Summary of Product Characteristics
The summary of product characteristics is an essential part of the product of each drug and summarizes the key features and related information together, as agreed between the pharmaceutical company and the competent regulatory authority. Familiar and commonly used is mainly the English term, Summary of Product Characteristics (SPC, also SmPC for differentiation of Supplementary Protection Certificate). It is virtually identical to the prescribing information of each drug.
Within the framework of Directive 2001/83/EC of the European Parliament and Council form and content were determined for the SPC for human use within the European judicial area:
- Trade name
- Qualitative and quantitative composition
- Dosage form
- Clinical information such uses ( indications), Posology 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 ( contained other ingredients ( excipients), shelf life, information on the container or packaging, special precautions for storage, etc.)
- Authorization holder (usually a pharmaceutical company )
- Approval number
- Date of approval
- Date of Text Revision
SPC is developed during the process of the Drug. For this, a proposal is submitted by the applicant as part of the NDA. Once the procedure is completed, the wording of the SPC contains the agreed between the relevant regulatory authority of the Member State concerned and the applicant, definitive statement of the medicinal products concerned. The competent authority shall make the SPC approved each of their product available to the public.
Key contents of the SPC can not be changed without the consent of the competent authority. In addition to serving as a basis for specialized information regarding the safe and effective use of this product, it forms the basis for the content of the leaflet. It must be written in the official language of the Member State in which the product is authorized and shall be placed on the market.