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WebGuideline on good pharmacovigilance practices (GVP) – Module IX EMA/827661/2011 Page 5/19 125 authorities should try to gain further information related to reactions they become aware of from such 126 sources. If the available information is limited, suspected serious adverse reactions should be WebSpecific rules for adaptation listed under Column 2 of Annex IX, sections 9.2.1.2-4 and 9.2.3 and the general rules of Annex XI apply. You must clearly define and justify the legal basis … how to use syringe
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