a comprehensive summary of the characteristics and properties of a medicinal product. It includes information on its indications, contraindications, dosage, administration, precautions, and other relevant details.
Who is required to file summary of product characteristics?
Marketing authorization holders or pharmaceutical companies are required to file the summary of product characteristics for each medicinal product they want to market.
How to fill out summary of product characteristics?
The summary of product characteristics is filled out by providing accurate and up-to-date information about the medicinal product in a standardized format. This includes details on the product's indications, contraindications, dosage, administration, precautions, and any other relevant information specified by regulatory authorities.
What is the purpose of summary of product characteristics?
The purpose of the summary of product characteristics is to provide healthcare professionals and patients with essential information about a medicinal product. It helps ensure the safe and effective use of the product by providing comprehensive information on its characteristics, indications, contraindications, and other relevant details.
What information must be reported on summary of product characteristics?
The summary of product characteristics must include information on the medicinal product's indications, contraindications, dosage, administration, precautions, interactions, adverse reactions, and any other relevant details specified by regulatory authorities.
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