Summary of Product Characteristics
Encyclopedia
The Summary of Product Characteristics is a specific document required within the European Commission
before any medicinal product is authorized 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 to the European Medicines Agency
before marketing is authorized. The document is thus an intrinsic part of the authorization. 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 specific product safely and effectively. The package leaflet
supplied (Patient information leaflet
) with the product contains information from and is drawn up using guidelines 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.
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.
European Commission
The European Commission is the executive body of the European Union. The body is responsible for proposing legislation, implementing decisions, upholding the Union's treaties and the general day-to-day running of the Union....
before any medicinal product is authorized 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 to the European Medicines Agency
European Medicines Agency
The European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
before marketing is authorized. The document is thus an intrinsic part of the authorization. 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 specific product safely and effectively. The package leaflet
Package insert
A package insert or prescribing information is a document provided along with a prescription medication to provide additional information about that drug.-Responsible agencies:In the United States, the Food and Drug Administration determines the requirements...
supplied (Patient information leaflet
Patient information leaflet
Patient information leaflets are leaflets containing specific information about medical conditions, doses, side effects that packed with medicines to give the user information about the product. PIL is the European version of the Package insert. The PIL is written by the manufacturing...
) with the product contains information from and is drawn up using guidelines 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.
Limitation of data: Data included in the SPC is from the individual companies proposal to MHRA
Medicines and Healthcare products Regulatory Agency
The Medicines and Healthcare products Regulatory Agency is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe....
for licensing purposes only, so by its nature will not include speculative information.
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 PregnancyPregnancyPregnancy refers to the fertilization and development of one or more offspring, known as a fetus or embryo, in a woman's uterus. In a pregnancy, there can be multiple gestations, as in the case of twins or triplets...
and lactationLactationLactation describes the secretion of milk from the mammary glands and the period of time that a mother lactates to feed her young. The process occurs in all female mammals, however it predates mammals. In humans the process of feeding milk is called breastfeeding or nursing... - 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. PHARMACOLOGICALPharmacologyPharmacology is the branch of medicine and biology concerned with the study of drug action. More specifically, it is the study of the interactions that occur between a living organism and chemicals that affect normal or abnormal biochemical function...
PROPERTIES - 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. PHARMACEUTICAL PARTICULARS
- 6.1 List of excipientExcipientAn excipient is generally a pharmacologically inactive substance used as a carrier for the active ingredients of a medication. In many cases, an "active" substance may not be easily administered and absorbed by the human body; in such cases the substance in question may be dissolved into or...
s - 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
Sources
- Guidelines document produced by the EU for using and filling in the SPC.
- Package leaflet guidelines
- electronic Medicines Compendium, SPC explanation of headings
- electronic Medicines Compendium, Patient Information Leaflet