Summary of Product Characteristics

The summary of the product characteristics is an essential product component of every medicinal product and summarizes its essential properties as well as accompanying information, as agreed between the pharmaceutical company and the responsible regulatory authority. The English term Summary of Product Characteristics (SPC , also SmPC to distinguish between Supplementary Protection Certificate ) is common and in common use . It is practically identical to the product information for the medicinal product in question.

Legal basis and content

As part of Directive 2001/83 / EC of the European Parliament and of the Council , the form and content for the SPC of a medicinal product for human use within the European legal area were defined:

• Trade name
• Qualitative and quantitative composition
• Dosage form
• Clinical information such as applications ( indications ), dosage , type and method of administration, Contraindications ( contraindications ), precautions for use, interactions , use in pregnancy and lactation , effects on ability to drive and the ability to operate machinery, side effects and overdose
• Pharmacological properties
• Pharmaceutical properties (other ingredients contained ( auxiliary materials ), shelf life, information on the container or packaging, special precautionary measures for storage, etc.)
• Marketing authorization holder (usually a pharmaceutical company )
• Approval number
• Date of approval
• Date of text revision

Origin and use

The SPC is developed during the drug approval process. To this end, a proposal is first submitted by the applicant as part of the approval application. Once the procedure has been completed, the wording of the SPC contains the final statement on the medicinal product concerned as agreed between the competent medicinal product authority of the member state concerned and the applicant. The competent authority must make the SPC of each drug approved by it available to the public.

Essential contents of the SPC cannot be changed without the consent of the competent authority. In addition to its function as the basis for the specialist information relating to the safe and effective use of the drug, its content also forms the basis for the package insert . It must be written in the official language of the member state in which the medicinal product is authorized and is to be placed on the market.

Web links

• Homepage of the European Medicines Agency (EMA)
• Heads of Medicines Agencies website (homepage of the national drug approval authorities in the EU)
• European Commission / Directorate General for Health and Food Safety - Legal framework (English)
• Extract from the instructions for manufacturers regarding SmPC (English; PDF file; 40 kB)