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15/02/2010
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…
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28/01/2010
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…
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22/01/2010
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27/12/2009
§ 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…
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23/12/2009
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…
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18/12/2009
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…
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15/12/2009
Electronic submission possible for human medicines
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10/12/2009
As of 10.12.2009, a new, slightly modified application form is available for purely national variation applications. These changes are not related to the new Variation Regulation. We kindly ask you to use only the new form for your purely national…
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05/10/2009
PSUR Worksharing - Europe adopts Austrian practice
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18/09/2009
Reporting behavior of marketing authorization holders pleasingly good