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 to cooperate more closely in the future in the regulation of medicinal products for the diagnosis and immunotherapy of allergies. Prof. Stefan Vieths, Vice President of the PEI, and Prof. Vera…

The marketing authorization holder has informed its supplied customers in a letter dated December 27, 2018, that the above-mentioned batch occasionally shows a yellow coloration of the infusion solution concentrate outside the approved color specification. For this reason, the above batch is being recalled as a precautionary measure.

No acute danger, all packages available in Austria have already been recalled by BASG.

Situation in Austria The Federal Office for Safety in Health Care (BASG) has received information that several packages of the drug "ALIMTA 500 mg Powder for the Preparation of a Concentrate for the Preparation of an Infusion Solution", for which there is an urgent suspicion of counterfeiting, have entered the legal distribution chain through…

Supposed natural products turn out to be counterfeit drugs.

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 submitted and processed electronically via the web form at the Federal Office for Safety in Health Care. The PDF forms used in recent years will no longer exist for the 2018 levy declaration. You will…

The marketing authorization holder informed its supplied customers in a letter dated December 18, 2018, that follow-up inspections of the finished product revealed isolated glass defects in the area of the bottle neck. This rarely occurring, production-related defect affects the tightness of the piercing bottle. For this reason, the above batch is…

The Federal Office for Safety in Health Care was notified by the DanishDanish authority that this from the Danish tissue bank Cryos International (DK257551) about the disease of the donor with the donor ID QADIR was.In the course of DNA analysis of the donor, a heterozygous variant at theCFTR-gene (NM_000492.3:c.1046C>T.p.Ala349Val)was…

The Federal Office for Safety in Health Care was informed by the Danish authority that it was informed by the Danish tissue bank Cryos International (DK257551) about the disease of a child conceived with the semen of the sperm donor MITTO. In the report of the disease, a 5-year-old child was diagnosed with autism.

In the past, "Poppers" have been defined as functional drugs by the Federal Office for Safety in Health Care (BASG). This classification was also confirmed in 2014 by a ruling of the Administrative Court (see below), whereby the provisions of the Medicines Act applied to the marketing of "Poppers". By a later decision of the European Court of…