The National Immunization Schedule 2019 ("Österreichischer Impfplan") is now available. link: https://www.sozialministerium.at/site/Gesundheit/Krankheiten_und_Impfen/Impfen/Oesterreichischer_Impfplan_2019

In December 2018 the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a guideline on the assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products. The calculated threshold values are intended to ensure the safety of medicinal products for veterinary use not only for animals but also for the…

The EMA published a revision of the “Guideline on the environmental risk assessment (ERA) of human medicines” on 30 November 2018. The guideline is now open for public consultation until 30 June 2019. The purpose of the ‚Guideline on Environmental Risk Assessment of Medicinal Products for Human Use‘ (EMEA/CHMP/SWP/4447/00 Corr 2) is the…

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…

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 marketing authorization holder informed its supplied customers in a letter dated December 3, 2018, that there are increased reports of side effects for the two batches 180619 and 180620, which refer to "severe burning sensation in the eye". The batches correspond in terms of quality, but are being recalled as a precaution due to the side effect…