Based on a re-evaluation of the safety and efficacy data, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommends the withdrawal of the marketing authorization for all bufexamac-containing medicinal products within the EU, as the benefit/risk ratio for these preparations is no longer given.…

AGES PharmMed receives a large number of requests for decentralized procedures (DCP) and mutual recognition procedures (MRP) to act as procedure managing state (RMS). The slot allocation procedure for DCP submissions has been designed to allow for the best possible planning of requests and optimal utilization of reviewer resources. AGES PharmMed…

On March 29, 2010, the delivery of generic drugs containing Clopidogrel, which used the active ingredient of the supplier Glochem Industries Ltd., was stopped for the time being on wholesale level by BASG/AGES PharmMed. It was determined that the production of the active ingredient was not carried out in compliance with GMP (Good Manufacturing…

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…