Tobacco product manufacturer means an entity that after the date of enactment of this act directly (and not exclusively through any affiliate):
Finished Product means the final packaged product intended for human consumption;
cGMP means current Good Manufacturing Practices as specified in the United States Code of Federal Regulations, ICH Guideline Q7A, or equivalent laws, rules, or regulations of an applicable Regulatory Authority at the time of manufacture.
Regulatory Data means any and all research data, pharmacology data, chemistry, manufacturing and control data, preclinical data, clinical data and all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with regulatory filings for the Product (including any applicable Drug Master Files (“DMFs”), Chemistry, Manufacturing and Control (“CMC”) data, or similar documentation).
Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;