REGISTRATION FILES

REGISTRATION FILES. Means the following documents and related correspondence with REGULATORY AUTHORITIES: (a) REGULATORY FILINGS; (b) Drug Master Files (the "DMF's") and Registration Dossier for the PRODUCTS; (c) labeling for all dosage forms of the PRODUCTS; (d) all clinical raw data concerning PRODUCT, expert reports, pre-clinical and clinical reports; (e) stability study reports; (f) existing 3 specifications (including copies of validation of analytical methods); (g) formulations data... included in the registration dossier for the PRODUCT; (h) any adverse event and pharmacovigilance reports; and (i) a summary of any outstanding regulatory issues. View More