Messages in brief
Federal Office for Safety in Health Care
Importation of active ingredients for medicinal products for human use: new regulation
As of 02.07.2013, new regulations apply to the import of active ingredients for medicinal products for human use into the European Union. As of this…
Risk for medication errors Methotrexate
Information: eService "Marketing Authorization and Lifecycle of Pharmaceutical Specialties
As of 01.07.2013, the transmission of Austrian product information texts is to take place via the eService "Marketing Authorization and Lifecycle Drug…
Highly Variable Drugs
If there are major differences in the measurement of pharmacokinetic parameters, such as the AUC or Cmax, after repeated administration of the…
Oral contraceptives
Combined oral contraceptives (COCs) are divided into four generations depending on the type of progestogen they contain.
The European Medicines…
Local scientific literature and suspected side effects
The "Guideline on good pharmacovigilance practices", Module VI obliges marketing authorization holders, among other things, to monitor the local…
Control of the distribution network
In order to achieve the highest possible level of health protection, very high quality requirements are placed on the manufacture of medicinal…
Discontinued pharmaceuticals
Unless marketing authorization holders have made use of the legal provision (Section 94 c (10) of the Austrian Medicines Act) and submitted the…
PANGEA V and BASG: Dubious Internet Sources of Supply
The BMG, BMI, BMF and BASG participated in this year's action week. The operation took place this year from 25.09. to 02.10.2012. In total, more than…
