Red-hand letter
The Rote-Hand-Brief (RHB) is a form of information letter commonly used in Germany with which pharmaceutical companies inform health professionals about newly identified drug risks, recall faulty drug batches or provide other important information. In English , information letters called Dear Doctor Letters (actually Direct Healthcare Professional Communication , DHPC ) correspond to the Rote-Hand-Letters .
The designation with the symbol of a "red hand" goes back to an initiative of the Federal Association of the Pharmaceutical Industry (BPI) and was introduced in 1969. The symbol is a registered trademark of the BPI. In accordance with the codes of the BPI and the Voluntary Self-Regulation for the Pharmaceutical Industry (FSA), the member companies have agreed to use a uniform presentation and not to use this for other mailings (advertisements, advertising material, etc.). The red hand symbol with the inscription “Important information about a medicine” is affixed to both the envelopes and the letters themselves.
According to the German Medicines Act, Section 11a , Paragraph 2, pharmaceutical entrepreneurs are obliged to make changes to the specialist information that are important for therapy available to specialist groups in a suitable form. Rote-Hand-Letters are distributed in consultation with the responsible German higher federal authority, the Federal Institute for Drugs and Medical Devices (BfArM) or the Paul Ehrlich Institute (PEI). Both work with the supervisory authorities of the federal states, the authorities of other European countries and with the European Medicines Agency (EMA), especially the " Pharmacovigilance Risk Assessment Committee " ( PRAC) located there. You are also in contact with authorities in non-European countries, the World Health Organization (WHO) and the medicinal product commissions of the medical professions .
Web links
- Publication of Rote-Hand letters for pharmaceuticals in the area of responsibility of the Federal Institute for Drugs and Medical Devices (BfArM)
- Publication of Rote-Hand letters for medicinal products in the area of responsibility of the Paul Ehrlich Institute (PEI)
- Current Rote-Hand- Liefe on the website of the Drugs Commission of the German Medical Association (AKdÄ) including an image of the symbol
Individual evidence
- ^ Center for Drug Evaluation and Research: Dear Health Care Provider Letters: Improving Communication of Important Safety Information. April 10, 2019, accessed January 7, 2020 .
- ^ Chronicle of the BPI - The 1960s ( Memento of February 18, 2011 in the Internet Archive ), accessed December 19, 2013.
- ↑ Trademark register of the DPMA , register number: 30052433 , registered November 27, 2000.
- ↑ Federal Association of the Pharmaceutical Industry: Code of the members of the Federal Association of the Pharmaceutical Industry eV in the version of June 28, 1995, last amended by a resolution of the BPI management with effect from November 27, 2001, § 27. In: Pharma Codex 2014, Volume 1, Ed .: BPI-Service GmbH, Berlin 2014, ISBN 978-3-9814054-6-0 , p. 813.
- ↑ FSA Code of Conduct for Cooperation with Experts of May 20, 2014, Section 14.