Specialist information (pharmaceuticals)
The product information for a drug is a detailed document that contains, among other things, data on the dosage form and strength, areas of application ( indications ), dosage , effect, side effects , drug interactions and contraindications ( contraindications ) of the preparation. Apart from a few national peculiarities such as sales demarcation or prescription status (over the counter, pharmacy , prescription , prescription narcotic or narcotic drug, repeated dispensing), the content of the technical information corresponds to the summary of the characteristics of the drug . The specialist information is aimed primarily at specialist groups in the health professions , is generally accessible to all citizens and can be accessed online from the drug authorities .
Legal regulation
The text of the technical information must be approved by the competent authority, i. H. from the European Commission or the relevant national authority. In Germany this is the Federal Institute for Drugs and Medical Devices (BfArM), in Switzerland the Swiss Medicines Institute Swissmedic and in Austria the (federal) Austrian Agency for Health and Food Safety (AGES, Medical Market Supervision Division).
For national approvals in Germany, the Drugs Act regulates the content and sequence of the information . It also obliges pharmaceutical representatives to present the specialist information on the medicinal products discussed when they visit a doctor.
See also
- Yellow list
- EudraPharm
- PharmNet.Bund
- Red List
- Drug information publication system AIPS
- Swiss Medicines Compendium
Web links
- BfArM database of sample and reference texts for specialist information
- Specialist information Yellow List Online. Medical Media Informations GmbH
Individual evidence
- ↑ Technical information BfArM 2006, p. 8 "Sales definition".
- ↑ BASG - prescription requirement , August 8, 2018.
- ↑ AMG § 11a
- ↑ AMG § 76