The update of the general data for Austria was sent to the European Commission on 03.03.2010. The last update was in July 2008. Since the updated document will be published on the Commission's website only in the next few weeks, you will find the list available for download. Queries: Institute Admission & Lifecycle Management DI Dr. Christa…

On March 21, 2010, an amendment to the Medical Devices Act (MPG) (Federal Law Gazette I No. 143/2009 of December 30, 2009) will come into force. Changes concern the reporting procedure for clinical trials with medical devices and the reporting obligations of adverse events. Overview of the reporting procedures according to § 40 MPG BGBl. Nr.…

Due to the current supply situation of certain radiopharmaceuticals, the Federal Office for Safety in Health Care (BASG)/AGES PharmMed points out particularities in the use of unapproved medicinal specialties, especially with unapproved radiopharmaceuticals. Radiopharmaceuticals are considered medicinal products/specialties and are therefore…

On 31.12.2009 the AMG amendment BGBl. I No. 146/2009 came into force, and with it the provision according to which medicinal products containing prohibited substances according to the Anti-Doping Act must include a special notice. This applies directly to newly approved proprietary medicinal products; for already approved proprietary medicinal…

The OMCL of AGES PharmMed recently tested wafers from illegal production that were fortified with anabolic steroids. The wafers were produced in Waldviertel and sold 30,000 times worldwide. According to OMCL analyses, they contained the two anabolic steroids methandienone or stanozolol, as well as traces of clenbuterol, yohimbine as well as…

§ Section 1 of the Pharmaceutical Operations Ordinance 2009 (AMBO 2009) circumscribes the scope of the operations ordinance. New regulations concern the scope of application in para. 3, in particular the demarcation from the "usual pharmacy operation" of public pharmacies or institutional pharmacies. In order to be able to quantify the extent of…

Due to technical changes and conversions, there were more error messages in the PharmaIS web portal from 27.11.2009 to 23.12.2009. If you have entered data for marketing during this period, we kindly ask you to check these entries and - if necessary - re-enter them. We regret this incident and thank you for your understanding.

As of Dec. 17, 2009, Vikela 1.5 mg tablet (levonorgestel) was made available without a prescription to women of all ages by a decision proposed by the Federal Office for Safety in Health Care (BASG). When used correctly, Vikela is a relatively safe method of preventing unwanted pregnancy after unprotected sexual intercourse or when a contraceptive…

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