Messages in brief
BASG Consultation
The increasing complexity of the legal materials AMG and MPG, in particular the areas of clinical testing, medical devices in general, in vitro…
Deadline for the extension of the authorisation of existing products
We would like to point out that the deadline set in accordance with Section 94c(10) of the Austrian Medicines Act, Federal Law Gazette No. 185/1983,…
Caution with methotrexate dosing in autoimmune disease.
Methotrexate (MTX) is used to treat severe forms of psoriasis, autoimmune diseases (e.g., rheumatoid arthritis), and various tumor diseases. It is…
Telephone inquiries / calls on behalf of AGES
The BASG / AGES Medical Market Inspectorate became aware that pharmaceutical companies were contacted by telephone in the name of AGES, or by persons…
Statement on metal on metal hip implants.
As early as April 2010, the Federal Office for Safety in Health Care was informed about potential problems with the use of metal-on-metal hip…
Good Vigilance Practice
The European Medicines Agency (EMA) has published a first tranche of modules of the Good Vigilance Practice (GVP) guide for public comment.
In…
Update: Xenical, alli (Orlistat)
The preparations Xenical and alli (active ingredient: orlistat) have been approved throughout Europe since 1998 and 2007, respectively, for weight…
Medical Device Tax Ordinance
This ordinance serves to implement the power to issue ordinances under Section 12a(2) of the Health and Food Safety Act. It regulates the detailed…
Ukrain (celandine extract)
The illegally sold and used drug Ukrain, which is advertised as a remedy against cancer, may not be manufactured and sold in Austria for the…
Propofol information
The Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen) has announced that propofol must not be used in children…