User:DavidLon/Summary of Product Characteristics

The Summary of Product Characteristics is a specific document required within the European Commission before any medicinal product is authorised for marketing. This summary is the definitive description of the product both in terms of its properties, chemical, pharmacological and pharmaceutical etc and the clinical use to which it can put. The EU provide guidelines on the use of this document for applicants.

The Summary must be completed and submitted as an application before marketing is authorised. The document is thus an intrinsic part of the authorisation. This document can thus not be changed following approval.

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 specicic product safely and effectively. The package leaflet supplied with the product contains information from and is drawn up using guidlines 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 electronic Medicines Compendium. This is not the same structure in use by the British BNF although that organization takes data from the SPC for the products it indexes.

Summary of Product Characteristics
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

Links

 * Guidelines document produced by the EU for using and filling in the SPC. http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/eudralex/vol-2/c/spcguidrev1-oct2005_en.pdf
 * Package leaflet guidlines http://www.ema.europa.eu/pdfs/human/productinfo/3bc7a_200307en.pdf