A document describing the properties and the officially approved conditions of use of a medicine. Summaries of product characteristics form the basis of information for healthcare professionals on how to use the medicine safely and effectively. Abbreviated as SmPC.
Summary of Product Characteristics also can be abbreviated as SPC.
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.
Content of Summary of Product Characteristics
SmPC contains the Product Summary. Here is topics which ideally includes in SmPC.
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
4.4. Special warnings and precautions for use
4.6. Pregnancy and lactation
4.7. Effects on ability to drive and use machines
4.8. Undesirable effects
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
5.2. Pharmacokinetic properties
5.3. Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
6.3. Shelf life
6.4. Special precautions for storage
6.5. Nature and contents of container
6.6. Instruction for use and handling (, and disposal)
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
SmPC is the basis of information for health professionals on how to use the medicinal product safely and effectively. They are written and updated by pharmaceutical companies and are based on their research and product knowledge.