SmPCs Characteristics

Summary of Product Characteristics (SmPC) (for products with marketing authorisation in the Community)... 

The first of these can be used when a product is to be marketed in a single country. It can be used for any type of application except for certain types of biotechnology-based items. Having been approved in one country, in most cases an application to a second country will trigger the Mutual Recognition procedure in other concerned countries. There are certain exceptions to this, e.g., where a product has different summaries of product characteristics (SmPCs) in different countries, and these have not been subjected to a harmonization procedure. Line extensions to such products could also remain subject to national procedures. 

PMO postmenopausal osteoporosis SmPC summary of product characteristics... 

Another source is the electronic Medicines Compendium (eMC http //emc.vhn.net/), with electronic versions of data sheets and Summaries of Product Characteristics (SPCs, sometimes also called SmPCs to differentiate them from Supplementary Patent Certihcates) for medicines. It provides the same information as that contained in the latest edition of the Compendium of Data Sheets and SPCs, which covers thousands of medicines licensed in the UK. As an ongoing process, the eMC is also incorporating the SPCs of several thousand other medicines approved by the licensing authorities. 

The doctor who has prescribed the medicine does not generally handle it personally. He or she does, however, require reliable information on the name, presentation and strength, indications, contra-indications, dosage instructions, precautions, interactions, side-effects and pack sizes which must be absolutely consistent with the details on the immediate label, carton label and any package leaflets enclosed. Since he or she does not handle the product, some other mechanism must be found to provide him or her with this information separately from the product. This is probably the SPC or summary of major product characteristics (SmPC, see below) data sheet. 

The key document from which all other text is derived, is the summary of product characteristics (SPC), sometimes referred to as the summary of major product characteristics (SmPC) to differentiate it, as abbreviated, from the supplementary protection certificate which is concerned with patent protection. 

European Commission. 2009. A guideline on summary of product characteristics (SmPC). Revision 2. Available from http //ec.europa.eu/health/files/eudralex/ vol-2/c/smpc guideline rev2 en.pdf. Accessed August 5,2014. 

Administer medicines (RTAs). Reconstitution of parenterals is not always described in the Summary of Product Characteristics (SmPC) and Package Information Leaflet (PIL). If so this process may be called reconstitution in excess of the SmPC (see Fig. 1.2). If this is considered to be a variance from the SPmC, it results legally in off-label use and should be supported by evidence, e.g. an appropriate risk assessment including the benefits and evidence about compatibility and a possible longer shelf life (see Sect. 22.6). 

Table 5.4 indicates the clinical adverse reactions which are highlighted in the summary of product characteristics (SmPC) for Betaferon, and whether preclinical studies predicted the outcome. 

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