Presentation of the Dossier

Summary of Product Characteristics Labei and Package insert 

Specific measures concerning prevention of transmission of animal Spongiform Encephalopathies (TSEs) (if applicable) 

Residue Testing (Metabolism and residue kinetics, Routine analytical method for the detection of residues) 

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Administrative guidelines, on the other hand, are generally less flexible. Examples include the number of copies of documentation to be submitted, forms to be completed for administrative purposes, and the presentation of the dossier. Once approved for marketing, medicines are included in the ARTG. 

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