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Importation Act (Arzneiwareneinfuhrgesetz, AWEG) The shipment of blood products has to be notified to BASG at least 3 weeks in advance (Art 14 AWEG). This has repeatedly resulted in problems when using the [...] needed but the 3-week waiting period applies, trial sites wish to hold IMP in stock, etc.). Therefore, BASG suggests a new, 2-step, procedure. A. Preliminary notification of estimated IMP requirements Step-by-step [...] IMP already imported up to the date of notification should be stated. (It has to be made clear to BASG how much IMP has already been shipped and how much IMP still requires shipment.) All of the other
Medicinal Product Index Pharmaceutical companies Register of retailers Internet pharmacies BASG official announcement BASG voting results Reporting Human adverse reaction notification Veterinary Adverse Event [...] monographs for comments Archive of monographs Archive of deleted monographs CHMP Meeting Highlights-BASG The CHMP introduces itself For Companies Online services Login online services Reporting adverse reactions [...] (PSURs) FAQ pharmacovigilance Guideline pharmacovigilance Medicinal products Scientific advice by BASG Quality of medicines Medicines for children Plasma derived products Batch release Recombinant proteins
current supply situation of certain radiopharmaceuticals, the Federal Office for Safety in Health Care (BASG)/AGES PharmMed draws attention to particularities in the use of unauthorised medicinal products,