Messages in brief
German and Austrian drug agencies intensify cooperation on regulation of allergen products
A team from the Austrian Federal Office for Safety in Health Care (BASG) was a guest at the Paul Ehrlich Institute (PEI) on Jan. 14, 2019. The aim was…
Falsification suspicion of parallel-imported "ALIMTA 500 mg powder for the preparation of a concentrate for infusion solution".
Situation in Austria The Federal Office for Safety in Health Care (BASG) has received information that several packages of the drug "ALIMTA 500 mg…
Changes in the declaration procedure for the medical device levy 2018
The procedure for declaring duties for the year 2018 will change fundamentally as of 01.01.2019. As of this date, the self-declaration must be…
Fluoroquinolones: restrictions on use
Action at EU level The European Medicines Agency (EMA) has scientifically reassessed the serious, disabling and potentially permanent side effects of…
Round table on "Availability of medicines in Austria" (1)
On November 27, 2018 a big "round table" took place on the topic of availability of medicines in Austria. At the top-class event, which was organised…
BASG OMCL plans to join the WHO-National Control Laboratory Network for Biologicals
Production-related contamination with N-nitrosodiethylamine (NDEA) in the active ingredient valsartan from the manufacturer "Mylan Laboratory Limited".
"Valsartan/HCT ratiopharm 80 mg/12.5 mg Film-Coated Tablets" and "Valsartan/HCT ratiopharm 160 mg/25 mg Film-Coated Tablets" (active ingredient:…
Mock-Up-Guidance Document
To summarize legal provisions, requirements regarding content as well as information how to submit and handle Mock-Ups a new Guidance Document was set…
Recall of Jakavi 15 mg tablets due to suspected counterfeiting
Situation in Austria: The Federal Office for Safety in Health Care has received information that several packages of the drug Jakavi 15 mg tablets,…
Possible longer usability of "EpiPen 300 microgram solution for injection in a ready-to-use pen" to alleviate the current supply shortage
Information is provided on the possibility of prolonged usability of certain batches of "EpiPen 300 microgram solution for injection in a ready-to-use…
