Summary of Product Characteristics

The Summary of Product Characteristics (SPC or SmPC) is a specific document required within the European Commission before any medicinal product or biocidal product is authorized for marketing. This document is required under a number of different European Regulations, e.g. Regulations concerning medicines and Regulations concerning biocidal products.^[1] Depending on which Regulation this document is required under the fields contained in the summary may vary. However, in general this summary is the definitive description of the product both in terms of its properties, chemical, hazardardous properties, pharmacological and pharmaceutical etc. and the clinical use or industrial use to which it can put. The EU provide ^[2] on the use of this document for applicants.

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.

The SPC is not intended to give general advice about treatment of a condition but does state how the product is to be used for a specific treatment. It forms the basis of information for health professionals to know how to use the specific product safely and effectively. The package leaflet supplied (Patient information leaflet) with the product contains information from and is drawn up using ^[3] set out for the purpose.

The summary list is the structure used by a number of organizations when medicine information is delivered from web sites such as the ^[4] This is not the same structure in use by the British BNF^[5] although that organization takes data from the SPC for the products it indexes.

Limitation of data: Data included in the SPC is from the individual companies proposal to MHRA for licensing purposes only, so by its nature will not include speculative information.

The list of headings that organizes the information

• 1. NAME OF THE MEDICINAL PRODUCT
• 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
• 3. PHARMACEUTICAL FORM
• 4. CLINICAL PARTICULARS
  • 4.1 Therapeutic indications
  • 4.2 Posology and method of administration
  • 4.3 Contraindications
  • 4.4 Special warnings and precautions for use
  • 4.5 Interaction with other medicinal products and other forms of interaction
  • 4.6 Pregnancy and lactation
  • 4.7 Effects on ability to drive and use machines
  • 4.8 Undesirable effects
  • 4.9 Overdose
• 5. PHARMACOLOGICAL PROPERTIES
  • 5.1 Pharmacodynamic properties
  • 5.2 Pharmacokinetic properties
  • 5.3 Preclinical safety data
• 6. PHARMACEUTICAL PARTICULARS
  • 6.1 List of excipients
  • 6.2 Incompatibilities
  • 6.3 Shelf life
  • 6.4 Special precautions for storage
  • 6.5 Nature and contents of container
  • 6.6 Special precautions for disposal and other handling
• Administrative Data
• 7. MARKETING AUTHORISATION HOLDER
• 8. MARKETING AUTHORISATION NUMBER(S)
• 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
• 10. DATE OF REVISION OF THE TEXT
• 11. DOSIMETRY (IF APPLICABLE)
• 12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

See also

• Patient information leaflet

References

2. guidelines
3. guidelines
4. electronic Medicines Compendium
5. British BNF

General

• European Commission (2009): A guideline on summary of product characteristics (SmPC)
• How to prepare and review a summary of product characteristics, Webpage
• electronic Medicines Compendium, SPC explanation of headings
• electronic Medicines Compendium, Patient Information Leaflet