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parties in the field of their professional activities in AGES MEA in the execution of the above-mentioned material laws. They shall not engage in any activity which may adversely affect the independence [...] innovation, interdisciplinarity, and excellence . European We live and promote the European idea. We actively participate in shaping the European regulatory environment, thereby contributing to safeguarding [...] is prohibited for this business division. AGES MEA thus operates independently of parties whose activities are regulated by the material laws under the jurisdiction of the BASG. The services of the BASG
the Federal Office for Safety in Health Care. Inspections are part of this market surveillance activities. An inspection can relate to all aspects that can influence the safety, functionality or quality
Care (BASG) any serious incidents of which they become aware as a result of their professional activities. The manufacturer or, if applicable, the authorized representative of the product must also be
amended, subject to surveillance by the BASG. Inspections are part of this market surveillance activities. An inspection can relate to all aspects that can influence the safety, functionality or quality
Care (BASG) any serious incidents of which they become aware as a result of their professional activities. The manufacturer or, if applicable, the authorized representative of the product must also be
Illegal websites New
counterfeits that either do not contain the active ingredient specified or contain the wrong concentration, or impurities or contaminations with other active compounds. How can you detect suspicious websites [...] of medicines without pharmacy licence, suspicion of fraud, selling of counterfeit medicines (no active substance present), potential health hazards osterreich24rx.com Information about this website: no
assessed in a worst case scenario. Active substances should also be included in the risk assessment in an appropriate way considering the source and the dilution of the active substance. Applications for marketing [...] the active substance? No. In accordance with the Guideline on `Excipients in the labelling and package leaflet of medicinal products for human use´, excipients used in the manufacture of the active substance [...] Is it necessary to determine the content of PA in all homoeopathic medicinal products containing active substances of herbal origin? 11. Pyrrolizidine alkaloids (PA): What limits for PA are acceptable
Contacts Media enquiries relating activities including press releases, press articles and interviews: presse-basg@basg.gv.at Functional E-Mail Addresses Subject E-Mail Active Substance Master File (ASMF, EDMF) [...] at Compassionate use compassionate-use@basg.gv.at Data protection datenschutz@basg.gv.at Dunning activities, due dates basg.mahnungen@basg.gv.at DHPC and education material dhpc-em@basg.gv.at eAF - regulatory [...] lus spp., Streptococcus spp., Phospholipids bovine/porcine (see also CMDh Overview of biological active substances of non-recombinant origin) Quality and Medical assessment of Herbal and Homeopathic Medicinal
containing more than one active ingredient, data on the combination should be provided. In case traditional use has been demonstrated for the combination, but not for the single active substances, data on the [...] registration. The phrase ‘same active ingredient’ is somewhat difficult to interpret, especially with respect to extracts from herbal drugs. However, what is clear is that ‘same active ingredient’ means the same [...] of at least 30 years of medicinal use has to be provided for the herbal active substance or the combination of the herbal active substances. For additional vitamins and minerals data have to be submitted